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The Life Cycle and Management of Protocol Deviations.

The Life Cycle and Management of Protocol Deviations.

Authors :
Mehra, Munish
Kurpanek, Katharina
Petrizzo, Maryrose
Brenner, Sonia
McCracken, Yvonne
Katz, Terry
Gurian, Margaret
Source :
Therapeutic Innovation & Regulatory Science; Nov2014, Vol. 48 Issue 6, p762-777, 16p
Publication Year :
2014

Abstract

The article discusses a study on having a common definition for protocol deviations in clinical trials, documenting its life cycle and best practices to manage, detect and classify them. Topics covered include the protocol deviations handling plan (PDHP), Corrective Action Preventive Action (CAPA) programs and the clinical study report (CSR) data. Conclusions include recommendations for minimizing protocol deviations including well-reviewed clinical trial protocols with standard terminology.

Details

Language :
English
ISSN :
21684790
Volume :
48
Issue :
6
Database :
Supplemental Index
Journal :
Therapeutic Innovation & Regulatory Science
Publication Type :
Academic Journal
Accession number :
99412154
Full Text :
https://doi.org/10.1177/2168479014530119