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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

eCF APAC Workshop -- All's well that ends well

  • 18 November 2023
  • Author: Kenichi Nakano
  • Number of views: 297
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eCF APAC Workshop -- All's well that ends well

eClinical Forum's two-day APAC Workshop was held in Kobe on 13 & 14-Nov-2023. This was an in-person-only event and there were 26 attendees. Lots of opportunities for discussions ... after each presentation, and in break-out sessions, breaks and over dinner. The workshop was such a great success thanks to generous and attentive hosting by Eli Lilly and thanks to all the participants from sponsors, investigator sites and system integrators who made contributions through thought-provoking presentations, intelligent comments/questions and friendly discussions.

We will let you know once the host/place of the 2024 APAC Workshop is determined. We are looking forward to seeing you all at the next APAC Workshop wherever it will be.

eClinical Forum members can access the materials and presentation slides in the members area of this website.

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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.

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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.

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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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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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