LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.

ECF Teams and Projects

eSRA Handbook and Assessment Forms V2025 25 April 20250

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 24 April 20250

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 23 April 20250

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

26 November 2024

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 20240

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 20 May 20240

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 02 April 20240

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 02 April 20240

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 30 January 20240

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.

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