Version 2025 has been released!!! This version includes updates based on ICH E6(R3) Good Clinical Practice.    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

Birds-of-a-Feather Round-table on eCOA Topics

Published on 22 July 2025

Birds-of-a-Feather Round-table on eCOA Topics

Aug 13, 2025 at UTC 1400

Event date: 13/08/2025 Export event

 

Background: eClinical Forum Birds-of-a-Feather webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

 

For This Topic: This session is not intended to provide firm answers to the below questions. It is about exchanging views with other participants and gaining insights into the different challenges and needs. This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. To encourage candid discussion, we will not be recording this session

This is a continuation of the eCF eCOA Round table from July 9th (as well as discussions at the Spring workshops), as we had so much discussion that we did not finish all the topics!

 

This time we will discuss:

  1. Are Sponsors submitting to FDA item level QSSTAT and QSREASND for item level for reasons not done?

  2. Are Sponsoring submitted to FDA, ZQ datasets following the IRT Guidance?

  3. What are the challenges for Sponsor UAT execution?

Reference: Submitting Clinical Trial Datasets and Documentation  for Clinical Outcome Assessments Using  Item Response Theory.  FDA Guidance:  Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory | FDA

This Round-table will be facilitated by Jeanna Radick and Trish Delong of Johnson & Johns

Anyone from an eCF Member Company may register for this online round-table discussion by sending a note to WEBINARS@ECLINICALFORUM.ORG 

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Author: Suzanne Bishop (Americas Administrator)

Categories: Webinar/Telecon, Electronic Data Capture, Visible by Public

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