SOCRA Updated CCRP Exam Questions and Answers by madiha

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.

ICH directs investigators todocument and explainany deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:

ICH E6(R2) 4.5.3: “The investigator should document and explain any deviationfrom the approved protocol.”

ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible.Here, absent immediate hazard, the required action is documentation and explanation (B).

Form FDA 1572 is the “Statement of Investigator” for IND studies.

21 CFR 312.53(c)(1)(vi)(b):Requires investigators to “read and understand the Investigator’s Brochure.”

By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.

Other options (B–D) are not part of 1572 requirements.

Correct answer:A.

AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical investigation.

21 CFR 812.1(a):“An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply.”

It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).

Thus, the correct answer isA (Shipped lawfully for clinical study).