Protocol Deviation Report
In the spirit of this responsibility, Primary Investigators frequently conduct internal audits. Through this self-evaluative process the PI will occasionally uncover unforeseen deviations and will report any activity that rises to the level of a protocol deviation to the IRB. There are also times in which a deviation is planned and in this case it is required to be reported prior to initiating this deviation. It is the responsibility of the PI to report protocol deviations to the appropriate overseeing authority either for planned deviations or deviations that are uncovered later in time.
Submission Deadline: Rolling submissions are accepted but must be received, reviewed, and approved prior to initiation of a planned deviation.
Submission Requirements: Complete Protocol Deviation/Eligibility Exception Form. All the questions on the form are to be answered appropriately.
Sample Forms & Documents: All necessary documents with instructions can be downloaded from the www.irbnet.org in the "State of New Hampshire DHHS CPHS, Manchester, NH" Library.