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

Published on 03 February 2024

eClinical Forum has released the 2024 version of their “eSource Readiness Assessment” – eSRA

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 .

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Author: Suzanne Bishop (Americas Administrator)

Categories: PRIVACY, Visible by Public

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