OCI Term Compilation (Jennifer)

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source	draft category	term / definition
CDISCglossary	unscheduled	adverse event (AE). Synonyms: side effect, adverse experience.
CDISCglossary	role	analysis variables.
CDISCglossary	document	approval letter. An official communication from FDA;allow marketing
CDISCglossary	time	arm. A planned sequence of elements, typically equivalent to a treatment group. [SDTM]
CDISCglossary	protocol	audit
CDISCglossary	protocol	baseline assessment
CDISCglossary	document	Biologics Licensing Application (BLA). An application to FDA for a license to market
CDISCglossary	study design	blinded study. A study in which is unaware of the treatment assignment
CDISCglossary	data	causality assessment. An evaluation performed by a medical professional
CDISCglossary	quality	clinical benefit.
CDISCglossary	data	clinical clarification. A query resolution from the sponsor See also self evident change.
CDISCglossary	quality	clinical efficacy.
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.
CDISCglossary	data	clinical trial information. Data collected in the course of a clinical trial
CDISCglossary	document	Common Technical Document. A format agreed upon by ICH See also eCTD.
CDISCglossary	data	confidentiality. Prevention of
CDISCglossary	study design	confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.
CDISCglossary	person role	consumer safety officer (CSO). FDA official who coordinates the review
CDISCglossary	role	control group. The group of subjects
CDISCglossary	person role	coordinating investigator.
CDISCglossary	statistics	covariate (prognostic). Factor or condition that influences outcome of a trial.
CDISCglossary	document	curriculum vitae (cv).
CDISCglossary	organization role	data and safety monitoring board (DSMB). See data monitoring committee.
CDISCglossary	document	data clarification form. A form used to query an investigator and collect feedback to resolve questions
CDISCglossary	data	data integrity. An attribute of data
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.
CDISCglossary	protocol	decision rule. Succinct statement of
CDISCglossary	data	discrepancy. The failure of a datapoint to pass a validation check. NOTE:
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.
CDISCglossary	quality	dosage form. Physical characteristicsof a drug product, (e.g., tablet,capsule, or solution) that contains adrug substance, generally
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.
CDISCglossary	science	drug development process. The
CDISCglossary	role	drug product. 1. A dosage form thatcontains an active drug ingredient orplacebo; 2. A finished dosage form asdescribed in regulations. [SPL Glossary]
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.
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.
CDISCglossary	quality	efficacy. The capacity of a drug ortreatment to produce beneficial effects
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.
CDISCglossary	data	endpoint. Variable that pertains tothe efficacy or safety evaluations of a
CDISCglossary	aggregate population	enrollment (cumulative). Current enrollment as well as any ever-enrolled subjects who have ended participation.
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.
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.
CDISCglossary	document	eSource document (electronic
CDISCglossary	organization role	Ethics Committees
CDISCglossary	protocol	exclusion criteria. List of
CDISCglossary	conclusion	finding. A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis.
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.
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.
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
CDISCglossary	computer	Internet service provider (ISP). A
CDISCglossary	quality	inter-rater reliability. The property of scales yielding equivalent results when used by different raters ondifferent occasions.
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;
CDISCglossary	role	investigational product. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial
CDISCglossary	role	investigational treatment. An intervention under investigation in a clinical trial.
CDISCglossary		investigator/institution. An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
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.
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)
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
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.
CDISCglossary	role	medicinal product. Synonym for therapeutic intervention, but usually a drug.
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.
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).
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;
CDISCglossary	time	open to enrollment. The status of a study such that a subject can be enrolled into that study.
CDISCglossary	standard	operational model. The set of CDISC data standards (including ODMand LAB) used to capture and archive data from clinical trials.
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
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
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.
CDISCglossary	data	patient-reported outcome Patient-reported outcomes are subjective measurements.
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.
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.
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.
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.
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
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
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
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.
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.
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.
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.
CDISCglossary	statistics	random number table.
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
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)
CDISCglossary	time	recruitment period. Time period during which subjects are or are planned to be enrolled in a clinical trial.
