What must be included in source data to evaluate a clinical trial?

The inclusion of original records and certified copies of clinical findings in source data is essential for evaluating a clinical trial. Source data provides the foundational evidence needed to assess the trial's integrity and ensure that the reported outcomes reflect the actual observations made during the study. This documentation includes medical histories, laboratory results, and any other clinical findings that support the efficacy and safety of the intervention being tested.

Having original records and certified copies is crucial for maintaining a verifiable and traceable data collection process. It ensures compliance with regulatory standards and Good Clinical Practice (GCP) guidelines, which require that all data reported in clinical trial results must be traceable back to the raw data. This transparency helps to confirm that the trial's conclusions are reliable and based on accurate information, which is vital for both regulatory submission and the scientific community's trust in the findings.

In contrast, options that suggest including only patient-reported outcomes, financial records, or statistical analyses would not provide the comprehensive evaluative framework that original clinical records do. While those other factors may play a role in certain aspects of the trial's assessment, they cannot replace the importance of robust source data derived from original clinical findings.