Birds-of-a-Feather Round Table Discussion:  Risk Based Approach to SDV

Date:  Thursday, 21-Nov-2024      Duration: One hour

Facilitator:  Gina Wood, eClinical Solutions

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:   This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions.  The discussion will be around:

• 100% SDV provides little value for a whole lot of work … but how do we define “critical” data such that not everything is considered critical?
• How can we implement a risk-based approach without compromising down-stream activities?

This session is not intended to provide firm answers to the above 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.

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

eCF Members - please use this link to register:   eCF BoF Round-Table Risk-based SDV