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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: 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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