Authentic SOCRA Certification Exam CCRP Questions Answers

Theinformed consent processmust include all basic elements listed in federal regulations.

21 CFR 50.25(a)(4):Requires “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”

ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.

This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.

Incorrect options:

A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.

B: Financial disclosures may be required for IRB review, not subject-facing.

C: Subjects do receive a copy, but it is not a required consentelementin regulations.

Correct answer:D.

Investigators must formally close out a trial with the IRB/IEC.

ICH E6(R2) 4.13.2:“Upon completion of the trial, the investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome.”

21 CFR 312.66:Reinforces investigator’s duty to keep IRB informed throughout study lifecycle.

This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).

Thus, the correct answer isA (Provide final report to IRB/IEC).

ICH E6(R2) 4.5.1:Investigators must follow the protocol approved by the IRB/IEC.

Any modification that is not pre-specified must be approved by sponsor and IRB before continuing.

Only deviations eliminating immediate hazard can be done without prior approval; in this case, continuation requires sponsor + IRB agreement.