Tips of the Month
June 2008
For those of you who may not yet be aware of it, there have been some significant changes to the definition of "Protocol Violation".
A Protocol Violation is no longer only an event over which the Investigator has control. Any unapproved deviation from the protocol, or GCPs, or the IRB policies is considered a Protocol Violation: whether or not it is intentional and whether or not it is under the control of the Investigator.
One other item of note: if you happen to have an event that meets the definitions of a Serious Adverse Event, and a Protocol Violation, and an Unanticipated Problem, you only need to report it once.
The algorithm for reporting is: SAE, then Protocol Violation, then Unanticipated Problem.
Please refer to the IRB website: http://www.virginia.edu/vprgs/irb/maintain.html for more explicit instructions.
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