Certified Clinical Research Coordinator (CCRC) Practice Exam

What constitutes a Source Document in clinical research?

1. A validated protocol for the study

2. The original documents, data, records

3. A copy of the data entries

4. A report summarizing findings

The correct answer is: The original documents, data, records

A Source Document in clinical research refers to the original documents, data, or records that provide evidence of the clinical trial's activities, including the collected data about participants and necessary observations. These documents are crucial as they include raw data such as patient charts, laboratory results, and other records that are used to support the findings reported in the study. They serve as the primary evidence of what has occurred during the trial and ensure the integrity and reliability of the data reported in trial results. The validated protocol, while fundamental to a study's design and methodology, outlines how the research should be conducted rather than serving as the original evidence of collected data. Copies of data entries provide a secondary representation of the information, and reports summarizing findings present interpreted results but do not hold the raw evidence needed to track the conduct and outcomes of the trial. Thus, the essence of a Source Document is its role as the primary, original evidence used for verification and validation of clinical research data, making it indispensable for regulatory compliance and audit purposes.