Other Modification – CTA Amendments

Other Modification - CTA Amendments

Short TitleCreate a short description of the request that is identifiable in the Award Workspace. Do not use "MD-SURG-Smith" naming convention."Budget Amendment #1"


"Contract Amendment #1 - Budget v2"
Review existing AMRs in Award Workspace for consistency of title format
Date RequestedDate of Submission/Request
Full DescriptionInclude all information needed to complete the subsequent Mod request.
1. Describe full request details, including specific Terms & Conditions being amended."Budget Amendment #1 to reflect changes from Protocol version 4."Include reference to Legacy rUVA record, if applicable.
2. Updated IRB Approval & Updated SBCA, if applicable."IRB #12345 attached"


"No updated SBCA needed"
SBCA = Study Billing Coverage Analysis
3. If necessary, contact info for Sponsor communication. This is required for all CTA or other bilateral agreements/amendments or if we are submitting a request to the Sponsor for the action.
4. Compliance of all S/K Personnel "Compliance:

Person 1 - Complete/Clear

Person 2 - Complete [SFI flag]

Person 3 - Complete [EAD flag]"
Review personnel compliance via QlikSense "Research Conflicts of Interest" report. Please see instructions for accessing this report here.
Supporting Documents1. Draft contract amendment and supporting documentsFile naming convention:

"001 - DRAFT - CTA Amendment"
Other possible contracting documents: draft Budget, updated Protocol, original FE CTA [for reference], updated ICF, etc
2. IRB approvalFile naming convention:

"002 - IRB #12345_Expires 01Jan2023"
3. Updated SBCAFile naming convention:

"003 - SBCA_Date"
4. Compliance printout from QlikSenseFile naming convention:

"004 - Compliance Review"
SubmitterAssign Submitter as your SOMOGC administratorDO NOT click "Submit to Specialist"
Request Type [dropdown]Other Modification
General Tips/NotesSend AMR # and/or link to somogc@uvahealth.org to get the action logged into the SOMOGC work queue.Without this email, we will have no idea that your AMR is ready for review
PI and Department approvals should be captured via "Log Comment" activity.If necessary, approvals can be provided outside of the system and uploaded as supporting documentation. See template here.
For all AMR types, please include relevant email communication thread to provide context for the action being requested.
Include all relevant attachments within SmartForm request page, not through "Add Comment" or on History tab.
Don't use the WITHDRAW activity unless you really want to discard/trash the action. It cannot be reinstated once withdrawn.