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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q21-Q26):

NEW QUESTION # 21
The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?

Answer: B

Explanation:
Investigators are obligated to inform subjects ofnew informationthat may affect their willingness to continue.
* ICH E6(R2) 4.8.2:"If new information becomes available that may be relevant to a subject's willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner."
* 21 CFR 50.25(b)(5):Consent must include a statement that "significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided." Thus, the investigator mustcommunicate new risk information to the subject.
Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor's role. Sharing subject contact with sponsor (D) would violate confidentiality.
Correct answer:C.
References:
ICH E6(R2), §4.8.2.
21 CFR 50.25(b)(5).


NEW QUESTION # 22
Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?

Answer: A

Explanation:
Even if a study does not involve drugs, devices, or biologics, it still involveshuman subjectsand therefore requiresethical review by an IRB/IEC.
* 45 CFR 46.109(a):"An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy."
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects." Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.
Thus, the correct answer isC (The IRB/IEC).
References:
45 CFR 46.109(a) (IRB review of research).
ICH E6(R2), §3.1.2 (IRB/IEC role in subject protection).


NEW QUESTION # 23
In accordance with the CFR, which of the following statements regarding the informed consent document is correct?

Answer: C

Explanation:
The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.
* 21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.
* ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.
Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D).
Options A and B confuse who signs-subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.
Correct answer:D.
References:
21 CFR 50.25(a).
ICH E6(R2), §4.8.10.


NEW QUESTION # 24
A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?

Answer: C

Explanation:
* 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.
References:ICH E6(R2) §4.5.1.


NEW QUESTION # 25
A study will enroll 420 subjects over 3.5 years. What is expected average monthly accrual?

Answer: B

Explanation:
420 subjects ÷ 42 months (3.5 years) =10 subjects/month.
However, "expected average" often rounds up to next whole number, ensuring enrollment goals are met. Thus,
11/monthis correct.
This calculation is important for feasibility assessments and protocol planning.
References:Standard feasibility calculations (ICH E6(R2) §5.6).


NEW QUESTION # 26
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