WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

eSRA Handbook and Assessment Forms V2025

eSRA Handbook and Assessment Forms V2025

The one file you will need to complete an assessment of your e-Source or e-File systems.

Implementing eSRA - Sponsor Perspective

Implementing eSRA - Sponsor Perspective

This guideline provides additional information to sponsors/CROs evaluating the use of eSRA forms for their organisation.

V2025 vs V2024 and Regulatory Basis

V2025 vs V2024 and Regulatory Basis

Comparison of V2025 to V2024 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements

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

Japanese translation of Inv Site File Assessment V2024

  • 25 November 2024
  • Author: Kenichi Nakano
  • Number of views: 933
  • 0 Comments
Japanese translation of Inv Site File Assessment V2024

Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)

Japanese translation of eSRA V2024

Japanese translation of eSRA V2024

Version 2024JP1:  Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

The 2025 version is now available in the eSRA Handbook and Assessment Forms V2025. This version will be removed on June 30, 2025.

Investigator Site File System Assessment V2024 Handbook and Questionnaire

Investigator Site File System Assessment V2024 Handbook and Questionnaire

The 2025 version is now available in the eSRA Handbook and Assessment Forms V2025. This version will be removed on June 30, 2025.

Questions from eSRA Users

Questions from eSRA Users

This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team.

Instructions to save an immutable copy of just the completed eSRA without the handbook

Instructions to save an immutable copy of just the completed eSRA without the handbook

Step-by-step with screen shots

eSRA was used in a Japanese research paper on data quality of medical information systems

Japan Society for Medical Informatics

  • 26 August 2021
  • Author: Kenichi Nakano
  • Number of views: 2540
  • 0 Comments
eSRA was used in a Japanese research paper on data quality of medical information systems

Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."

RESULTS: Investigator Site Survey

2019

  • 31 October 2019
  • Author: Webmaster
  • Number of views: 25702
  • 0 Comments
RESULTS: Investigator Site Survey

Voluntary Investigator Site Survey survey concluded with 528 responses.

12

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«June 2025»
MonTueWedThuFriSatSun
2627282930311
2345678
91011
eCF “Birds of a Feather” Webinar:  Patient Voices: Transforming Healthcare Innovation

eCF “Birds of a Feather” Webinar:  Patient Voices: Transforming Healthcare Innovation

We will have a discussion with Savvy Cooperative on how engaging patient experiences can lead to better clinical, regulatory, and commercial outcomes.

Read more
12131415
16171819202122
23242526272829
30123456