Each project amendment/modification should include a cover sheet; send all documents to [email protected]. Types of amendments and their associated forms are below.
Add New Research Staff or Co-Investigator(s)
- Supplemental Agreement with New Research Staff
- Data Security Plan for each new staff member
- Acceptable Use Policy for each new staff member
- Updated List of Users Requesting LINKAGE Enclave Access
- CV or Biosketch for Co-Investigator
Remove Research Staff or Co-Investigators
- Email [email protected] to remove Research Staff or Co-Investigators from a project
Change the Investigator
- Letter to NHATS explaining the change in Investigator
- Investigator amendment form
- IRB approval with new Investigator listed
- Data Security Plan and Acceptable Use Policy for new Investigator
- New Data Use Agreement (DUA) listing the new Investigator
Investigator or Staff Changing Institutions
All staff and investigators must be covered by both IRB approval and an active DUA at their primary institution. If Co-Is or staff change institutions, they must collaborate with a PI at their new primary institution, who then is required to submit all forms required for an initial application. If a current NHATS CMS-Linked Files Project PI changes institutions, the following is required:
- Email to NHATS explaining the change
- IRB approval with new Institution
- Updated Data Security Plan
- New Data Use Agreement (DUA) with new Institution
Change in or Addition of Data Access Location or Workstation/Computer
Add New Years of Previously Approved CMS files
Add New CMS Files Not Previously Approved
- NHATS-CMS Linked Files Request Form
- Updated Research Plan (send tracked and clean versions)
- IRB approval for new work scope
Modify or Add Research Aims for Existing Folders or Files
- Note that modifying aims and adding folders or files may require a new application. Contact [email protected] for guidance.
- Updated Research Plan (tracked and clean versions)
- IRB approval for new work scope
Request a New External File Linkage
- External File Request Form
- If extending work scope:
- Update the Research Plan (tracked and clean versions) to describe and justify the purpose and contents of the linkage(s)
- Submit IRB approval for new work scope