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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 Views & News

February 2024

eCF Views & News

eCF "Views and News" is a monthly newsletter to our members. eCF webinars, online discussion forum, and project team participation are offered to staff from eCF member companies only. For more information on eCF membership and which companies are eCF members, please see the Membership Tab on this website.

 

Did you know … that eCF is powered by our many teams … please check them out: Teams/Projects (eclinicalforum.org) 

 

eCF Views:

Are you dealing with an issue that could benefit from other’s experience and ideas? Post a question on the eCF Members-only Discussion Forum! It’s easy… Just login to the  Discussion Forums (eclinicalforum.org)(If you don’t have an eCF member account, register via  Home (eclinicalforum.org) … it will take up to 2 business days for your account to be confirmed.)

 

Some new chatter to some older questions in the online Discussion Forum this month….

  • Distributed TMF (i.e, parts of the TMF are kept not by the Sponsor but by the Sites, Vendors and others involved in the study)
    • This topic is discussed in these 2 threads:
      • eSRA Filing in ISF?
      • eISF when technical solution is proposed by the sponsor…

 

 eCF News:

  • Mark your calendar for our Spring 2024 Workshops!! Each eCF member organization has a number of seats that can be used for in-person attendance at either of these 2 workshops. Please discuss with your organization’s eCF Primary Representative regarding seats.  Virtual seats (live-streamed or recorded) for our European workshop is unlimited for anyone from an eCF member organization around the globe.
    • European Workshop, kindly hosted by BSI Life Sciences in Zurich, Switzerland on April 16-18. This will be live-streamed and recorded so that any eCF member, anywhere can attend virtually. For more information and registration: eCF Spring Workshop in Zurich, Switzerland (eclinicalforum.org) or contact Wolfgang Summa.
    • Americas Workshop, kindly hosted by Boehringer-Ingelheim in Ridgefield Connecticut, USA on April 30-May 2. This will be an in-person-only workshop. For more information and registration: eCF Spring Workshop in Ridgefield, Connecticut USA (eclinicalforum.org) or contact Suzanne Bishop.
    • Please send in your ideas for discussion topics and presenters ASAP!  We are looking for looking for presenter(s) with experience with regulatory submissions using risk-based monitoring, experiences with sites that have done truly remote studies, and other hot topics.
  • Audit Trail Review – survey of how eCF member companies are handling audit trail review, specifically after the eCF team posted their recommendations in 2021. Survey results will be presented at the Spring workshops. Please complete and/or pass to a colleague who has experience in this area: eCF Members Audit Trail Review Survey (eclinicalforum.org). To review the Audit Trail review paper from 2021: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org)

 

 

 

 

 

 

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eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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