Study Amendments

Protocol Amendment Activation Workflows

On 12/1/2021 the Clinical Trial Process Improvement (CTPI) Initiative implemented a revised post start-up amendment workflow and improved REDCap Amendment Submission Survey. In partnership with the Study Team Advisory Committee (STAC), the revised 2-step amendment workflow will utilize amended billing grids upon IRB approval of the amended protocol. For more information, OnCore CTMS users may access 11/17 CTPI Forum slides here for current OnCore users or here for OnCore trainees (OnCore login required).

A recording of the 11/17 CTPI Forum is available here for current OnCore users or here for OnCore trainees (OnCore login required).

Amendment Exclusions List

The improved REDCap Amendment Submission Survey has been updated from an ‘inclusion’ model for determining when an amendment needs to be submitted to an ‘exclusion’ model. A protocol-specific link to the REDCap Amendment Survey is found in the protocol’s OnCore record within the PC Console > Documents/Info > FAQs tab (OnCore login required).

If protocol changes ONLY include one or more of the items below, a REDCap Amendment is NOT required. 

Amendment Exclusion List
Amendment Exclusion List

If there are change(s) NOT described in the table above, an amendment submission is required.