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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.
eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
eCF Webinar: "Strategies for Implementing Audit Trail Review"
The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.
Registration for the eCF Americas Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Indianapolis, Indiana on October 21-23, 2025.
The workshop will be available for in-person participation only. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14
Registration for the eCF Europe Autumn Hybrid Workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Medidata in London, UK, on November 4-6, 2025
The workshop will be available for both in-person participation and remote access. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 in-person seats depending on your membership type and as allocated by your eCF Primary Representative. Remote access of the live-streamed workshop is available gratis to all staff from eCF Member companies. Click to get more information on the planned topics.
Registration for the eCF Asia Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.
The workshop will be available for in-person participation only. There will be a networking/social event in the evening. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics.