"This is the best use of my time to remain current with what is going on in the industry."
Event date: 13/08/2025 Export event
Background: eClinical Forum Birds-of-a-Feather webinar sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic: This session is not intended to provide firm answers to the below questions. It is about exchanging views with other participants and gaining insights into the different challenges and needs. This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. To encourage candid discussion, we will not be recording this session
This is a continuation of the eCF eCOA Round table from July 9th (as well as discussions at the Spring workshops), as we had so much discussion that we did not finish all the topics!
This time we will discuss:
Are Sponsoring submitted to FDA, ZQ datasets following the IRT Guidance?
What are the challenges for Sponsor UAT execution?
Reference: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory. FDA Guidance: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory | FDA
This Round-table will be facilitated by Jeanna Radick and Trish Delong of Johnson & Johns
Anyone from an eCF Member Company may register for this online round-table discussion by sending a note to WEBINARS@ECLINICALFORUM.ORG
eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
Birds-of-a-Feather Round-table on eCOA Topics
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )
eCF Webinar: "Strategies for Implementing Audit Trail Review"
The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.
Registration for the eCF Americas Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Indianapolis, Indiana on October 21-23, 2025.
The workshop will be available for in-person participation only. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14
Registration for the eCF Europe Autumn Hybrid Workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Medidata in London, UK, on November 4-6, 2025
The workshop will be available for both in-person participation and remote access. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. Click to get more information on the planned topics.