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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q79-Q84):
NEW QUESTION # 79
In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC's review after a trial has been completed?
- A. At least 3 years
- B. Until the regulatory authority has approved the investigational product for use
- C. Indefinitely
- D. At least 15 years
Answer: A
Explanation:
IRBs/IECs must retain records to permit evaluation of compliance.
* ICH E6(R2) 3.4.2:"IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least3 years after completion of the trial." Extended retention (B-D) may occur institutionally, but ICH minimum is3 years.
Correct answer:A (At least 3 years).
References:
ICH E6(R2), §3.4.2.
NEW QUESTION # 80
A study coordinator is preparing an IRB submission for a Phase II oncology study. Which document must be included?
- A. List of potential subjects
- B. Record storage plan
- C. Case report forms
- D. Recruitment materials
Answer: D
Explanation:
* ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998):Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.
* CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.
References:ICH E6(R2) §3.1.2; FDA Recruitment Guidance, 1998.
NEW QUESTION # 81
In accordance with the ICH GCP Guideline, who is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the case report forms and in all required reports?
- A. The IRB/IEC coordinator
- B. The contract research organization monitor
- C. The clinical investigator
- D. The quality control specialist
Answer: C
Explanation:
The investigator holds ultimate responsibility for all data reported.
* ICH E6(R2) 4.9.1:"The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports."
* Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.
Correct answer:A (The clinical investigator).
References:
ICH E6(R2), §4.9.1.
NEW QUESTION # 82
After completion of a Phase III trial, which document should IRB/IEC retain?
- A. Investigational product labels
- B. Occupations and affiliations of IRB members
- C. Subject enrollment logs
- D. Sponsor/investigator contracts
Answer: B
Explanation:
* 21 CFR 56.115(a)(5):IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).
* Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB's.
References:21 CFR 56.115(a)(5).
NEW QUESTION # 83
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
- A. OHRP
- B. Site coordinator
- C. Reviewing IRBs/IECs
- D. Investigational pharmacies
Answer: C
Explanation:
* 21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.
* Ensures subjects are protected and sites stop enrollment.
References:21 CFR 312.56(d).
NEW QUESTION # 84
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