https://www.bioontology.org//mediawiki/api.php?action=feedcontributions&feedformat=atom&user=Carini NCBO Wiki - User contributions [en] 2026-06-05T11:45:34Z User contributions MediaWiki 1.35.9 https://www.bioontology.org//mediawiki/index.php?title=Other_members_of_OCI_WG&diff=5726 Other members of OCI WG 2007-06-22T16:33:05Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> * [[Matthias Brochhausen]]<br /> * [[Amar K. Das]]<br /> * [[Dave Parrish]]<br /> * [[Ida Sim]]<br /> * [[Barry Smith]]</div> Carini https://www.bioontology.org//mediawiki/index.php?title=File:CTO-may3-RCT.xls&diff=5573 File:CTO-may3-RCT.xls 2007-05-07T16:24:01Z <p>Carini: </p> <hr /> <div></div> Carini https://www.bioontology.org//mediawiki/index.php?title=OCI_Term_Compilation_(Jennifer)&diff=5572 OCI Term Compilation (Jennifer) 2007-05-07T16:22:19Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> Download the term list here:<br /> [[Image:CTO-may3.xls]]<br /> <br /> <br /> Or view the list here:<br /> <br /> {| {{table}}<br /> | align=&quot;center&quot; style=&quot;background:#f0f0f0;&quot;|'''source'''<br /> | align=&quot;center&quot; style=&quot;background:#f0f0f0;&quot;|'''draft category'''<br /> | align=&quot;center&quot; style=&quot;background:#f0f0f0;&quot;|'''term / definition'''<br /> |-<br /> | CDISCglossary||unscheduled||adverse event (AE). Synonyms: side effect, adverse experience.<br /> |-<br /> | CDISCglossary||role||analysis variables.<br /> |-<br /> | CDISCglossary||document||approval letter. An official communication from FDA;allow marketing<br /> |-<br /> | CDISCglossary||time||arm. A planned sequence of elements, typically equivalent to a treatment group. [SDTM]<br /> |-<br /> | CDISCglossary||protocol||audit<br /> |-<br /> | CDISCglossary||protocol||baseline assessment<br /> |-<br /> | CDISCglossary||document||Biologics Licensing Application (BLA). An application to FDA for a license to market<br /> |-<br /> | CDISCglossary||study design||blinded study. A study in which is unaware of the treatment assignment<br /> |-<br /> | CDISCglossary||data||causality assessment. An evaluation performed by a medical professional<br /> |-<br /> | CDISCglossary||quality||clinical benefit.<br /> |-<br /> | CDISCglossary||data||clinical clarification. A query resolution from the sponsor See also self evident change.<br /> |-<br /> | CDISCglossary||quality||clinical efficacy.<br /> |-<br /> | CDISCglossary||quality||clinical significance. Change in a subject’s clinical condition regarded as important whether or not due to the test intervention. criteria for clinical significance should be stated in the protocol.<br /> |-<br /> | CDISCglossary||data||clinical trial information. Data collected in the course of a clinical trial<br /> |-<br /> | CDISCglossary||document||Common Technical Document. A format agreed upon by ICH See also eCTD.<br /> |-<br /> | CDISCglossary||data||confidentiality. Prevention of<br /> |-<br /> | CDISCglossary||study design||confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.<br /> |-<br /> | CDISCglossary||person role||consumer safety officer (CSO). FDA official who coordinates the review<br /> |-<br /> | CDISCglossary||role||control group. The group of subjects<br /> |-<br /> | CDISCglossary||person role||coordinating investigator.<br /> |-<br /> | CDISCglossary||statistics||covariate (prognostic). Factor or condition that influences outcome of a trial.<br /> |-<br /> | CDISCglossary||document||curriculum vitae (cv).<br /> |-<br /> | CDISCglossary||organization role||data and safety monitoring board (DSMB). See data monitoring committee.<br /> |-<br /> | CDISCglossary||document||data clarification form. A form used to query an investigator and collect feedback to resolve questions<br /> |-<br /> | CDISCglossary||data||data integrity. An attribute of data<br /> |-<br /> | CDISCglossary||data||data model. Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use.<br /> |-<br /> | CDISCglossary||protocol||decision rule. Succinct statement of<br /> |-<br /> | CDISCglossary||data||discrepancy. The failure of a datapoint to pass a validation check. NOTE:<br /> |-<br /> | CDISCglossary||||disease. Any deviation from or interruption of the normal structure orfunction of a part, organ, or system of the body as manifested by characteristic symptoms and signs.<br /> |-<br /> | CDISCglossary||quality||dosage form. Physical characteristicsof a drug product, (e.g., tablet,capsule, or solution) that contains adrug substance, generally<br /> |-<br /> | CDISCglossary||quality||dosage strength. 1. Proportion of active substance to excipient, measured in units of volume or concentration. 2.The strength of a drug product. tells how much of the active ingredient is present in each dosage. <br /> |-<br /> | CDISCglossary||science||drug development process. The<br /> |-<br /> | CDISCglossary||role||drug product. 1. A dosage form thatcontains an active drug ingredient orplacebo; 2. A finished dosage form asdescribed in regulations. [SPL Glossary]<br /> |-<br /> | CDISCglossary||data||effect. An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments. <br /> |-<br /> | CDISCglossary||quality||effectiveness. The desired measure of a drug’s influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.<br /> |-<br /> | CDISCglossary||quality||efficacy. The capacity of a drug ortreatment to produce beneficial effects<br /> |-<br /> | CDISCglossary||time||element. 1. In trial design, a basicbuilding block for time within a clinicaltrial comprising the followingcharacteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.<br /> |-<br /> | CDISCglossary||data||endpoint. Variable that pertains tothe efficacy or safety evaluations of a<br /> |-<br /> | CDISCglossary||aggregate population||enrollment (cumulative). Current enrollment as well as any ever-enrolled subjects who have ended participation.<br /> |-<br /> | CDISCglossary||time||epoch. An interval of time in the planned conduct of a study during which the treatment is consistent. Synonyms: period, cycle, phase, stage.<br /> |-<br /> | CDISCglossary||quality||equipoise. A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient.<br /> |-<br /> | CDISCglossary||document||eSource document (electronic<br /> |-<br /> | CDISCglossary||organization role||Ethics Committees<br /> |-<br /> | CDISCglossary||protocol||exclusion criteria. List of<br /> |-<br /> | CDISCglossary||conclusion||finding. A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis.<br /> |-<br /> | CDISCglossary||conclusion||global assessment variable. A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator’s overall impression about the state or change in state of asubject. <br /> |-<br /> | CDISCglossary||hypothesis||hypothesis to test. In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesistest, which generates a P value.<br /> |-<br /> | CDISCglossary||protocol||inclusion criteria. The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population.See also exclusion criteria.independent data monitoring<br /> |-<br /> | CDISCglossary||computer||Internet service provider (ISP). A<br /> |-<br /> | CDISCglossary||quality||inter-rater reliability. The property of scales yielding equivalent results when used by different raters ondifferent occasions. <br /> |-<br /> | CDISCglossary||role||intervention. The drug, device, therapy or process under investigationin a clinical trial which has an effect on outcome of interest in a study: e.g.,health-related quality of life, efficacy,safety, pharmacoeconomics. Synonyms:therapeutic intervention, medical product. See also: test articles; devices;<br /> |-<br /> | CDISCglossary||role||investigational product. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial<br /> |-<br /> | CDISCglossary||role||investigational treatment. An intervention under investigation in a clinical trial.<br /> |-<br /> | CDISCglossary||||investigator/institution. An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”. <br /> |-<br /> | CDISCglossary||data||item definition. 1. In a questionnaire or form to be completed in a clinical trial, the specification of a question and the specification of the format and semantics of the response.2. Formal specification of the properties of an item or field of data in an eClinical trial.<br /> |-<br /> | CDISCglossary||||Janus. 1. A logical design conceivedby Dr. Norman Stockbridge of the FDAfor a data warehouse intended to integrate submission data, protocol descriptions and analysis plans from clinical and animal studies into as an FDA review environment that uses a set of validated, standards-based tools toallow reproducible cross-study, datamining and retrospective comparative analysis. 2) the name assigned to acomponent of the NCI’s CaBIG ClinicalResearch Information Exchange (CRIX)<br /> |-<br /> | CDISCglossary||time||last subject out/complete(LSC/LPC or LSO/LPO). 1. The dateand time when the last subject hasreached a planned or achievedmilestone representing the completionof the trial. 2. The last subject tocomplete a trial. See also subject, pt, completion<br /> |-<br /> | CDISCglossary||time||legal authentication. A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document. <br /> |-<br /> | CDISCglossary||role||medicinal product. Synonym for therapeutic intervention, but usually a drug.<br /> |-<br /> | CDISCglossary||data model||model. A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context, e.g., clinical trial data. <br /> |-<br /> | CDISCglossary||document||Nuremberg Code. Code of ethics,set forth in 1947, for conducting human medical research.objective. The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. NOTE: The primary objective is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). <br /> |-<br /> | CDISCglossary||data||objective measurement. A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment. See also outcome, patient-reported outcome; <br /> |-<br /> | CDISCglossary||time||open to enrollment. The status of a study such that a subject can be enrolled into that study. <br /> |-<br /> | CDISCglossary||standard||operational model. The set of CDISC data standards (including ODMand LAB) used to capture and archive data from clinical trials.<br /> |-<br /> | CDISCglossary||data||outcome (of adverse event).Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved,recovering/ resolving, not recovered/notresolved, recovered /resolved with sequelae, fatal, or unknown<br /> |-<br /> | CDISCglossary||data||outcome. 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. SDTM; The result of carrying out a mathematical or statistical procedure. NOTE:outcome is more general than endpoint in that it does not necessarily relate to a planned objective<br /> |-<br /> | CDISCglossary||mixed||packaging. The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.<br /> |-<br /> | CDISCglossary||data||patient-reported outcome Patient-reported outcomes are subjective measurements.<br /> |-<br /> | CDISCglossary||role||per-protocol analysis set. The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model.<br /> |-<br /> | CDISCglossary||protocol||pharmacogenetic test. An assay intended to study inter individual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.<br /> |-<br /> | CDISCglossary||study design||phase. Clinical trials are generally categorized into four (sometimes five) phases A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.<br /> |-<br /> | CDISCglossary||role||primary variable. An outcome of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation.NOTE: Differences between groups in the primary and secondary variable(s)are believed to be the result of the group-specific interventions. <br /> |-<br /> | CDISCglossary||role||product. 1. Drug product: A finished dosage form that contains a drug substance. 2. A physical entity that isintended to diagnose, treat, or preventa disease or other abnormal condition,and subject to regulatory authority<br /> |-<br /> | CDISCglossary||protocol||protocol approval (Sponsor).Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated<br /> |-<br /> | CDISCglossary||unscheduled||protocol violation. A significant departure from processes or procedures that were required by the protocol.Violations often result in data that are not deemed evaluable for a per protocol analyis, and may require that the subject(s) who violate the protocol<br /> |-<br /> | CDISCglossary||person role||proxy respondent. Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. Compare to observer assessment.<br /> |-<br /> | CDISCglossary||statistics||qualitative variable. One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categoriesaccording to their attributes.<br /> |-<br /> | CDISCglossary||quality||quality of life. A broad ranging concept that incorporates an individual’s physical health, psychological state, level of independence, social relationships,personal beliefs and their relationships to salient features of the environment.<br /> |-<br /> | CDISCglossary||document||query. A request for clarification on a data item collected for a clinical trial;specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review.<br /> |-<br /> | CDISCglossary||statistics||random number table. <br /> |-<br /> | CDISCglossary||statistics||random sample. Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection.randomization. The process of assigning trial subjects to treatment or<br /> |-<br /> | CDISCglossary||data||raw data. Data as originally collected.Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes,evaluations, data recorded by automated instruments)<br /> |-<br /> | CDISCglossary||time||recruitment period. Time period during which subjects are or are planned to be enrolled in a clinical trial.<br /> |-<br /> | CDISCglossary||data model||Reference Information Model(RIM). An information model used as the ultimate defining reference for al lHL7 standards.<br /> |-<br /> | CDISCglossary||data||registry. A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.<br /> |-<br /> | CDISCglossary||quality||reliability, psychometric. The degree to which a psychometric “instrument” is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time<br /> |-<br /> | CDISCglossary||hypothesis||research hypothesis. The proposition that a study sets out to support (or disprove); for example,“blood pressure will be lowered by[specific endpoint] in subjects who receive the test product.” See also null hypothesis.<br /> |-<br /> | CDISCglossary||data||Researcher’s records of subjects/patients, such as patient medical charts, hospital records, X-rays,and attending physician’s notes. NOTE:These records may or may not accompany an application to a Regulatory Authority, but must be kept<br /> |-<br /> | CDISCglossary||quality||risk. In clinical trials, the probability of harm or discomfort for subjects. NOTE:Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat,for example, will be expected to have a low incidence of troubling side effects.<br /> |-<br /> | CDISCglossary||quality||safety and tolerability. The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs andsymptoms), and other special safetytests (e.g., ECGs, ophthalmology). The tolerability of the medical productrepresents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]<br /> |-<br /> | CDISCglossary||quality||safety. Relative freedom from harm.In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests andprocedures, psychiatric evaluation,<br /> |-<br /> | CDISCglossary||||semantic. In the context of a technical specification, semantic refers to the meaning of an element asdistinct from its syntax. Syntax canchange without affecting semantics.<br /> |-<br /> | CDISCglossary||study design||single-blind study. A study in which one party, either the investigatoror the subject, does not know which medication or placebo is administered to the subject; also called single masked study. See also blind study,double-blind study, triple-blind study.<br /> |-<br /> | CDISCglossary||data||source data. All information in original records and certified copies of original records of clinical findings,observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.<br /> |-<br /> | FCR||||1. Basic vs applied<br /> |-<br /> | FCR||||1. Hierarchical – show vertical relationships<br /> |-<br /> | FCR||quality||1. Morbidity<br /> |-<br /> | FCR||data||1. Outcome assessment<br /> |-<br /> | FCR||||1. Physical<br /> |-<br /> | FCR||protocol||1. Tradition (precedent)<br /> |-<br /> | FCR||study design||10. Historical research<br /> |-<br /> | FCR||quality||10. self-assessment of functional capacity<br /> |-<br /> | FCR||role||10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> |-<br /> | FCR||||11. Propositions – state the relationships between variables<br /> |-<br /> | FCR||quality||11. quality of life<br /> |-<br /> | FCR||study design||11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> |-<br /> | FCR||data model||12. Model – symbolic representation of the elements of a system<br /> |-<br /> | FCR||study design||12. Single-subject design<br /> |-<br /> | FCR||conclusion||13. Inductive theory – theory based on empirically verifiable observations<br /> |-<br /> | FCR||study design||13. Sequential clinical trial<br /> |-<br /> | FCR||study design||14. Evaluation research – assessment of the success of a program or policy<br /> |-<br /> | FCR||conclusion||14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> |-<br /> | FCR||conclusion||15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> |-<br /> | FCR||study design||15. Quasi-experimental research<br /> |-<br /> | FCR||protocol||16. Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> |-<br /> | FCR||study design||16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> |-<br /> | FCR||protocol||17. Deduction – theory testing<br /> |-<br /> | FCR||study design||17. Qualitative vs quantitative research<br /> |-<br /> | FCR||protocol||18. Induction – theory development<br /> |-<br /> | FCR||data||2. Acute conditions and chronic conditions<br /> |-<br /> | FCR||protocol||2. Authority (trusted expert)<br /> |-<br /> | FCR||quality||2. mortality<br /> |-<br /> | FCR||study design||2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> |-<br /> | FCR||||2. Schematic<br /> |-<br /> | FCR||time||2. Temporal – order concepts in time and states a sequence of events<br /> |-<br /> | FCR||study design||3. Case study – description of one or more patients<br /> |-<br /> | FCR||data||3. length of stay<br /> |-<br /> | FCR||||3. Process<br /> |-<br /> | FCR||time||3. Quantitative – frequency or duration of a specific behavior<br /> |-<br /> | FCR||data||3. Sources of knowledge<br /> |-<br /> | FCR||protocol||3. Trial and error<br /> |-<br /> | FCR||study design||4. Developmental research – description of pattern of change over time<br /> |-<br /> | FCR||protocol||4. Logical reasoning - Deductive reasoning, Inductive reasoning<br /> |-<br /> | FCR||data||4. readmission<br /> |-<br /> | FCR||||4. Statistical<br /> |-<br /> | FCR||science||4. Types of research<br /> |-<br /> | FCR||study design||5. Normative research – establishing normal values<br /> |-<br /> | FCR||quality||5. Physical<br /> |-<br /> | FCR||protocol||5. Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> |-<br /> | FCR||study design||6. Qualitative research – gathering data through interview or observation<br /> |-<br /> | FCR||quality||6. social<br /> |-<br /> | FCR||data model||6. Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> |-<br /> | FCR||study design||7. Cohort or case-control studies – establish associations<br /> |-<br /> | FCR||hypothesis||7. Hypothesis - specific predictions based on a theory.<br /> |-<br /> | FCR||quality||7. psychological well-being<br /> |-<br /> | FCR||data||8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> |-<br /> | FCR||study design||8. Methodological studies – establish reliability and validity of a new method<br /> |-<br /> | FCR||quality||8. Patient satisfaction<br /> |-<br /> | FCR||data||9. Constructs – concepts that represent non-observable behaviors or events<br /> |-<br /> | FCR||quality||9. patient preference<br /> |-<br /> | FCR||study design||9. Secondary analysis – exploring new relationships in old data<br /> |-<br /> | MUSC||data||accrual rate<br /> |-<br /> | MUSC||role||active control<br /> |-<br /> | MUSC||||adherence<br /> |-<br /> | MUSC||unscheduled||adjustment<br /> |-<br /> | MUSC||unscheduled||adverse event<br /> |-<br /> | MUSC||data||allocation ratio<br /> |-<br /> | MUSC||statistics||alternative hypothesis<br /> |-<br /> | MUSC||data||analysis datasets<br /> |-<br /> | MUSC||protocol||assessment<br /> |-<br /> | MUSC||statistics||assessment bias<br /> |-<br /> | MUSC||time||assessment schedule<br /> |-<br /> | MUSC||||as-treated<br /> |-<br /> | MUSC||protocol||auditing<br /> |-<br /> | MUSC||study design||balanced design<br /> |-<br /> | MUSC||||baseline<br /> |-<br /> | MUSC||||baseline comparability<br /> |-<br /> | MUSC||statistics||bias<br /> |-<br /> | MUSC||protocol||biased coin randomizaiton<br /> |-<br /> | MUSC||statistics||binormial<br /> |-<br /> | MUSC||quality||bioequivalence<br /> |-<br /> | MUSC||protocol||blinding<br /> |-<br /> | MUSC||role||block<br /> |-<br /> | MUSC||data||carryover effect<br /> |-<br /> | MUSC||document||case report<br /> |-<br /> | MUSC||document||case report form<br /> |-<br /> | MUSC||study design||case-control design<br /> |-<br /> | MUSC||protocol||censoring<br /> |-<br /> | MUSC||data||clinical trial management system<br /> |-<br /> | MUSC||protocol||cluster randomization<br /> |-<br /> | MUSC||protocol||coding<br /> |-<br /> | MUSC||role||cohort<br /> |-<br /> | MUSC||study design||community intervention trial<br /> |-<br /> | MUSC||quality||comparative treatment efficacy<br /> |-<br /> | MUSC||quality||complaince<br /> |-<br /> | MUSC||role||concurrent controls<br /> |-<br /> | MUSC||statistics||confidence interval<br /> |-<br /> | MUSC||study design||confirmatory trial<br /> |-<br /> | MUSC||role||confounder<br /> |-<br /> | MUSC||role||confounding factor<br /> |-<br /> | MUSC||document||CONSORT statement<br /> |-<br /> | MUSC||||constrain<br /> |-<br /> | MUSC||||context<br /> |-<br /> | MUSC||data||continous<br /> |-<br /> | MUSC||role||controls<br /> |-<br /> | MUSC||study design||crossover<br /> |-<br /> | MUSC||study design||crossover trial<br /> |-<br /> | MUSC||||cross-sectional analysis<br /> |-<br /> | MUSC||organization role||data and safety monitoring board<br /> |-<br /> | MUSC||document||data clarification query<br /> |-<br /> | MUSC||document||data clarification request<br /> |-<br /> | MUSC||time||data collection schedule<br /> |-<br /> | MUSC||protocol||data management<br /> |-<br /> | MUSC||protocol||data management plan<br /> |-<br /> | MUSC||organization role||data safety monitoring committee<br /> |-<br /> | MUSC||data||database<br /> |-<br /> | MUSC||protocol||data-dependent stopping<br /> |-<br /> | MUSC||data||derived data<br /> |-<br /> | MUSC||||deterministic<br /> |-<br /> | MUSC||study design||diagnostic trial<br /> |-<br /> | MUSC||||dichotomous<br /> |-<br /> | MUSC||data||discret<br /> |-<br /> | MUSC||conclusion||dose finding<br /> |-<br /> | MUSC||protocol||double blinding<br /> |-<br /> | MUSC||protocol||double masking<br /> |-<br /> | MUSC||unscheduled||dropouts<br /> |-<br /> | MUSC||quality||drug lot<br /> |-<br /> | MUSC||unscheduled||early termination<br /> |-<br /> | MUSC||quality||efficacy<br /> |-<br /> | MUSC||protocol||electronic data capture<br /> |-<br /> | MUSC||protocol||eligibility<br /> |-<br /> | MUSC||data||endpoint<br /> |-<br /> | MUSC||quality||equipoise<br /> |-<br /> | MUSC||study design||equivalence trials<br /> |-<br /> | MUSC||protocol||estimate<br /> |-<br /> | MUSC||protocol||evaluation<br /> |-<br /> | MUSC||organization role||excecutive committee<br /> |-<br /> | MUSC||protocol||exclusion criteria<br /> |-<br /> | MUSC||||expectation bias<br /> |-<br /> | MUSC||||experiment<br /> |-<br /> | MUSC||study design||factorial design<br /> |-<br /> | MUSC||protocol||follow-up<br /> |-<br /> | MUSC||||group sequential<br /> |-<br /> | MUSC||role||historic controls<br /> |-<br /> | MUSC||statistics||imbalance<br /> |-<br /> | MUSC||protocol||imputation of missing data<br /> |-<br /> | MUSC||protocol||inclusion criteria<br /> |-<br /> | MUSC||protocol||informed consent<br /> |-<br /> | MUSC||organization role||institutional review board<br /> |-<br /> | MUSC||protocol||intention to treat<br /> |-<br /> | MUSC||role||intention to treat population<br /> |-<br /> | MUSC||statistics||interaction<br /> |-<br /> | MUSC||protocol||interim analysis<br /> |-<br /> | MUSC||||intersubject<br /> |-<br /> | MUSC||role||intervention<br /> |-<br /> | MUSC||||intrasubject<br /> |-<br /> | MUSC||document||investigational