REDCap Overview Institute for Clinical and Translational Science Fred McClurg Neil Nuehring What is REDCap? REDCap (Research Electronic Data Capture) is a web-based application used to create forms and manage databases in order to support data capture and surveys for research studies. (Research Electronic Data Capture) is a web based application used to create and manage databases and surveys in order to support data capture for research studies. REDCap Form Types • Survey Intended for a subject or participant Can be anonymous • Data Capture Intended for a research team member or collaborator Who can use REDCap? Any University of Iowa investigator or research team can use REDCap. You can log into REDCap via: https://redcap.icts.uiowa.edu Video training modules are available via: https://redcap.icts.uiowa.edu/redca p/index.php?action=training Why choose REDCap over Excel and Access? • Access to REDCap is authenticated Uses University of Iowa LDAP HawkID and password • Secure hosting and regular data backups Data backups, software upgrades, and system maintenance are handled automatically by ICTS Data is secured via SSL • Allows multi-site access Research teams can input data simultaneously, from across the hall or across the country Additional reasons why to choose REDCap over Excel and Access Researchers can build databases rapidly Any user can login and start a project Research teams have autonomy Create a new database or survey Assign user permissions and roles to others (done in accordance with the IRB) Granting rights for data import and export REDCap Web Interface Form creation and data entry are easy in the web interface REDCap Data Collection • Classic Data Collection Form used for a single time period (questions asked once) • Longitudinal Data Collection Form used for multiple time periods (e.g. vitals at initial visit, 30 days, 60 days, etc.) Same form used for all time periods Calendar used to schedule subject visits REDCap Features o o o o Branching logic is supported Calculated fields are supported Researchers can copy projects Researchers can make modifications to their project any time during the study Draft mode (design phase) Production mode (data collection phase) REDCap Confidential Data Identified data • Identified data can be selected in REDCap to create access limits on those fields • What are identifiers? Examples: MRN, Name, Social Security Number, etc. REDCap Access Control Researchers choose which individuals have access to what features: • Identified data (Team Members) • De-identified data (Data Analyst) • Data export (Principal Investigator) • Import capability (Data Entry) • User rights (Project Owner) • View reports (Project Manager) • View logging (Auditor) • Data quality (Quality Control) REDCap Report Generation Reports are: • Easy to generate Any field can be specified as a report column Sort order and column order specified Simple filtering (e.g. males > age 21) • Saved and recalled later • Can be limited to certain users • Often used as an interface for accessing individual records REDCap File Sharing File Repository • Project-specific files can be stored here Consent form template Standard Operating Procedure (SOP) No need for shared network drive • Files can be securely shared with project members and non project members Via REDCap login (members) Via email and a token (non-members) REDCap Graphing Graphics Data View & Stats REDCap Data Quality Control • Data Comparison Tool Used to compare two records in a project • Data Quality Tool Missing Values Validation Errors (incorrect or out of range) Outliers Hidden fields with values Multiple choice fields with invalid data REDCap Features Double Data Entry • Two persons perform data entry • Each data entry is independent DDE1 and DDE2 roles are assigned to different individuals • A reviewer reconciles differences Reviewer role is assigned to a third person • An admin must to enable capability REDCap Extensions • API Allows external applications to connect to REDCap Used to retrieve or modify data in REDCap (via data export and import) Admin needs to enable • Plugins For web developers to extend REDCap functionality. • Dynamic Data Pull (DDP) Integrated solution for retrieving data from external sources (e.g. Epic’s Clarity database) into a REDCap project. REDCap Analysis Researchers can export data to a variety of statistical analysis packages (SPSS, SAS, Stata, R or Excel) Researchers can grant or restrict access to export data for analysis Data exports are customizable, including all or some of the data forms and fields Exports can include identified or only deidentified data depending on user and group rights REDCap Auditing Data logging records information: • Who changed the data • What data was accessed • When these events occurred REDCap System Security Things the IRB will want to know • Physical Security Primary Data – HCIS Pomerantz Data Center Data backups – ITS Lindquist Data Center • Operating System Security HawkID based logins Data encrypted on the hard drive REDCap Data Backups • Backups are encrypted … • Via the disk. Even the system admins who have access to the hard drive are unable to read it. • Via the network. If someone where listening to network transmission they would be unable to decipher the information. • Copies of data replicated to remote data center every 15 minutes • 100+ point in time copies of data available at any time • Disaster recovery strategy has been tested without data loss Reminder • Hands-On Lab Training tomorrow: http://www.icts.uiowa.edu/content/events • Newsletter wiki page: https://www.icts.uiowa.edu/confluence/displ ay/REDCapDocs/REDCap+Newsletter • Internal REDCap documentation: https://www.icts.uiowa.edu/confluence/displ ay/REDCapDocs/REDCap Questions?