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

Japanese Translation: eSRA Handbook and Assessment Forms V2025 30 June 20250

Japanese Translation: eSRA Handbook and Assessment Forms V2025

の日本語版2025.2JP1が2025年6月30日にリリースされました。

eSRA Handbook and Assessment Forms V2025.3 25 April 20250

eSRA Handbook and Assessment Forms V2025.3

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

Questions from eSRA Users 09 April 20250

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.

26 November 2024

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

Instructions to save an immutable copy of just the completed eSRA without the handbook 24 March 20230

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 26 August 20210

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 31 October 20190

RESULTS: Investigator Site Survey

Voluntary Investigator Site Survey survey concluded with 528 responses.

12