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Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment)

V2024

Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment)

Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment)

Release 2024 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China), MHRA (UK) and ICH (International). In particular, this version incorporates updates from the EMA Guideline on computerised systems and electronic data in clinical trials (Sep 2023). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA or ISF Assessment questions should be updated.

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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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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eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.

The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.

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