Certified Clinical Research Coordinator (CCRC) Practice Exam

What is an audit trail in clinical research?

1. Documentation of all financial transactions in the trial

2. Systematic documentation allowing event reconstruction

3. A summary of the trial results

4. A list of all participants' contact information

The correct answer is: Systematic documentation allowing event reconstruction

An audit trail in clinical research is a systematic documentation that allows for the reconstruction of events related to the study. This includes tracking changes made to data, recording who made the changes, and establishing a timeline of activities. The purpose of an audit trail is to ensure transparency, promote accountability, and verify the integrity of the data collected during the research study. By maintaining a thorough audit trail, research teams can demonstrate compliance with regulations, confirm the accuracy of data collection and handling procedures, and facilitate the verification of study results if needed. This is critical in ensuring trust in the findings of clinical research and is a key component of good clinical practice (GCP). The other options do not capture the essence of an audit trail. Documentation of financial transactions pertains to budgeting and fund management, a summary of trial results focuses on outcomes rather than process, and a list of participants' contact information is related to data management but does not reflect the comprehensive nature of an audit trail in tracking study processes and changes.