How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant? - We (Clinical Compliance )
Venue: Online Event
|Event Date/Time: Aug 09, 2011||End Date/Time: Aug 09, 2011|
Areas Covered in the Seminar:
- The Primacy of the study Protocol.
- What are Protocol â€œDeviationâ€ and other terms / categories.
- The many cause of protocol deviations.
- The Regulatory requirements for handling protocol deviations and violations.
- The importance of documentation of protocol deviations as well as violations.
- How to define and handle instances of PNF.
- What is the reason different IRBs define deviations and violations differently.
- What is the basis of the difference between a â€œDeviationâ€ and a â€œViolationâ€.
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