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  4. PI change requires a full modification form, and not a staff-only modification

PI change requires a full modification form, and not a staff-only modification

The PI is the one study staffer who cannot be changed using a “staff-only modification” form in CLARA. To change a PI in CLARA, please submit a regular modification form, and not a staff-only modification. Please ensure the new PI’s CV is uploaded to his or her profile in CLARA as well. Using a regular modification form routes the change through the office staff to a reviewer, who verifies the PI’s qualifications. Any document changes stemming from the PI can be submitted with this modification form as well, which will allow the amended documents to be approved. Staff-only modifications are processed in the office, not by a reviewer, and any documents submitted with them would only be acknowledged rather than approved. Also, please note that a modification form changing the PI is just like any other modification, in that only one such form can be pending at a time in CLARA. That means if your PI changes is pending, you won’t be able to submit other CLARA forms, such as the continuing review. Please be sure to time your submissions appropriately so you don’t accidentally miss an approval deadline.

Posted by Edith Paal on May 15, 2015

Filed Under: Research News

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