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 13 May 2024

Assessing Investigator Site File Systems for Clinical Research

By Pablo Perez, Lead Quality Assurance Data Integrity, Astellas

Assessing Investigator Site File Systems for Clinical Research

This article was compiled using information from the eCF eSRA and eISF Teams by: Pablo Perez, Lead Quality Assurance Data Integrity, Astellas

More and more, clinical research sites are implementing electronic systems for managing essential records generated from conducting a clinical trial. Sites are either internally developing a system or purchasing an off-the-self solution. In either case, the records that the system will manage must meet data integrity principles, global regulations and regulatory guidelines for Good Clinical Practice (GCP) from FDA, EMA, MHRA PMDA and ICH to be acceptable for use for the clinical trial. The recent EMA “Guideline on Computerized Systems and Electronic Data In Clinical Trials”[3] section 4.6 Criticality and Risks, states “For systems deployed by the investigator/institution, the sponsor should determine during site selection whether such systems (e.g. electronic medical records and other record keeping systems for source data collection and the investigator site file) are fit for purpose.”

The eClinical Forum[1], a transatlantic, not-for-profit and non-commercial, technology independent group representing members of the pharmaceutical, biotechnology, and allied industries have created an assessment tool that is available for free to both Sponsors and Sites. The assessment tool is to determine GCP compliance of a site’s Electronic Investigator Site File (eISF) System for managing essential records used in a regulated clinical trials. Completing the tool is not a regulatory requirement; however, it may be used to demonstrate that regulatory requirements have been satisfied. Sponsors and sites can use the assessment to discuss any potential risks and appropriate mitigations. NOTE: Sponsor-supplied systems do not need to be assessed by the clinical research site. This assessment is only intended for investigator site supplied systems.

The eClinical Forum ISF assessment tool contains a set of questions based on regulations and regulatory agency guidelines for electronic systems used in clinical research as identified in the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials[2] ”.  

The ISF assessment tool is available for free download (no information is collected in return), along with its “sister” assessment tool for assessing clinical reasearch source systems (e.g. patient medical records systems) from their website at www.eclinicalforum.org/site-sys-assessments.

The eISF assessment tool is of great benefit to all players in the clinical research realm. In particular, the following should be noted:

Clinical Investigators

  • Clinical Investigators are encouraged to use this tool to assess their systems, for which they are responsible, that manage essential records that will be used in a clinical trial.
  • A site should be aware that a “No” answer to a question does NOT mean that the site will be rejected, but rather that the Sponsor will work with the site to ensure that any potential risk is mitigated.
  • It is the site’s responsibility with respect to system installation, validation and maintenance. This may be handled by their organization’s IT department and/or a vendor. In these cases, the site is still responsible for ensuring that these other parties are fulfilling these responsibilities for any system providing data/documents in the clinical trial through a contract/agreement.
  • Sites should retain a record of this assessment for use in improving their system and processes and to assist them with future system assessments.
  • A site can avoid multiple requests from different Sponsors for information pertaining to regulatory appropriateness of their system, as the same completed eISF assessment can be given to each Sponsor they work with for review.

Sponsors / CROs

  • Sponsors are encouraged to ask sites to use this assessment tool to determine if a site’s eISF is GCP compliant.
  • Sponsors should obtain a completed assessment from their site and this assessment should be retained in their Trial Master File.
  • Sponsors may have additional questions for determining if a site is suitable for their clinical trial; however, the questions in this assessment are the minimum requirements based on US, EU and Japan regulations, guidance documents, directives and reflection papers. A list of all regulatory documents used as a basis for the assessment can be found at www.eclinicalforum.org/esra.aspx. 
  • The assessment tool does not “certify” or “qualify” the site’s system but merely provides information to the Sponsor for evaluation of the appropriateness of site’s eISF. 
  • It is up to each individual Sponsor to review a completed a completed eISF assessment and does not provide certification or an “answer” as to whether the site as a whole is appropriate – it only indicates the site responses to each question. If a site is not compliant with all the questions, we recommend that the Sponsor work with the site to find suitable mitigations for the potential risks. 
  • If after reviewing a completed eISF assessment from a site, the Sponsor believes there are too many risks to warrant using the system, then the system (and perhaps the site) should not be used for clinical research. However, the site may be given a period of time to make necessary adjustments to comply with questions in the assessment and may ultimately comply such that the system can be used for clinical research.

Regulators

  • Regulators benefit by a common assessment that is mapped to US, EU and Japan regulations, guidance documents, directives and reflection papers. 

The eClinical Forum commits to updating the eISF assessment questions as needed when updates are made to the underlying regulatory documents and/or new pertinent documents are released from any of the regulatory authorities listed above. The eISF Handbook and Assessment template can be downloaded for free at  www.eclinicalforum.org/site-sys-assmts.

All are encouraged to provide feedback to the eClinical Forum regarding interpretations of regulations, eISF assessment questions, etc. via ISFA@eclinicalforum.org.

___________________________________________________________

[1] The eClinical Forum’s mission is to serve the clinical research industry by focusing on those systems, processes and roles relevant to electronic capture, handling, and submission of clinical data.  For further information on the eClinical Forum, visit the website at http://www.eclinicalforum.org.

[2] “eCF Requirements for Electronic Data for Regulated Clinical Trials” is available to the public at www.eclinicalforum.org/downloads.

[3] EMA Guideline on Computerized Systems and Electronic Data In Clinical Trials https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf

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Author: Suzanne Bishop (Americas Administrator)

Categories: eInvestigator Site File Questionaire (eISFQ), Visible by Public, Press Article

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