eCF Views & News

April 2024

eCF Views:

Three great questions this month:

• How does your company handle user access after study close-out and all subject PDFs are downloaded?
• We are required to deliver data in dynamic formats, such that data can be sorted, filtered, etc., … so can we stop delivering it also in PDF (which is not required)?
• A series of questions around the development of the Data Management Plan

Please login to the  Discussion Forums (eclinicalforum.org) to respond or to read the full discussion … (You will need a member account to login … but it’s easy to get one .. just register via  Home (eclinicalforum.org) … it will take up to 2 business days for your account to be confirmed.)

 eCF News:

• The recording of the 21-March-24 webinar “EHR-EDC Integration – Implementation Overview and Learnings” is now available in the Members section of the website: https://eclinicalforum.org/members/webinar-recordings/emodule/508/eitem/1153. Thank you to Thanh Tran and Carrie Young of Astellas for presenting this very interesting topic and fielding all the many questions at the end. Slides are also available the Members Document Repository.
• Still time to register for our Spring 2024 Workshops!! Each eCF member organization has a number of in-person seats that can be used for 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 offered for anyone from an eCF member organization around the globe.
  • European Hybrid Workshop, kindly hosted by BSI Life Sciences in Zurich, Switzerland on April 16-18. Of course, in-person is the best experience and we hope you can join us, however this will also be live-streamed/recorded so that any eCF member, anywhere can attend. 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.
• URGENT! Audit Trail Review – eCF Member’s 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)
• Stay tuned for the eISF System Assessment! The team will be releasing their first assessment tool in about a week. It will be on a tab on our website.
• Do you want us to come to you for the Autumn workshops? We are looking for host companies! Let’s discuss the many benefits of hosting. Please contact Suzanne Bishop (North America), Wolfgang Summa (Europe) or Sean Higashio (Asia).

Your eCF facilitators are always interested in what you have to say … Suzanne.Bishop@eClinicalForum.org, Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org . Technical or Administrative inquiries should be directed to Adam.Perkins@eClinicalForum.org.