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.

Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper 12 February 20260

Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper

The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review". 

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 27 April 20250

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The eClinical Forum is releasing its 8th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA, TFDA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

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

08 November 2024

Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

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