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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”.
Study-level JHS Data Access
The following information is available as a checklist: JHS Data Access Checklist_2023-06-06.docx
Access to JHS data is permitted for up to five years from when the JHS Data and Materials Distribution Agreement (DMDA) is fully executed.
Requirements for Study-level 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 |
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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 DPHSFISMA-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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[2] If the JHS CVD WG account will not be covering the study’s provisioning costs
JHS and Linked Medicare Data Access under the Umbrella Protocol
Access to the Linux folder containing all JHS data and associated Medicare claims is only permitted for VC faculty and the CVD WG statistician. Note that some VC faculty may choose not to have access. Costs are bourne by the JHS CVD WG account.
VC faculty:
- Emily O'Brien, PhD (JHS VC DUA's PI)
- LáShauntá (Tay) Glover, PhD
- Brad Hammill, DrPH
- Robert Mentz, MD
Drs. O'Brien and Glover are co-PIs for the JHS CVD WG.
Requirements for Umbrella JHS/Medicare Data Access
- DataShare resource request submitted
- Intended data user added to the JHS DUA with UMMC
- Intended data user added as key personnel to Pro00101989
- Intended data user has completed the required LMS modules
- REDCap request approval complete and supporting documents uploaded
- PACE services requested in CoreResearch@Duke
- PACE services requested through ServiceNow
- Intended data user has completed 1:1 DataShare provisioning training
Steps to Obtain Umbrella JHS/Medicare Data Access
Step | Responsible | Action |
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1 | DataShare | Determine the number of data access seats available given the fees paid by the JHS CVD WG during the current billing year. |
(1a) | JHS CVD WG project manager (PM) | If all seats purchased for the current billing year are occupied, then ask the PI(s) whether an existing seat holder should be removed to make room for the intended data user or if the JHS CVD WG account will pay DataShare for an additional seat. If the former, remove the designated seat holder per the instructions on the Getting FISMA-DPHS PACE Access page. |
2 | JHS CVD WG PM | Ensure the intended data user is listed on the current JHS VC DUA with UMMC. If not, work with ORC to add this individual. Many of the following steps may be completed while the DUA is being updated, but a fully-executed DUA that includes the intended data user is necessary before data access is granted to him/her. |
3 | JHS CVD WG PM | Submit a KSP change to add the intended user to Pro00101989 study’s personnel. |
4 | JHS CVD WG PM | Submit a DataShare resource request for access request data access. Include:
If the intended data user necessitates the purchase of an additional seat (see step 1a), also state that this should be charged to the JHS CVD WG account. |
5 | 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). |
6 | Intended data user | If applicable, complete training and notify DataShare once complete. |
7 | JHS CVD WG PM | Ask the JHS CVD PI(s) if the intended data user will serve as a transfer agent. Notify the JHS CVD PI(s) of all anticipated PACE fees and provisioning costs and obtain approval to charge them to the JHS CVD WG account. |
8 | JHS CVD WG PM | Update the study’s REDCap record. Include the JHD VC DUA and training reports as supporting documents. |
9 | JHS CVD WG PM | Obtain REQ#s for PACE services through CoreResearch@Duke. Instructions are here.
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10 | JHS CVD WG PM | 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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11 | DataShare | Complete the steps for “Getting Data Access: DataShare Project Directory (Linux server, plp-phsp01)” |
12 | Intended data user | If applicable, submit a “Transfer agent folder” request form. |
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