Please submit your protocol amendments to the IRB first, in accordance with their guidelines. (*Exception: If your amendment will result in significant changes to the science of the protocol, or if the amendment represents a significant CTRC budget change, it must be submitted to SARC first.)
Below are the steps for submitting protocol amendments to SARC.
- Request a SARC amendment form from Ronnie Calzada at firstname.lastname@example.org.
- Submit the following items to Ronnie:
-- Completed SARC amendment form
-- IRB approval of the amendment including the date-stamped informed consent (if the amendment involved changes to the informed consent).
-- Any other documents that changed because of said amendment. Please include tracked version as well.
-- Tracked copy of the informed consent and the New Protocol Application (NPA). Since highlighting is not an option in the NPA, the changes must be manually marked so the SARC reviewer can easily identify what has changed.
- Your amendment request will be forwarded to the Research Subject Advocate (RSA) for review and approval.
- Ronnie will submit your amendment request with all of the appropriate documentation to SARC for review and final approval.
- You will receive an approval letter once the amendment has been approved by SARC.
*If your amendment involves significant changes to the science of the protocol or the CTRC budget, contact Ronnie Calzada before submitting it the IRB.