Regulatory & Documentation
Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
An Institutional Review Board (IRB) in the U.S. or Independent Ethics Committee (IEC) outside the U.S. is an independent body that reviews and approves clinical trial protocols, informed consent, and recruitment materials to protect the rights, safety, and welfare of human research participants.
IRBs operate under 21 CFR Parts 50 and 56 in the U.S. and ICH E6(R3) globally. Composition must include at least five members with diverse backgrounds, including a non-scientist and a community representative independent of the institution.
Central IRBs (WCG, Advarra) accelerate multi-site trial activation by providing single-IRB review under the NIH single-IRB policy and FDA's 2018 cooperative-research IRB rule.
Related terms
Informed Consent Form (ICF)
An informed consent form (ICF) is the document a clinical trial participant signs after a documented informed-consent discussion confirming they understand the study's purpose, procedures, risks, benefits, alternatives, and their rights as a research participant.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
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