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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

Investigator Site File (ISF Assessment)

Investigator Site File (ISF Assessment)

There has been a request from our members to develop a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations. This would be similar to what we already offer (for free) to sites around the globe to evaluate their EHR systems or other systems that originate data that may become part of a clinical trial (this questionnaire is called “eSRA” for “e-Source Readiness Assessment” and can be found on our website at eSRA (eclinicalforum.org)).  The team is under the guidance of the eCF REG team, which produces the “eCF Requirements” that the eSRA and ISF assessments are based on.  A Pilot of the eISF Assessment Questionnaire and Handbook was run in 2023. We anticipate a public/free release of this product in early 2024.  For more information or to become involved in this team, members should send an email to ISFA@eclinicalforum.org. 

 

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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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eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”

eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”

This is an eCF Birds-of-a-Feather Round-table discussion on the new landscape of AI use in clinical research document automation.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.

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