eClinical Forum has released the 2024 version of their “eSource Readiness Assessment” – eSRA.  It is a response to the growing expectation by regulatory agencies for clinical trial sponsors to verify that clinical research site systems (e.g., EHRs) comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment.  In particular, the EMA Guideline on computerised systems and electronic data in clinical trials (effective Sep 2024) states s in A6.2: “the sponsor should assess the systems in use by the investigator/institution to determine whether the systems are fit for their intended use in the clinical trial (e.g. include an audit trail). The assessment should cover all computerised systems used in the clinical trial and should include consideration of the rights, safety, dignity and wellbeing of trial participants and the quality and integrity of the trial data. If the systems do not fulfil the requirements, the sponsor should consider whether to select the investigator/institution. The use of systems not fulfilling requirements should be justified, either based on planned implementation of effective mitigating actions or a documented impact assessment of residual risks.”

eSRA is a free tool and easy to access via one .pdf file that includes a Handbook and Assessment questionnaire. It can be downloaded from eSRA (eclinicalforum.org)   It truly is free – we are not gathering your email or other identifying information in return.

From the EMA Guidance mentioned above, and FDA’s guidance “Use of Electronic Health Record Data in Clinical Investigations” (July 2018), and the EMA reflection paper on eSource (June 2010), there is a clear expectation that sponsors evaluate the healthcare systems that may provide data for their studies. However, identifying all global requirements for these site systems can be a daunting task for sponsors, investigative sites and technology vendors.  To add to the complexity, sponsor companies have varied ways of assessing and documenting an site system’s readiness for use in clinical research, making it time consuming for sites to comply.

The eClinical Forum, a non-commercial, non-profit global organization with over 45 organizations active in clinical research, has established criteria to allow compliant use of data from healthcare systems for regulated clinical research. Their eSource Readiness Assessment (eSRA) questionnaire has been created with sponsors and research sites to simplify the self-assessment of research site systems. It is a standardized approach and free of charge. It allows sites to reuse their assessment across all their clinical trial sponsors.  It provides all users (clinical research sponsors, CROs, sites, regulators, technology vendors) with the ease of a common assessment that is solely based on regulatory guidance. eSRA has already been used in several thousand sites worldwide since 2016. The 2024 version has been updated based on regulatory guidance issued during 2023.

Many valuable resources are available for free download on eSRA (eclinicalforum.org).

• eSRA Handbook and Assessment Questionnaire V2024 – this is the one document sites will need to download to complete an eSRA
• Implementing eSRA: Sponsor Perspective V2024 – white paper discussing different aspects sponsors may want to consider
• “Differences between eSRA 2024 and eSRA 2023” – this document shows the updates made from V2023 to V2024. These were made based on updates to underlying regulatory documents and to facilitate easier understanding of the questions by the site staff.
• Regulatory basis for V2024 eSRA questions
• Japanese Translation of eSRA Handbook and Questionnaire – Currently, only the translation of eSRA V2023 is on our website …We are working on a 2024 version and it will be on our website in a few weeks. Please check back!!

As always, we appreciate your feedback and questions regarding eSRA. We are particularly interested if sponsors or CROs evaluate eSRA and decide instead to make their own site system assessment as we feel strongly that sites are best served by being able to complete one system assessment (eSRA) to provide to all of their sponsors. Please send comments and questions to esra@eclinicalforum.org .