Certified Clinical Research Coordinator (CCRC) Practice Exam

What are two main reasons a sponsor might audit a clinical trial site?

1. Financial discrepancies and participant feedback

2. Compliance with regulations and data integrity

3. Staff performance and documentation accuracy

4. Trial completion rates and safety concerns

The correct answer is: Compliance with regulations and data integrity

The primary motivations for a sponsor to audit a clinical trial site revolve around ensuring compliance with regulations and maintaining data integrity. Compliance with regulations is crucial as it ensures that the trial is conducted in accordance with applicable laws, ethical standards, and good clinical practice (GCP) guidelines. This compliance not only protects the rights and well-being of participants but also enhances the credibility of the trial's results. Data integrity is equally important, as it relates to the accuracy, reliability, and consistency of the collected trial data. An audit helps identify any discrepancies or issues that could affect the validity of the study’s outcomes, ensuring that the data presented for regulatory submissions is trustworthy and reflects true patient experiences. Other options, while relevant to clinical trials, do not encapsulate the primary reasons behind a sponsor's decision to conduct an audit. Financial discrepancies and participant feedback do not directly assess adherence to regulatory obligations or the integrity of the data. Staff performance and documentation accuracy may be components evaluated during an audit but are not the main focus. Similarly, trial completion rates and safety concerns may inform overall trial management but do not specifically encapsulate the core objectives of a sponsor audit. Thus, compliance and data integrity stand out as the most critical aspects driving the audit process.