Which aspect of source data is emphasized in ICH E6 Section 4.9.0?

Section 4.9.0 of ICH E6 emphasizes the importance of maintaining adequate and accurate source documents. This aspect is critical in clinical trials as it ensures that the data collected is reliable and can be verified. Source documents are the original records that contain the data needed for compliance with regulatory requirements, and having detailed and accurate source data is essential for the integrity of the clinical trial process.

Maintaining accurate source documents supports the validity of the study findings and allows for transparency and traceability. It helps ensure that the information can be audited and verified, which is vital for regulatory compliance and the protection of trial subjects. The integrity of clinical data ultimately rests on the quality of the source documents. Through proper documentation practices, the potential for errors can be minimized, and the data can be trusted for further evaluation and decision-making.