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The CRI is proud to offer REDCap, a self-managed, secure, web-based solution designed to support data collection strategies for research studies.

Note: If you would like to use REDCap for COVID-19 research, please refer to this summary of available resources and find further information here.


FDA Updates Guidance on Collecting Race and Ethnicity Data


The FDA recently issued a draft guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”. This guidance document would replace the current guidance document from 2016 entitled “Collection of Race and Ethnicity Data in Clinical Trials”. This new guidance document is meant to set FDA expectations and standards for collecting race and ethnicity data in submissions. Standardizing language and setting expectations for race and ethnicity data in this guidance document ensures that this data is consistently collected and reported to the FDA.

The FDA notes in this guidance document that collecting and reporting race and ethnicity data using standardized terminology is critically important in identifying population-specific signals, which while uncommon, have been observed in racially and ethnically diverse populations.

The draft guidance is proposing a two-question system for documenting race and ethnicity data in Clinical Trials and Clinical Studies using first “Are you Hispanic/Latino or not Hispanic/not Latino?” followed by “What is your race?”. They recommend the following options at a minimum for a response to this question regarding race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.  They list OMB Policy Directive 15 recommended language regarding ethnicity and race question responses, noting that nonwhite is not demographic data that can be reported to the federal government. The FDA guidance recommends following best practices by having participants self-report their ethnicity and race rather than it being assigned by study team members, as well as instructing the participants to mark one or more race if needed in their self-report.

It is noted in the draft guidance that the FDA does recognize that racial and ethnicity data and recommendations provided in this guidance are focused in United States and may not be applicable to clinical trials that occur outside of the US and if more granularity is needed to follow the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status.

The FDA also recommends in this guidance document that Investigation New Drug (IND), New Drug Applications (NDA), and Biologics License Applications (BLA) use the race and ethnicity guidelines laid out within this proposed guidance document to tabulate demographic data for new clinical trials and clinical studies.

This guidance document is open to comments from the public until April 29, 2024.

Original News Source: University of Chicago – Office of Clinical Research, February 2024 Newsletter (Volume 13, Issue 8)




REDCap is a self-managed, secure, web-based solution that is designed to support data collection strategies for research studies. Its free use is offered by the Center for Research Informatics (CRI). This easy-to-use and intuitive tool provides functionality and features to enable researchers to rapidly develop databases and surveys for collecting and managing research data. Data is securely kept on BSD servers at the Kenwood Data Center.

The REDCap project was initiated at Vanderbilt University and includes more than 7,000 active institutional partners from CTSAs, GCRCs, RCMI, and other institutions, including the University of Chicago, in a collaborative international consortium. The consortium contributes to the continuing evolution of the tool and provides a valuable sounding board and testing resource for the Vanderbilt team. REDCap is currently in production use or development build status for more than 2 million projects, with over 3 million end users in over 150 countries spanning numerous research focus areas across the consortium. Here at the University, we have over 16,000 projects with over 11,000 end users.


REDCap offers the following features:

  • Fast. Quick project start-up. Data entry forms and surveys can be implemented without the need for a programmer.
  • Easy. Intuitive user interface and workflow, readily available online training materials, and assistance from the CRI all make it easy to get started.
  • Fully customizable. You are in control of shaping your database.
  • Web-based. Enter data or build your database from anywhere in the world over a secure web connection with authentication and data logging.
  • Secure. Backed up offsite nightly and hosted in a secure environment maintained by the CRI.
  • Data hosting. No need to worry about security issues regarding third party websites hosting your private data.
  • Data import. Import data from Microsoft Excel and Access (csv files).
  • Data export. Export data to Excel, SAS, Stata, R, and SPSS.
  • Audit trail. Track data manipulation, project changes, imports, and exports by date and user.
  • Advanced features. Mid-study modifications, auto-validation, branching logic, and calculated fields.
  • Scheduling. Utilize a built-in project calendar and scheduling module for organizing your events and appointments.
  • Reports and stats. Online tool allows you to view reports of your data, export your reports, and turn your reports into plots, graphs, and statistics.
  • Autonomous user management. Research groups have complete autonomy and control to add new users and set several levels of specific user rights.
  • Multi-site access. REDCap can be used by researchers from multiple sites and institutions.
  • Survey participant list. Build a list of email contacts, create custom email invitations, and track who responds.
  • Anonymous surveys. Keep your participant responses anonymous (default), or if desired, responses from email contacts can be identified.
  • Survey PDF. Generate a PDF version of your survey for printing to collect responses offline.
  • Mobile app. Available for iOS and Android for offline data collection by the project team.

