Back to Search
Start Over
The Life Cycle and Management of Protocol Deviations.
The Life Cycle and Management of Protocol Deviations.
- 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