new drug (IND) application<br /> |-<br /> | MUSC||quality||investigator competence<br /> |-<br /> | MUSC||||local control<br /> |-<br /> | MUSC||data||lost to follow-up<br /> |-<br /> | MUSC||statistics||main effect<br /> |-<br /> | MUSC||protocol||masking<br /> |-<br /> | MUSC||person role||medical safety monitor<br /> |-<br /> | MUSC||protocol||meta-analysis<br /> |-<br /> | MUSC||protocol||minimization randomization<br /> |-<br /> | MUSC||||minority representation<br /> |-<br /> | MUSC||data||missing data<br /> |-<br /> | MUSC||protocol||monitoring<br /> |-<br /> | MUSC||study design||multi-center<br /> |-<br /> | MUSC||study design||multi-site<br /> |-<br /> | MUSC||statistics||multivariable<br /> |-<br /> | MUSC||conclusion||negative findings<br /> |-<br /> | MUSC||statistics||nesting design<br /> |-<br /> | MUSC||document||new drug application (NDA)<br /> |-<br /> | MUSC||statistics||Neyman allocation<br /> |-<br /> | MUSC||unscheduled||nonadherence<br /> |-<br /> | MUSC||unscheduled||noncomplaince<br /> |-<br /> | MUSC||||noninferiority<br /> |-<br /> | MUSC||statistics||null hypothesis<br /> |-<br /> | MUSC||data||observation<br /> |-<br /> | MUSC||statistics||odds<br /> |-<br /> | MUSC||statistics||odds ratio<br /> |-<br /> | MUSC||statistics||one-sided test<br /> |-<br /> | MUSC||||optimal allocation<br /> |-<br /> | MUSC||quality||over-the -count (OTC)<br /> |-<br /> | MUSC||study design||parallel design<br /> |-<br /> | MUSC||protocol||permuted block randomization<br /> |-<br /> | MUSC||role||per-protocol population<br /> |-<br /> | MUSC||study design||phase I trial<br /> |-<br /> | MUSC||study design||phase II trial<br /> |-<br /> | MUSC||study design||phase IIA<br /> |-<br /> | MUSC||study design||phase IIB<br /> |-<br /> | MUSC||study design||phase IIB<br /> |-<br /> | MUSC||study design||phase III trial<br /> |-<br /> | MUSC||study design||phase IV trial<br /> |-<br /> | MUSC||study design||pivotal trials<br /> |-<br /> | MUSC||study design||placebo controlled<br /> |-<br /> | MUSC||protocol||play the winner<br /> |-<br /> | MUSC||role||plecabo<br /> |-<br /> | MUSC||aggregate||population<br /> |-<br /> | MUSC||conclusion||positive findings<br /> |-<br /> | MUSC||statistics||power<br /> |-<br /> | MUSC||study design||prevention trials<br /> |-<br /> | MUSC||||primary efficacy<br /> |-<br /> | MUSC||conclusion||primary outcome<br /> |-<br /> | MUSC||data||primary response<br /> |-<br /> | MUSC||person role||principal investigator<br /> |-<br /> | MUSC||role||prognostic factor<br /> |-<br /> | MUSC||protocol||project management<br /> |-<br /> | MUSC||protocol||project management plan<br /> |-<br /> | MUSC||protocol||protocal complaince<br /> |-<br /> | MUSC||protocol||protocol<br /> |-<br /> | MUSC||unscheduled||protocol exception<br /> |-<br /> | MUSC||unscheduled||protocol violation<br /> |-<br /> | MUSC||statistics||pseudorandom<br /> |-<br /> | MUSC||statistics||p-value<br /> |-<br /> | MUSC||protocol||quality assurance<br /> |-<br /> | MUSC||protocol||random play the winner<br /> |-<br /> | MUSC||protocol||recruitment<br /> |-<br /> | MUSC||protocol||regulatory management<br /> |-<br /> | MUSC||data||repeat measurement<br /> |-<br /> | MUSC||data||response<br /> |-<br /> | MUSC||protocol||response adaptive randomization<br /> |-<br /> | MUSC||study design||retrospective design<br /> |-<br /> | MUSC||quality||safety<br /> |-<br /> | MUSC||statistics||sample size<br /> |-<br /> | MUSC||||sample size inflation<br /> |-<br /> | MUSC||protocol||screening<br /> |-<br /> | MUSC||||selection bias<br /> |-<br /> | MUSC||study design||sequential design<br /> |-<br /> | MUSC||unscheduled||serious adverse event<br /> |-<br /> | MUSC||role||sham treatment<br /> |-<br /> | MUSC||study design||single-center<br /> |-<br /> | MUSC||study design||single-site<br /> |-<br /> | MUSC||document||source document<br /> |-<br /> | MUSC||person role||sponsor<br /> |-<br /> | MUSC||protocol||statistical analysis plan<br /> |-<br /> | MUSC||statistics||statistical significant<br /> |-<br /> | MUSC||organization role||steering committee<br /> |-<br /> | MUSC||protocol||stop rule<br /> |-<br /> | MUSC||statistics||stratification<br /> |-<br /> | MUSC||person role||study coordinator<br /> |-<br /> | MUSC||role||subject<br /> |-<br /> | MUSC||quality||superiority<br /> |-<br /> | MUSC||conclusion||surrogate outcome<br /> |-<br /> | MUSC||time||time to event<br /> |-<br /> | MUSC||protocol||titration<br /> |-<br /> | MUSC||quality||tocxicity<br /> |-<br /> | MUSC||quality||tolerability<br /> |-<br /> | MUSC||role||treatment<br /> |-<br /> | MUSC||||treatment allocation<br /> |-<br /> | MUSC||role||treatment group<br /> |-<br /> | MUSC||unscheduled||treatment-emergenet adverse event (TEAE)<br /> |-<br /> | MUSC||protocol||trilple blinding<br /> |-<br /> | MUSC||protocol||triple masking<br /> |-<br /> | MUSC||statistics||two-sided test<br /> |-<br /> | MUSC||statistics||type I error<br /> |-<br /> | MUSC||statistics||type II error<br /> |-<br /> | MUSC||statistics||univariable<br /> |-<br /> | MUSC||protocol||urn randomization<br /> |-<br /> | MUSC||||varibility<br /> |-<br /> | MUSC||time||washout period<br /> |-<br /> | MUSC||protocol||withdrawal consent<br /> |-<br /> | RCT||role||Analyzed population<br /> |-<br /> | RCT||time||Anchored-time<br /> |-<br /> | RCT||conclusion||Ancillary-outcome<br /> |-<br /> | RCT||data||Baseline<br /> |-<br /> | RCT||protocol||Blinding<br /> |-<br /> | RCT||protocol||Blinding-method<br /> |-<br /> | RCT||study design||Cointervention*<br /> |-<br /> | RCT||study design||Comparison-arm<br /> |-<br /> | RCT||quality||Cost<br /> |-<br /> | RCT||role||Crossover population<br /> |-<br /> | RCT||time||Date<br /> |-<br /> | RCT||||Device<br /> |-<br /> | RCT||time||Double-anchored-interval<br /> |-<br /> | RCT||role||Drug<br /> |-<br /> | RCT||protocol||Drug-step<br /> |-<br /> | RCT||time||Duration<br /> |-<br /> | RCT||role||Eligible-population<br /> |-<br /> | RCT||role||Enrolled-population<br /> |-<br /> | RCT||role||Excluded population<br /> |-<br /> | RCT||protocol||Exclusion-rule<br /> |-<br /> | RCT||protocol||Executed-protocol<br /> |-<br /> | RCT||protocol||Executed-secondary-study-protocol<br /> |-<br /> | RCT||study design||Experimental-arm<br /> |-<br /> | RCT||protocol||Follow-up activity<br /> |-<br /> | RCT||role||Funder<br /> |-<br /> | RCT||protocol||Inclusion-rule<br /> |-<br /> | RCT||organization||Institution<br /> |-<br /> | RCT||protocol||Intended-protocol<br /> |-<br /> | RCT||protocol||Intended-secondary-study-protocol<br /> |-<br /> | RCT||time||Interval<br /> |-<br /> | RCT||study design||Intervention*<br /> |-<br /> | RCT||study design||Intervention-arm<br /> |-<br /> | RCT||protocol||Intervention-step<br /> |-<br /> | RCT||role||Investigator<br /> |-<br /> | RCT||protocol||Non-drug-intervention-step<br /> |-<br /> | RCT||||No-treatment<br /> |-<br /> | RCT||data||Outcome<br /> |-<br /> | RCT||data||Outcomes-followup<br /> |-<br /> | RCT||role||Placebo<br /> |-<br /> | RCT||conclusion||Primary-outcome<br /> |-<br /> | RCT||protocol||Primary-recruitment-flowchart<br /> |-<br /> | RCT||protocol||Procedure<br /> |-<br /> | RCT||protocol||Protocol<br /> |-<br /> | RCT||unscheduled||Protocol-change<br /> |-<br /> | RCT||protocol||Protocol-concept<br /> |-<br /> | RCT||role||Randomized-population<br /> |-<br /> | RCT||||Reason<br /> |-<br /> | RCT||role||Recruited-population<br /> |-<br /> | RCT||protocol||Recruitment-flowchart<br /> |-<br /> | RCT||role||Screened-population<br /> |-<br /> | RCT||conclusion||Secondary-outcome<br /> |-<br /> | RCT||study design||Secondary-study<br /> |-<br /> | RCT||protocol||Secondary-study-protocol<br /> |-<br /> | RCT||data||Side-effect<br /> |-<br /> | RCT||time||Single-anchored-interval<br /> |-<br /> | RCT||role||Site-enrollment<br /> |-<br /> | RCT||protocol||Stopping-rule<br /> |-<br /> | RCT||role||Study-arm population<br /> |-<br /> | RCT||organization role||Study-committee<br /> |-<br /> | RCT||conclusion||Study-outcome<br /> |-<br /> | RCT||organization role||Study-site<br /> |-<br /> | RCT||time||Timepoint<br /> |-<br /> | RCT||time||Time-range<br /> |-<br /> | RCT||role||Treatment-assignment<br /> |-<br /> | RCT||||Trial<br /> |-<br /> | RCT||role||Trial-participant<br /> |-<br /> | RCT||data||Withdrawal-reason<br /> |-<br /> | <br /> |}<br /> <br /> Some notes from Simona on the RCT terms as classified above<br /> [[Image:CTO-may3-RCT.xls]]</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5550 Term Lists 2007-05-03T16:43:16Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> '''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br /> <br /> [[High-level_Concepts_v0.2|On this page]] there is a draft positioning of some of our terms into the high level concept list drafted by Richard. <br /> <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development<br /> <br /> <br /> Terms collected by Wenle Zhao from MUSC<br /> * adherence<br /> * accrual rate<br /> * active control<br /> * adjustment<br /> * type I error<br /> * type II error<br /> * balanced design<br /> * baseline<br /> * bias<br /> * prognostic factor<br /> * confounding factor<br /> * block<br /> * permuted block randomization<br /> * minimization randomization<br /> * biased coin randomizaiton<br /> * urn randomization<br /> * response adaptive randomization<br /> * play the winner <br /> * random play the winner<br /> * case report<br /> * case report form<br /> * data clarification request<br /> * data clarification query<br /> * censoring<br /> * efficacy<br /> * safety<br /> * treatment<br /> * intervention<br /> * crossover<br /> * comparative treatment efficacy<br /> * interim analysis<br /> * deterministic<br /> * stop rule<br /> * phase I trial<br /> * phase II trial<br /> * phase III trial<br /> * phase IV trial<br /> * dichotomous<br /> * dose finding<br /> * dropouts<br /> * eligibility<br /> * experiment<br /> * estimate<br /> * follow-up<br /> * sequential design<br /> * group sequential<br /> * endpoint<br /> * intention to treat<br /> * data-dependent stopping<br /> * lost to follow-up<br /> * meta-analysis<br /> * monitoring<br /> * data and safety monitoring board<br /> * institutional review board<br /> * null hypothesis<br /> * alternative hypothesis<br /> * nesting design<br /> * observation<br /> * odds<br /> * odds ratio<br /> * parallel design<br /> * plecabo<br /> * power<br /> * sample size<br /> * primary outcome<br /> * surrogate outcome<br /> * protocol<br /> * per-protocol population<br /> * intention to treat population<br /> * pseudorandom<br /> * p-value<br /> * treatment allocation<br /> * imbalance<br /> * selection bias<br /> * expectation bias<br /> * statistical significant<br /> * stratification<br /> * univariable<br /> * multivariable<br /> * adverse event<br /> * serious adverse event<br /> * cluster randomization<br /> * community intervention trial<br /> * coding<br /> * complaince<br /> * protocal complaince<br /> * protocol violation<br /> * protocol exception<br /> * auditing<br /> * allocation ratio<br /> * assessment<br /> * assessment bias<br /> * early termination<br /> * informed consent<br /> * withdrawal consent<br /> * source document<br /> * principal investigator<br /> * study coordinator<br /> * data management<br /> * project management<br /> * regulatory management<br /> * case-control design<br /> * blinding<br /> * double blinding <br /> * tocxicity<br /> * cohort<br /> * evaluation<br /> * confidence interval<br /> * confirmatory trial<br /> * confounder<br /> * CONSORT statement<br /> * constrain<br /> * context<br /> * diagnostic trial<br /> * controls<br /> * concurrent controls<br /> * historic controls<br /> * crossover trial<br /> * carryover effect<br /> * recruitment<br /> * washout period<br /> * equivalence trials<br /> * statistical analysis plan<br /> * data management plan<br /> * project management plan<br /> * sponsor<br /> * inclusion criteria<br /> * equipoise<br /> * exclusion criteria<br /> * factorial design<br /> * interaction<br /> * main effect<br /> * one-sided test<br /> * two-sided test<br /> * missing data<br /> * imputation of missing data<br /> * investigator competence<br /> * local control<br /> * masking<br /> * double masking<br /> * triple masking<br /> * trilple blinding<br /> * data safety monitoring committee<br /> * minority representation<br /> * negative findings<br /> * positive findings<br /> * noninferiority<br /> * nonadherence<br /> * sample size inflation<br /> * noncomplaince<br /> * repeat measurement<br /> * time to event<br /> * medical safety monitor<br /> * pivotal trials<br /> * prevention trials<br /> * assessment schedule<br /> * data collection schedule<br /> * quality assurance<br /> * electronic data capture<br /> * clinical trial management system<br /> * database<br /> * analysis datasets<br /> * retrospective design<br /> * screening<br /> * sham treatment<br /> * steering committee<br /> * excecutive committee<br /> * baseline comparability<br /> * optimal allocation<br /> * Neyman allocation<br /> * response<br /> * intersubject<br /> * subject<br /> * intrasubject<br /> * population<br /> * varibility<br /> * binormial<br /> * continous<br /> * derived data<br /> * discret<br /> * primary efficacy<br /> * primary response<br /> * placebo controlled<br /> * single-site<br /> * single-center<br /> * multi-site<br /> * multi-center<br /> * superiority<br /> * bioequivalence<br /> * treatment group<br /> * titration<br /> * tolerability<br /> * phase IIA<br /> * phase IIB<br /> * phase IIB<br /> * investigational new drug (IND) application<br /> * new drug application (NDA)<br /> * over-the -count (OTC)<br /> * drug lot<br /> * treatment-emergenet adverse event (TEAE)<br /> * as-treated<br /> * cross-sectional analysis</div> Carini https://www.bioontology.org//mediawiki/index.php?title=High-level_Concepts_v0.2&diff=5465 High-level Concepts v0.2 2007-05-01T23:01:32Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> ==High-Level Concepts version 0.2==<br /> Initial High-level Concepts in black font<br /> <br /> Additions from Simona in &lt;font style=color:blue&gt;blue&lt;/font&gt; font<br /> <br /> Additions from Richard in &lt;font style=color:green&gt;green&lt;/font&gt; font<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> **&lt;font style=&quot;color:green&quot;&gt;Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics<br /> ***Case study – description of one or more patients<br /> ***Developmental research – description of pattern of change over time<br /> ***Normative research – establishing normal values<br /> ***Qualitative research – gathering data through interview or observation<br /> ***Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires<br /> **Exploratory research<br /> ***Cohort or case-control studies – establish associations through epidemiological studies<br /> ***Methodological studies – establish reliability and validity of a new method<br /> ***Secondary analysis – exploring new relationships in old data<br /> ***Historical research – reconstructing the past through an assessment of archives or other records<br /> **Experimental research<br /> ***Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ****Single-subject design<br /> ****Sequential clinical trial<br /> ****Evaluation research – assessment of the success of a program or policy<br /> ***Quasi-experimental research<br /> ***Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> &lt;/font&gt;<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Study committee&lt;/font&gt;<br /> **Sponsors<br /> *Populations<br /> **&lt;font style=&quot;color:blue&quot;&gt;Recruited population<br /> ***Randomized population<br /> ***Enrolled population<br /> ***Eligible population<br /> ***Screened population&lt;/font&gt;<br /> **&lt;font style=&quot;color:blue&quot;&gt;Excluded population<br /> ***Excluded postrandomization population<br /> ***Not-randomized-population<br /> ***Not-enrolled-population<br /> ***Not-eligible-population&lt;/font&gt;<br /> **&lt;font style=&quot;color:blue&quot;&gt;Analyzed-population<br /> ***All subjects<br /> ***Study arm population<br /> ***Crossover population<br /> ***Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> ****&lt;font style=&quot;color:blue&quot;&gt;Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> **&lt;font style=&quot;color:blue&quot;&gt;Intended protocol<br /> **Executed protocol<br /> **Protocol change&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> **&lt;font style=&quot;color:blue&quot;&gt;Treatment assignment<br /> **Blinding <br /> **Follow-up&lt;/font&gt;<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> **&lt;font style=&quot;color:blue&quot;&gt;Baseline characteristic&lt;/font&gt;<br /> <br /> ----<br /> ==High-Level Structure from BFO-OBI==<br /> <br /> [[Image:High Level BFO_OBI.jpg]]</div> Carini https://www.bioontology.org//mediawiki/index.php?title=High-level_Concepts_v0.2&diff=5464 High-level Concepts v0.2 2007-05-01T22:47:27Z <p>Carini: </p> <hr /> <div>==High-Level Concepts version 0.2==<br /> Initial High-level Concepts in black font<br /> <br /> Additions from Simona in &lt;font style=color:blue&gt;blue&lt;/font&gt; font<br /> <br /> Additions from Richard in &lt;font style=color:green&gt;green&lt;/font&gt; font<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> **&lt;font style=&quot;color:green&quot;&gt;Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics<br /> ***Case study – description of one or more patients<br /> ***Developmental research – description of pattern of change over time<br /> ***Normative research – establishing normal values<br /> ***Qualitative research – gathering data through interview or observation<br /> ***Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires<br /> **Exploratory research<br /> ***Cohort or case-control studies – establish associations through epidemiological studies<br /> ***Methodological studies – establish reliability and validity of a new method<br /> ***Secondary analysis – exploring new relationships in old data<br /> ***Historical research – reconstructing the past through an assessment of archives or other records<br /> **Experimental research<br /> ***Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ****Single-subject design<br /> ****Sequential clinical trial<br /> ****Evaluation research – assessment of the success of a program or policy<br /> ***Quasi-experimental research<br /> ***Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> &lt;/font&gt;<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Study committee&lt;/font&gt;<br /> **Sponsors<br /> *Populations<br /> **&lt;font style=&quot;color:blue&quot;&gt;Recruited population<br /> ***Randomized population<br /> ***Enrolled population<br /> ***Eligible population<br /> ***Screened population&lt;/font&gt;<br /> **&lt;font style=&quot;color:blue&quot;&gt;Excluded population<br /> ***Excluded postrandomization population<br /> ***Not-randomized-population<br /> ***Not-enrolled-population<br /> ***Not-eligible-population&lt;/font&gt;<br /> **&lt;font style=&quot;color:blue&quot;&gt;Analyzed-population<br /> ***All subjects<br /> ***Study arm population<br /> ***Crossover population<br /> ***Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> ****&lt;font style=&quot;color:blue&quot;&gt;Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> **&lt;font style=&quot;color:blue&quot;&gt;Intended protocol<br /> **Executed protocol<br /> **Protocol change&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> **&lt;font style=&quot;color:blue&quot;&gt;Treatment assignment<br /> **Blinding <br /> **Follow-up&lt;/font&gt;<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> **&lt;font style=&quot;color:blue&quot;&gt;Baseline characteristic&lt;/font&gt;<br /> <br /> ----<br /> ==High-Level Structure from BFO-OBI==<br /> <br /> [[Image:High Level BFO_OBI.jpg]]</div> Carini https://www.bioontology.org//mediawiki/index.php?title=High-level_Concepts_v0.2&diff=5463 High-level Concepts v0.2 2007-05-01T22:42:13Z <p>Carini: Undo revision 5462 by Special:Contributions/Carini (User talk:Carini)</p> <hr /> <div>==High-Level Concepts version 0.2==<br /> Initial High-level Concepts in black font<br /> <br /> Additions from Simona in &lt;font style=color:blue&gt;blue&lt;/font&gt; font<br /> <br /> Additions from Richard in &lt;font style=color:green&gt;green&lt;/font&gt; font<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> **&lt;font style=&quot;color:green&quot;&gt;Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics<br /> ***Case study – description of one or more patients<br /> ***Developmental research – description of pattern of change over time<br /> ***Normative research – establishing normal values<br /> ***Qualitative research – gathering data through interview or observation<br /> ***Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires<br /> **Exploratory research<br /> ***Cohort or case-control studies – establish associations through epidemiological studies<br /> ***Methodological studies – establish reliability and validity of a new method<br /> ***Secondary analysis – exploring new relationships in old data<br /> ***Historical research – reconstructing the past through an assessment of archives or other records<br /> **Experimental research<br /> ***Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ****Single-subject design<br /> ****Sequential clinical trial<br /> ****Evaluation research – assessment of the success of a program or policy<br /> ***Quasi-experimental research<br /> ***Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> &lt;/font&gt;<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Study committee&lt;/font&gt;<br /> **Sponsors<br /> *Populations<br /> **&lt;font style=&quot;color:blue&quot;&gt;Recruited population<br /> ***Randomized population<br /> ***Enrolled population<br /> ***Eligible population<br /> ***Screened population<br /> **Excluded population<br /> ***Excluded postrandomization population<br /> ***Not-randomized-population<br /> ***Not-enrolled-population<br /> ***Not-eligible-population<br /> **Analyzed-population<br /> ***All subjects<br /> ***Study arm population<br /> ***Crossover population<br /> ***Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> ****&lt;font style=&quot;color:blue&quot;&gt;Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> **&lt;font style=&quot;color:blue&quot;&gt;Intended protocol<br /> **Executed protocol<br /> **Protocol change&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> **&lt;font style=&quot;color:blue&quot;&gt;Treatment assignment<br /> **Blinding <br /> **Follow-up&lt;/font&gt;<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> **&lt;font style=&quot;color:blue&quot;&gt;Baseline characteristic&lt;/font&gt;<br /> <br /> ----<br /> ==High-Level Structure from BFO-OBI==<br /> <br /> [[Image:High Level BFO_OBI.jpg]]</div> Carini https://www.bioontology.org//mediawiki/index.php?title=High-level_Concepts_v0.2&diff=5462 High-level Concepts v0.2 2007-05-01T22:39:06Z <p>Carini: </p> <hr /> <div>==High-Level Concepts version 0.2==<br /> Initial High-level Concepts in black font<br /> <br /> Additions from Simona in &lt;font style=color:blue&gt;blue&lt;/font&gt; font<br /> <br /> Additions from Richard in &lt;font style=color:green&gt;green&lt;/font&gt; font<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> **&lt;font style=&quot;color:green&quot;&gt;Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics<br /> ***Case study – description of one or more patients<br /> ***Developmental research – description of pattern of change over time<br /> ***Normative research – establishing normal values<br /> ***Qualitative research – gathering data through interview or observation<br /> ***Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires<br /> **Exploratory research<br /> ***Cohort or case-control studies – establish associations through epidemiological studies<br /> ***Methodological studies – establish reliability and validity of a new method<br /> ***Secondary analysis – exploring new relationships in old data<br /> ***Historical research – reconstructing the past through an assessment of archives or other records<br /> **Experimental research<br /> ***Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ****Single-subject design<br /> ****Sequential clinical trial<br /> ****Evaluation research – assessment of the success of a program or policy<br /> ***Quasi-experimental research<br /> ***Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> &lt;/font&gt;<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Study committee&lt;/font&gt;<br /> **Sponsors<br /> *Populations<br /> **&lt;font style=&quot;color:blue&quot;&gt;Recruited