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 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, 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: 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 FISMA-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.

[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

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
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: Request is associated with REDCap #228 DUHS IRB and DRDL information Medicare data is obtained under CMS DUA 54827 Fully-executed JHS VC DUA showing listing the intended data user Individual who needs PACE access to the data 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). DPHS Data Asset Access Training (00138206) PACE Training for Duke Employees and Affiliates -Citrix Users (00138004) Annual HIPAA Privacy and Security Training (00156846)
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. New PACE workspace (only if the intended PACE user(s) lack accounts) New shared project folder Transfer agent, if applicable
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. New PACE workspace (only if the intended PACE user(s) lack accounts) New shared project folder
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.

	File	Modified
Labels No labels Preview View	Microsoft Word Document JHS Data Access Checklist_2023-06-06.docx	Jun 06, 2023 by Katie Arnold