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Japanese Translation: eSRA Handbook and Assessment Forms V2025

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

Updated with the new eCF logo!

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

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

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

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.

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

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

Japan Society for Medical Informatics

  • 26 August 2021
  • Author: Kenichi Nakano
  • Number of views: 4055
  • 0 Comments
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

2019

  • 31 October 2019
  • Author: Webmaster
  • Number of views: 27374
  • 0 Comments
RESULTS: Investigator Site Survey

Voluntary Investigator Site Survey survey concluded with 528 responses.

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

  • 1 October 2019
  • Author: Webmaster1
  • Number of views: 8625
  • 0 Comments
Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

eSRA Use is Growing!

eSRA Use is Growing!

Feb 2018 Statistics on use of eSRA around the globe

«March 2026»
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eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data

Log in to your eCF website account to see more:

RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities? 

The webinar is available to all our members. Date and Time: Wednesday, 25 February 2026, 14:00 UTC.

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eCF Public Webinar March: Turning the ATRA Position Paper into Practice

Log in to your eCF website account to see more:

This webinar focuses on practical implementations of the eCF industry position paper "Strategies for implementing Audit Trail Review"

The webinar is available to all our members as well as the general public. Date and Time: Thursday, 19 March 2026, 9:00 am EDT / 1:00 pm UTC. Sign up here

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