Good Clinical Practice (GCP) Practice Exam

What does the term 'source data' refer to in clinical trials?

1. Data collected solely from surveys

2. Information in original records or certified copies necessary for evaluation

3. Statistical analysis of collected data

4. Data derived from peer-reviewed publications

The correct answer is: Information in original records or certified copies necessary for evaluation

The term 'source data' in clinical trials refers to the original records or certified copies of information that are crucial for the evaluation and verification of clinical trial data. This can include various forms of documentation, such as patient medical records, laboratory results, or any other forms of data that support the findings and conclusions drawn from a clinical trial. Source data serves as the foundational evidence that substantiates the results, ensuring that the process is transparent and that findings can be accurately reproduced and validated. In the context of clinical research, having reliable source data is essential for compliance with regulatory standards and for maintaining the integrity of the trial outcomes. Source data provides traceability and allows for audits and inspections to ensure that the data collected are accurate and true representations of the participants' experiences and clinical outcomes. The other options represent aspects related to data collection and analysis but do not encapsulate the definition of 'source data' as it is understood in clinical trials. Surveys, statistical analysis, and peer-reviewed publications pertain to different phases of data handling and dissemination rather than to the original documentation needed for verifying clinical trial results.