Source Documentation

December 14, 2011


Q: What constitutes valid source documentation in a clinical trial?

A:  Source documents in a clinical trial are the hard copies on which clinical observations are first recorded. They are legally valid raw data that support a study’s findings. A cardinal rule in GCP compliance is that case report forms (CRF) and the source documents must match, data point to data point. Source documentation is the beginning of a clean, verifiable audit trail.

The protocol should specify which data will be directly entered in to the CRF and will not be supported by any other source document.  Copies of source documents are considered valid as originals as long as they are certified copies. Such a copy is a document that has all the same attributes and information as the original and has been verified as such. This verification process must be described within a SOP.

SA GCP 2006 & ICH GCP E6