A Statistical Model for Risk-Based Monitoring of Clinical Trials

Author:

Hather Gregory J.

Publisher

Springer International Publishing

Reference28 articles.

1. Williams, G.W., 2006. The other side of clinical trial monitoring; assuring data quality and procedural adherence. Clinical Trials, 3(6), pp.530-537.

2. Morrison, B.W., Cochran, C.J., White, J.G., Harley, J., Kleppinger, C.F., Liu, A., Mitchel, J.T., Nickerson, D.F., Zacharias, C.R., Kramer, J.M. and Neaton, J.D., 2011. Monitoring the quality of conduct of clinical trials: a survey of current practices. Clinical Trials, 8(3), pp.342-349.

3. Bhatt, A., 2011. Quality of clinical trials: A moving target. Perspectives in clinical research, 2(4), p.124.

4. TransCelerate BioPharma Inc. (2013). Position paper: risk-based monitoring methodology. http://www.transceleratebiopharmainc.com/wp-content/uploads/2013/10/TransCelerate-RBM-Position-Paper-FINAL-30MAY2013.pdf .

5. Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring. U.S. Department of HHS, FDA, August 2013 OMB Control No. 0910–0733.

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