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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

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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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.

Read more
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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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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.

Read more
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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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Japanese translation of Inv Site File Assessment

Japanese translation of Inv Site File Assessment

Version 2024JP1 (25-Nov-2024)

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

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