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

Implementing eSRA: Sponsor Guide 2026 04 May 20260

Implementing eSRA: Sponsor Guide 2026

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

V2026 vs V2025 and Regulatory Basis 04 May 20260

V2026 vs V2025 and Regulatory Basis

Comparison of V2026 to V2025 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements

eSRA Handbook and Assessment Forms V2026 04 May 20260

eSRA Handbook and Assessment Forms V2026

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

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

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