Clinical trial
Definition
research study in which one or more human subjects are prospectively assigned to one or more interventions (may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes
45 CFR 46
Clinical Investigation
Definition
any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to FDA under section 505(i) or 520(g) of the act, or the results of which are intended to be later submitted to, or held for inspection by FDA as part of an application for a research or marketing permit (includes IND (part 312) and IDE (part 812))
The terms “research”, “clinical research”, “clinical study”, “study”, and “clinical investigation” are deemed to be synonymous for purpose of this part.
21 CFR 56
Federal Department or agency
Definition
Refers to a federal departemnt or agency (the department or agency itself rather than its bureaus, offices or divisions) that takse appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g. the U.S. Department of Health and Human Services, the U.S. Department of Defense, the Central Intelligence Agency)
45 CFR 46
Human subject
Definition
an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. May be healthy or a patient.
21 CFR 56
Human subject
Definition
living individual about whom an investigator conducting research
- obtains information or biospecimens through intervention or interaction and uses, studies, or analyzes the information or biospecimens; or
- obtaines, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
45 CFR 46
Institutional Review Board (IRB)
Definition
any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects.
21 CFR 56
Intervention
Definition
includes both physical procedure by which information or biospecimens are gathered and manipulations of the subject of the subject’s environment that are performed for research purposes.
45 CFR 46
Investigator
Definition
an individual who actually conducts a clinical investigation (under whose immediate direction the test article is administered or dispensed to, or used involving a subject). In a team of individuals, it is the responsible leader of that team.
21 CFR 56
Legally authorized representative (LAR)
Definition
If there is no applicable law addressing this issue, LAR means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the propsective subject to the subject’s participantion in the procedure(s) involved in the research
45 CFR 46
Minimal risk
Definition
the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
21 CFR 56
Minimal risk
Definition
the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
45 CFR 46
Research
Definition
a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
45 CFR 46
Sponsor
Definition
a person or other entity that initiates a clinical investigation, but that does not actually conduct the investigation
21 CFR 56
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The Nuremberg Code (Oct 1946 - April 1949) - C14
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The Belmont Report 1979- C37
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The Declaration of Helsinki 1964 - C17
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45 CFR 46 (Protection of Human Subjects - Common Rule) - C51
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21 CFR 11 (Electronic records)9
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21 CFR 50 (Protection of Human Subjects, ICF)1
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21 CFR 54 (Financial Disclosure)5
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21 CFR 56 (IRB) - C29
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21 CFR 312 (IND)1
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21 CFR 812 (IDE)1
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ICH GCP Rev21
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ICH GCP Rev3 (on exam from 1/1/2026)1
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ICH E2A (Clinical Data Safety Management, AEs)7
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FDA forms7
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Audits and inspections of clinical trials6
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Definitions13
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Timelines29
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FDA vs ICH0
