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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

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

eSRA Handbook and Assessment Forms V2025

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

Japanese translation of Inv Site File Assessment V2024

  • 25 November 2024
  • Author: Kenichi Nakano
  • Number of views: 1284
  • 0 Comments
Japanese translation of Inv Site File Assessment V2024

Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)

Japanese translation of eSRA V2024

Japanese translation of eSRA V2024

Version 2024JP1:  Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

The 2025 version is now available in the eSRA Handbook and Assessment Forms V2025. This version will be removed on June 30, 2025.

Investigator Site File System Assessment V2024 Handbook and Questionnaire

Investigator Site File System Assessment V2024 Handbook and Questionnaire

The 2025 version is now available in the eSRA Handbook and Assessment Forms V2025. This version will be removed on June 30, 2025.

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: 2665
  • 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."

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Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

の日本語版2025.2JP1が2025年6月30日にリリースされました。

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eCF "BoF" Round table: "A Chat about eCOA"

eCF "BoF" Round table: "A Chat about eCOA"

eClinical Forum Birds-of-a-Feather round-table webinars focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing. 

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