eCF Views & News

eCF Views: Despite the “lazy days of summer” (at least for some of us…) we do have some new responses (!) … and some questions still waiting for responses…

• Does eCOA "skipped visit reason" need to be reconciled?
• Are your study sites objecting to downloading patient data at the end of the study?
• Switching from the term "subject" to "participant" — is there a regulatory basis?
• Or...what are YOU wondering about??  Just  login to the  Discussion Forums (eclinicalforum.org)  … You will need a member account to login … but it’s easy to get one .. anyone from an eCF member organization can register for free via  Home (eclinicalforum.org).

eCF News:

• eCF 25th Anniversary Fun-Fact: What makes us unique (and has kept us around for 25 years)...is that our goal is not to put on conferences or produce white papers...our goal is in our tagline...”a network powered by peers”...our goal is to get people together...in all the different areas that touch on “eclinical”... and listen to every voice...powered by peers...no marketing, no fancy titles...just people who each bring a unique piece of the puzzle … toward progressing clinical research through improving the “e” side of it.  It's all about the discussion...and through that we've been able to help move forward together.  (Oh, and a side-goal…to have fun in the process!)
• Join us for our Autumn workshops!! Preliminary agendas and registration information have been sent out via email. Each eCF member company has seats allocated according to their membership type and how many they have already used this year. Please contact your eCF Primary Rep to use a seat (or contact us if you don’t know who this is…). We look forward to seeing you!!
  • Oct 21-23 in Indianapolis, hosted by Eli Lilly. For more information: News & Events
  • Nov 4-6 in London, hosted by Medidata  This workshop will also be live-streamed which provides unlimited (and gratis!) access to all eCF members around the globe. For more information: News & Events
  • Nov 13-14 in Tokyo, hosted by Kyowa Kirin. For more information: News & Events
  • Topics are being developed... and we still have room for one or two more presenters. Please contact one of the eCF Facilitators with offers!
• The AI/ML discussion group will have a session on Fri, Sept 5 (0900EDT/1500CEST) to discuss AI system development and validation. If you are not already on the list to get the AI/ML discussion invitations and would like to join, please contact Suzanne.Bishop@eclinicalforum.org.
• Birds-of-a-Feather Round-table "A chat about eCOA" — Our round-tables in July and August were very popular! We have decided to have them again every few months. If you have not been getting our eCOA-related email invitations, and you want to join us – please send us a note. If you have an eCOA topic you want to discuss, please send it in. Reply to Suzanne.Bishop@eclinicalforum.org.
• The eCF ATRA (Audit Trail Review Analytics) team will be discussing their soon-to-be-released paper at a webinar on Sept 25 (to be presented twice to accommodate all time zones.) To register for this webinar: eCF Webinar: "Strategies for Implementing Audit Trail Review"  
• The FDA, in collaboration with CTTI, is hosting a free hybrid public workshop on “Artificial Intelligence in Drug and Biological Product Development” on Oct 7, 2025 from 9am-5pm EDT. For more information or to register: Meeting Registration - Zoom

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. Please feel free to forward this email to your colleagues. Please let us know if colleague(s) want to be added to this monthly distribution!

Your eCF facilitators are always interested in what you have to say … Wolfgang.Summa@eClinicalForum.org,  Suzanne.Bishop@eClinicalForum.org,  Sean.Higashio@eClinicalForum.org,  Jana.Summa@eClinicalForum.org