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During an audit of a sponsor, the following documents and activities were reviewed: the protocol, applicable regulatory requirements, and compliance with Good Clinical Practice (GCP). What additional documents must be reviewed during the sponsor audit?
A. Financial reports
B. Standard Operating Procedures (SOPs)
C. Personnel records
D. Audit reports
Answer: D
Explanation:
Sponsor audits ensure systems comply with GCP.
* ICH E6(R2) 5.19.3:"The sponsor's auditing procedures should include a review ofquality assurance audits and audit reports."
* Audit reports document findings from independent evaluations and are essential for ensuring compliance.
SOPs (A) are reviewed during audits but are not mandated as standalone "audit review documents." Personnel files (B) and financial reports (C) are not required under GCP auditing provisions.
Correct answer (Audit reports).
References:
ICH E6(R2), ¡ì5.19.3.
NEW QUESTION # 64
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
A. 0
B. 1
C. 2
D. 3
Answer: C
Explanation:
This question tests drug accountability and dosing calculation, which is central to ICH E6(R2) 4.6 (Investigational product management). Subjects must receive the correct supply and any discrepancy must be reconciled.
The prescribed regimen is 2 mg twice daily = 4 mg per day. With 1 mg tablets, this equals 4 tablets daily.
Over 10 days, the subject should consume 40 tablets (4 ¡Á 10 = 40). Since 45 tablets were dispensed, the subject should have 5 tablets remaining after 10 days.
Accurate accountability ensures trial integrity and subject safety. Investigators are responsible for maintaining investigational product (IP) records, including dispensing, usage, and returns. According to ICH:
4.6.3: "The investigator/institution should maintain records of the product's delivery to the trial site, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."
4.6.5: "The investigator should ensure that investigational products are used only in accordance with the approved protocol." Thus, the correct answer is C (5 tablets remain). This reflects proper dosing compliance and highlights the importance of meticulous IP tracking in clinical trials.
References:
ICH E6(R2), ¡ì4.6 (Investigational Product(s)).
NEW QUESTION # 65
On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records?
A. 15 May 2022
B. 16 May 2022
C. 15 May 2034
D. 16 May 2021
Answer: B
Explanation:
Record retention requirements ensure regulatory access to data even after development is discontinued.
* 21 CFR 312.62(c):"An investigator shall retain records... for2 years after the date a marketing application is withdrawn or discontinuedand FDA is notified."
* In this case, development was terminated15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is15 May 2021, but FDA requires records to be maintaineduntil after the 2-year period ends. Theearliest permissible destruction date is 16 May 2022 (C).
Options A and B are premature; D (2034) is far beyond requirements.
Thus, the correct answer isC (16 May 2022).
References:
21 CFR 312.62(c) (Investigator record retention).
21 CFR 312.57(c) (Sponsor record retention).
NEW QUESTION # 66
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?
A. To provide the subject with information regarding the significant new findings
B. To give the subject's contact information to the sponsor in order to allow the sponsor to contact the subject
C. To discontinue the subject's study drug
D. To submit this safety update to the regulatory authority
Answer: A
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), ¡ì4.8.2.
21 CFR 50.25(b)(5).
NEW QUESTION # 67
In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?
A. In a timely manner before, during, and after the study
B. Every 4-6 weeks until study close-out
C. Once a year until study close-out
D. At least weekly
Answer: A
Explanation:
Monitoring ensures trial integrity and subject safety.
* ICH E6(R2) 5.18.3:"The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial."
* Monitoring must occurbefore (initiation visit), during (periodic), and after (closeout).
It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it is risk-adapted and flexible, but must cover all phases of the study.
Correct answer:C (Timely manner before, during, and after).
References:
ICH E6(R2), ¡ì5.18.3.
NEW QUESTION # 68
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(Audit reports).