population<br /> ***Randomized population<br /> ***Enrolled population<br /> ***Eligible population<br /> ***Screened population<br /> **Excluded population<br /> ***Excluded postrandomization population<br /> ***Not-randomized-population<br /> ***Not-enrolled-population<br /> ***Not-eligible-population<br /> **Analyzed-population<br /> ***All subjects<br /> ***Study arm population<br /> ***Crossover population<br /> ***Subgroup population &lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> ****&lt;font style=&quot;color:blue&quot;&gt;Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> **&lt;font style=&quot;color:blue&quot;&gt;Intended protocol<br /> **Executed protocol<br /> **Protocol change&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> **&lt;font style=&quot;color:blue&quot;&gt;Treatment assignment<br /> **Blinding <br /> **Follow-up&lt;/font&gt;<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> **&lt;font style=&quot;color:blue&quot;&gt;Baseline characteristic&lt;/font&gt;<br /> <br /> ----<br /> ==High-Level Structure from BFO-OBI==<br /> <br /> [[Image:High Level BFO_OBI.jpg]]</div> Carini https://www.bioontology.org//mediawiki/index.php?title=High-level_Concepts_v0.2&diff=5461 High-level Concepts v0.2 2007-05-01T22:38:36Z <p>Carini: </p> <hr /> <div>==High-Level Concepts version 0.2==<br /> Initial High-level Concepts in black font<br /> <br /> Additions from Simona in &lt;font style=color:blue&gt;blue&lt;/font&gt; font<br /> <br /> Additions from Richard in &lt;font style=color:green&gt;green&lt;/font&gt; font<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> **&lt;font style=&quot;color:green&quot;&gt;Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics<br /> ***Case study – description of one or more patients<br /> ***Developmental research – description of pattern of change over time<br /> ***Normative research – establishing normal values<br /> ***Qualitative research – gathering data through interview or observation<br /> ***Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires<br /> **Exploratory research<br /> ***Cohort or case-control studies – establish associations through epidemiological studies<br /> ***Methodological studies – establish reliability and validity of a new method<br /> ***Secondary analysis – exploring new relationships in old data<br /> ***Historical research – reconstructing the past through an assessment of archives or other records<br /> **Experimental research<br /> ***Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ****Single-subject design<br /> ****Sequential clinical trial<br /> ****Evaluation research – assessment of the success of a program or policy<br /> ***Quasi-experimental research<br /> ***Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> &lt;/font&gt;<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Study committee&lt;/font&gt;<br /> **Sponsors<br /> *Populations<br /> **&lt;font style=&quot;color:blue&quot;&gt;Recruited population<br /> ***Randomized population<br /> ***Enrolled population<br /> ***Eligible population<br /> ***Screened population<br /> **Excluded population<br /> ***Excluded postrandomization population<br /> ***Not-randomized-population<br /> ***Not-enrolled-population<br /> ***Not-eligible-population<br /> **Analyzed-population<br /> ***All subjects<br /> ***Study arm population<br /> ***Crossover population<br /> ***Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> ****&lt;font style=&quot;color:blue&quot;&gt;Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> **&lt;font style=&quot;color:blue&quot;&gt;Intended protocol<br /> **Executed protocol<br /> **Protocol change&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> **&lt;font style=&quot;color:blue&quot;&gt;Treatment assignment<br /> **Blinding <br /> **Follow-up&lt;/font&gt;<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> **&lt;font style=&quot;color:blue&quot;&gt;Baseline characteristic&lt;/font&gt;<br /> <br /> ----<br /> ==High-Level Structure from BFO-OBI==<br /> <br /> [[Image:High Level BFO_OBI.jpg]]</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Draft4RCT&diff=5416 Draft4RCT 2007-04-26T19:27:42Z <p>Carini: </p> <hr /> <div>==High-Level Concepts==<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> **Sponsors<br /> *Populations<br /> **&lt;font style=&quot;color:blue&quot;&gt;Screened population<br /> **Recruited population<br /> **Eligible population<br /> **Enrolled population<br /> **Randomized population<br /> **Analysed population<br /> **Crossover population<br /> **Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> ****&lt;font style=&quot;color:blue&quot;&gt;Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> **&lt;font style=&quot;color:blue&quot;&gt;Intended protocol<br /> **Executed protocol&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> **&lt;font style=&quot;color:blue&quot;&gt;Baseline characteristic&lt;/font&gt;</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Draft4RCT&diff=5414 Draft4RCT 2007-04-26T19:26:10Z <p>Carini: </p> <hr /> <div>==High-Level Concepts==<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> **Sponsors<br /> *Populations<br /> **&lt;font style=&quot;color:blue&quot;&gt;Screened population<br /> **Recruited population<br /> **Eligible population<br /> **Enrolled population<br /> **Randomized population<br /> **Analysed population<br /> **Crossover population<br /> **Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> ***&lt;font style=&quot;color:blue&quot;&gt;Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> &lt;font style=&quot;color:blue&quot;&gt;****Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> &lt;font style=&quot;color:blue&quot;&gt;***Intended protocol<br /> ***Executed protocol&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> &lt;font style=&quot;color:blue&quot;&gt;**Baseline characteristic&lt;/font&gt;</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Draft4RCT&diff=5413 Draft4RCT 2007-04-26T19:25:28Z <p>Carini: </p> <hr /> <div>==High-Level Concepts==<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> *Research types<br /> **&lt;font style=&quot;color:blue&quot;&gt;Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> **Sponsors<br /> *Populations<br /> &lt;font style=&quot;color:blue&quot;&gt;**Screened population<br /> **Recruited population<br /> **Eligible population<br /> **Enrolled population<br /> **Randomized population<br /> **Analysed population<br /> **Crossover population<br /> **Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> &lt;font style=&quot;color:blue&quot;&gt;***Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> &lt;font style=&quot;color:blue&quot;&gt;****Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> &lt;font style=&quot;color:blue&quot;&gt;***Intended protocol<br /> ***Executed protocol&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> &lt;font style=&quot;color:blue&quot;&gt;**Baseline characteristic&lt;/font&gt;</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Draft4RCT&diff=5412 Draft4RCT 2007-04-26T19:24:39Z <p>Carini: New page: ==High-Level Concepts== *Events *Periods **Study phases **Protocol phases *Sequence of events *Study designs *Research types &lt;font style=&quot;color:blue&quot;&gt;**Randomized Clinical Trial&lt;/font&gt; *M...</p> <hr /> <div>==High-Level Concepts==<br /> *Events<br /> *Periods<br /> **Study phases<br /> **Protocol phases <br /> *Sequence of events<br /> *Study designs<br /> *Research types<br /> &lt;font style=&quot;color:blue&quot;&gt;**Randomized Clinical Trial&lt;/font&gt;<br /> *Methods<br /> *Stakeholders<br /> **Participants<br /> **Investigators<br /> **Monitors<br /> **Sponsors<br /> *Populations<br /> &lt;font style=&quot;color:blue&quot;&gt;**Screened population<br /> **Recruited population<br /> **Eligible population<br /> **Enrolled population<br /> **Randomized population<br /> **Analysed population<br /> **Crossover population<br /> **Subgroup population&lt;/font&gt;<br /> *Variables<br /> **Independent variable<br /> &lt;font style=&quot;color:blue&quot;&gt;***Intervention<br /> ****Procedure<br /> ****Device implantation<br /> ****Drug treatment<br /> ****Placebo treatment<br /> ****Sham procedure<br /> ****Usual care<br /> ****Counseling<br /> ***Cointervention&lt;/font&gt;<br /> **Dependent variable (responding variable)<br /> ***Outcome<br /> &lt;font style=&quot;color:blue&quot;&gt;****Primary outcome<br /> ****Secondary outcome<br /> ****Adverse event/Side effect<br /> ****Ancillary outcome&lt;/font&gt;<br /> *Digital and paper artifacts<br /> *Protocol<br /> &lt;font style=&quot;color:blue&quot;&gt;***Intended protocol<br /> ***Executed protocol&lt;/font&gt;<br /> *Protocol application<br /> **Assessments<br /> ***Experimental assays<br /> ***Observations<br /> ****Physical exam<br /> ***Interview<br /> ***Self-assessments<br /> **Data analysis<br /> ***Data partitioning<br /> ***Data transformation<br /> ***Data pooling<br /> ***Data summarization<br /> ***Reliability<br /> ***Correlation<br /> **Specimen processing<br /> ***Procurement<br /> ***Specimen partitioning/purification<br /> ***Specimen storage<br /> *Measurement scale<br /> **Nominal<br /> **Ordinal<br /> **Interval<br /> **Ratio<br /> *Participant characteristic (phenotype)<br /> &lt;font style=&quot;color:blue&quot;&gt;**Baseline characteristic&lt;/font&gt;</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5411 Term Lists 2007-04-26T19:24:20Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> '''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br /> <br /> [[Draft4RCT|On this page]] there is a draft positioning of some of our terms into the high level concept list drafted by Richard. <br /> <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development<br /> <br /> <br /> Terms collected by Wenle Zhao from MUSC<br /> * adherence<br /> * accrual rate<br /> * active control<br /> * adjustment<br /> * type I error<br /> * type II error<br /> * balanced design<br /> * baseline<br /> * bias<br /> * prognostic factor<br /> * confounding factor<br /> * block<br /> * permuted block randomization<br /> * minimization randomization<br /> * biased coin randomizaiton<br /> * urn randomization<br /> * response adaptive randomization<br /> * play the winner <br /> * random play the winner<br /> * case report<br /> * case report form<br /> * data clarification request<br /> * data clarification query<br /> * censoring<br /> * efficacy<br /> * safety<br /> * treatment<br /> * intervention<br /> * crossover<br /> * comparative treatment efficacy<br /> * interim analysis<br /> * deterministic<br /> * stop rule<br /> * phase I trial<br /> * phase II trial<br /> * phase III trial<br /> * phase IV trial<br /> * dichotomous<br /> * dose finding<br /> * dropouts<br /> * eligibility<br /> * experiment<br /> * estimate<br /> * follow-up<br /> * sequential design<br /> * group sequential<br /> * endpoint<br /> * intention to treat<br /> * data-dependent stopping<br /> * lost to follow-up<br /> * meta-analysis<br /> * monitoring<br /> * data and safety monitoring board<br /> * institutional review board<br /> * null hypothesis<br /> * alternative hypothesis<br /> * nesting design<br /> * observation<br /> * odds<br /> * odds ratio<br /> * parallel design<br /> * plecabo<br /> * power<br /> * sample size<br /> * primary outcome<br /> * surrogate outcome<br /> * protocol<br /> * per-protocol population<br /> * intention to treat population<br /> * pseudorandom<br /> * p-value<br /> * treatment allocation<br /> * imbalance<br /> * selection bias<br /> * expectation bias<br /> * statistical significant<br /> * stratification<br /> * univariable<br /> * multivariable<br /> * adverse event<br /> * serious adverse event<br /> * cluster randomization<br /> * community intervention trial<br /> * coding<br /> * complaince<br /> * protocal complaince<br /> * protocol violation<br /> * protocol exception<br /> * auditing<br /> * allocation ratio<br /> * assessment<br /> * assessment bias<br /> * early termination<br /> * informed consent<br /> * withdrawal consent<br /> * source document<br /> * principal investigator<br /> * study coordinator<br /> * data management<br /> * project management<br /> * regulatory management<br /> * case-control design<br /> * blinding<br /> * double blinding <br /> * tocxicity<br /> * cohort<br /> * evaluation<br /> * confidence interval<br /> * confirmatory trial<br /> * confounder<br /> * CONSORT statement<br /> * constrain<br /> * context<br /> * diagnostic trial<br /> * controls<br /> * concurrent controls<br /> * historic controls<br /> * crossover trial<br /> * carryover effect<br /> * recruitment<br /> * washout period<br /> * equivalence trials<br /> * statistical analysis plan<br /> * data management plan<br /> * project management plan<br /> * sponsor<br /> * inclusion criteria<br /> * equipoise<br /> * exclusion criteria<br /> * factorial design<br /> * interaction<br /> * main effect<br /> * one-sided test<br /> * two-sided test<br /> * missing data<br /> * imputation of missing data<br /> * investigator competence<br /> * local control<br /> * masking<br /> * double masking<br /> * triple masking<br /> * trilple blinding<br /> * data safety monitoring committee<br /> * minority representation<br /> * negative findings<br /> * positive findings<br /> * noninferiority<br /> * nonadherence<br /> * sample size inflation<br /> * noncomplaince<br /> * repeat measurement<br /> * time to event<br /> * medical safety monitor<br /> * pivotal trials<br /> * prevention trials<br /> * assessment schedule<br /> * data collection schedule<br /> * quality assurance<br /> * electronic data capture<br /> * clinical trial management system<br /> * database<br /> * analysis datasets<br /> * retrospective design<br /> * screening<br /> * sham treatment<br /> * steering committee<br /> * excecutive committee<br /> * baseline comparability<br /> * optimal allocation<br /> * Neyman allocation<br /> * response<br /> * intersubject<br /> * subject<br /> * intrasubject<br /> * population<br /> * varibility<br /> * binormial<br /> * continous<br /> * derived data<br /> * discret<br /> * primary efficacy<br /> * primary response<br /> * placebo controlled<br /> * single-site<br /> * single-center<br /> * multi-site<br /> * multi-center<br /> * superiority<br /> * bioequivalence<br /> * treatment group<br /> * titration<br /> * tolerability<br /> * phase IIA<br /> * phase IIB<br /> * phase IIB<br /> * investigational new drug (IND) application<br /> * new drug application (NDA)<br /> * over-the -count (OTC)<br /> * drug lot<br /> * treatment-emergenet adverse event (TEAE)<br /> * as-treated<br /> * cross-sectional analysis</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5410 Term Lists 2007-04-26T19:22:36Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> '''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br /> <br /> Here is a draft positioning of some of our terms into the high level concept list drafted by Richard <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development<br /> <br /> <br /> Terms collected by Wenle Zhao from MUSC<br /> * adherence<br /> * accrual rate<br /> * active control<br /> * adjustment<br /> * type I error<br /> * type II error<br /> * balanced design<br /> * baseline<br /> * bias<br /> * prognostic factor<br /> * confounding factor<br /> * block<br /> * permuted block randomization<br /> * minimization randomization<br /> * biased coin randomizaiton<br /> * urn randomization<br /> * response adaptive randomization<br /> * play the winner <br /> * random play the winner<br /> * case report<br /> * case report form<br /> * data clarification request<br /> * data clarification query<br /> * censoring<br /> * efficacy<br /> * safety<br /> * treatment<br /> * intervention<br /> * crossover<br /> * comparative treatment efficacy<br /> * interim analysis<br /> * deterministic<br /> * stop rule<br /> * phase I trial<br /> * phase II trial<br /> * phase III trial<br /> * phase IV trial<br /> * dichotomous<br /> * dose finding<br /> * dropouts<br /> * eligibility<br /> * experiment<br /> * estimate<br /> * follow-up<br /> * sequential design<br /> * group sequential<br /> * endpoint<br /> * intention to treat<br /> * data-dependent stopping<br /> * lost to follow-up<br /> * meta-analysis<br /> * monitoring<br /> * data and safety monitoring board<br /> * institutional review board<br /> * null hypothesis<br /> * alternative hypothesis<br /> * nesting design<br /> * observation<br /> * odds<br /> * odds ratio<br /> * parallel design<br /> * plecabo<br /> * power<br /> * sample size<br /> * primary outcome<br /> * surrogate outcome<br /> * protocol<br /> * per-protocol population<br /> * intention to treat population<br /> * pseudorandom<br /> * p-value<br /> * treatment allocation<br /> * imbalance<br /> * selection bias<br /> * expectation bias<br /> * statistical significant<br /> * stratification<br /> * univariable<br /> * multivariable<br /> * adverse event<br /> * serious adverse event<br /> * cluster randomization<br /> * community intervention trial<br /> * coding<br /> * complaince<br /> * protocal complaince<br /> * protocol violation<br /> * protocol exception<br /> * auditing<br /> * allocation ratio<br /> * assessment<br /> * assessment bias<br /> * early termination<br /> * informed consent<br /> * withdrawal consent<br /> * source document<br /> * principal investigator<br /> * study coordinator<br /> * data management<br /> * project management<br /> * regulatory management<br /> * case-control design<br /> * blinding<br /> * double blinding <br /> * tocxicity<br /> * cohort<br /> * evaluation<br /> * confidence interval<br /> * confirmatory trial<br /> * confounder<br /> * CONSORT statement<br /> * constrain<br /> * context<br /> * diagnostic trial<br /> * controls<br /> * concurrent controls<br /> * historic controls<br /> * crossover trial<br /> * carryover effect<br /> * recruitment<br /> * washout period<br /> * equivalence trials<br /> * statistical analysis plan<br /> * data management plan<br /> * project management plan<br /> * sponsor<br /> * inclusion criteria<br /> * equipoise<br /> * exclusion criteria<br /> * factorial design<br /> * interaction<br /> * main effect<br /> * one-sided test<br /> * two-sided test<br /> * missing data<br /> * imputation of missing data<br /> * investigator competence<br /> * local control<br /> * masking<br /> * double masking<br /> * triple masking<br /> * trilple blinding<br /> * data safety monitoring committee<br /> * minority representation<br /> * negative findings<br /> * positive findings<br /> * noninferiority<br /> * nonadherence<br /> * sample size inflation<br /> * noncomplaince<br /> * repeat measurement<br /> * time to event<br /> * medical safety monitor<br /> * pivotal trials<br /> * prevention trials<br /> * assessment schedule<br /> * data collection schedule<br /> * quality assurance<br /> * electronic data capture<br /> * clinical trial management system<br /> * database<br /> * analysis datasets<br /> * retrospective design<br /> * screening<br /> * sham treatment<br /> * steering committee<br /> * excecutive committee<br /> * baseline comparability<br /> * optimal allocation<br /> * Neyman allocation<br /> * response<br /> * intersubject<br /> * subject<br /> * intrasubject<br /> * population<br /> * varibility<br /> * binormial<br /> * continous<br /> * derived data<br /> * discret<br /> * primary efficacy<br /> * primary response<br /> * placebo controlled<br /> * single-site<br /> * single-center<br /> * multi-site<br /> * multi-center<br /> * superiority<br /> * bioequivalence<br /> * treatment group<br /> * titration<br /> * tolerability<br /> * phase IIA<br /> * phase IIB<br /> * phase IIB<br /> * investigational new drug (IND) application<br /> * new drug application (NDA)<br /> * over-the -count (OTC)<br /> * drug lot<br /> * treatment-emergenet adverse event (TEAE)<br /> * as-treated<br /> * cross-sectional analysis</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5409 Term Lists 2007-04-26T19:21:47Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> '''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br /> <br /> Here is a draft positioning of some of our terms into the high level <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development<br /> <br /> <br /> Terms collected by Wenle Zhao from MUSC<br /> * adherence<br /> * accrual rate<br /> * active control<br /> * adjustment<br /> * type I error<br /> * type II error<br /> * balanced design<br /> * baseline<br /> * bias<br /> * prognostic factor<br /> * confounding factor<br /> * block<br /> * permuted block randomization<br /> * minimization randomization<br /> * biased coin randomizaiton<br /> * urn randomization<br /> * response adaptive randomization<br /> * play the winner <br /> * random play the winner<br /> * case report<br /> * case report form<br /> * data clarification request<br /> * data clarification query<br /> * censoring<br /> * efficacy<br /> * safety<br /> * treatment<br /> * intervention<br /> * crossover<br /> * comparative treatment efficacy<br /> * interim analysis<br /> * deterministic<br /> * stop rule<br /> * phase I trial<br /> * phase II trial<br /> * phase III trial<br /> * phase IV trial<br /> * dichotomous<br /> * dose finding<br /> * dropouts<br /> * eligibility<br /> * experiment<br /> * estimate<br /> * follow-up<br /> * sequential design<br /> * group sequential<br /> * endpoint<br /> * intention to treat<br /> * data-dependent stopping<br /> * lost to follow-up<br /> * meta-analysis<br /> * monitoring<br /> * data and safety monitoring board<br /> * institutional review board<br /> * null hypothesis<br /> * alternative hypothesis<br /> * nesting design<br /> * observation<br /> * odds<br /> * odds ratio<br /> * parallel design<br /> * plecabo<br /> * power<br /> * sample size<br /> * primary outcome<br /> * surrogate outcome<br /> * protocol<br /> * per-protocol population<br /> * intention to treat population<br /> * pseudorandom<br /> * p-value<br /> * treatment allocation<br /> * imbalance<br /> * selection bias<br /> * expectation bias<br /> * statistical significant<br /> * stratification<br /> * univariable<br /> * multivariable<br /> * adverse event<br /> * serious adverse event<br /> * cluster randomization<br /> * community intervention trial<br /> * coding<br /> * complaince<br /> * protocal complaince<br /> * protocol violation<br /> * protocol exception<br /> * auditing<br /> * allocation ratio<br /> * assessment<br /> * assessment bias<br /> * early termination<br /> * informed consent<br /> * withdrawal consent<br /> * source document<br /> * principal investigator<br /> * study coordinator<br /> * data management<br /> * project management<br /> * regulatory management<br /> * case-control design<br /> * blinding<br /> * double blinding <br /> * tocxicity<br /> * cohort<br /> * evaluation<br /> * confidence interval<br /> * confirmatory trial<br /> * confounder<br /> * CONSORT statement<br /> * constrain<br /> * context<br /> * diagnostic trial<br /> * controls<br /> * concurrent controls<br /> * historic controls<br /> * crossover trial<br /> * carryover effect<br /> * recruitment<br /> * washout period<br /> * equivalence trials<br /> * statistical analysis plan<br /> * data management plan<br /> * project management plan<br /> * sponsor<br /> * inclusion criteria<br /> * equipoise<br /> * exclusion criteria<br /> * factorial design<br /> * interaction<br /> * main effect<br /> * one-sided test<br /> * two-sided test<br /> * missing data<br /> * imputation of missing data<br /> * investigator competence<br /> * local control<br /> * masking<br /> * double masking<br /> * triple masking<br /> * trilple blinding<br /> * data safety monitoring committee<br /> * minority representation<br /> * negative findings<br /> * positive findings<br /> * noninferiority<br /> * nonadherence<br /> * sample size inflation<br /> * noncomplaince<br /> * repeat measurement<br /> * time to event<br /> * medical safety monitor<br /> * pivotal trials<br /> * prevention trials<br /> * assessment schedule<br /> * data collection schedule<br /> * quality assurance<br /> * electronic data capture<br /> * clinical trial management system<br /> * database<br /> * analysis datasets<br /> * retrospective design<br /> * screening<br /> * sham treatment<br /> * steering committee<br /> * excecutive committee<br /> * baseline comparability<br /> * optimal allocation<br /> * Neyman allocation<br /> * response<br /> * intersubject<br /> * subject<br /> * intrasubject<br /> * population<br /> * varibility<br /> * binormial<br /> * continous<br /> * derived data<br /> * discret<br /> * primary efficacy<br /> * primary