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 ForumThe 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 Americas Autumn workshop is now open!

Published on 03 August 2025

Registration for the eCF Americas Autumn workshop is now open!

Oct 21-23, 2025 in Indianapolis, Indiana USA

Event date: 21/10/2025 - 23/10/2025 Export event

eClinical Forum Americas Workshop:  October 21-23, 2025

The workshop will feature the below sessions (and there are still some open slots if you have a suggestion/presentation to offer). It 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 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.

 

Meeting Topics are being developed:

  • Direct Data Entry Panel Discussion (looking for panelists)

  • Innovations in Centralized Monitoring (looking for presenters)

  • Direct access to EHR/EMR Systems for Monitors (looking for presenters)

  • Risk-based Monitoring

  • EHR2EDC

  • Using Synthetic Data Arms

  • Also an open spot for an "innovation" topic... Please contact us!!

 Meeting will take place at:  Lilly Corporate Center, 893 S Delaware St, Indianapolis, IN 46285

Please register early! The room is limited to 40 people. Any company registering >2 people will have the "extras" put on a waiting list. Waiting list seats will be announced 3 weeks prior to the workshop (Oct 1).

For more information or to register, please contact webmaster3@eclinicalforum.org. 

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