The eSOURCE-READINESS ASSESSMENT TOOL (eSRA)

The tool contains questions based on regulations and regulatory agency guidelines for clinical research data sources and should be used to evaluate the suitability of an Investigator Site computerized system to provide data for clinical trials. An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs and representatives from sites, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized system's ability to be compliant with clinical research regulations.

Clinical research draws on a combination of data collected during a clinical trial and historical medical information relating to the research subject(s). Many of the data points needed for clinical research are originating in Electronic Health Record Systems, making them "eSource" for clinical research. Even if these data points are not used directly from the site's healthcare system, but are re-entered into a Sponsor's system for a clinical trial, the source of the information (the healthcare system) must still be confirmed as compliant with standards set forth in clinical research regulations and applicable guidance documents.

The eSRA Questionnaire Version 2024 can be downloaded as part of the eSRA Handbook below. (This version incorporates changes based on the EMA Guideline on computerised systems and electronic data in clinical trials.)

Notice to those intending to include eSRA in their own materials: Copyrighted by the eClinical Forum 2024. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. We welcome eSRA to be used in other formats, however, it is required that eSRA text be used exactly, that all eSRA questions are included, that your use of eSRA is updated when eCF eSRA is updated, 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 the eSRA materials as distributed via the eClinical Forum website. If using the eCF form, downloaded from this website, in it's 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 eSRA questions should be updated. To be notified of future releases of the eSRA Questionnaire, 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 eSRA.

Sponsors & CROS -- Please take our very brief survey regarding how you are using eSRA. This will help us improve eSRA. Survey link: eCF eSRA Survey (eclinicalforum.org) THANK YOU!!!

Do we keep a list of sites that have completed eSRAs?

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 eSRA questionnaire, 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 eSRA from. We encourage sites to store their completed eSRA in a central location (such as their IT department) so that other groups within the same organization / using the same electronic healthcare system, can use the completed eSRA as a basis to complete their own eSRA.

eSRA RESOURCES – Scroll to see all resources

Published on 13 April 2026

eCF Views & News

April 2026

eCF Views:

What’s new in the world of clinical research? Any questions you urgently need answers to, or topics that keep you up at night? Share them with your fellow eCF members on our eCF Discussion Forum.

1. EU AI Act Full Applicability Is Now Just Months Away - eClinical Tools Are in Scope

The EU AI Act becomes fully applicable on 2 August 2026. The European Commission has now made clarifying the research exemptions under Article 2, specifically covering pre-clinical research and product development for medicines and medical devices, a stated priority for 2026 implementation guidance. For global sponsors and eClinical technology vendors, the compliance window is now measured in months, and AI tools used in patient recruitment, eligibility screening, and endpoint assessment sit squarely in the high-risk frame. 🔗 EU AI Act Implementation — European Commission

2. AI as a Medical Device in Trials: Regulatory Fragmentation Remains the Core Problem

A PRISMA-guided scoping review published in PMC in March 2026 found that evidence and regulatory expectations for AI as a Medical Device in clinical trials remain fragmented across jurisdictions, with recurring unmet standards around predefined change management, performance drift controls, dataset representativeness, bias evaluation, and cybersecurity. Reporting frameworks such as SPIRIT-AI, CONSORT-AI, and MI-CLAIM are increasingly cited as practical mechanisms for improving regulatory readiness - worth building into AI validation SOPs now. 🔗 AIaMD Scoping Review — PMC, March 2026

3. AI-Driven Trials Are Outpacing IRB Oversight — A New Framework Responds

A paper published in Frontiers in Digital Health (late March 2026) argues that traditional annual IRB review frameworks are inadequate for AI-driven trials, where algorithmic bias and model performance degradation can emerge between scheduled reviews, and proposes a risk-sensitive interim review model with deviation-triggered audit mechanisms and quantitative risk thresholds. For sponsors and ethics committees, this is an early signal that IRB oversight SOPs may need a structural update as AI-driven trial designs become standard. 🔗 Wong C-S & Hsu T-W. Frontiers in Digital Health, 2026. DOI: 10.3389/fdgth.2026.1782

These articles are not endorsed by the eCF and don’t necessarily represent our own views

eCF News:

1. eCF Requirenments Members Release 2026 and Public Release 2025 now available

"Where does it say that?“ - If you work in Quality, Regulatory, or Validation for clinical trials, you’ve probably heard this question more times than you can count. The eCF Requirements, released annually by our Regulatory Expert Group (REG), provide a single reference mapped across FDA, EMA, ICH, PMDA, NMPA, MHRA, and TFDA for anyone working with electronic systems in clinical research. The eCF Requirements Public Release PR2025 is now available for free download on our website. For our members, the eCF Requirements Members Release MR2026 is also available in the Members document repository of the eCF. This year's update includes a new User Requirement for risk assessment of clinical trial computing systems, mapped to ICH E6(R3) and the EMA Computerised Systems Guideline. Log into your account and access MR2026 in the Members area.

2. Successful conclusion of eCF APAC Workshop Spring 2026

This year’s eCF Workshop Season was off to a great start with our Asia Pacific workshop, hosted by Novartis in Tokyo. We had two days of great presentations and discussions, particularly about Artificial Intelligence in Clinical Research - what is already used today, how to validate the different kinds of AI technology and what are potential new applications in our area. A big “Thank You” to Makoto Abe and the Novartis team for their great hospitality, and of course for all our participants for the lively discussions and fantastic insights! All presentations and more pictures can be found in the members area of our Webpage.

3. Registrations for 2026 Hybrid Workshop still open

There is still time to join us remotely for our European Workshop, April 14-16. Anyone from our member companies can register for free, and there are no seat limitations! Sign up here to participate remotely. Topics will include

Essential Metadata - report of our team meeting with EMA inspectors working group
Data Governance in Clinical Research
Current use and future opportunities of Artificial Intelligence in our industry
Regulatory Guidance on AI use in Clinical Research
Risk-Based Frameworks for Software Validation

4. More eCF News on LinkedIn!

After a little bit of a hiatus, our LinkedIn profile is up and running again. Follow us and be the first to know about new publications, webinar announcements, workshop insights and more!

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. Please feel free to forward this email to your colleagues. Please let us know if colleague(s) want to be added to this monthly distribution!

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Author: Jana Summa

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