CDISCglossary	data model	Reference Information Model(RIM). An information model used as the ultimate defining reference for al lHL7 standards.
CDISCglossary	data	registry. A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
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
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.
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
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.
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]
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,
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.
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.
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.
FCR		1. Basic vs applied
FCR		1. Hierarchical – show vertical relationships
FCR	quality	1. Morbidity
FCR	data	1. Outcome assessment
FCR		1. Physical
FCR	protocol	1. Tradition (precedent)
FCR	study design	10. Historical research
FCR	quality	10. self-assessment of functional capacity
FCR	role	10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
FCR		11. Propositions – state the relationships between variables
FCR	quality	11. quality of life
FCR	study design	11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
FCR	data model	12. Model – symbolic representation of the elements of a system
FCR	study design	12. Single-subject design
FCR	conclusion	13. Inductive theory – theory based on empirically verifiable observations
FCR	study design	13. Sequential clinical trial
FCR	study design	14. Evaluation research – assessment of the success of a program or policy
FCR	conclusion	14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
FCR	conclusion	15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
FCR	study design	15. Quasi-experimental research
FCR	protocol	16. Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
FCR	study design	16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
FCR	protocol	17. Deduction – theory testing
FCR	study design	17. Qualitative vs quantitative research
FCR	protocol	18. Induction – theory development
FCR	data	2. Acute conditions and chronic conditions
FCR	protocol	2. Authority (trusted expert)
FCR	quality	2. mortality
FCR	study design	2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
FCR		2. Schematic
FCR	time	2. Temporal – order concepts in time and states a sequence of events
FCR	study design	3. Case study – description of one or more patients
FCR	data	3. length of stay
FCR		3. Process
FCR	time	3. Quantitative – frequency or duration of a specific behavior
FCR	data	3. Sources of knowledge
FCR	protocol	3. Trial and error
FCR	study design	4. Developmental research – description of pattern of change over time
FCR	protocol	4. Logical reasoning - Deductive reasoning, Inductive reasoning
FCR	data	4. readmission
FCR		4. Statistical
FCR	science	4. Types of research
FCR	study design	5. Normative research – establishing normal values
FCR	quality	5. Physical
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.
FCR	study design	6. Qualitative research – gathering data through interview or observation
FCR	quality	6. social
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.
FCR	study design	7. Cohort or case-control studies – establish associations
FCR	hypothesis	7. Hypothesis - specific predictions based on a theory.
FCR	quality	7. psychological well-being
FCR	data	8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations
FCR	study design	8. Methodological studies – establish reliability and validity of a new method
FCR	quality	8. Patient satisfaction
FCR	data	9. Constructs – concepts that represent non-observable behaviors or events
FCR	quality	9. patient preference
FCR	study design	9. Secondary analysis – exploring new relationships in old data
MUSC	data	accrual rate
MUSC	role	active control
MUSC		adherence
MUSC	unscheduled	adjustment
MUSC	unscheduled	adverse event
MUSC	data	allocation ratio
