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

18 September 2024

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

Recording available from our public webinar which provided information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. These tools are absolutely free to download as a service to the industry that we serve; we do not even collect email or other information.

Japanese translation of eSRA V2024 20 May 20240

Japanese translation of eSRA V2024

Version 2024JP1 (20-May-2024)

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

This is the ONE FILE that you need to perform an eSRA Assessment.

Investigator Site File System Assessment V2024 Handbook and Questionnaire 02 April 20240

Investigator Site File System Assessment V2024 Handbook and Questionnaire

This is the ONE FILE that you need to perform an ISF Assessment.

Implementing eSRA - Sponsor Perspective 31 January 20240

Implementing eSRA - Sponsor Perspective

How to assess site's systems for appropriateness of use for regulated clinical research. (Applies to both eSRA and ISF Assessment 2024.)

Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment) 31 January 20240

Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment)

Differences between eSRA V2024 to eSRA V2023 31 January 20240

Differences between eSRA V2024 to eSRA V2023

What has changed?

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.

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

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