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

Digital Health Technologies Governance

Digital Health Technologies Governance

This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators.  Address the problem of generic regulations and create industry guidelines more tangible and actionable.

4 September 2024 0
127
Audit Trail Review Analytics (ATRA)

Audit Trail Review Analytics (ATRA)

Team started in August 2024.  The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor companies and technology vendors.

16 July 2024 0
378
Essential Metadata

Essential Metadata

The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.

29 January 2024 0
419
Artificial Intelligence and Machine Learning

Artificial Intelligence and Machine Learning

The joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.

2 November 2022 0
843
Decentralised Clinical Trials

Decentralised Clinical Trials

The DCT Working Group is a joint effort between eClinical Forum and EUCROF. The team's objectives are to define DCT terms and to develop position papers and roadmaps on DCT solutions that simplify patient and site experiences. 

2 November 2022 0
739
Investigator Site File (ISF Assessment)

Investigator Site File (ISF Assessment)

Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.

14 October 2022 0
972
Principal Investigators’ Signatures

Principal Investigators’ Signatures

Aligning the existing eCF best practices document with the most recent regulatory expectations

4 March 2021 0
5545
Audit Trail Review

Audit Trail Review

Best practices for meeting regulatory expectations for Audit Trail Review

29 January 2019 0
4070