eClinical Forum is 25 years old this year!  eSRA V2025.3 is celebrating with our new logo (no other content changed).  eSRA has been used globally since 2016!!

The eClinical Forum offers 2 absolutely free system assessment forms that consist of regulatory-based questions for evaluating the suitability of an investigator site system to provide data/records for clinical trials.Both forms are part of the eSRA Handbook which provides guidance to sites on how to complete the forms.  We request that Sponsors and CROs do not separate the forms from the handbook. Sites may separate the forms from the handbook after completion such that they are only sharing and storing the completed forms.

  • Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
  • Form/F for e-Investigator Site File Systems
  • A Japanese translation of eSRA V2025

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. By using these materials, you acknowledge the terms and conditions for use as described in the eSRA documents.  The eClinical Forum is only responsible for materials as distributed via the eClinical Forum website. If using the eCF forms downloaded from this website in original formats, there is no need to notify eCF.

Stay Current!!

eSRA materials are updated annually and released at the end of Q1. To be notified of future releases and/or to provide feedback to the team, please send an email to eSRA@eClinicalForum.org.  Your email address will not be used for purposes other than to inform you of updates to eCF Site System Assessments.

Does the eClinical Forum keep a list of sites that have completed eCF Site Assessments?

Due to privacy laws in different countries, we do not keep such a list, however sponsors can keep a list of eSRAs they have received.We encourage sites to store their completed assessments in a central location (such as their IT dept) so that other groups within the same organisation / using the same computer system, can use the previously completed assessment as a starting point.

eCF Site System Assessment Resources – Scroll to see all resources

Registration for the eCF Asia Autumn workshop is now open!

Published on 20 August 2025

Registration for the eCF Asia Autumn workshop is now open!

Nov 13-14, 2025 in Tokyo, Japan

Event date: 13/11/2025 - 14/11/2025 Export event

eClinical Forum Asia Workshop:  November 14-15, 2025

The workshop will feature the below sessions. There are still some open slots -- if you have a suggestion/presentation to offer, please contact us soon. It 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 Rep. 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 (and gratis to all eCF members).

 

 

Meeting Topics are being developed: (Please contact us if you want to participate in any of these presentations and/or have another topic to offer.)

  • Direct Data Entry Panel Discussion

  • Innovations in Centralized Monitoring

  • Direct access to EHR/EMR Systems for Monitors

  • EHR-to-Sponsor

  • Using External Data Arms and Real World Data

  • Topics in AI relating to "eClinical"

 Meeting will be hosted and take place at:  Kyowa Kirin

Please register early! The room size is limited.

For more information or to register or to offer to present, please contact Sean.Higashio@eclinicalforum.org. 

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Author: Suzanne Bishop (eCF Facilitator)

Categories: EVENTS, Asia Pacific Meetings, Visible by Public

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