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In the table below, blue sections correspond to processes mediated by DataShare personnel and peach sections to those mediated by the PACE team.

Contact pophealthdatashare@duke.edu with any Governance Team questions.

Step


Requestor

(PI or PI Delegate)

User

PACE team

DataShare Governance Team

DataShare Programming and Informatics

How to Start Working with DataShare

1

Visit the Duke PopHealth DataShare website

  • Read the Frequently Asked Questions
  • Click “Get Started” link
  • Complete the REDCap request form

X





2

DataShare creates a budget for review and approval by Requestor.

If project is funded and approved, the DataShare Operations Director notifies the DataShare Governance team that the project can move forward.




X


Regulatory Steps

3

DataShare Governance team communicates with project team about requirements for data access (e.g. IRB approval, DUA documentation, FISMA-DPHS PACE Account, Annual HIPAA training, DPHS Training Requirements, background check, etc.)




X


4

Requestor and users fulfill all requirements and notify the DataShare Governance team

X

X




5

DataShare Governance team confirms all required training and documentation. If all is in compliance, Governance team notifies project team and DataShare Programming/Informatics team that account/access provisioning can move forward.




X


DataShare Project Directory (Linux server: plp-phsp01)

Projects using DataShare data assets will need a project directory on the DataShare Linux server to store all project-related analysis files such as programs/scripts, analysis datasets, output, and logs. The DataShare Linux server is a high-performance, high-capacity server equipped to handle the size and complexity of DataShare project analyses. Statistical software packages, including SAS/SAS Studio, R/RStudio, and Stata, are installed directly on this Linux server.

6

DataShare will provision access to the project directory and notify users that access has been granted.





X

7

For new DataShare users only: DataShare will contact user to schedule the orientation to the DataShare environment. See:





X

DataShare Oracle Server (phsdbp01)

Most DataShare data assets are stored in an Oracle database due to their size and complexity. Access to these data is managed by the DHTS Database group and the DataShare Programming and Informatics team. Users can use SAS to query the Oracle database and extract the records that are needed for their specific project(s).

8

DataShare will submit a request to the DHTS Database group to create an account on the Oracle server for each user.





X

9

Once the Oracle account has been created, the DataShare team will provision access to the specific Oracle data schemas, tables, and data years authorized for use by the project, and notify users that access has been granted.





X

10

For new DataShare users only: DataShare will contact user to schedule the orientation to the DataShare environment. See:





X

PACE: Account and FISMA-DPHS PACE Workspace (Approved DMP SAQ environment)

PACE workspaces are secure virtual machines that authorized users can use to interact with the DataShare computing environment. All fees related to the provisioning of PACE accounts and PACE workspaces go to the PACE group, not DPHS DataShare.  See PACE brochure for an overview of PACE.

1

Users who are not affiliated with Duke Health or School of Medicine (DHE) must have a DHE sponsor and establish a DHE account. See Get PACE (duke.edu) or contact  pophealthdatashare@dm.duke.edu

X

X


X


2

Complete PACE training  PACE Training for Duke Employees and Affiliates in LMS


X




3

Complete Annual HIPAA Privacy and Security Training  in LMS


X




4

Obtain a CoreResearch@Duke Request ID (REQ-######) for PACE services. Instructions on how to obtain a Request ID can be found here.

This  step must be completed by the Principal Investigator, PI delegate, Facility User or Financial/Grants Manager who is authorized to use the project fund code to pay for the PACE services.

X





5

Submit ServiceNow IT request for a new PACE workspace (aka VDI, virtual machine) from Get PACE (duke.edu)

Note: DataShare access requires a “FISMA - DPHS”, “Complex” PACE workspace, which have certain software and security features that are not available in standard PACE workspaces. If the user has an existing PACE workspace, it may need to be replaced with a FISMA-DPHS one.

  • Select “Request a new individual PACE workspace”
  • Enter the CoreResearch Service Request ID (REQ-######)
  • Select the appropriate PACE workspace User Role
  • Answer “Yes” about PACE training
  • Select the appropriate Project Type and enter the Project Identifier
  • Select “DPHS FISMA” for the Operating System
  • Select “Complex” for the workstation size.
  • Select “Project need”
  • Select the appropriate source of funding
  • Submit the request by clicking on the “Request Now” button.

X





6

PACE team creates PACE account, provisions access to FISMA-DPHS PACE workspace/VDI, including necessary software.



X



7

Check that user can log into PACE workspace successfully and notify DataShare.


X




PACE: Shared folder

PACE Shared Folders, also referred to as PACE Project folder or Isilon folder, provide a directory accessible to all authorized project team members from the PACE workspace.

1

Obtain a CoreResearch@Duke Request ID for PACE services from https://coreresearch.duke.edu/.

This must be completed by the Principal Investigator, PI delegate, Facility User, or Financial/Grants Manager who is authorized to use the project fund code to pay for the PACE services.

X





2

Submit ServiceNow IT request for a “new shared folder” from Get PACE (duke.edu)

  • Enter the CoreResearch Service Request ID (REQ-######)
  • Enter the project identifier (usually the IRB #)
  • Enter the PI or PI Delegate (This is the person who will be able to manage user access to this shared folder using Duke’s Grouper site

X





3

PACE provisions folder, creates an access group, and gives access to owner (PI or PI delegate).



X



4

Folder owner adds authorized project members to access group on Duke’s Grouper site.

X





PACE: Transfer Agent Folder

Files must be reviewed before they can be exported out of PACE to ensure compliance with HIPAA, cell suppression, and other relevant policies. There are two ways to have files reviewed for export: PACE’s Honest Broker system or by using a Transfer Agent folder. Transfer Agents are designated users on the project team who are authorized by the PACE team to review files before export. Transfer Agent folders are sub-directories within the PACE Shared folder and are accessible only to the authorized user. This means TAs can’t export data from PACE without first requesting a PACE Shared Folder. Exports by Transfer Agents are auditable.  You must have a Core Research Request ID (REQ-######) to request Transfer Agent status.

1

Submit a “Transfer agent folder” request form for each user that should have Transfer Agent privileges.

X





2

PACE reviews/approves Transfer Agent request and provisions folder



X



3

Files that are put into the TA folder within PACE are then accessible from the PACE Data Portal  



X



Data Access (FISMA-DPHS PACE Oracle and Linux servers)

Add/remove users to a Linux drive, obtain access to data assets

1

Submit request using the Qualtrics request form

X





2

DataShare Governance team reviews the request




X


3

DataShare team provisions access to user or data assets. This process may include requesting Oracle and Linux accounts.





X

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