response<br /> * placebo controlled<br /> * single-site<br /> * single-center<br /> * multi-site<br /> * multi-center<br /> * superiority<br /> * bioequivalence<br /> * treatment group<br /> * titration<br /> * tolerability<br /> * phase IIA<br /> * phase IIB<br /> * phase IIB<br /> * investigational new drug (IND) application<br /> * new drug application (NDA)<br /> * over-the -count (OTC)<br /> * drug lot<br /> * treatment-emergenet adverse event (TEAE)<br /> * as-treated<br /> * cross-sectional analysis</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5408 Term Lists 2007-04-26T19:01:10Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> '''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br /> <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development<br /> <br /> <br /> Terms collected by Wenle Zhao from MUSC<br /> * adherence<br /> * accrual rate<br /> * active control<br /> * adjustment<br /> * type I error<br /> * type II error<br /> * balanced design<br /> * baseline<br /> * bias<br /> * prognostic factor<br /> * confounding factor<br /> * block<br /> * permuted block randomization<br /> * minimization randomization<br /> * biased coin randomizaiton<br /> * urn randomization<br /> * response adaptive randomization<br /> * play the winner <br /> * random play the winner<br /> * case report<br /> * case report form<br /> * data clarification request<br /> * data clarification query<br /> * censoring<br /> * efficacy<br /> * safety<br /> * treatment<br /> * intervention<br /> * crossover<br /> * comparative treatment efficacy<br /> * interim analysis<br /> * deterministic<br /> * stop rule<br /> * phase I trial<br /> * phase II trial<br /> * phase III trial<br /> * phase IV trial<br /> * dichotomous<br /> * dose finding<br /> * dropouts<br /> * eligibility<br /> * experiment<br /> * estimate<br /> * follow-up<br /> * sequential design<br /> * group sequential<br /> * endpoint<br /> * intention to treat<br /> * data-dependent stopping<br /> * lost to follow-up<br /> * meta-analysis<br /> * monitoring<br /> * data and safety monitoring board<br /> * institutional review board<br /> * null hypothesis<br /> * alternative hypothesis<br /> * nesting design<br /> * observation<br /> * odds<br /> * odds ratio<br /> * parallel design<br /> * plecabo<br /> * power<br /> * sample size<br /> * primary outcome<br /> * surrogate outcome<br /> * protocol<br /> * per-protocol population<br /> * intention to treat population<br /> * pseudorandom<br /> * p-value<br /> * treatment allocation<br /> * imbalance<br /> * selection bias<br /> * expectation bias<br /> * statistical significant<br /> * stratification<br /> * univariable<br /> * multivariable<br /> * adverse event<br /> * serious adverse event<br /> * cluster randomization<br /> * community intervention trial<br /> * coding<br /> * complaince<br /> * protocal complaince<br /> * protocol violation<br /> * protocol exception<br /> * auditing<br /> * allocation ratio<br /> * assessment<br /> * assessment bias<br /> * early termination<br /> * informed consent<br /> * withdrawal consent<br /> * source document<br /> * principal investigator<br /> * study coordinator<br /> * data management<br /> * project management<br /> * regulatory management<br /> * case-control design<br /> * blinding<br /> * double blinding <br /> * tocxicity<br /> * cohort<br /> * evaluation<br /> * confidence interval<br /> * confirmatory trial<br /> * confounder<br /> * CONSORT statement<br /> * constrain<br /> * context<br /> * diagnostic trial<br /> * controls<br /> * concurrent controls<br /> * historic controls<br /> * crossover trial<br /> * carryover effect<br /> * recruitment<br /> * washout period<br /> * equivalence trials<br /> * statistical analysis plan<br /> * data management plan<br /> * project management plan<br /> * sponsor<br /> * inclusion criteria<br /> * equipoise<br /> * exclusion criteria<br /> * factorial design<br /> * interaction<br /> * main effect<br /> * one-sided test<br /> * two-sided test<br /> * missing data<br /> * imputation of missing data<br /> * investigator competence<br /> * local control<br /> * masking<br /> * double masking<br /> * triple masking<br /> * trilple blinding<br /> * data safety monitoring committee<br /> * minority representation<br /> * negative findings<br /> * positive findings<br /> * noninferiority<br /> * nonadherence<br /> * sample size inflation<br /> * noncomplaince<br /> * repeat measurement<br /> * time to event<br /> * medical safety monitor<br /> * pivotal trials<br /> * prevention trials<br /> * assessment schedule<br /> * data collection schedule<br /> * quality assurance<br /> * electronic data capture<br /> * clinical trial management system<br /> * database<br /> * analysis datasets<br /> * retrospective design<br /> * screening<br /> * sham treatment<br /> * steering committee<br /> * excecutive committee<br /> * baseline comparability<br /> * optimal allocation<br /> * Neyman allocation<br /> * response<br /> * intersubject<br /> * subject<br /> * intrasubject<br /> * population<br /> * varibility<br /> * binormial<br /> * continous<br /> * derived data<br /> * discret<br /> * primary efficacy<br /> * primary response<br /> * placebo controlled<br /> * single-site<br /> * single-center<br /> * multi-site<br /> * multi-center<br /> * superiority<br /> * bioequivalence<br /> * treatment group<br /> * titration<br /> * tolerability<br /> * phase IIA<br /> * phase IIB<br /> * phase IIB<br /> * investigational new drug (IND) application<br /> * new drug application (NDA)<br /> * over-the -count (OTC)<br /> * drug lot<br /> * treatment-emergenet adverse event (TEAE)<br /> * as-treated<br /> * cross-sectional analysis</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5407 Term Lists 2007-04-26T19:00:54Z <p>Carini: </p> <hr /> <div>Go back to [[CTO:Main Page]]<br /> <br /> <br /> '''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br /> <br /> *&lt;font style=&quot;color:red&quot;&gt;Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development<br /> <br /> <br /> Terms collected by Wenle Zhao from MUSC<br /> * adherence<br /> * accrual rate<br /> * active control<br /> * adjustment<br /> * type I error<br /> * type II error<br /> * balanced design<br /> * baseline<br /> * bias<br /> * prognostic factor<br /> * confounding factor<br /> * block<br /> * permuted block randomization<br /> * minimization randomization<br /> * biased coin randomizaiton<br /> * urn randomization<br /> * response adaptive randomization<br /> * play the winner <br /> * random play the winner<br /> * case report<br /> * case report form<br /> * data clarification request<br /> * data clarification query<br /> * censoring<br /> * efficacy<br /> * safety<br /> * treatment<br /> * intervention<br /> * crossover<br /> * comparative treatment efficacy<br /> * interim analysis<br /> * deterministic<br /> * stop rule<br /> * phase I trial<br /> * phase II trial<br /> * phase III trial<br /> * phase IV trial<br /> * dichotomous<br /> * dose finding<br /> * dropouts<br /> * eligibility<br /> * experiment<br /> * estimate<br /> * follow-up<br /> * sequential design<br /> * group sequential<br /> * endpoint<br /> * intention to treat<br /> * data-dependent stopping<br /> * lost to follow-up<br /> * meta-analysis<br /> * monitoring<br /> * data and safety monitoring board<br /> * institutional review board<br /> * null hypothesis<br /> * alternative hypothesis<br /> * nesting design<br /> * observation<br /> * odds<br /> * odds ratio<br /> * parallel design<br /> * plecabo<br /> * power<br /> * sample size<br /> * primary outcome<br /> * surrogate outcome<br /> * protocol<br /> * per-protocol population<br /> * intention to treat population<br /> * pseudorandom<br /> * p-value<br /> * treatment allocation<br /> * imbalance<br /> * selection bias<br /> * expectation bias<br /> * statistical significant<br /> * stratification<br /> * univariable<br /> * multivariable<br /> * adverse event<br /> * serious adverse event<br /> * cluster randomization<br /> * community intervention trial<br /> * coding<br /> * complaince<br /> * protocal complaince<br /> * protocol violation<br /> * protocol exception<br /> * auditing<br /> * allocation ratio<br /> * assessment<br /> * assessment bias<br /> * early termination<br /> * informed consent<br /> * withdrawal consent<br /> * source document<br /> * principal investigator<br /> * study coordinator<br /> * data management<br /> * project management<br /> * regulatory management<br /> * case-control design<br /> * blinding<br /> * double blinding <br /> * tocxicity<br /> * cohort<br /> * evaluation<br /> * confidence interval<br /> * confirmatory trial<br /> * confounder<br /> * CONSORT statement<br /> * constrain<br /> * context<br /> * diagnostic trial<br /> * controls<br /> * concurrent controls<br /> * historic controls<br /> * crossover trial<br /> * carryover effect<br /> * recruitment<br /> * washout period<br /> * equivalence trials<br /> * statistical analysis plan<br /> * data management plan<br /> * project management plan<br /> * sponsor<br /> * inclusion criteria<br /> * equipoise<br /> * exclusion criteria<br /> * factorial design<br /> * interaction<br /> * main effect<br /> * one-sided test<br /> * two-sided test<br /> * missing data<br /> * imputation of missing data<br /> * investigator competence<br /> * local control<br /> * masking<br /> * double masking<br /> * triple masking<br /> * trilple blinding<br /> * data safety monitoring committee<br /> * minority representation<br /> * negative findings<br /> * positive findings<br /> * noninferiority<br /> * nonadherence<br /> * sample size inflation<br /> * noncomplaince<br /> * repeat measurement<br /> * time to event<br /> * medical safety monitor<br /> * pivotal trials<br /> * prevention trials<br /> * assessment schedule<br /> * data collection schedule<br /> * quality assurance<br /> * electronic data capture<br /> * clinical trial management system<br /> * database<br /> * analysis datasets<br /> * retrospective design<br /> * screening<br /> * sham treatment<br /> * steering committee<br /> * excecutive committee<br /> * baseline comparability<br /> * optimal allocation<br /> * Neyman allocation<br /> * response<br /> * intersubject<br /> * subject<br /> * intrasubject<br /> * population<br /> * varibility<br /> * binormial<br /> * continous<br /> * derived data<br /> * discret<br /> * primary efficacy<br /> * primary response<br /> * placebo controlled<br /> * single-site<br /> * single-center<br /> * multi-site<br /> * multi-center<br /> * superiority<br /> * bioequivalence<br /> * treatment group<br /> * titration<br /> * tolerability<br /> * phase IIA<br /> * phase IIB<br /> * phase IIB<br /> * investigational new drug (IND) application<br /> * new drug application (NDA)<br /> * over-the -count (OTC)<br /> * drug lot<br /> * treatment-emergenet adverse event (TEAE)<br /> * as-treated<br /> * cross-sectional analysis</div> Carini https://www.bioontology.org//mediawiki/index.php?title=File:ForCTO_041807.doc&diff=5343 File:ForCTO 041807.doc 2007-04-18T20:54:29Z <p>Carini: </p> <hr /> <div></div> Carini https://www.bioontology.org//mediawiki/index.php?title=File:ForCTO_031207.doc&diff=5342 File:ForCTO 031207.doc 2007-04-18T20:54:10Z <p>Carini: </p> <hr /> <div></div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5341 Term Lists 2007-04-18T20:53:50Z <p>Carini: </p> <hr /> <div>'''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br /> <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5340 Term Lists 2007-04-18T20:52:03Z <p>Carini: </p> <hr /> <div>'''RCT Schema Terms'''<br /> <br /> The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Image:ForCTO_031207.doc]]<br /> <br /> We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br /> [[Image:ForCTO_041807.doc]]<br /> <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Conference_Call-in_Information&diff=5317 Conference Call-in Information 2007-04-12T22:01:55Z <p>Carini: New page: Conference Dial In Instructions (US/Canada): 1. Dial: 1.877.208.9784 or 1.877.246.9080 (Toll Free USA and Canada) 2. Enter Entry Code: 53029 (followed by the # key) If you experience pro...</p> <hr /> <div>Conference Dial In Instructions (US/Canada):<br /> <br /> 1. Dial: 1.877.208.9784 or 1.877.246.9080 (Toll Free USA and Canada)<br /> 2. Enter Entry Code: 53029 (followed by the # key)<br /> <br /> If you experience problems connecting, please call LINK <br /> Conference Service at 1.800.756.8280.