REDCap Information for Grants / Ethics

Grants

The text below, or something similar, is suitable for use in your grant.

REDCap (Research Electronic Data Capture) is a secure, web-based application designed exclusively to support data capture for research studies. REDCap provides: 1) an intuitive interface for data entry (with data validation); 2) 128 bit encryption between the data entry client and the server (https); 3) audit trails for tracking data manipulation and export procedures; 4) automated export procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R); 5) procedures for importing data from external sources; and 6) advanced features, such as branching logic, calculated fields and data quality checks. REDCap is developed and maintained by a team at Vanderbilt University and licensed free of charged by the Women & Children's Health Research Institute (WCHRI). The application and data are housed on servers provided by the Faculty of Medicine at the University of Alberta. These servers are located within the faculty's secure data center in the University Hospital. Local support is provided by WCHRI.

 Ethics

We are often asked to help answer some of the questions posed in the ethics application. In general HREB is familiar with REDCap and the steps that we take to protect the data that the system contains. The information you provide in your ethics application needs to be study specific but the following is an example of the information that you can provide.

If the database is to be maintained locally, what steps have been taken to ensure the privacy and security of the database are upheld?

The study database will be created in the REDCap system provided by WCHRI and hosted in the Faculty of Medicine & Dentistry's data centre. Data collection and storage will comply with the measures outlined in WCHRI's REDCap privacy document (See this page). Study participants will be allocated a unique study code and identifiers will not be entered in the study database. Documents linking the study participant to their unique study code will be stored in a locked filing cabinet.

Or as an example for more complex projects...

• The study database will be created in the REDCap system provided by WCHRI and hosted in the Faculty of Medicine & Dentistry's data centre.

• Data collection and storage will comply with the measures outlined in WCHRI's REDCap privacy document (See this page).

• Participants will be "coded" with a unique study code and personal identifiers will not be used as unique identifiers in REDCap.

• Email addresses and other contact information will be stored in the same project database as participant survey responses. This juxtaposition of data elements is required by the REDCap software in order that personalized survey invitations may be emailed to the study participants.

• Identifiers will be flagged as such in the REDCap system which then provides additional protection for these data elements.

• Identifiers will only be available to specified individuals or user roles

• Identifiers will automatically be removed from all printed or exported materials generated by REDCap where the user has not been given access to identifiers

• Date shifting techniques may be used when exporting and/or reporting data externally so that individuals cannot be identified through dates or birth, clinic visits, etc. Two-factor authentication will be enabled for the project in order to provide additional security when the application is accessed from outside the MEDIT/AHS networks.

Who is responsible for the database?

The database structure and content will be maintained by the Principal Investigator and the study team. The database software and hardware is maintained by WCHRI in collaboration with the Faculty of Medicine and NACTRC. 

Citing REDCap

Please cite the publication below in study manuscripts using REDCap for data collection and management. The REDCap consortium and WCHRI recommend the following boilerplate language:

Study data were collected and managed using REDCap1 electronic data capture tools hosted and supported by the Women and Children’s Health Research Institute at the University of Alberta. 

References

1Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

You can access this article here.