Risk-based Monitoring of Clinical Trials: An Integrative Approach

Author:

Agrafiotis Dimitris K.ORCID,Lobanov Victor S.,Farnum Michael A.,Yang Eric,Ciervo Joseph,Walega Michael,Baumgart Adam,Mackey Aaron J.

Publisher

Elsevier BV

Subject

Pharmacology (medical),Pharmacology

Reference31 articles.

1. Evaluation of data entry errors and data changes to an electronic data capture clinical trial database;Mitchel;Drug Inf J,2011

2. The value of source data verification in a cancer clinical trial;Smith;PLoS ONE,2012

3. Time to change the clinical trial monitoring paradigm: results from a multicenter clinical trial using a quality by design methodology, risk-based monitoring and real-time direct data entry;Mitchel;Appl Clin Trials,2014

4. A comparison of the effectiveness of on-site and central monitoring activities across six phase III multi-center clinical trials;Dillon,2014

5. Source data verification by statistical sampling: issues in implementation;Grieve;Drug Inf J,2012

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