eCF Views & News

We are celebrating our 25th anniversary with a new logo that shows that we are truly a global "network" of peers! You will start seeing it on all our communications and documents.

eCF Views: Can you add some perspective on these topics? Your eCF colleagues want to hear from you!

• 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...Start a new discussion! (none are too narrow or too broad). 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: Are you using the "eCF Requirements" to stay updated on all the regulations and regulatory guidance that pertains to electronic records and data for clinical trials? We have been publishing these to eCF members since 2015 and to the public since 2019.  It all started with the EHR/CR project in 2007 in which the eClinical Forum set out to develop an HL7 functional profile showing system requirements for using electronic healthcare systems to provide data for clinical research.  HL7 adopted it as a functional profile in 2009, and in 2010 EuroRec adopted it in and it also became an ANSI standard. During this project, we realized that we had developed a list of regulatory requirements that pertained to all systems being used for clinical research (not just healthcare systems). This was an exhaustingly long list and we decided to put like requirements together under a single statement ... and the "eCF Requirements" were born.  They were first shared with only eCF members in 2015 and then in 2019, our vendor members (who were using them to develop test suites) asked us to share them publicly. We still keep the current version for just eCF members ("membership has it's privileges!") and the previous year's version gets released to the public.  Since its public release in April '25, the public (i.e. non-member release of last year's version) PR2024 has had 650+ downloads. If you did not receive an email with the current version (MR2025) and would like one, please send a note to REG@eclinicalforum.org. 

• Save-the-date for our Autumn workshops!! 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 if you plan to register. We look forward to seeing you!!

  • Oct 21-23 in Indianapolis, hosted by Eli Lilly

  • 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.

  • Nov 13-14 in Tokyo, hosted by Kyowa Kirin

  • Topics are being developed... and we are looking for presentations on "any novel or innovative system used in clinical research", site perspective on direct data entry, and innovations in centralized monitoring, and direct review-access to EHR/EMR systems. Please contact one of the eCF Facilitators with offers!

  • More details on these workshops will be coming to your email inbox soon!!

• Birds-of-a-Feather Round-table "A chat about eCOA" — Our round-table last month was very popular! Thanks to Leigh Bobowski and Siva Bala of Pfizer for facilitating the discussion. A lot of terrific discussion, but we ran out of time to discuss all the suggested questions.  We will hold another eCOA Round-table on Aug 13, this time facilitated by Jeanna Radick and Trish Delong of J&J. Everyone who registered for the July 9th session has been automatically registered for this one. If you didn't register for that, and would like to join Aug 13, please send a note to Suzanne.Bishop@eclinicalforum.org. 

• The ATRA (Audit Trail Review Analytics) team is ready to release the first draft of their paper for review! If you would like assist with this review, please contact Jana.Summa@eclinicalforum.org. They expect to be ready to release the first version of the paper (for eClinical Forum members only) in the first week of September. A webinar is planned for Sept 25 in which the ATRA team will present the paper (to be presented twice to accommodate all time zones.) To register for this webinar: eCF Webinar: "Strategies for Implementing Audit Trail Review"

• Drafts for Annex 11 “Computerised Systems” and the newly added Annex 22 “Artificial Intelligence” were published by the EU Commission on 7 July 2025, together with the revised version of Chapter 4 “Documentation” of the EU GMP Guide. The eCF REG team will be reviewing and submitting comments on all 3 documents. If you would like to participate in this activity, please contact REG@eClinicalForum.org to receive a comment template. All comments are due to the REG team by 1-Sep-25.