eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data for Clinical Trials (ACDM UK 10Mar14)

Investigators are frequently asked to complete sponsor-specific assessments of their EHR systems to enable sponsors to evaluate clinical trial data that will be sourced from these systems. The eClinical Forum has developed a free, standard tool that can help sites to do this quickly, easily, and once for all sponsors.

This presentation provides an overview of the assessment tool and information on access and use.

Key points:

• • Why assess EHR systems
  • Why develop and use a standardized tool
  • The self-assessment tool – process, content, system
  • Feedback
  • Implementation

It is important that electronic health record systems (EHRS) that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors bear the responsibility for ensuring that data sourced from these systems are acceptable. As a result investigators are frequently being asked to complete sponsor-specific assessments of their EHR systems. 

The eClinical Forum, a non-commercial, global organization has developed a free and standard self-assessment tool that can help sites to do this quickly, easily, and once for all sponsors.  With the aid of information provided by their EHR vendor, the site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place.

Using this assessment tool will enable sponsors to evaluate and manage risk. Regulators and sponsors should feel confident in the quality of eSource coming from assessed sites.