Contact dphsmedicaid@dm.dukedphsmedicaid@duke.edu with submissions and/or questions about post-approval requirements.
Required Submissions and Reviews
In addition to institutional regulatory requirements, NC Medicaid studies must keep NC DHHS abreast of developments. Submissions are required for the following:
Manuscripts or any other form of dissemination, including conference abstracts, websites, and handouts/resources
Addition or removal of a data user*
Amendment*
PI change
PI contact information or institutional affiliation change
Additions or significant changes to the NC Medicaid variables used during analysis
New DUHS IRB number
Revised project duration (i.e., data access period)
Request new data: years, quarters, and/or files
Alter study objectives
Link additional data assets
* Contact dphsmedicaid@dmdphsmedicaid@duke.duke.edu to request the required forms.
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Publication Pre-review by NC DHHS
Publications include abstracts, websites, white papers, reports for external stakeholders, etc.
Prior to publication, all materials must be reviewed and approved by the NC DHHS Division of Health Benefits (DHB). Materials should be submitted for review 45calendar daysprior to publication. DHB may ask follow-up questions or provide comments and feedback based on their review of the publication product. They may request a revised copy of your publication prior to granting approval.
Revisions to the results (e.g., new data, variables, or strata; how the results are presented; etc.), methods, or interpretation require re-review by NC DHHS.
Materials that are completely internal to Duke (e.g., departmental presentation exclusive to Duke faculty/staff/students) do not require prior review by the NC DHHS.
Annual Updates
Active studies will be asked to review their NC DHHS applications for accuracy and completeness, and to submit a list of dissemination products on an annual basis. Studies will be considered active until data access is revoked or dissemination is complete, whichever comes last.
DPHS REDCap Record Maintenance
The research team is responsible for updating their study's DPHS REDCap promptly record when there are changes. The two instruments that are required are the Request Approval and Supporting Documents instruments.
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