What does source data refer to in a clinical trial?

Source data in a clinical trial refers to the original records and verified copies of trial-related activities, which include documents such as case report forms, medical records, laboratory reports, and other documentation that establishes the existence of the data collected during the trial. This data is essential as it forms the foundation for the integrity of the clinical trial results, ensuring that the information recorded is accurate and verifiable.

The emphasis on original records highlights the importance of maintaining accurate and complete documentation to support the study's findings. Source data serves as the primary evidence that can be referred to during audits and regulatory reviews, ensuring compliance with Good Clinical Practice (GCP) guidelines. This documentation is crucial for the validity of the study, as it helps to confirm that the data collected accurately reflects the actual events and outcomes observed throughout the trial.