Other Modification – CTA Amendments
Other Modification - CTA Amendments
|Short Title||Create 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 Requested||Date of Submission/Request|
|Full Description||Include 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 Documents||1. Draft contract amendment and supporting documents||File naming convention:|
"001 - DRAFT - CTA Amendment"
|Other possible contracting documents: draft Budget, updated Protocol, original FE CTA [for reference], updated ICF, etc|
|2. IRB approval||File naming convention:|
"002 - IRB #12345_Expires 01Jan2023"
|3. Updated SBCA||File naming convention:|
"003 - SBCA_Date"
|4. Compliance printout from QlikSense||File naming convention:|
"004 - Compliance Review"
|Submitter||Assign Submitter as your SOMOGC administrator||DO NOT click "Submit to Specialist"
|Request Type [dropdown]||Other Modification|
|General Tips/Notes||Send AMR # and/or link to email@example.com 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.|