WHO WE ARE

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 of eSRA V2024

Japanese translation of eSRA V2024

Version 2024JP1 (20-May-2024)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

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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: 2205
  • 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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RESULTS: Investigator Site Survey

2019

  • 31 October 2019
  • Author: Webmaster
  • Number of views: 25312
  • 0 Comments
RESULTS: Investigator Site Survey

Voluntary Investigator Site Survey survey concluded with 528 responses.

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

  • 1 October 2019
  • Author: Webmaster1
  • Number of views: 7181
  • 0 Comments
Prominent Industry Magazines address the need for investigator site systems assessment and eSRA
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08/11/2024

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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11/11/2024 - 12/11/2024
eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

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11/11/2024 - 12/11/2024
eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

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21/11/2024
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions.  The discussion will be around:

  • 100% SDV provides little value for a whole lot of work … but how do we define “critical” data such that not everything is considered critical?
  • How can we implement a risk-based approach without compromising down-stream activities?
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05/12/2024
eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

Presenter:        Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic:  The final piece of the GCP renovation puzzle, revision 3 of ICH GCP.  Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.

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