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 2024The 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

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

Published on 02 April 2024

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2024

This is the ONE FILE that you need to perform an eSRA Assessment.

This 2024 version has updates based on the EMA Guideline on computerised systems and electronic data in clinical trials.

- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess any site computerized system that could originate or handle electronic data that could become part of a clinical research study to determine it's suitability for this.  The questionnaire is based on regulatory authority expectations.

- Download the Handbook file and save to your computer. The instructions for completing eSRA are in section 3, and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors. One completed assessment can be sent to all of a site's sponsors.

Creative Commons License These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

Feedback is always welcome (both positive and critical) -- please send to esra@eclinicalforum.org. 

TO DOWNLOAD THE HANDBOOK & SITE FORM (ONE FILE), CLICK ON THE LINK UNDER "DOCUMENTS TO DOWNLOAD" BELOW.

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Author: Suzanne Bishop (Americas Administrator)

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