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

The eClinical Forum offers 2 system assessment forms for investigator sites, sponsors, CROs, and regulators to use free of charge, to evaluate the suitability of an investigator site system to provide data/records for clinical trials. They are:

  • Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
  • Form/F for e-Investigator Site File Systems

The 2 system assessment forms contain questions based on regulations and guidelines from global regulatory agencies for clinical research.  Since 2016, eSRA has been globally in use and regulators have accepted its inclusion in study materials. The eCF intends to publish an update to these materials annually, in Q1, to keep current with regulations and guidelines. (Note -- in 2025, we released in April in order to include updates from ICH E6(R3) GCP which was released in Jan '25).

  • The 2 eSRA Forms (Form/S and Form/F) are attached to 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.
  • Sponsors and CROs can get additional guidance in “Implementing eSRA – Sponsor Assessment”
  • “Comparison of V2025 to V2024 and regulatory basis" shows the correlation between the 2 assessment forms and the underlying regulatory documents as well as what changes were made from the 2024 version.

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum in 2025. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the Handbooks and “Implementing eSRA” Guide. We welcome our assessment forms to be used in other formats, however, it is required that all question text be used exactly, that all questions are included, that your use is updated when the eCF forms are updated (annually, Q1), and that eClinical Forum is notified in writing and credited. By using these materials, you acknowledge the terms and conditions for use.  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!!

As new regulations are released or updated, the eClinical Forum will evaluate if the site system assessment form questions should be updated. To be notified of future releases of the eClinical Forum Site System Assessment Forms 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.

Do we keep a list of sites that have completed eCF Site Assessments?

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the site system assessment forms free of charge.. We encourage sponsors to keep a list for themselves of which sites they have received a completed assessment from. We encourage sites to store their completed assessments in a central location (such as their IT department) so that other groups within the same organization / using the same computerised system, can use the previously completed assessment as a starting point.

eCF Site System Assessment Resources – Scroll to see all resources

eCF Views & News

Published on 01 April 2025

eCF Views & News

April 2025

eCF Views: The conversations continue…

    • Discussion on: Validation of Systems used for Real World Data / Real World Evidence capturing/processing/analysis/reporting (several new discussions have been added to this thread since last month)
    • Discussion on: Inspectors' direct access into data acquisition tools
    • Or...Start a new discussion! (none are too narrow or too broad). Just  login to the  Discussion Forums (eclinicalforum.org)  … You will need a member account to login … but it’s easy to get one .. anyone from an eCF member organization can register via  Home (eclinicalforum.org).

 

  eCF News:

  • Welcome to our newest eClinical Forum members, YPrime and Evinova!!
  • eCF 25th Anniversary Fun-Fact: As you know… eClinical Forum is a “Discussion and Action Group” and as such, we have launched many project teams over the past 25 years. Here’s a look back into the different topics that the teams have dealt with (those with * are currently active): Artificial Intelligence and Machine Learning (AI/ML)*, Archiving and Decommissioning, Audit Trail Review, Audit Trail Review Analytics (ATRA)*, Data Standards Governance, Decentralised Clinical Trials (DCT)*, Digital Health Technologies Governance (DHT)*, eCOA Data Changes, eConsent, EDC eSource Checklist, EDC Hosting, EDC Performance Metrics, EDC Scale-up, EHRCR (Electronic Health Records for Clin Rsch), eISF Site System Questionnaire*, ePRO Validation, eSource Readiness Assessment (eSRA)*, Essential Metadata*, eTMF, Investigator Site Survey, PI Signatures, Regulatory Expert Group (REG)*, Risk-based Monitoring, RWE Guidance, Trial of the Future, Trial Reconstruction, Unified Vendor Audit, Unique Investigator IDs. Please see Teams/Projects for more information on active teams.
  • Are you waiting for the 2025 version of the REG team’s Requirements for Electronic Data for Regulated Clinical Trials (“eCF Requirements) or the 2025 version of the eSource Readiness Assessment or the Investigator Site File System Assessment? We typically have the annual release out by the end of March. However, the teams are still sifting through ICH E6 R3 and making appropriate updates to these eCF tools. We hope to have all 3 of these tools released in a few weeks. You will get an email when they are released. Thank you to the REG and eSRA teams for your diligence here!!
  • Digital Health Technologies Governance Survey -- The eCF DHT team are working on identifying gaps in regulatory guidance on DHTs. They are seeking additional information regarding this topic from eCF members. Please participate in their brief survey: Survey link: Digital Health Technologies Governance - Survey of eCF Members. This topic will be presented at all 3 eCF Spring workshops (including the live-stream workshop on May 13-15 in which remote access is gratis to anyone from an eCF member company… see below.)
  • The Audit Trail Review Analytics team will be releasing their draft paper for review/comment soon. If you want to be part of the review team, please contact Suzanne Bishop.
  • Recording available: Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention – AiCure discussed the importance of engagement with clinical trial participants and innovative AI strategies to improve it:  Using AI to improve patient adherence, compliance and retention > Webinar Recordings
  • Our 3 eCF Spring workshops are coming up fast!  Each eCF member company has seats that can be used at any workshop, depending on their membership type (please contact your eCF primary representative to obtain approval to use a seat). In addition, the European Hybrid workshop will be live-streamed and anyone from an eCF member company can join remotely, gratis (see registration below).
    • All 3 workshops have similar agendas, with topics including Risk Based Monitoring ROI, eSource Myth Busting, Audit Trail Review Analytics, Decentralised Trials, Digital Health Technologies/Measures, Challenges in eCOA, ICH E6 R3 select discussion topics, AI Round tables.
    • India workshop April 8-10 – kindly hosted by i2e in Bangalore, India. Online registration for this workshop is now closed. Please contact Sean.Higashio@eClinicalForum.org for more information or last minute registration.
    • Americas workshop April 29-May 1 – kindly hosted by CSL Behring in King of Prussia, Pennsylvania USA. In-person only, however seats are filling up. Please contact Suzanne.Bishop@eclinicalforum.org to see if your organization has any seats still available.
    • European Hybrid workshop May 13-15 -- kindly hosted by Pfizer in Walton Oaks, Surrey, UK. In-person and live-streamed; registration: eCF Hybrid Workshop Walton Oaks 13-15 May 2025
  • Webinar: Patient Advocacy in Clinical Research – June 11 at 10am EDT/1600 CEST/1930 IST , Presented by Savvy Cooperative (savvy.coop); keep an eye on your inbox for an email with more information and registration!

 

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Author: Suzanne Bishop (Americas Administrator)

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