REDCap – Research Electronic Data Capture
REDCap is a secure, web-based application for data collection where users can build and manage online surveys and databases. Among other services, it offers a platform to create electronic case report forms to capture clinical data into a database for prospective, retrospective and/or longitudinal research.
- Export data to common data analysis packages – Export your data to Microsoft Excel, PDF, SAS, Stata, R, or SPSS for analysis.
- Generate reports – Create custom queries for generating reports to view or download.
- Schedule projects – Utilize a built-in project calendar and scheduling module for organizing your events and appointments.
- Easily manage a contact list of survey respondents or create a simple survey link – Build a list of email contacts, create custom email invitations, and track who responds, or you may also create a single survey link to email out or post on a website.
- Save your data collection instruments as a PDF to print – Generate a PDF version of your forms and surveys for printing to collect data offline.
Visit the UHealth IT’s REDCap knowledge page to start your REDCap project and learn more.
Periodic trainings and personalized assistance with REDCap is available through the CTSI’s Biostatistics Collaboration and Consulting Core. Request a consultation by emailing Maria Jimenez-Rodriguez at MJR[email protected] .
You can use this new REDCap e-consent Framework to obtain electronic consent from research participants enrolling in FDA regulated studies. FDA-regulated studies investigate a drug, medical device or biologic.
With this new e-consent Framework, there are now two REDCap e-Consent Templates:
- The CTSI e-Consent template for use with non-FDA regulated studies; and
- The 21 CFR Part 11 e-Consent Template for use with FDA-regulated studies.
You can find the new template in REDCAP under the Choose a project template section under the New Project view – please see screenshot below.
Process to request access to the 21 CFR Part 11 e-Consent Template
Before submitting a request to access the 21 CFR Part 11 e-Consent Template, all study team members who are involved in the consent process must complete the 21 CFR Part 11: REDCap e-consent Workflow training. The 21 CFR Part 11 e-Consent Template meets the FDA’s requirements for electronic signatures, so you must use this consent template when you obtain electronic consent from research participants for FDA regulated studies. The REDCap system administrator will verify proof of training for all study team members before approving your project request.
How does the 21 CFR Part 11 e-Consent Template differentiate from the CTSI e-Consent Template?
The 21 CFR Part 11 e-Consent Template is only for FDA regulated studies. The CTSI e-Consent Template is available to obtain electronic consent for studies that are not FDA-Regulated. The CTSI template is also available under REDCap’s Choose a Project template section under the New Project view.
How to access the e-Consent trainings?
- Visit https://www.e-gcrme.com/ctsi/
- If you haven’t done so, register for an account with your University of Miami email address.
- Select the e-Consent course you want and click on “enroll me” to add it. This will allow you to view the video and materials. Direct course links are here:
CTSI e-Consent Template for non-FDA regulated studies
21 CFR Part 11 for FDA regulated studies
You will be able to download a training certificate upon training completion to store for your records. When you submit your research project request to use either of these e-Consent templates, you will be asked if you and the members on your team who will obtain electronic consent have completed this required training. You only need to complete the training for the e-Consent option that you plan to use – you do not need to complete the 21 CFR Part 11: REDCap e-Consent Workflow training to use the CTSI e-Consent Template. Likewise, you also do not need to complete the CTSI e-Consent training to use the 21 CFR Part 11 e-Consent Template.
Questions & Feedback
For any questions, please email [email protected]. We also welcome your feedback on your use and experience with the new 21 CFR Part 11 e-Consent Template.