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:
If requesting linked JHS-Medicare data:
|
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. 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.
|
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.
|
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