CCRP Dump Collection - Valid CCRP Exam Online

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q32-Q37):

NEW QUESTION # 32
The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should the sponsor maintain all sponsor-specific essential documents?

Answer: B

Explanation:
Retention of essential documents ensures accountability and inspection readiness.
* ICH E6(R2) 5.5.12 & 8.1:Sponsors should retain essential documents "until at least2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applicationsor at least 2 years after formal discontinuation of clinical development of the investigational product." This standard balances subject protection with practical recordkeeping. Longer durations (B-D) may apply under institutional or national rules, but ICH establishes2 years minimum.
Correct answer:A (2 years).
References:
ICH E6(R2), §5.5.12, §8.1.


NEW QUESTION # 33
According to 21 CFR Part 11, each electronic signature must be unique and:

Answer: A

Explanation:
* 21 CFR 11.100(a):Requires that electronic signatures be "unique to one individual and shall not be reused or reassigned to anyone else."
* This ensures accountability and audit trail integrity.
References:21 CFR 11.100(a).


NEW QUESTION # 34
A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis" is an example of a:

Answer: B

Explanation:
Phase classification is based on study objectives, not just subject numbers.
* Phase I:Focuses on safety, pharmacokinetics, dose-ranging, usually in healthy volunteers or small patient groups.
* Phase II:Evaluateseffectiveness in patients with the conditionand monitors common short-term side effects.
* Phase III:Confirms effectiveness in larger populations, compares to standard therapy, gathers more safety data.
* Phase IV:Post-marketing studies exploring new indications, long-term safety, or special populations.
The given study aims toevaluate effectiveness and common short-term side effectsin 30 arthritis patients, which clearly aligns withPhase IIobjectives. It is not exploratory safety (Phase I), not confirmatory comparative (Phase III), nor post-marketing (Phase IV).
Thus, the correct answer isB (Phase II).
References:
FDA Guidance: The IND Application - §312.21 (Phases of an investigation).
ICH E8(R1), General Considerations for Clinical Studies.


NEW QUESTION # 35
The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?

Answer: A

Explanation:
Minimal risk studiesmay qualify for exemption or expedited review under45 CFR 46.101(b).
* 45 CFR 46.109(f):"Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk."
* ICH E6(R2) 3.1.4:Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.
Therefore, once exempted, there isno requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.
Thus, the correct answer isD (No such requirement).
References:
45 CFR 46.109(f) (Exempt and expedited reviews).


NEW QUESTION # 36
A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?

Answer: C

Explanation:
Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.
* ICH E6(R2) 8.3.21:"Subject Identification Code List - A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period."
* ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.
Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.
Thus, the correct answer isB (Completed Subject Identification Code List).
References:
ICH E6(R2), §8.3.21 (Essential documents: Subject identification code list).
ICH E6(R2), §8.4 (Essential documents for trial closure).


NEW QUESTION # 37
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