INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy.
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SUBMITTER: Hullsiek KH
PROVIDER: S-EPMC4426264 | biostudies-literature | 2015 Mar
REPOSITORIES: biostudies-literature
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INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy.
Hullsiek Katherine Huppler KH Kagan Jonathan M JM Engen Nicole N Grarup Jesper J Hudson Fleur F Denning Eileen T ET Carey Catherine C Courtney-Rodgers David D Finley Elizabeth B EB Jansson Per O PO Pearson Mary T MT Peavy Dwight E DE Belloso Waldo H WH
Therapeutic innovation & regulatory science 20150301 2
<h4>Background</h4>Trial monitoring protects participant safety and study integrity. While monitors commonly go on-site to verify source data, there is little evidence that this practice is efficient or effective. An ongoing international HIV treatment trial (START) provides an opportunity to explore the usefulness of different monitoring approaches.<h4>Methods</h4>All START sites are centrally monitored and required to follow a local monitoring plan requiring specific quality assurance activiti ...[more]
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