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 Europe Autumn Hybrid Workshop is now open!

Published on 19 August 2025

Registration for the eCF Europe Autumn Hybrid Workshop is now open!

Nov 4-6 in London, United Kingdom

Event date: 04/11/2025 13:00 - 06/11/2025 15:00 Export event

eClinical Forum Europe Workshop:  November 4-6, 2025

The workshop will feature the below sessions. There are still some open slots, and we'd love to hear from you if you have a suggestion/presentation to offer. The workshop will be available for both in-person participation as well as remote access via live streaming. For in-person participants, networking and social events are planned for both evenings. Each eCF Member company can use 1 or 2 seats depending on membership type and as allocated by your eCF Primary   Rep.Remote access of the live-streamed workshop is available gratis to all staff from eCF Member companies.

 

 

Meeting Topics are being developed:

  • Direct Data Entry Panel Discussion 

  • Innovations in Centralized Monitoring (looking for presenters)

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

  • EHR-to-Sponsor

  • Using External Data Arms and Real World Data

  • Topics in AI

  • There's also an open spot for an "innovation" topic... Please contact us!!

The meeting will take place at:  Medidata, 12 Hammersmith Grove, Hammersmith and Fulham, London W6 7AP, United Kingdom

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 (Nov 14).

For more information, please contact jana.summa@eclinicalforum.org

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Author: Jana Summa

Categories: EVENTS, Europe Meetings, Visible by Public

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