MUSC	statistics	alternative hypothesis
MUSC	data	analysis datasets
MUSC	protocol	assessment
MUSC	statistics	assessment bias
MUSC	time	assessment schedule
MUSC		as-treated
MUSC	protocol	auditing
MUSC	study design	balanced design
MUSC		baseline
MUSC		baseline comparability
MUSC	statistics	bias
MUSC	protocol	biased coin randomizaiton
MUSC	statistics	binormial
MUSC	quality	bioequivalence
MUSC	protocol	blinding
MUSC	role	block
MUSC	data	carryover effect
MUSC	document	case report
MUSC	document	case report form
MUSC	study design	case-control design
MUSC	protocol	censoring
MUSC	data	clinical trial management system
MUSC	protocol	cluster randomization
MUSC	protocol	coding
MUSC	role	cohort
MUSC	study design	community intervention trial
MUSC	quality	comparative treatment efficacy
MUSC	quality	complaince
MUSC	role	concurrent controls
MUSC	statistics	confidence interval
MUSC	study design	confirmatory trial
MUSC	role	confounder
MUSC	role	confounding factor
MUSC	document	CONSORT statement
MUSC		constrain
MUSC		context
MUSC	data	continous
MUSC	role	controls
MUSC	study design	crossover
MUSC	study design	crossover trial
MUSC		cross-sectional analysis
MUSC	organization role	data and safety monitoring board
MUSC	document	data clarification query
MUSC	document	data clarification request
MUSC	time	data collection schedule
MUSC	protocol	data management
MUSC	protocol	data management plan
MUSC	organization role	data safety monitoring committee
MUSC	data	database
MUSC	protocol	data-dependent stopping
MUSC	data	derived data
MUSC		deterministic
MUSC	study design	diagnostic trial
MUSC		dichotomous
MUSC	data	discret
MUSC	conclusion	dose finding
MUSC	protocol	double blinding
MUSC	protocol	double masking
MUSC	unscheduled	dropouts
MUSC	quality	drug lot
MUSC	unscheduled	early termination
MUSC	quality	efficacy
MUSC	protocol	electronic data capture
MUSC	protocol	eligibility
MUSC	data	endpoint
MUSC	quality	equipoise
MUSC	study design	equivalence trials
MUSC	protocol	estimate
MUSC	protocol	evaluation
MUSC	organization role	excecutive committee
MUSC	protocol	exclusion criteria
MUSC		expectation bias
MUSC		experiment
MUSC	study design	factorial design
MUSC	protocol	follow-up
MUSC		group sequential
MUSC	role	historic controls
MUSC	statistics	imbalance
MUSC	protocol	imputation of missing data
MUSC	protocol	inclusion criteria
MUSC	protocol	informed consent
MUSC	organization role	institutional review board
MUSC	protocol	intention to treat
MUSC	role	intention to treat population
MUSC	statistics	interaction
MUSC	protocol	interim analysis
MUSC		intersubject
MUSC	role	intervention
MUSC		intrasubject
MUSC	document	investigational new drug (IND) application
MUSC	quality	investigator competence
MUSC		local control
MUSC	data	lost to follow-up
MUSC	statistics	main effect
MUSC	protocol	masking
MUSC	person role	medical safety monitor
MUSC	protocol	meta-analysis
MUSC	protocol	minimization randomization
MUSC		minority representation
MUSC	data	missing data
MUSC	protocol	monitoring
MUSC	study design	multi-center
MUSC	study design	multi-site
MUSC	statistics	multivariable
MUSC	conclusion	negative findings
MUSC	statistics	nesting design
MUSC	document	new drug application (NDA)
MUSC	statistics	Neyman allocation
MUSC	unscheduled	nonadherence
MUSC	unscheduled	noncomplaince
MUSC		noninferiority
MUSC	statistics	null hypothesis
MUSC	data	observation
MUSC	statistics	odds
MUSC	statistics	odds ratio
MUSC	statistics	one-sided test
MUSC		optimal allocation
MUSC	quality	over-the -count (OTC)
MUSC	study design	parallel design
MUSC	protocol	permuted block randomization
MUSC	role	per-protocol population
MUSC	study design	phase I trial
MUSC	study design	phase II trial
MUSC	study design	phase IIA
MUSC	study design	phase IIB
MUSC	study design	phase IIB
MUSC	study design	phase III trial
MUSC	study design	phase IV trial
MUSC	study design	pivotal trials
MUSC	study design	placebo controlled
