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:

  • e-Source-Readiness Assessment (eSRA)
  • e-Investigator Site File System Assessment (ISF Assessment)

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. In 2024, the The ISF Assessment, based on eSRA, was released on the request of our eSRA users.  The eCF intends to publish an update to these materials annually, in Q1, to keep current with regulations and guidelines.

  • Each assessment form is packaged in a handbook providing guidance to sites on how to complete the form. The form should not be separated from the handbook, except after completion. 
  • The document “Implementing eSRA – Sponsor Assessment”, while written for eSRA, applies equally to implementing the ISF Assessment.
  • A joint document, “Regulatory documents used as a basis for the eClinical Forum eSRA and ISF Assessments” shows the correlation between these 2 assessment tools and the underlying regulatory documents.

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 2024. 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 form, downloaded from this website in its original format, 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 eSRA and ISF Assessment and/or to provide feedback to the team, please send an email to eSRA@eClinicalForum.org or  ISFA@eClinicalForum.org.  Your email address will not be used for purposes other than to inform you of updates to eSRA and ISF Assessment.

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 questionnaires (eSRA and ISF Assessment), free of charge, to anyone who wants to use it. 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 eSRA or ISF Assessment 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 February 2025

eCF Views & News

February 2025

 eCF Views: New thoughts from your fellow eCF members … what do YOU think?

    • What is the definition of a Triple-blind study vs definition of a Double-blind study?
    • How should we handle privacy data that are in audio recordings (e.g. eConsent)?
  • Post your thoughts! 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 .. register via  Home (eclinicalforum.org).

  eCF News:

  • eCF 25th Anniversary Fun-Fact: In 2000, we were called the “EDC Forum” and started in Europe with 11 pharmaceutical companies and 8 “allied associates” from the vendor/service industry. Over the years, many were acquired or merged, but 8 of the original founding members are still members in 2025: Bayer, Eli Lilly, Johnson & Johnson, Medidata, Novartis, Novo Nordisk, Oracle (acquired our founding member Phase Forward), Pfizer (merged with our founding member Pharmacia).  Now, 25 years later, the eCF has grown to include 2700+ participants from 62 organisations in 36 countries. Want to know who are members now? See our graphic on the Membership page:  Membership  eCF, Going strong!
  • “How to get the most out of your eCF Membership 2025” slides are available from our website: Downloads, and a recording of the webinar given on Jan 9th is available in the Members section of our website: Getting the most out of your eCF Membership > Webinar Recordings. Of course, if you want to discuss details of your organisation’s membership, your eCF facilitators are happy to discuss (see below for contact information).
  • February is a very busy month for eCF! Check out these events (These are eCF members-only events and are gratis to anyone from an eCF member organisation.):
    • Feb 5, 2025: Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping. This technology showcase will be presented by Achilleas Zaras of eClinical Solutions at both UTC 0800 and UTC 1700 and recorded.  To register, please contact Suzanne.Bishop@eClinicalForum.org.
    • Feb 6, 2025 (rescheduled from 16-Jan-25): eCF “Think GCP” webinar on ICH E6 R(3). This presentation will be given by Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3). This will occur at 2 times: UTC 0900 and UTC 1600. This webinar will not be recorded, so please encourage your colleagues to block out their calendars and join us! (Note, this webinar is for those in eCF member companies only.) To register, please contact Suzanne.Bishop@eClinicalForum.org.
    • Feb 20, 2025: Webinar: Audit Trail Review – Is your Audit Trail fit for purpose? Given by Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM) at UTC 15:00 (NYC 10am; Brussels 4pm; Mumbai 8:30pm; Beijing 11pm). eCF members can register by using this link:  eCF Webinar: Audit Trail Review
  • And this one in March!
  • Mark your calendars for the eCF 2025 Spring workshops!
    • Americas workshop – April 29-May 1, kindly hosted by CSL Behring near Philadelphia, Pennsylvania, USA (This workshop is in-person only.)
    • European Hybrid workshop – May 13-15, kindly hosted by Pfizer near London, UK (This workshop will be in-person and live-streamed and is gratis to anyone from an eCF member organization.)
    • Additional information: eCF Spring 2025 Workshops Announced.   More information will also be sent to eCF members soon!
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Author: Suzanne Bishop (Americas Administrator)

Categories: PRIVACY, Visible by Public

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