No subjects who fail to meet eligibility criteria shall be enrolled in a study without IRB approval. Failure to meet this standard may potentiate the CPHS Non-Compliance process. The PI shall immediately report any unplanned exceptions to eligibility criteria to the CPHS Chairperson and the CPHS Administrator.
Submission Deadline: Rolling submissions are accepted but must be received, reviewed, and approved prior to initiation of a planned eligibility exception.
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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