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:

1. Are Sponsors submitting to FDA item level QSSTAT and QSREASND for item level for reasons not done?

2. Are Sponsoring submitted to FDA, ZQ datasets following the IRT Guidance?

3. 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, please send a note to WEBINARS@ECLINICALFORUM.ORG