Facilitator: Tom Haag, Cardinal Solutions Consulting
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.
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