The How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant 2013 is a webinar that covers topics such as:
- What are Protocol "Deviation" and other terms / categories
- The Primacy of the study Protocol
- The Regulatory requirements for handling protocol deviations and violations
- The many cause of protocol deviations
- How to define and handle instances of PNF
- The importance of documentation of protocol deviations as well as violations
- What is the basis of the difference between a "Deviation" and a "Violation"
- What is the reason different IRBs define deviations and violations differently
The How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant 2013 brings together:
- Clinical Research Scientists (PKs, Biostatisticians,)
- Principal Investigators / Sub-investigators
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Safety Nurses
- QA / QC auditors and staff
- Recruiting staff
- Clinical Research Data managers