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SMPH REDCap	Global Health REDCap	FDA Regulated REDCap

What is REDCap?

REDCap (Research Electronic Data Capture) is a largely self-service, secure, web-based application used for building and managing data collection forms. REDCap provides data management functionality by allowing the development of electronic instruments and surveys to support data capture for research studies, including those that involve protected health information (PHI). REDCap can also be used to collect data for quality improvement and operational support projects.

REDCap provides:

1. An intuitive interface (with optional data validation for data captured on forms and surveys).
2. Audit trails for tracking data manipulation and export procedures.
3. Export procedures for seamless data downloads to common statistical packages (e.g. SPSS, SAS, Stata, & R).
4. Reporting capabilities.
5. Procedures for importing data from external sources.

If you are collecting data for the purposes of human subjects research, review and approval of the project is required by your Institutional Review Board. REDCap should NOT be used just as a file storage system as that is not its intended purpose. For file storage, please consult with the UW-Madison Data Storage Finder.

REDCap Instances

The School of Medicine and Public Health Informatics and Information Technology (SMPH IIT) team manages 3 separate REDCap instances available to UW-Madison staff.  The SMPH (soon to be called WISC), Global Health and FDA Regulated REDCap instances will be hosted in the Azure Cloud environment. Each instance has different intended purposes and requirements, so please review additional information below for each instance.

Who Can Use REDCap?

• UW-Madison staff and faculty
  • External collaborators working with UW-Madison staff/faculty (a UW staff member MUST be the project PI or project 'owner')
• UW students working on research related projects
• UW Health staff for research projects only (non-research projects should use the UW Health REDCap instance)

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REDCap Training and Resources

Licensing and Citing

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SMPH REDCap

*NOTE: In 2025, the SMPH (ICTR) REDCap will be transitioning to the new 'WISC REDCap' instance. The services and features will remain the same as the current SMPH REDCap, but the name, URL, support address and some processes will be updated. More information will be coming on this in 2025.

Purpose:

• SMPH (soon to be WISC) REDCap is available to all UW-Madison staff for research related projects (including PHI), quality improvement projects and operational support projects.  

Requirements:

• All users in this system must complete current HIPAA training - regardless of project type. Since the system contains PHI, anyone accessing the system must have this training.
  • https://compliance.wisc.edu/hipaa/training/
    • UW-Madison Staff can access training in Canvas (see link above)
    • External Collaborators can provide proof of training from their institution/organization or they can take the external training offered by UW-Madison (available at the bottom of the link above)
• Training is required for users with high-level privileges of User Rights and Project Design & Setup access
  • Currently only required for UW-Madison staff with a NetID
  • User Rights Training - self enrollment: https://canvas.wisc.edu/enroll/M7FDAT 
  • Project Design & Setup Training - self enrollment: https://canvas.wisc.edu/enroll/9G87PN

Fees:

• There is no cost for using the SMPH REDCap instance when you build your own project.
• There will be an hourly cost for requesting a project build by REDCap Administrators. A project build is a specific request for the REDCap Admins to create your instruments, enter branching logic, create alerts, etc. Requesting a consult or asking general questions is not considered a project build. 

Website:

• https://redcap.ictr.wisc.edu/

Support:

• redcap@ictr.wisc.edu 

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Global Health REDCap

Purpose:

• Global Health REDCap is available for projects collecting international participant data.  If you are planning to collect international participant data, please reach out to our support team to ensure your project is set up in the correct instance.

Requirements:

• This instance does NOT allow for PHI to be collected within it. This is due to the complexities of collecting PHI data and following international regulations of the country(ies) you are collaborating with.
• Projects using this instance MAY need to obtain a Data Transfer Use Agreement: https://rsp.wisc.edu/contracts/dtua.cfm
  • Any questions about a DTUA should be directed towards Research and Sponsored Programs staff.  REDCap Admins cannot answer questions relating to DTUAs or other contracts.
• Training is required for users with high-level privileges of User Rights and Project Design & Setup access
  • Currently only required for UW-Madison staff with a NetID
  • User Rights Training - self enrollment: https://canvas.wisc.edu/enroll/M7FDAT 
  • Project Design & Setup Training - self enrollment: https://canvas.wisc.edu/enroll/9G87PN

Fees:

• There is no cost for using the Global Health REDCap instance when you build your own project.
• There will be an hourly cost for requesting a project build by REDCap Administrators. A project build is a specific request for the REDCap Admins to create your instruments, enter branching logic, create alerts, etc. Requesting a consult or asking general questions is not considered a project build. 

Website:

• https://globalhealth.redcap.wisc.edu/

Support:

• ghredcap@wisc.edu 

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FDA Regulated REDCap - Coming in 2025

Purpose:

• FDA Regulated REDCap is a fully validated instance for projects needing to be 21 CFR part 11 compliant.  This typically applies to projects involving an IND or IDE and allows project teams to collect data directly in an electronic system (no paper documentation required), including electronic signatures for consenting.

Requirements:

• All users in this system must complete current HIPAA training - regardless of project type. Since the system contains PHI, anyone accessing the system must have this training.
  • https://compliance.wisc.edu/hipaa/training/
    • UW-Madison Staff can access training in Canvas (see link above)
    • External Collaborators can provide proof of training from their institution/organization or they can take the external training offered by UW-Madison (available at the bottom of the link above)
• Training is required for users with high-level privileges of User Rights and Project Design & Setup access
  • Currently only required for UW-Madison staff with a NetID
  • User Rights Training - self enrollment: https://canvas.wisc.edu/enroll/M7FDAT
  • Project Design & Setup Training - self enrollment: https://canvas.wisc.edu/enroll/9G87PN
• Additional training related to using a 21 CFR part 11 validated project - including, but not limited to Change Management. More information will be provided at project team meetings with the REDCap Validation team.

Fees:

• Using this instance will incur a fee. Please contact the REDCap Administrators for additional information.

Website:

• https://fda.redcap.wisc.edu/

Support:

• fdaredcap@wisc.edu 

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If you have a UW-Madison REDCap project and have questions about REDCap, please send them to REDCap@ictr.wisc.edu

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