Introduction to REDCap

REDCap – electronic data capture app for clinical research studies

Karolinska Institutet (KI) offers REDCap as an application for secure data capture for clinical research studies to collect clinical research data. The service enables real-time and/or offline data collection. 

In KI REDCap the data is saved locally at KI servers and is backed up every 24 hours. All network traffic to and from REDCap is encrypted and database access requires user authentication with password and 2-step verification. REDCap also provides audit trails for tracking data manipulation and user activity. As a project owner you can invite members of the research team to access your REDCap project and for each member you will be able to assign different levels of access if needed. 

For information on how to access REDCap at KI, please visit our webpage on Access to REDCap and project creation/management.

REDCap features

REDCap is most commonly used to create questionnaires or web-based case report forms to collect clinical data. The application contains many features and below you will find a description of the most commonly used ones. 

• Online/Offline project creation - Projects within REDCap can be created using either an online method from your web browser using the Online Designer tool or via an offline method by constructing a ‘data dictionary’ template file in Microsoft Excel, which can later be uploaded to REDCap. 
• Advanced Features – When designing your questionnaire/form in REDCap you can use advanced features to adjust your survey according to your needs (e.g., validation, calculations, branching logic, file uploading, matrix fields and more useful functions). 
• Easily manage a contact list of survey respondents or create a simple survey link – By using REDCap's survey tools, a user can collect anonymous responses or track and identify responses from survey participants by:
  • sending a survey link via email
  • entering data manually, and/or
  • posting a link on their website
• Mobile App – REDCap users can collect their data via the REDCap Mobile App on an Android or iOS tablet or mobile device. The data can be collected in an offline mode on that device and may later be synced back to the REDCap project on the online server. 
• Export data to common data analysis packages – All data entered into REDCap can be automatically exported to Microsoft Excel, SAS, Stata, R, or SPSS for subsequent data analysis.
• Ad hoc reporting – Custom queries can be created for generating reports to view or download.

Managing personal data in REDCap

REDCap can be used to collect data that is subject to GDPR. The system guarantees the security of the data and fulfills the information security requirements set by KI’s information security function.

Consistent with the GPDR, stored data should be pseudonymized so that data cannot be attributed to a specific subject without additional information. We therefore prefer not to have personal identification numbers in REDCap as long as it’s not necessary for the project. You should keep all data pseudonymized to the extent possible and thereby keeping the code key outside of REDCap. In the ‘User Rights’ function in REDCap one can limit access for research members so that only the Principle Investigator (PI), and other relevant study staff, can see and export identifiers from the dataset. REDCap can also remove identifiers from a dataset prior to exporting for analysis. Pseudonymized personal data is still subject to the GDPR and requires ethical approval before project is initiated.

REDCap at KI

If you invite external users to your REDCap project or if you will share data with external partners, you must make sure that there are relevant collaboration and data agreements in place before data collection is started. 

REDCap is primarily considered a data collection tool, meaning that once the study is completed you should export your data from REDCap and use another system (e.g., ELN or other KI approved systems) for long-term storage of the data. The project should then be removed from REDCap so that any personal data is not stored in REDCap longer than necessary. 

In case your REDCap account has been inactive for > 2 years, your account will be suspended. If you wish to keep your account, you will need to contact your REDCap administrator (redcap@ki.se) who can unsuspend your account, otherwise your account will be deleted after another 6 months.