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- Proposal approved by JHS P&P
- DataShare resource request submitted
- Fully-executed JHS DMDA signed by the study PI, Office of Research Contracts, and a JHS Coordinating Center authorized representative
- Study and key personnel covered by an active IRB application
- Study and key personnel covered by an active DRDL
- All data users have completed the required LMS modules
- REDCap request approval complete and supporting documents uploaded
- PACE services requested in CoreResearch@Duke
- PACE services requested through ServiceNow
- All data users have completed 1:1 DataShare provisioning training
- Medicare linkage only: Study covered by an active, approved CMS DUA
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Step | Responsible | Action |
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1 | Researcher | Submit a research proposal to the JHS Publications and Presentations (P&P) group for review. The JHS website explains the process and has a flowchart. As of April 2023, proposal instructions are saved at P:\Projects\JHS\Working Groups\JHS Vanguard Center DUA\Proposed Research\JHS Vanguard Application Proposed Research_Final.docx (accessible to JHS VC PI and project manager (PM)). |
2 | JHS P&P | JHS P&P approves the proposal. |
3 | JHS CVD WG PI, Researcher | The proposal’s PI, ORC Office of Research Contracts, and a JHS CC authorized representative from UMMC sign the JHS DMDA. |
4a | JHS CVD WG project manager (PM) | Determine if the proposal requires its own IRB application or is within the scope of Pro00101989. If the latter, submit a KSP change to add the study’s personnel. The researcher is responsible for study-specific IRB submissions. |
(4b) | Researcher | If necessary, establish a study-specific IRB application and obtain approval. If requesting unlinked JHS data only, skip to step 6. |
5a | JHS CVD WG PM | Medicare linkage only: Determine if the proposal requires DUA 54827 to be amended. Consider both the proposed research’s aims and requested linkages. |
(5b) | JHS CVD WG PM | Medicare linkage only: If necessary, submit a DUA amendment. |
6 | Researcher | Submit a DataShare resource request for access request data access. Include:
If requesting linked JHS-Medicare data:
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7a | DataShare | Determine if each PACE user already has a DPHS-PACE account and has completed the required training. If not, send the training information to the user(s). |
7b | Researcher | If applicable, complete training and notify DataShare once complete. |
8 | DataShare | Ask the JHS CVD WG PI if the JHS CVD WG account will pay the study’s PACE fees and provisioning costs. |
9 | Update the study’s REDCap record's Request Approval and Supporting Documents instruments. Please:
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10 | JHS CVD WG PM1 or Researcher2 | Obtain REQ#s for PACE services through CoreResearch@Duke. Instructions are here.
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11 | JHS CVD WG PM1 or Researcher2 | Submit PACE ServiceNow ticket(s) for access. See “PACE Account and PACE Workspace (DPHS FISMA-compliant virtual machine)” step 5 for instructions.
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12 | DataShare | Complete the steps for “Getting Data Access: DataShare Project Directory (Linux server, plp-phsp01)” |
13 | Researcher | The person who will be the transfer agent submits a “Transfer agent folder” request form. |
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