JHS Vanguard Center (VC) faculty and the JHS Cardiovascular Workgroup (CVD WG) statistician have the option to access all JHS and Medicare data via the JHS CVD WG Linux folder. Other Duke investigators may access the minimum-necessary data for their investigation through separate study-level PACE folders.

JHS CVD WG PACE folders:

Isilon: \duhs-prot-nc1.dhe.duke.edu\dusom_openstack_rsh_projects\Pro00101989 - JHS CVD Working Group
Linux: plp-phs01.dhe.duke.edu/dphs/jhs
- The permission group for this directory is “dphs.prj-jhs”.

The following information is available as a checklist: JHS Data Access Checklist_2023-06-06.docx

Requirements for JHS Data Access

Proposal approved by JHS P&P
DataShare resource request submitted
Fully-executed JHS Data and Materials Distribution Agreement (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

Steps to Obtain Study-level Data Access

Step	Responsible	Action
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, 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. Include the DMDA and training reports 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.

[1] If the JHS CVD WG account will be covering the study’s provisioning costs

[2] If the JHS CVD WG account will not be covering the study’s provisioning costs

	File	Modified