THE USE OF ELECTRONIC SOURCE DOCUMENTATION - V1.1 May 2003

This 13-page position paper on eSource (source data that has been captured by an electronic tool which is a replacement for paper) describes the regulatory environment for the ultimate benefit of all stakeholders involved in EDC.

eSource has been selected as a priority because of recently conducted surveys on the impact of EDC on Investigational sites. These surveys have revealed that the workload at sites using EDC may increase, despite the easier data entry that is being reported. The reason is linked to dissatisfaction with the multiple data entry being demanded due in part to the lack of clarity on the level of acceptance of eSource. For example, where patient data are being recorded in legitimate clinic electronic source records before being entered into the sponsor’s EDC system, some sponsors appear to be demanding the creation of additional paper records to act as source for the purposes of Source Data verification.

The position paper regarding eSource presents the general consensus of the EDM Forum rather than individual organisations. The paper was prepared as a response to ‘Draft Guidance for Industry: Part 11, Electronic Records, Electronic Signatures – Scope and Application’ in the expectation that the clarification of electronic source data would strongly support adoption of electronic technologies and reduce the cost of current EDC implementations.

Thes position paper details:

1. The EDMF definition of eSource, including
   • Electronic Patient/Hospital Records
   • Self-Assessment/Diary Data
   • E-CRF Data
   • Derived Electronic Data – Laboratory Results, ECG, EEG
2. The potential advantages and potential disadvantages of eSource
   • How eSource can objectively monitor patient safety and improve potential fraud identification
   • Our understanding of the current regulatory environment and the regulatory implications of eSource