</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Conference_Call_Schedule&diff=5309 Conference Call Schedule 2007-04-12T13:48:56Z <p>Carini: New page: Thursday April 12, 2007 at 9:30 EDT</p> <hr /> <div>Thursday April 12, 2007 at 9:30 EDT</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5224 Term Lists 2007-03-15T19:28:37Z <p>Carini: </p> <hr /> <div>'''RCT Schema Terms'''<br /> <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Design_Principles&diff=5223 Design Principles 2007-03-15T19:27:26Z <p>Carini: </p> <hr /> <div>== Goals of the Clinical Trial Ontology Initiative==<br /> <br /> The proposed CTO should:<br /> <br /> (1) fully and faithfully capture the types of entities and relationships involved in clinical trials of any experimental design<br /> <br /> (2) comprehend terms like: ''cohort, randomization, placebo, response, efficacy, control, protocol, null hypothesis, confidence interval, finding, biomarker, primary outcome, secondary outcome, intervention group, experimental design,'' etc., including also major relevant statistical terms and terms drawn from resources such as the CDISC [http://www.cdisc.org/glossary/clinicalterminologyv4.pdf glossary] and <br /> all terms needed for the task of meta-analysis of clinical trials; <br /> <br /> (3) organize these terms in a structured way, providing definitions and logical relations designed to enhance retrieval of, reasoning with, and integration of the data annotated in its terms.<br /> <br /> (4) support trial bank interoperation<br /> <br /> (5) form an integral part of the more comprehensive framework of the Ontology for Biomedical Investigations [http://obi.sourceforge.net/ OBI], which itself forms part of the [http://obofoundry.org/ OBO Foundry]<br /> <br /> (6) draw on and seek maximal alignment with existing clinical trial ontologies, including the [http://smi.stanford.edu/smi-web/research/details.jsp?PubId=1227 Epoch ontology] used by the [http://www.immunetolerance.org/ Immune Tolerance Network] and the [http://rctbank.ucsf.edu/ontology/outline/index.htm RCT Schema] ontology used by the [http://rctbank.ucsf.edu/ Trial Bank Project]<br /> <br /> (7) rest on a clear understanding of the relation between CTO and an epidemiology study ontology<br /> <br /> (8) rest on a clear understanding of the relation between CTO and data-model-oriented initiatives such as CDISC and BRIDG.<br /> <br /> (9) meet the requirements of the [http://obofoundry.org OBO Foundry], and in particular support an adequate treatment of the distinction between ''types'' (''surgical intervention'', ''tumor'', ''human being'') and ''instances'' (Jane's oophorectomy, John's tumor, Fritz)</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Design_Principles&diff=5222 Design Principles 2007-03-15T19:27:07Z <p>Carini: </p> <hr /> <div>== Goals of the Clinical Trial Ontology Initiative==<br /> <br /> The proposed CTO should:<br /> <br /> (1) fully and faithfully capture the types of entities and relationships involved in clinical trials of any experimental design<br /> <br /> (2) comprehend terms like: ''cohort, randomization, placebo, response, efficacy, control, protocol, null hypothesis, confidence interval, finding, biomarker, primary outcome, secondary outcome, intervention group, experimental design,'' etc., including also major relevant statistical terms and terms drawn from resources such as the CDISC [http://www.cdisc.org/glossary/clinicalterminologyv4.pdf glossary] and <br /> all terms needed for the task of meta-analysis of clinical trials; <br /> <br /> (3) organize these terms in a structured way, providing definitions and logical relations designed to enhance retrieval of, reasoning with, and integration of the data annotated in its terms.<br /> <br /> (4) support trial bank interoperation<br /> <br /> (5) form an integral part of the more comprehensive framework of the Ontology for Biomedical Investigations [http://obi.sourceforge.net/ OBI], which itself forms part of the [http://obofoundry.org/ OBO Foundry]<br /> <br /> (6) draw on and seek maximal alignment with existing clinical trial ontologies, including the [http://smi.stanford.edu/smi-web/research/details.jsp?PubId=1227 Epoch ontology] used by the [http://www.immunetolerance.org/ Immune Tolerance Network] and the [http://rctbank.ucsf.edu/ontology/outline/index.htm RCT Schema] ontology used by the[http://rctbank.ucsf.edu/ Trial Bank Project]<br /> <br /> (7) rest on a clear understanding of the relation between CTO and an epidemiology study ontology<br /> <br /> (8) rest on a clear understanding of the relation between CTO and data-model-oriented initiatives such as CDISC and BRIDG.<br /> <br /> (9) meet the requirements of the [http://obofoundry.org OBO Foundry], and in particular support an adequate treatment of the distinction between ''types'' (''surgical intervention'', ''tumor'', ''human being'') and ''instances'' (Jane's oophorectomy, John's tumor, Fritz)</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5221 Term Lists 2007-03-15T19:25:21Z <p>Carini: </p> <hr /> <div>'''[http://rctbank.ucsf.edu/ontology/outline/index.htm RCT Schema] Terms'''<br /> <br /> *Secondary-study<br /> *Trial<br /> *Anchored-time<br /> *Interval<br /> *Double-anchored-interval<br /> *Single-anchored-interval<br /> *Timepoint<br /> *Time-range<br /> *Duration<br /> *Date<br /> *Exclusion-rule<br /> *Inclusion-rule<br /> *Recruitment-flowchart<br /> *Primary-recruitment-flowchart<br /> *Recruited-population<br /> *Randomized-population<br /> *Enrolled-population<br /> *Eligible-population<br /> *Screened-population<br /> *Excluded population<br /> *Analyzed population<br /> *Crossover population<br /> *Study-arm population<br /> *Site-enrollment<br /> *Protocol-concept<br /> *Follow-up activity<br /> *Protocol-change<br /> *Treatment-assignment<br /> *Protocol<br /> *Executed-protocol<br /> *Intended-protocol<br /> *Reason<br /> *Withdrawal-reason<br /> *Outcomes-followup<br /> *Secondary-study-protocol<br /> *Intended-secondary-study-protocol<br /> *Executed-secondary-study-protocol<br /> *Stopping-rule<br /> *Cost<br /> *Outcome<br /> *Baseline<br /> *Study-outcome<br /> *Primary-outcome<br /> *Secondary-outcome<br /> *Ancillary-outcome<br /> *Side-effect<br /> *Study-site<br /> *Trial-participant<br /> *Investigator<br /> *Study-committee<br /> *Funder<br /> *Institution<br /> *Blinding<br /> *Blinding-method<br /> *Intervention-step<br /> *Drug-step<br /> *Non-drug-intervention-step<br /> *Intervention-arm<br /> *Comparison-arm<br /> *Experimental-arm<br /> *Cointervention*<br /> *Intervention*<br /> *Procedure<br /> *Device<br /> *Drug<br /> *No-treatment<br /> *Placebo<br /> <br /> '''Foundations of Clinical Research (Scheuermann list)'''<br /> <br /> #Outcome assessment<br /> ##Morbidity<br /> ##mortality<br /> ##length of stay<br /> ##readmission<br /> ##Physical<br /> ##social<br /> ##psychological well-being<br /> ##Patient satisfaction<br /> ##patient preference<br /> ##self-assessment of functional capacity<br /> ##quality of life<br /> #Acute conditions and chronic conditions<br /> #Sources of knowledge<br /> ##Tradition (precedent)<br /> ##Authority (trusted expert)<br /> ##Trial and error<br /> ##Logical reasoning - Deductive reasoning, Inductive reasoning<br /> ##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br /> #Types of research<br /> ##Basic vs applied<br /> ##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br /> ##Case study – description of one or more patients<br /> ##Developmental research – description of pattern of change over time<br /> ##Normative research – establishing normal values<br /> ##Qualitative research – gathering data through interview or observation<br /> ##Cohort or case-control studies – establish associations<br /> ##Methodological studies – establish reliability and validity of a new method<br /> ##Secondary analysis – exploring new relationships in old data<br /> ##Historical research<br /> ##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br /> ##Single-subject design<br /> ##Sequential clinical trial<br /> ##Evaluation research – assessment of the success of a program or policy<br /> ##Quasi-experimental research<br /> ##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br /> ##Qualitative vs quantitative research<br /> #Research process<br /> ##Phase I: Identify the research question<br /> ###Identify the research problem<br /> ###Review of literature to provide a theoretical framework<br /> ###Identify variables<br /> ###State hypothesis<br /> ##Phase II: Design the study<br /> ###Design the protocol<br /> ###Choose a sample<br /> ##Phase III: Methods<br /> ###Collect data<br /> ###Reduce data<br /> ##Phase IV: Data analysis<br /> ###Analyze data<br /> ###Interpret findings<br /> ##Phase V: Communication<br /> ###Report findings<br /> ###Suggest future studies<br /> #Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.<br /> #Hypothesis - specific predictions based on a theory.<br /> #Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br /> #Constructs – concepts that represent non-observable behaviors or events<br /> #Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br /> #Propositions – state the relationships between variables<br /> ##Hierarchical – show vertical relationships<br /> ##Temporal – order concepts in time and states a sequence of events<br /> ##Quantitative – frequency or duration of a specific behavior<br /> #Model – symbolic representation of the elements of a system<br /> ##Physical<br /> ##Schematic<br /> ##Process<br /> ##Statistical<br /> #Inductive theory – theory based on empirically verifiable observations<br /> #Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br /> #Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br /> #Empirical observations =&gt; Facts =&gt; Conceptual Framework =&gt; Theory =&gt; Research hypothesis =&gt; Facts<br /> #Deduction – theory testing<br /> #Induction – theory development</div> Carini https://www.bioontology.org//mediawiki/index.php?title=Design_Principles&diff=5220 Design Principles 2007-03-15T19:23:29Z <p>Carini: </p> <hr /> <div>== Goals of the Clinical Trial Ontology Initiative==<br /> <br /> The proposed CTO should:<br /> <br /> (1) fully and faithfully capture the types of entities and relationships involved in clinical trials of any experimental design<br /> <br /> (2) comprehend terms like: ''cohort, randomization, placebo, response, efficacy, control, protocol, null hypothesis, confidence interval, finding, biomarker, primary outcome, secondary outcome, intervention group, experimental design,'' etc., including also major relevant statistical terms and terms drawn from resources such as the CDISC [http://www.cdisc.org/glossary/clinicalterminologyv4.pdf glossary] and <br /> all terms needed for the task of meta-analysis of clinical trials; <br /> <br /> (3) organize these terms in a structured way, providing definitions and logical relations designed to enhance retrieval of, reasoning with, and integration of the data annotated in its terms.<br /> <br /> (4) support trial bank interoperation<br /> <br /> (5) form an integral part of the more comprehensive framework of the Ontology for Biomedical Investigations [http://obi.sourceforge.net/ OBI], which itself forms part of the [http://obofoundry.org/ OBO Foundry]<br /> <br /> (6) draw on and seek maximal alignment with existing clinical trial ontologies, including the [http://smi.stanford.edu/smi-web/research/details.jsp?PubId=1227 Epoch ontology] used by the [http://www.immunetolerance.org/ Immune Tolerance Network] and the[http://rctbank.ucsf.edu/ontology/outline/index.htm RCT Schema] ontology used by the[http://rctbank.ucsf.edu/ Trial Bank Project]<br /> <br /> (7) rest on a clear understanding of the relation between CTO and an epidemiology study ontology<br /> <br /> (8) rest on a clear understanding of the relation between CTO and data-model-oriented initiatives such as CDISC and BRIDG.<br /> <br /> (9) meet the requirements of the [http://obofoundry.org OBO Foundry], and in particular support an adequate treatment of the distinction between ''types'' (''surgical intervention'', ''tumor'', ''human being'') and ''instances'' (Jane's oophorectomy, John's tumor, Fritz)</div> Carini