Office of Clinical Research
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.
IMPORTANT NOTE: REDCap at Penn Medicine is NOT a 21 CFR Part 11 compliant system; therefore, REDCap is best used for studies that are not under an IND or IDE. You can find more information about 21 CFR Part 11 here. 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.
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 PSOM REDCap Support.
REDCap & 21 CFR Part 11 Compliance
Penn Medicine’s version of REDCap is not Part 11 compliant; however, it is Part 11 capable, meaning that if implemented in conjunction with appropriate procedures, documentation, and qualifications, then a study using REDCap may meet Part 11 compliance requirements. 21 CFR Part 11 compliance requires compliance on two fronts: 1) the technical software specifications described in the Part 11 regulations AND 2) essential processes put in place by the user or study team.
Penn Medicine provides a secure environment for REDCap. However, to be fully compliant, the entire environment, i.e., the people, procedures, and documentation, must also follow the requirements found under Part 11 regulations. The individual user or study team is also responsible for ensuring compliance, including establishing appropriate standard operating procedures to protect and document data. Many of the activities encouraged by Part 11 are good practice in general, including explicit definition of study team roles and responsibilities, database change control and documentation, and record retention. Personnel training commensurate with responsibilities is also required.
OCR can assist study teams to run a study in REDCap as closely as possible in accordance with Part 11; however, you should make it clear to your sponsor that the system is not Part 11 at the institutional level. At this time, REDCap is best used for studies not under an IND or IDE.
Some advantages for using REDCap:
- Secure and web-based: Input data from anywhere in the world with secure web authentication, data logging, and Secure Sockets Layer (SSL) encryption
- Fast and flexible: Conception to production-level database in less than one day
- Diverse and flexible survey distribution options: Use anonymous surveys links or invite subjects to take surveys via email; tracked survey completion
- Multisite access: Projects can be used by researchers from multiple sites and institutions
- Fully customizable: You are in total control of shaping your database or survey
- Advanced question features: Auto-validation, calculation fields, branching logic, and survey stop actions
- Data quality: Use field validation, branching logic, and missing data codes to improve data quality during data entry; open data queries to identify and resolve discrepancies in real time
- Data-based triggers and alerts: Send real-time alerts and notifications to your team via email based certain data being entered
- Custom reporting: Create custom searches for generating reports to view aggregate data
- Mid-study modifications: You may modify the database or survey at any time during the study
- Data import functions: Data may be imported from external data sources to begin a study or to provide mid-study data uploads
- Data comparison functions: Double data entry / Blinded data entry
- Export data to common data analysis packages: Export your data to Microsoft Excel, SAS, STATA, R, or SPSS for analysis
- Save your survey or forms as PDFs: Generate a PDF version for printing to collect responses offline
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