A Case Example of the Review of Audit Trails in GCP Inspections (11of11) GCP Data Integrity Workshop

Phillip D. Kronstein from CDER’s Good Clinical Practice Assessment Branch provides a case study when a sponsor submitted an NDA for a new molecular entity. The drug was the first targeted treatment for a serious disorder and the OND review division requested data audit inspections of the sponsor, CRO, and several clinical investigators.
For more data integrity case studies, visit www.fda.gov/dr...
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