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In addition to institutional regulatory requirements, NC Medicaid studies must keep NC DHHS abreast of developments.  Submissions are required for the following:

• Publication Manuscripts or any other form of dissemination, including conference abstracts, websites, and handouts/resources
• Addition or removal of a data user*
• Amendment*
  • PI change (person or their
  • PI contact information or institutional affiliation )change
  • Additions or significant changes to the NC Medicaid variables used during analysis
  • Changed funder, grant number, or New DUHS IRB number
  • Revised project duration
  • Request new data: years, quarters, and/or files
  • Alter study objectives
  • Link additional data assets

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• 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.

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

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