REDCap (Research Electronic Data Capture) is a browser-based, metadata-driven EDC software solution and workflow methodology for designing clinical and translational research databases. Using REDCap’s streamlined process for developing projects, you may create surveys, databases, or a combination of both using our Online Designer with your preferred web browser, or offline by constructing a data dictionary within Excel.
Additionally, REDCap has the ability to save a PDF copy of the signed consent in the REDCap File Repository (called the eConsent Framework). It must be explicitly enabled, but it’s a good standard procedure for eConsents (it further solidifies the integrity piece as well as meets the records retention requirement). The participant can print the PDF or it can be printed for them (e.g., if they are completing it in clinic).
REDCap has an electronic signature feature that meets university requirements for a legally binding electronic signature when configured appropriately. The authenticity requirement for electronic signatures can vary in REDCap depending on the protocol.
Remote Signing, Username & Password – REDCap can be used to collect signatures remotely online when configured with a password for participants. Participants need to establish a password with the study coordinator either in person or via phone. The study coordinator enters the passcode in the participant’s REDCap record. Participants are sent a link to sign the consent form in REDCap via email, which does not include the password. Participants are then asked for the password which is cross referenced with the password already on file in the REDCap project.
Remote Signing, Personal Data Reference – Study coordinators can verify authenticity of a participant by setting 1-4 data points as survey login(s). Participants are then emailed a link to sign consent form in REDCap where they will be asked to enter the personal information (name, date of birth, address, etc.) to be cross referenced with data already on file in the REDCap project. A password or unique de-identified data point is preferable to using PHI elements for the login field(s)
In-Person Signing – Study coordinators can verify the participants identity in person. Participants can provide ID, insurance card, name and date of birth, etc.
More Information:
https://ccts.osu.edu/content/redcap
Contact:
Heather Lansky – CCTS-Informatics@osumc.edu