Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

Date:  Wednesday, 10-Aug-22      Duration: One hour

Facilitator:           Diego Gayon, Merck

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum 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:   We will be discussing about the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management with the following discussion points:

• What quality measures are currently being used to measure clinical trial data quality?
• Are those measures applied to every single clinical trial? Or to a sample of the portfolio of trials in your organization?
• Are the quality control results registered on an essential document? (eg. Data Management Plan)
• Are those current approaches effective?
• With the progressive implementation of RBDM, how are the Quality Control activities and measures evolving? RBQM

This session is not intended to provide answers to the above questions. It is about exchanging views with other participants and gaining insights into the different parties’ challenges and needs. This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion.

Time – We apologize for the inconvenient time in some time zones. Please feel free to forward this invitation to your colleagues around the globe.

eCF Members can use this link to register:   eCF BoF Round-table Registration (eclinicalforum.org)

Not an eCF Member? Find out about membership in our membership tab, or contact us via info@eclinicalforum.org