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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

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

"When should audit trail begin?"

Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?"  It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

Authors: Jules Mitchel, PhD, is the Co-Founder of Target Health, US. Yumi Sugiura is the Associate Director of Global Data Management & Centralized Monitoring for Bristol Myers Squibb, Japan. Valdo Arnera, MD, is a Scientific Advisor for ERT, Switzerland. Greg Gogates is the Vice President of Quality/Regulatory for Fasor, US. Alan Yeomans is a Quality Manager for Viedoc Technologies, Sweden. Devry Spreitzer is a Senior Director, Data Integrity Quality Assurance for Astellas Pharma Global Development, US. Suzanne Bishop is the Americas Administrator for eClinical Forum.

We welcome feedback! Please send to: REG@eclinicalforum.org 

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HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

We are pleased to announce our next Workshops:

- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies

- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb

- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.

The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.

We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.

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Views & News -- August 2022

Views & News -- August 2022

We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org.   Click "Read More" to see this month's "Views & News"!

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eClinical Forum APAC Workshop

eClinical Forum APAC Workshop

This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station.  We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

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Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality

We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.

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