Penn Medicine REDCap

 REDCap - Research Electronic Data Capture

REDCap was created by Vanderbilt University and is available at Penn Medicine via a license agreement. Penn Medicine’s REDCap is a HIPAA-compliant web platform for building and managing online databases and surveys. REDCap's streamlined process for rapidly creating and designing projects offers a vast array of tools to fit many data collection strategies, such as single-/multi-site studies, longitudinal studies, cross-sectional studies, collecting data via surveys, and/or a combination. REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (e.g., SPSS, SAS, Stata, R).

IMPORTANT NOTES

  • Only Penn Medicine’s REDCap instance is HIPAA-compliant
  • Penn Medicine’s REDCap is NOT a 21 CFR Part 11-compliant system and should not be used for studies reporting to the FDA (i.e., IND, IDE, abbreviated IDE, IND-exempt, and IDE-exempt).

Access for new Penn Medicine REDCap Accounts

To obtain a Penn Medicine REDCap account, users must have active PennKeys and PMACS credentials.

Users with the above requirements must complete the below steps, in order, to obtain a new Penn Medicine REDCap account:

  1. Required eLearning (REDCap: Best Practices for Maintaining HIPAA Compliance and Protecting Personal Health Information (PHI))
  2. Submit account creation request via this submission form

Penn Medicine REDCap Accounts for External Users (non-Penn staff)

Non-Penn employees/external users will need a Guest PennKey. A PennKey is a unique username required to authenticate your identity for access to many of Penn’s online resources and systems, including PMACS credentials, Penn Medicine REDCap, and Workday Learning, the Learning Management System.

External users should follow these steps:

  1. A Penn staff member “sponsoring” the external user should submit a request for a guest PennKey
  2. If you do not already have access to Workday Learning, submit a Solutions Center ticket indicating “Learning Support” as the ticket category and the Workday Learning training you need.
  3. Complete required eLearning (REDCap: Best Practices for Maintaining HIPAA Compliance and Protecting Personal Health Information (PHI))
  4. Submit REDCap account creation request via this submission form

Access for existing Penn Medicine REDCap Accounts

Log in to the Penn Medicine REDCap website using your PMACS account username and password.

If you are unable to log into your account, please contact PSOM REDCap Support. Provide as much information as possible when completing the form.

Policy Documents

SOP 405: REDCap Training and Access (Standard Operating Procedure)

Penn Medicine REDCap Training

Once your Penn Medicine REDCap account is created, watching all REDCap training videos is STRONGLY RECOMMENDED before building your first project.

OCR hosts three, monthly training courses for using Penn Medicine REDCap.

REDCap 101

REDCap 101 instructs users on basic REDCap functionality and building REDCap projects. After completing this 90-minute, instructor-led course, users will obtain a solid foundation on building REDCap projects that result in cleaner data sets. Topics include reviewing basic functions (i.e., field types, validation, etc.), using branching logic and Action Tags, designing REDCap surveys, and reviewing exported project data.

For more information, see the blended course offering in Workday Learning.

REDCap 201

Building on the basics covered in REDCap 101, this 3-hour, instructor-led course provides instruction on more complex REDCap functionality. Topics include a more in-depth review of survey functionality, survey invites, creating longitudinal projects, and how to use REDCap’s Data Resolution Workflow to create queries on project data. To register, users must complete the REDCap 101 course and have an active Penn Medicine REDCap account.

For more information, see the blended course offering in Workday Learning.

OCR Penn’s REDCap – Advance

Presented by Shawn Ballard, Technical Director, Software Systems Development at UPenn, this monthly lecture series presents REDCap functions that research teams can use to increase their efficiency while using the Penn Medicine REDCap application. Each lecture covers current and the latest application enhancements. NOTE: this is not a hands-on course; however, users will come away with an understanding of the covered functionalities.

For more information, see the course offering in Workday Learning.

REDCap was created by Vanderbilt University and is available at Penn Medicine via a license agreement between these two institutions. Additionally, REDCap is available at many institutions around the world using these agreements. This makes finding resources easy by using search engines. However, each organization can customize their REDCap system. It’s important to understand this because functionality described by another institution may not be available in Penn Medicine’s REDCap or may not work exactly the same.

The resources provided here are specific to Penn Medicine’s REDCap.

Penn Medicine REDCap Support

For login issues and/or questions regarding REDCap functionality/troubleshooting, email the REDCap Support Team. Alternatively, you can also use this REDCap Support Help Form (no login required).

