Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

Conclusions:
It is recommended that SDV, rather than just focusing on key primary efficacy and safety outcomes, focus on data clarification queries as highly discrepant (and the riskiest) data.

Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Tantsyura, V., Dunn, I. M., Fendt, K., Kim, Y. J., Waters, J., Mitchel, J. Tags: Clinical Trials Source Type: research