Note: REDCap is not intended for use with FDA-governed clinical trials. For assistance with FDA-governed clinical trials, please contact




REDCap allows users to build and manage online surveys and databases quickly and securely. Users have the freedom to start their projects and begin designing their forms and surveys often within a few short minutes. Start with our training page to help you learn the basics of REDCap via training videos, training manuals, advanced features, quick tips, and FAQs. You can then log in to REDCap with either your BSDAD or UCHAD account and explore the Help&FAQ page for additional help within the application itself. If you need further help at this point, email REDCap Support to set up a working session with the CRI’s REDCap Administrator.


We can help you determine whether REDCap is an appropriate solution for your research data collection needs by providing a brief demo and discussing whether REDCap is a good fit for your project. Please email REDCap Support to set up a consultation session with the CRI’s REDCap Administrator.


Julissa Acevedo, the CRI’s resident REDCap Administrator since 2012, is the point of contact for all REDCap inquiries at the University of Chicago. Julissa has guided numerous investigators with their study design and she takes pride in providing exceptional technical support. An active member of the REDCap Consortium, she attends REDCapCon annually to learn creative solutions and best practices, and to network with global experts to further advance REDCap’s capabilities locally. She was instrumental in UChicago’s successful hosting of 2018’s REDCapCon. She has been invited to train fellow REDCap Administrators at REDCapU, and she has won numerous REDCap Consortium awards for her user training materials. She was the 2020 recipient of the Biological Sciences Division’s Excellence in Staff Collaboration Award for her efforts to sustainably and securely support the data capture needs for our local COVID pandemic response, and for her development of a regulatory compliant remote electronic consent process enabling pre-COVID research studies to continue. Prior to joining the CRI, Julissa supported various applications at Motorola, Bank of America, and the U.S. Census Bureau.




New users can log in to REDCap using either a BSDAD or UCHAD account (use only one account).

If you do not have either account, a BSD sponsor may request an account for you by filling out the BSDIS Collaborator Account Request Form. The BSDIS Help Desk will follow up on this request. CNET accounts do not allow access to REDCap.


To request accounts for users from external collaborating institutions, fill out the BSDIS Collaborator Account Request Form. The BSDIS Help Desk will follow up on this request.


First, check to see if you have access to your project’s User Rights page which is on the left-hand side Applications menu. If you don’t have access, contact REDCap Support or check with other project user who may have access to the page to grant you access.

Next, click on the Add new user box and begin typing your user’s name. Select it once it appears in the list. Click on Add with custom rights. Click on the boxes of the rights to be assigned. Click on Add user. 

If you don’t see your user listed in the Add new user box, there are two possible reasons:

  1. If you do not find the user listed, and they have logged in before, their access may be suspended due to inactivity. Contact REDCap Support to have their access unsuspended.
  2. If they have never logged into REDCap, ask your user to log in and set up their profile with the following form. Once set up, you should be able to find and select their username in the Add new user box.

*Note, if your project has User Roles set up, make sure to add the user to the appropriate role if necessary.

**Please do not enter the user’s email address in the Add new user box, as this will not grant them access.


Passwords are not stored or managed by REDCap. To request password help, visit the UCMIT Password Reset Self-Service site. If you need further assistance, depending on your account type, contact the following help desks:

• internal accounts (BSDAD or UCHAD) – visit the UCMIT Service Now Portal or call 773-702-3456.

 external accounts (t.cri.____ or t-9____) – email or call 773-834-4000.


REDCap 21 CFR Part 11

Compliance Statement

Research faculty and staff often use electronic applications to maintain records and create signatures necessary to support human research activities, some of which are governed by FDA regulations. Sponsors occasionally request certification of compliance with 21 CFR Part 11. This notice provides information about the University’s use of the REDCap system with Part 11 requirements. University researchers, sponsors, or others seeking certification of compliance for FDA-regulated studies, may request a copy of our Statement of Compliance to maintain it with other required research documents.

Validation Report

The University’s instance of REDCap was initially validated for 21 CFR Part 11 compliance back in 2017. We upgrade yearly (approximately) and a revalidation of the system and a review  and update of SOPs is performed with each upgrade. The CRI ensures the REDCap system operates per its intended use, defined by the system requirements. The intended use statement for the REDCap system is as follows: The REDCap system will be available for electronic data capture across a number of research use cases, including but not limited to, general survey and case report form (CRF) data collection for IRB-approved research studies and investigator and sponsor-initiated clinical trials requiring adherence to 21 CFR Part 11, Electronic Records and Electronic Signatures. University researchers may request a copy of our Validation Summary Report which summarizes the results of the most recent validation.

Guidance Manual

University researchers may request a copy  of our Guidance Manual to learn about the specific Part 11 criteria, and the associated REDCap features that meet said criteria.

Questions? Contact REDCap Support.