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Protocol Deviation Report
The Principle Investigator (PI) is responsible for all aspects of the research activity, assuring that the research is conducted in accordance with federal regulations as well as ethical principles. The CPHS collaborates with and provides guidance to the investigator(s) to ensure that the rights and welfare of participants are protected throughout the process of research. This collaborative effort is dynamic and flexible to meet the changing needs of the research community while maintaining the essential element of human rights protections.

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.

 
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New Hampshire Department of Health and Human Services
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