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

Published on 18 September 2024

Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments

The eClinical Forum provided a webinar on 18-Sep-2024 to provide information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. These tools are absolutely free to download as a service to the industry that we serve; we do not even collect email or other information.

“eCF Requirements” - The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents (FDA, EMA, PMDA, NMPA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data. Each Requirement has, as its basis, one or more statements from one or more of these regulatory documents. The eCF Requirements can be used to determine if systems are consistent with regulatory requirements, and if systems and process that manage these data have the necessary features.  This set of requirements is the result of countless hours of discussion among regulatory experts from the eClinical Forum member organizations over the past 15 years. It is updated annually.

“eSRA” – The eClinical Forum’s free Investigator Site self-assessment, of the readiness of their healthcare systems to originate data that could be used in a regulated clinical trial, is based on the eCF Requirements and thus each question is grounded on one or more regulatory document statements.  It is easy to access and easy to use and has been used by thousands of sites around the globe and many pharmaceutical sponsors and CROs since it’s launch in 2015. It is updated annually. 

“ISF System Assessment” – A sister assessment to eSRA, this assessment (also free to download from the eCF website), was launched in April 2024 and provides an assessment for sponsors to determine if a site’s Investigator Site File System (or “Site Trial Master System”) is appropriate for holding information for their regulated clinical trial.  It is also based on eCF Requirements/regulatory authority statements. It will be updated annually.

The public version of the eCF Requirements can be downloaded at: Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) (eclinicalforum.org)

The eSRA and ISF Assessments can be downloaded at: https://eclinicalforum.org/site-sys-assmts

To review the 37-min webinar or download the slides, please see below.

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