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 firstname.lastname@example.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)
- How and where do you define the handling of changed data in ePRO for your trial?
- Do you deny changes to ePRO data (by the patient and/or site), and if so how and where is this described for your trial?
- What controls are in place to delineate fraud from data entry errors, and how to you manage recall bias?
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