Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What is the primary purpose of maintaining an audit trail in clinical research?

1. To reduce paperwork for the research team

2. To ensure data security and privacy

3. To provide a transparent account of data changes and events

4. To simplify the data analysis process

The correct answer is: To provide a transparent account of data changes and events

The primary purpose of maintaining an audit trail in clinical research is to provide a transparent account of data changes and events. An audit trail serves as a chronological record that captures all modifications made to study data, including who made the changes, what was changed, when it occurred, and why these changes were necessary. This level of detail is crucial in clinical research as it enhances the reliability and integrity of the research findings. By documenting every change, the audit trail helps to ensure compliance with regulatory requirements and assists in the validation of data. It also facilitates the review process by offering insight into the data management practices throughout the study's lifecycle, which is essential for maintaining the trustworthiness of the research. Other factors such as data security and privacy are certainly important in a clinical setting but are not the primary objective of an audit trail. The same goes for reducing paperwork or simplifying data analysis; while these aspects may benefit indirectly from a well-maintained audit trail, they do not reflect the central purpose of this practice in clinical research.