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Real-World Data: Sponsors Should Ensure US FDA Access To Patient-Level Data Upon Submission

 
• By Sue Sutter

Informed consent from patients, or institutional review board waivers, are needed to allow bioresearch monitoring inspectors to review source records in a timely fashion without delaying a user fee date, FDA’s Cheryl Grandinetti tells an international good clinical practices workshop.

Cherries
FDA BIMO inspectors want to make sure sponsors aren't cherry-picking favorable real-world data. • Source: Alamy

Sponsors who submit a drug application containing real-world data should ensure that certain measures have been taken ahead of time so that US Food and Drug Administration bioresearch monitoring (BIMO) inspectors can timely review RWD source records without delaying a product’s user fee date.

Prior to data extraction from the RWD source, sponsors should obtain signed informed consent from patients, or institutional review board waivers, to allow US FDA inspectors to review source records,...

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