eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

eSRA Maintenance Working Group

eSRA (eSource-Readiness Assessment) is a questionnaire used by sites to self-evaluate their electronic systems that may originate or manage data for clinical research.  It has been provided, free of charge, since 2016 and is updated annually, based on updates to the underlying regulatory documents and new interpretations from regulatory authorities.  It was developed and continues to be updated, with extensive participation of global biopharma, CROs, technology providers, academia and with regulatory review.

It is important that site systems that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors ultimately bear the responsibility for ensuring that data harvested from these systems are acceptable, and investigators are frequently being asked to complete sponsor-specific assessments of their electronic record systems.  The eSRA project has developed a free tool that vendors and sites can use to quickly and easily evaluate their systems once for all sponsors, CROs, and regulators.

The tool offers a series of questions based on FDA, EMA and PMDA regulations and guidances. A 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 sites to quickly provide the information needed by sponsors on GCP compliance of systems holding source data and will enable sponsors to evaluate and manage risk.

The eSRA Maintenance Working Group welcomes all feedback/questions on any of the eSRA materials offered via their web page (www.eclinicalforum.org/esra).  Please send feedback to esra@eclinicalforum.org.  All feedback/questions will be responded to.