SOCRA CCRP Practice Exam

According to the ICH GCP, what is not required by FDA regulation for drug studies?

1. None

2. Annual financial report

3. Clinical trial report

4. Monthly progress report

The correct answer is: None

The choice of None is correct because according to the Food and Drug Administration (FDA) regulations, there is no specific requirement for a drug sponsor to submit an “annual report of financial information” for an ongoing study. However, the sponsor is still expected to maintain accurate financial records, which could be reviewed by FDA inspectors during an inspection or audit. Options B, C, and D are incorrect because these are all required reports by the FDA. Accounting for the financial aspects of a drug study is important, but it is not a specific regulatory requirement. The sponsor is required to submit an annual report of the study’s progress (option D), an annual report of clinical trial information (option C), and an annual financial report (option B) to the FDA. It is important to note that while an annual financial report is not required, the sponsor must still maintain accurate financial records and may be asked to provide