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Question 48/56
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?
Correct Answer: D
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:D (Audit reports).
References:
ICH E6(R2), §5.19.3.
* 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:D (Audit reports).
References:
ICH E6(R2), §5.19.3.
- Question List (56q)
- Question 1: Which of the following statements about the investigator's b...
- Question 2: Which of the following statements about the initial IND appl...
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- Question 4: Upon completion of a study, the investigator should do which...
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- Question 17: In accordance with the CFR, for at least how many years afte...
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- Question 19: A study subject in a double-blinded, placebo-controlled Phas...
- Question 20: Which of the following is one of the responsibilities of an ...
- Question 21: According to ICH GCP, an electronic data capture (EDC) syste...
- Question 22: A subject has creatinine 1.6 mg/dL, slightly above eligibili...
- Question 23: In accordance with the ICH GCP Guideline, which of the follo...
- Question 24: When can an IRB/IEC review a study using expedited review?...
- Question 25: Which of the following is an adequate definition of quality ...
- Question 26: In accordance with the CFR, the sponsor (who is not a sponso...
- Question 27: In accordance with the CFR, which of the following statement...
- Question 28: Which case history documents must be at both sponsor and sit...
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- Question 30: An investigator discovered a new serious unanticipated adver...
- Question 31: Which of the following is one of the responsibilities of an ...
- Question 32: In accordance with the Belmont Report, obtaining voluntary i...
- Question 33: A research assistant on a study was recently promoted to a c...
- Question 34: Which of the following entities, if any, must provide an app...
- Question 35: A nonrandomized study of 30 subjects entitled "A study to ev...
- Question 36: According to the CFR and the ICH GCP Guideline, which of the...
- Question 37: If a subject experiences a serious adverse event related to ...
- Question 38: When can the IRB/IEC require that additional information be ...
- Question 39: In accordance with 45 CFR 46, in addition to the Office for ...
- Question 40: A subject on a multi-drug regimen could not tolerate a non-i...
- Question 41: An investigator received an updated informed consent form (I...
- Question 42: What is included in the Statement of Investigator (Form FDA ...
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- Question 44: For a Significant Risk device study, an investigator must re...
- Question 45: In accordance with the ICH GCP Guideline, at what intervals ...
- Question 46: The reviewing IRB/IEC determined that a minimal risk sponsor...
- Question 47: According to 21 CFR Part 11, each electronic signature must ...
- Question 48: During an audit of a sponsor, the following documents and ac...
- Question 49: An investigator is working with a new sponsor to submit a ca...
- Question 50: In accordance with ICH/GCP Guidance, how long should an IRB/...
- Question 51: In accordance with the ICH GCP Guideline, prior to initiatin...
- Question 52: A subject was instructed to do a glucose check 4 times a day...
- Question 53: A physician with 20 years of experience is planning to be th...
- Question 54: Sponsor must maintain drug disposition records for how long ...
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