In clinical trials, what does a Source Document include?

A Source Document in clinical trials refers to the original records where data related to a clinical study is first recorded. This includes all materials that provide evidence for the information reported in the case report forms and the final study data. Source documents can include medical records, laboratory reports, and other files that capture the original data relating to participant activities and outcomes.

The correct interpretation of Source Documents encompasses both original and modified records of data, reflecting any amendments or additions made to the initial findings. This is essential for ensuring the integrity and accuracy of trial data, as they provide a comprehensive view of the data as it was generated and any modifications that occurred throughout the study. Maintaining thorough source documentation is critical for audits and for verifying the data's authenticity and reliability.

While guidelines on data collection, documentation of adverse events, and authorized copies of consent forms are important components of clinical research, they do not define what constitutes a Source Document. These elements may be part of the overall data collection process and regulatory compliance but do not constitute the original records that signpost the initial data entry within the study framework.