21CFR Part 11 defines requirements for the capture, storage, retrieval, maintenance, and security of data including electronic medical record systems utilized at clinical research sites.  Research study source documents are original observations that are recorded and retained to enable a reconstruction and evaluation of a research study.  When original observations are entered directly into a computerized system, the electronic record is the source document.  These systems must comply with Part 11 obligations as well as existing predicate good clinical practice (GCP) guidelines.  For instance, GCP dictates that changes made to source data must not obscure the original values.  The same principles remain for electronic source records.  Also, the system should be designed to ensure attributability of electronic signatures.

Frequently, research sponsors are requesting or requiring a statement of assessment of electronic data systems that store medical source data at the clinical research site.  The following process was developed to assist you with this evaluation.  Note: This applies to site based systems only. Validation of compliance for sponsor or contract research organization provided systems such as electronic data capture, are the responsibility of the sponsor.

All reviews are subject to resource availability.  In the event that an applicable system review or attestation is not available at the time of study initiation, the investigator should not sign a sponsor’s form verifying compliance of all site systems.  Sites may choose to retain back-up hard-copies of the electronic source data from that system with a stamp designating the copy “original to source”. 

NEW - Link to Final FDA guidance, Computerized Systems used in Clinical Investigations, May
           2007