A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?
Answer(s): B
The protocol governs all trial conduct, including whether subjects should be replaced when they withdraw.ICH E6(R2) 6.0: The protocol must contain "detailed information on trial design, methodology, statistical considerations, and the organization of the trial."ICH E6(R2) 6.9.2: The section on "Subject withdrawal or discontinuation" specifies "whether and under what conditions subjects may be replaced."Other documents serve different functions: the DSM plan (A) manages safety oversight, the IB (C) summarizes product background, and the consent form (D) explains subject rights but does not guide study conduct. Only the protocol provides the operational answer regarding replacement.Thus, the correct answer is B (The protocol).
ICH E6(R2), §6.0 (Protocol content).ICH E6(R2), §6.9.2 (Subject withdrawal/discontinuation).
In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?
Sponsors are responsible for distributing safety updates across all investigators and the FDA.21 CFR 312.55(b): "The sponsor shall promptly notify all participating investigators, and the FDA, of new significant adverse effects or risks with respect to the drug."Other responsibilities fall elsewhere:Case histories (C) are maintained by investigators (21 CFR 312.62(b)).Progress reports to IRBs (D) are the investigator's duty (21 CFR 312.66).Administration of investigational drug (A) is managed by the investigator at site level.Thus, the correct answer is B (Ensuring FDA and investigators are promptly informed).
21 CFR 312.55(b) (Sponsor notification requirements).
Which of the following identifies content that should be included in a clinical research protocol?
Answer(s): D
The protocol must provide scientific rationale, including prior nonclinical findings that justify human research.ICH E6(R2) 6.2.2: "The protocol should include... a summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial."Other listed options belong elsewhere:IRB approvals (A) are separate administrative records.SOPs for data collection (B) are sponsor-level procedural documents.Investigator selection (C) is a sponsor's responsibility, not protocol content.Thus, the correct answer is D (Summary of nonclinical findings with clinical relevance).
ICH E6(R2), §6.2.2 (Protocol contents).
A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?
Answer(s): C
Investigators must provide evidence of qualifications to conduct the study.ICH E6(R2) 4.1.1: "The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial."ICH E6(R2) 8.2.10: Essential documents include the curriculum vitae (CV) or other documents evidencing investigator qualifications, submitted to both sponsor and IRB/IEC.Proof of citizenship (A) and letters of recommendation (B) are irrelevant. A copy of a medical license(D) may be provided but is not specifically required by ICH. The CV is the universally required document.Thus, the correct answer is C (Curriculum vitae).
ICH E6(R2), §4.1.1 (Investigator qualifications).ICH E6(R2), §8.2.10 (Essential documents: CV).
In accordance with the CFR, the IRB/IEC membership must have:
IRBs must be diverse and independent to protect human subjects.21 CFR 56.107(d): "Each IRB shall include at least one member whose primary concerns are in nonscientific areas... and at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution."There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at least one unaffiliated member (D) to ensure independence.Thus, the correct answer is D (At least one unaffiliated individual).
21 CFR 56.107(d) (IRB membership requirements).
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