Please do not submit your amendment request to the CTRC and CU IRB simultaneously. For amendments that will result in significant scientific or budget changes to the protocol, please submit amendment request to the CTRC first and then to the Boulder IRB. Otherwise, the order of approval is CU IRB approval first, CTRC approval second.
If you are uncertain about where to apply first, please contact Nikki Leonardo.
To submit an amendment to your CTRC protocol, please email the following as attachments to the CTRC Protocol Submission Coordinator:
- CU Boulder CTRC Protocol Amendment Form
- CU IRB approval, including date-stamped consent forms (where applicable)
- Revised protocol documents as appropriate (which may include any or all of the following: CU IRB consent form(s), Attachment U–CTRC Utilization Form, full protocol, with changes highlighted
- Once submitted, changes must be approved by the following where applicable to your protocol and the proposed amendment: CTRC Scientific Advisory and Review Committee (SARC) co-chair, the Research Subject Advocate (RSA), nursing support, and the CU Boulder CTRC Administrator before your study changes can be implemented.
If you have any questions about the status of your protocol amendment, please contact the CTRC Protocol Submission Coordinator.