Contact dphsmedicaid@dm.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.  The following require submissions:

• Publication or any other form of dissemination, including conference abstracts
• PI change*
• Addition or removal of a data user*
• Additions or significant changes to the NC Medicaid variables used during analysis*
• Amendment to scope, data period, file types, linked data assets, etc.*

* Contact dphsmedicaid@dm.duke.edu to request the required forms.

Publication Pre-review

• 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 45 calendar days prior 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.

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.

REDCap instructions are here.