Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials

This article assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits. The results support the hypothesis that generalized SDV has limited value as a quality control measure and reinforce the value of other risk-based monitoring activities.

Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Sheetz, N., Wilson, B., Benedict, J., Huffman, E., Lawton, A., Travers, M., Nadolny, P., Young, S., Given, K., Florin, L. Tags: Sponsored Special Section by TransCelerate BioPharma: Challenging the Value of Source Data Verification Source Type: research