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Corrective and Preventive Action (CAPA) Plans
- Last updated:
- 07/01/2023
- Guidance Contact:
IU Human Research Protection Program (HRPP)
irb@iu.edu
Introduction
Despite a study team’s best efforts, errors in the conduct of research may occur. Errors may include deviations from the IRB approved study plan or noncompliance with applicable research regulations or policies. Whether the result of human oversight, process deficiencies, or technology failures, such errors should be identified and when appropriate, the steps taken to resolve them, and to ensure they do not happen again, should be well documented in the research records. This important documentation is known as a Corrective and Preventive Action (CAPA) Plan.
