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Event date: 16/04/2019 Export event
Birds-of-a-Feather Round-Table Discussion: ePRO Data Changes: How do we ensure Data Integrity and GCP Compliance?
Date: Tuesday April 16 2019 Duration: One hour - starting at UTC 13:00
Facilitator: Tom Haag, Cardinal Solutions Consulting
Open To: Staff from eClinical Forum member companies (If you are not an eCF member, please review our website www.eclinicalforum.org 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:
The use of ePRO in clinical studies presents an interesting challenge when data recorded by patients and site staff needs to change from initial entry. To the uninitiated, it would be logical to assume that once data is entered, it is never changed. Or at the very least, the data is cumulatively recorded in 21 CRF Part 11-compliant audit trails. This interactive discussion will focus on the data integrity and custody controls required by regulators, for changes that occur more often that we might think.
Webinar Discussion Questions (please come prepared to discuss)
Registration: Please send a note to webmaster3@eclinicalforum.org
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eCF Technology Showcase: Veeva Systems “End-to-End Clinical Data: Connecting Patients, Sites, and Sponsors”
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Veeva Systems, an eClinical Forum member company, will showcase their end-to-end solution for patients, sites, and sponsors. The eClinical Forum does not promote nor endorse any particular technology vendors.