Following exactly the signed and approved (IRB + PI) Protocol to the letter is the goal and mandate of all clinical research. This, in fact, is included on the FDA Form 1572.
This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of the investigator is handled.
Areas Covered in the Seminar:
- The Primacy of the study Protocol.
- What are Protocol “Deviation”
- 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 “Deviation”
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