Abstract PURPOSE Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety […]
The impact of clinical trial monitoring approaches on data integrity and cost–a review of current literature.
April 1, 2016
Eur J Clin Pharmacol