A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?
Correct Answer: B
The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and ensuring qualified, trained staff-regardless of employment source. Exact extracts: * ICH E6(R2) 4.1.1: "The investigator should bequalified... and haveadequate resourcesto properly conduct the trial." * ICH E6(R2) 4.1.5: "The investigatorshould ensure that all persons assistingwith the trial are adequately informedabout the protocol, the investigational product(s), and their trial-related duties and functions." * ICH E6(R2) 4.2.5: "The investigatormay delegate... butretains responsibilityfor the conduct of the trial at the site."Therefore, the investigator/institution (B) must implement procedures and oversight to maintain integrity of trial duties. References: ICH E6(R2) Good Clinical Practice, §4.1.1; §4.1.5; §4.2.5 (Investigator responsibilities; delegation and oversight).===========
Question 47
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
Correct Answer: C
The sponsor holds ultimate responsibility for trial oversight and compliance. * ICH E6(R2) 5.20.1:If noncompliance is discovered, the sponsor must "take prompt action to secure compliance" and, if necessary, terminate participation of the investigator/institution. * 21 CFR 312.56(b):Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB. While investigators commit to protocol adherence, once deviations are identified,the sponsor must actto safeguard subjects and trial validity. References:ICH E6(R2) §5.20.1; 21 CFR 312.56(b).
