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REDCap Central is dedicated to supporting research studies that necessitate 21 CFR Part 11 compliance. To ensure a consistent and secure environment, we have established the following guidelines for users engaging in such projects:
- IRB Protocol Approval:
- Each project must have an approved Institutional Review Board (IRB) protocol before commencing any activities on REDCap Central.
- Sponsor Dashboard Review:
- Sponsors of Users are required to review the User Dashboard monthly. This ensures that all users of REDCap Central remain appropriate for their respective roles and responsibilities.
- Timely Validation of Research Teams:
- Research Teams must validate their projects at the time of upgrades in a timely fashion, with a mandatory validation frequency of every 6 months.
- Continuous Compliance Monitoring:
- Users are expected to remain vigilant of any changes in 21 CFR Part 11 regulations and promptly implement necessary adjustments to maintain compliance.
- Electronic Signature Protocols:
- Strict adherence to electronic signature protocols outlined in 21 CFR Part 11, ensuring the authenticity and integrity of electronic records.
- Training and Awareness:
- All users must undergo training on the regulations outlined in 21 CFR Part 11 to enhance awareness and understanding.
- Record Retention:
- Project Owners are responsible for record-keeping and record retention and should follow these guidelines VUMC Records Retention Policy, Records Classification Schedule (see Research)
By using REDCap Central for your projects, you acknowledge and agree to comply with these guidelines. We appreciate your commitment to maintaining the highest standards of regulatory compliance, and we are here to support you in your research endeavors. If you have any further questions or require additional clarification, please do not hesitate to contact our support team at REDCapCentral@vumc.org .
All Users of REDCap Central must complete REDCap Training for System Compliance and Effective Data Management
To learn more about why REDCap Central has a strict policy for its use, we have established the following guidelines for users engaging in such projects.
Please log in with your user name and password. If you are having trouble logging in, please contact REDCap Central.
REDCap is a secure 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 that can be tailored to virtually any data collection strategy.
REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields.
Learn more about REDCap by watching a
brief summary video (4 min).
If you would like to view other quick video tutorials of REDCap in action and an overview of its features, please see the
Training Resources
page.
Please note that any publication that results from a project utilizing REDCap should cite grant support (UL1 TR000445 from NCATS/NIH).
NOTICE: 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.
If you require assistance or have any questions about REDCap, please contact REDCap Central.
Want to learn more about REDCap?
The REDCap Overview video is a detailed demonstration of the basic features and functionality.
All Users of REDCap Central must complete REDCap Training for System Compliance and Effective Data Management
Need help with REDCap?
If you have any questions about REDCap, please contact us at: redcapcentral@vumc.org. Most questions or problems can be resolved by email within 1-2 business days.
Supplementary self-help resources and other information are available on our public local User FAQ page.
REDCap Features
Build online surveys and databases quickly and securely in your browser - Create and design your project using a secure login from any device. No extra software required. Access from anywhere, at any time.
Fast and flexible - Go from project creation to starting data collection in less than one day. Customizations and changes are possible any time, even after data collection has begun.
Advanced instrument design features - Auto-validation, calculated fields, file uploading, branching/skip logic, and survey stop actions.
Diverse and flexible survey distribution options - Use a list of email addresses or phone numbers for your survey respondents and automatically contact them with personalized messages, and track who has responded. Or create a simple link for an anonymous survey for mass email mailings, to post on a website, or print on a flyer.
Data quality - Use field validation, branching/skip logic, and Missing Data Codes to improve and protect data quality during data entry. Open data queries to automatically identify and resolve discrepancies and other issues real-time.
Custom reporting - Create custom searches for generating reports to view aggregate data. Identify trends with built-in basic statistics and charts.
Export data to common analysis packages - Export your data as a PDF or as CSV data for easy analysis in SAS, Stata, R, SPSS, or Microsoft Excel.
Secure file storage and sharing - Upload and share any type of file with anyone in the world through the File Repository feature or Send-It tool. Also works with exports and other built-in file uploading features.
Data-based triggers and alerts - Send real-time alerts and notifications to your team or other stakeholders via email, text, or phone based on certain data being entered or specific questions having a particular answer.
Connect to other resources - Use built-in features (API) to move data to/from your project. Build your own custom software development features to connect your project to other systems.