For issues with your PMACS credentials, or to reset your PMACS password, please go to PMACS Password Reset.

FAQ

REDCap provides an in-site FAQ module.

After logging in, look for the “Help & FAQ” link in the menu at the top of the screen.

 

 

All FAQs will appear. You can scroll through all FAQs or click the tab that groups specific FAQs together. You can also use the search function for specifics.

 

The Penn Medicine (PSOM/UPHS) research community has increasingly expressed a need to complete and document the informed consent process electronically.

 

Penn Medicine REDCap is an electronic data capture tool that can be used for capturing informed consent documentation electronically for studies that do not require Part 11 compliant signatures.

 

Things to consider regarding the use of Penn Medicine REDCap for e-Consenting:  

  • Cannot be used for studies reporting to the FDA; this includes the below study types:
    • INDs
    • IDEs
    • Abbreviated IDEs
    • IND-exempt
    • IDE-exempt
  • Study team members must have active PMACS and Penn Medicine REDCap accounts
  • E-Consent projects must be created in Penn Medicine REDCap only
  • Benefits provided:
    • HIPAA compliant for e-signatures
    • Free - no cost associated with use of Penn Medicine REDCap
    • Easy self-service workflows
      • Upload UPenn IRB - approved consent
      • REDCap surveys allow:
        • Participants review and electronically sign informed consents
        • Study team representatives electronically sign their attestation of informed consent
  • All e-signed informed consent documentation is stored in REDCap in PDF format

To help create Penn Medicine REDCap e-Consent projects, OCR Operations has developed the below guidance document as well as a REDCap e-Consent template project. The guidance document contains all information needed regarding these projects, including step-by-step instructions to make one from scratch. The REDCap template project can be found in the list of REDCap templates on the “+Create a new REDCap Project” page. This template provides the needed forms, surveys, and alerts to capture eConsents for a single research study. When using the template, study teams must make a few revisions in order to make the template specific to their research study. Instructions can be found in the below REDCap eConsent Guidance document.

REDCap e-Consent Guidance 

Penn Medicine REDCap (REDCap) is a HIPAA-compliant EDC system with functionality to electronically document their Delegation of Authority Logs (eDoA) for research protocols. This allows research teams to electronically document:

  • Study role & responsibilities for all study personnel
  • Study personnel acknowledgment of their study responsibilities
  • Principal Investigator (PI) certification of study personnel’s responsibilities
  • PI certification that study personnel is no longer associated with the study

 

By using REDCap surveys, active REDCap accounts are not required by study’s personnel or the PI to acknowledge and certify study responsibilities. NOTE: An active REDCap account is required for the study personnel responsible for the creation and maintenance of the eDoA REDCap project.

 

Considerations before using:

  • Cannot be used for studies reporting to the FDA, this includes the below study types:
    • INDs/IND-exempt
    • IDEs/IDE-exempt/Abbreviated IDEs
  • Only use the Penn Medicine REDCap to create eDoA Tracking projects

 

To assist the Penn Medicine research community and create a standard workflow, please use the OCR-created REDCap Template project (“eDoA_OCR_Template_SingleStudy_PI”) and the below guidance document.

 

This Template project contains all fields and functions needed for eDoA Tracking. Study teams must make a few modifications to fit the template to the research study; these are described in the guidance document.

To use the Template project:

  1. Login to Penn Medicine REDCap (https://redcap.med.upenn.edu/).
  2. Click the “+ New Project” link in the top navigation menu.

   

  1. Provide project’s title & purpose.

  1. Project creation option: select “Use a template (choose one below)”.
  2. Select “eDoA OCR Template SingleStudy PI”.
  3. Click “Create Project” button.

 

Electronic Delegation of Authority (eDoA) Tracking in Penn Medicine REDCap

The guidance explains the template project’s standard workflow and provides instructions for:

  • Revising the template project to fit your research study.
  • Tracking project’s data.
  • Making post-Go-Live project revisions.

 

Currently, the template and guidance are intended for eDoA tracking projects used for single-site research projects conducted by a single Principal Investigator. We will provide templates and guidance for other study types (e.g., multi-site studies) in the future.

General

The below tip sheets are related to general REDCap application use.

Data Management

Tip Sheets for managing project data.

Data Reports/Exports

Tip Sheets on data reports and exports.

User Management

Tip Sheets on managing REDCap project users.

Penn Medicine REDCap: Contact

Do you have questions about Penn Medicine REDCap? Please contact the REDCap Support Team.

Log in to the Penn Medicine REDCap website using your PMACS account username and password.