MUSC	protocol	play the winner
MUSC	role	plecabo
MUSC	aggregate	population
MUSC	conclusion	positive findings
MUSC	statistics	power
MUSC	study design	prevention trials
MUSC		primary efficacy
MUSC	conclusion	primary outcome
MUSC	data	primary response
MUSC	person role	principal investigator
MUSC	role	prognostic factor
MUSC	protocol	project management
MUSC	protocol	project management plan
MUSC	protocol	protocal complaince
MUSC	protocol	protocol
MUSC	unscheduled	protocol exception
MUSC	unscheduled	protocol violation
MUSC	statistics	pseudorandom
MUSC	statistics	p-value
MUSC	protocol	quality assurance
MUSC	protocol	random play the winner
MUSC	protocol	recruitment
MUSC	protocol	regulatory management
MUSC	data	repeat measurement
MUSC	data	response
MUSC	protocol	response adaptive randomization
MUSC	study design	retrospective design
MUSC	quality	safety
MUSC	statistics	sample size
MUSC		sample size inflation
MUSC	protocol	screening
MUSC		selection bias
MUSC	study design	sequential design
MUSC	unscheduled	serious adverse event
MUSC	role	sham treatment
MUSC	study design	single-center
MUSC	study design	single-site
MUSC	document	source document
MUSC	person role	sponsor
MUSC	protocol	statistical analysis plan
MUSC	statistics	statistical significant
MUSC	organization role	steering committee
MUSC	protocol	stop rule
MUSC	statistics	stratification
MUSC	person role	study coordinator
MUSC	role	subject
MUSC	quality	superiority
MUSC	conclusion	surrogate outcome
MUSC	time	time to event
MUSC	protocol	titration
MUSC	quality	tocxicity
MUSC	quality	tolerability
MUSC	role	treatment
MUSC		treatment allocation
MUSC	role	treatment group
MUSC	unscheduled	treatment-emergenet adverse event (TEAE)
MUSC	protocol	trilple blinding
MUSC	protocol	triple masking
MUSC	statistics	two-sided test
MUSC	statistics	type I error
MUSC	statistics	type II error
MUSC	statistics	univariable
MUSC	protocol	urn randomization
MUSC		varibility
MUSC	time	washout period
MUSC	protocol	withdrawal consent
RCT	role	Analyzed population
RCT	time	Anchored-time
RCT	conclusion	Ancillary-outcome
RCT	data	Baseline
RCT	protocol	Blinding
RCT	protocol	Blinding-method
RCT	study design	Cointervention*
RCT	study design	Comparison-arm
RCT	quality	Cost
RCT	role	Crossover population
RCT	time	Date
RCT		Device
RCT	time	Double-anchored-interval
RCT	role	Drug
RCT	protocol	Drug-step
RCT	time	Duration
RCT	role	Eligible-population
RCT	role	Enrolled-population
RCT	role	Excluded population
RCT	protocol	Exclusion-rule
RCT	protocol	Executed-protocol
RCT	protocol	Executed-secondary-study-protocol
RCT	study design	Experimental-arm
RCT	protocol	Follow-up activity
RCT	role	Funder
RCT	protocol	Inclusion-rule
RCT	organization	Institution
RCT	protocol	Intended-protocol
RCT	protocol	Intended-secondary-study-protocol
RCT	time	Interval
RCT	study design	Intervention*
RCT	study design	Intervention-arm
RCT	protocol	Intervention-step
RCT	role	Investigator
RCT	protocol	Non-drug-intervention-step
RCT		No-treatment
RCT	data	Outcome
RCT	data	Outcomes-followup
RCT	role	Placebo
RCT	conclusion	Primary-outcome
RCT	protocol	Primary-recruitment-flowchart
RCT	protocol	Procedure
RCT	protocol	Protocol
RCT	unscheduled	Protocol-change
RCT	protocol	Protocol-concept
RCT	role	Randomized-population
RCT		Reason
RCT	role	Recruited-population
RCT	protocol	Recruitment-flowchart
RCT	role	Screened-population
RCT	conclusion	Secondary-outcome
RCT	study design	Secondary-study
RCT	protocol	Secondary-study-protocol
RCT	data	Side-effect
RCT	time	Single-anchored-interval
RCT	role	Site-enrollment
RCT	protocol	Stopping-rule
RCT	role	Study-arm population
RCT	organization role	Study-committee
RCT	conclusion	Study-outcome
RCT	organization role	Study-site
RCT	time	Timepoint
RCT	time	Time-range
RCT	role	Treatment-assignment
RCT		Trial
RCT	role	Trial-participant
RCT	data	Withdrawal-reason

Some notes from Simona on the RCT terms as classified above File:CTO-may3-RCT.xls