Page Comparison

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 approves the proposal.

3

JHS CVD WG PI, Researcher

The proposal’s PI, ORC, 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:

• DUHS IRB and DRDL information.  Must provide approvals if the study is not covered by Pro00101989.
• Fully-executed JHS DMDA
• Individual(s) who need PACE access

If requesting linked JHS-Medicare data:

• Wait to request data access until after the CMS DUA amendment is approved if an amendment was submitted. 
• Mention that the study will use CMS DUA 54827.

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).

• DPHS Data Asset Access Training (00138206)
• PACE Training for Duke Employees and Affiliates -Citrix Users (00138004)
• Annual HIPAA Privacy and Security Training (00156846)

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

JHS CVD WG PM^[1] or DataShare^[2]

Update the study’s REDCap record's Request Approval and Supporting Documents instruments. 

Please:

• Enter both the JHS DMDA and CMS DUAs if JHS and Medicare data will be used.  The expiration date for the JHS DMDA is 5 years from its execution date (i.e., the date of the last signature).
• Include the DMDA and training reports for those who will access the data as supporting documents.

10

JHS CVD WG PM¹ or Researcher²

Obtain REQ#s for PACE services through CoreResearch@Duke.  Instructions are here.

• New PACE workspace (only if the intended PACE user(s) lack accounts)
• New shared project folder
• Transfer agent

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.

• New PACE workspace (only if the intended PACE user(s) lack accounts)
• New shared project folder

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.