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 01 October 2024

eCF Views & News

December 2024

eCF Views: Join your eCF colleagues in these online discussions!

Some new chatter on these discussions…

eCRF Edit Checks and Cross-checks
Inter-company quality analytics around data

And these are still waiting for responses...

Use of clinical study data in medical evaluation
Performing IRT/eCOA UAT in a remote work environment
What are YOU wondering about ... please post your thoughts and get a conversation going!

Please login to the Discussion Forums (eclinicalforum.org) to respond or to read the full discussion … (You will need a member account to login … but it’s easy to get one .. just register via Home (eclinicalforum.org) … it can take up to 2 business days for your account to be confirmed.)

eCF News:

eCF Asia-Pacific workshop on Nov 11-12 near Tokyo, Japan. Thank you to all who participated and made this a very worthwhile time. Thank you to Clario for hosting us with wonderful food and venue. APAC members, please feel free to give us more topics you would like to talk/know about for the next workshop!

Dec 9, 2024: Online Birds-of-a-Feather round-table discussion “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation." To register: eCF BoF: Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation
Dec 12, 2024: FDA will hold a free hybrid public workshop that will focus on recent accomplishments, ongoing opportunities & challenges, and forward-looking initiatives regarding FDA’s Real-World Evidence Program for drugs and biological products. For more information and to register: Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products – Looking Forward
Jan 9, 2025: “How to get the most our of your eCF Membership” will be presented to all eCF member companies’ primary representatives as well as any other interested eCF members. Are you wondering what all the eCF does and how you can become more involved? eCF events and project team participation are available to all staff from an eCF member company … and all eCF members can help set the topics for discussion. This 45-min overview will be presented twice and will also be recorded. To register: eCF Overview 2025
Jan 16, 2025: eCF “Think GCP” webinar on ICH E6 R(3) has been rescheduled to Thurs Jan 16, 2025. 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. If you have already registered, there is no need to re-register and we will send you access information around Jan 10th. 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: eCF "Think GCP" Webinar: ICH E6(R3) (eclinicalforum.org)

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. Previous versions have been requested, in order to easily check the requirements that were in place in a particular year. You can find these in one place on our website: Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023. Current 2024 version is available only to eCF members in the login-side of our website.
The eSRA (eSource-Readiness Assessment) and ISFA (Inv Site File Assessment) teams have decided to join together as one team to maintain both of these valuable tools that we provide free to all sites and sponsors around the world. The combined team is “eCF Site System Assessment Maintenance” and will review outcomes of the REG team and decide if they have an impact on these 2 assessment tools. If anyone wants to join this team, please contact Suzanne.Bishop@eclinicalforum.org.
Japan Association of Clinical Study Textbook (JACST), a Japan non-profit organization, will include the eCF eSRA and ISFA in their pocket book for “International Clinical Trials” which lists global regulations/guidelines/reference materials: ポケット資料集のご利用案内. The Japanese translation of eSRA V2024 has been available on our website for a few months and the Japanese translation of ISFA has just become available on our website: Site Sys Assmts
FDA podcast on The Need for Artificial Intelligence in Pharmacovigilance - with Dr. Robert Ball (11 mins): fda.gov/media/183523/download?attachment=&utm_medium=email&utm_source=govdelivery
75th World Medical Association in October 2024 produced an update to the Declaration of Helsinki. This represents the ethical pillars for clinical trials, giving a full understanding of GCP: WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants – WMA – The World Medical Association
Invoices for the 2025 eClinical Forum membership dues have been sent out to the primary representative from each member company. The eCF Steering Committee has decided not to change the fees or fee structure from 2024. We kindly ask that all membership fees are received by the end of Q1 2025 in order to not disrupt services to our members. For more information, please contact Adam.Perkins@eClinicalforum.org .

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Author: Suzanne Bishop (Americas Administrator)

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