Supplemental Submission Forms                

Instructions                                

Principal Investigators are responsible for ensuring that this form is completed for each member of the research staff reporting a financial interest related to the research as per the Study Personnel Information Form.  

Submit this form for any medical device, drug, or biologic being investigated, used as a comparator or being administered to study participants to study human physiology.  

Use this form to respond to an IRB notification letter requiring modifications. 

Submit the Continuing Review Application at any time to close a protocol.  All human subjects research activities, including data analysis with identifiable data, must be complete at the time of this request.  Data analysis can continue when the data has been de-identified and the coding system (i.e., link) has been destroyed.

Submit this form if participants will be exposed to radiation as part of the research protocol. 

Submit this form to report new information within 5 business days from the time the study team became aware of the information.  For examples of what consitutes as "new information" refer to section B of this form.

Study Personnel Information  

Submit this form at the time of initial and continuing review. Include on it the complete list of study staff. In addition, submit this form (and a Modification of Approved Human Research Form) to add individuals to the study staff throughout the approval period. If removing staff only a Modification of Approved Human Research Form is required. Submit the revised personnel form with individuals removed at the next continuing review.

Submit this form if any study document will be administered in languages other than English.  A copy of the local language version is not required.