REDCap was created to put researchers in control of their work.

No programming or technical experience is needed to stand up a data collection project. At OHSU, personnel build and manage their own projects with guidance and help from the REDCap Team.

Topics Covered


OHSU Research Use

REDCap at OHSU is primarily used for research. It is available for OHSU investigator initiated research studies that are not FDA regulated. 

  • OHSU's REDCap is not configured or managed for 21 CFR Part 11 compliance for FDA regulated studies. 

  • Studies subject to international privacy laws such as GDPR require additional review to determine if data collected outside of the US can be hosted at OHSU, in REDCap or otherwise.

  • REDCap is not meant for storing big data.
  • REDCap is not available for collecting data for stem cell research.

A single project cannot be used to collect data for multiple protocols. For registry and repository data collection, the study team should plan on submitting a research repository protocol and identify in the protocol if data from multiple protocols will be stored in the repository or registry.

Other than consent, REDCap is not approved for digitizing forms that require legal oversight from the institution, such as the OHSU's agreement to release personal health information. 


OHSU Non-Research Use

Although REDCap's primary and intended use is for research data collection, REDCap can be used for the following kinds of OHSU non-research data collection projects: 

  • IRB exempted quality improvement projects
  • Feedback on provider or student training for quality improvement
  • Study team and department operations for supporting research
  • Department operations for processing applications for funding opportunities and awards.

REDCap is not available for collecting source data for patient care/clinical care, including billing, tracking referrals, and follow-up surveys for patient visits. REDCap is not approved for digitizing forms that require legal oversight from the institution, such as the OHSU's agreement to release personal health information.

REDCap is not available for non-OHSU non-research projects.

There is an annual fee for using REDCap for non-research projects, and training is required for persons building and managing non-research projects.

General Regulatory Information

All software and applications used at OHSU, including REDCap, are subject to compliance policies and procedures. REDCap use must conform to policies from a number of entities that govern the collection and hosting of data. These include:

  • All federal policies, as OCTRI is funded by the NIH and those funds support the administration and hosting of REDCap.
  • OHSU Information Privacy and Security Policies.
  • Policies and guidelines from OHSU groups that govern research, including Research Development and Administration (RDA) and the OHSU IRB.
  • OCTRI's contract with Vanderbilt University, where REDCap was founded and is maintained.

Contact OCTRI Navigator octri@ohsu.edu or 503-418-9790 if you have questions as to what may be allowable. 

Key Details

REDCap is widely used in the academic research community and has been in use at OHSU since 2007.

REDCap is designed to protect data privacy and integrity, and it complies with HIPAA regulations and IRB mandates. Review key security features for data storage and data transmission.



Allowable Uses Table

Uses

Yes (tick) 

Maybe (warning) 

No (minus) 

OHSU Research Use

OHSU investigator initiated research studies that are not FDA regulated including research with US collaborators.

  • OHSU research with international collaborators
  • OHSU research storing big data
  • Industry funded OHSU research
  • FDA regulated OHSU research that requires data be stored in a 21 CFR Part 11 EDC
  • OHSU research collecting data for stem cell research.
  • Digitizing forms that require legal oversight from the institution, such as the OHSU's agreement to release personal health information.
  • Consents from other institutions
OHSU Non-Research Use
  • IRB exempted quality improvement projects
  • Feedback on provider or student training for quality improvement
  • Study team and department operations for supporting research
  • Department operations for processing applications for funding opportunities and awards.
  • Participant tracking projects to support operations (no study data) for FDA regulated OHSU research that requires data be stored in a 21 CFR Part 11 EDC
  • Non-OHSU non-research 
  • Digitizing forms that require legal oversight from the institution, such as the OHSU's agreement to release personal health information. 
  • Collecting source data for patient care/clinical care, including billing, tracking referrals, and follow-up surveys for patient visits.