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

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

Published on 12 April 2023

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

The eClinical Forum Archiving and Decommission Team is pleased to announce the public release of three white papers:

  • "Nature of a Distributed Trial Master File ‐ Practical Aspects"
  • "The Decommissioning of Computerised Systems Used in Clinical Trials" 
  • "Data Formats Used in Clinical Trials"

These white papers were written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE  PAPERS: These white papers provide details of the positions described in a position paper titled “Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials” released on 26/Feb/2021. 

Nature of a Distributed Trial Master File ‐ Practical Aspects: The Essential records consist of trial-specific, non‐trial-specific documentation, and data. The non‐trial specific essential records may be retained separately and signposted in the sponsor (e)TMF. The location of these records will vary depending on the type and source of the records in question. Consequently, the whole (e)TMF will span across multiple locations and be distributed among multiple parties. The aggregation of trial and non‐trial specific essential records must allow for the seamless reconstruction of clinical development activities, must be open to audits and inspections, and must fulfill all regulatory and legal purposes for the applicable full retention periods. This white paper is intended to provide hands‐on practical guidance on (e)TMF implementation by describing examples of risks in practice with proposed recommendation(s).

The Decommissioning of Computerised Systems Used in Clinical Trials: Clinical trials typically involve the use of multiple computerised systems and many of these systems are rarely developed for use in one trial alone. Instead, specific trial configurations are built on common platforms across multiple sponsors and contract research organisations (CROs). This white paper addresses the decommissioning of computerised systems such as EDC/eCOA systems used in clinical trials

Data Formats Used in Clinical Trials: There are disparate views in our current climate on how data should be archived and handled. This follows regulatory guidance that expects information to be available in a way that allows queries whilst understanding that such formats are not necessarily practical over the full retention lifetime. This white paper explains the options, risks, and benefits of using a flexible multiformat approach to ensure recall can be conducted in the future.

 

 

Comments (0)Number of views (1121)
Print

Documents to download