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Access to the secure REDCap servers is provided in compliance with WUSM’s HIPAA guideline. Each user is responsible for the security of their WUSTL Key and password. All user access and user rights to individual REDCap Projects are controlled by the study team themselves. From a technical perspective, when a REDCap project is created, the person who creates project is responsible for adding other study team members. Study team members can be added with the ability to control other people's User Rights. Anyone given the ability to control user rights is able to add or remove people from the project as well as control what specific tasks they can complete in REDCap. The person who creates the project plus anyone added with the ability to control User Rights are responsible for the people who are added to that individual project. From a compliance perspective, the Principal Investigators (PI) of the study is responsible for ensuring only appropriate individuals have access to the project. For a research study, the PI is the person defined in the approved IRB protocol as the PI or Co-PI and appropriate study team members are those listed on the Research Team in the approved IRB protocol with proper regulatory training (e.g. CITI). The PI also is responsible for ensuring all study team members who are using REDCap are properly trained for the tasks they will complete. It is the responsibility of the PI and PA to restrict all user privileges to a level that they do not gain access to sensitive data to which they do not have proper approvals or to data which they are supposed to be blinded to. It is the responsibility of the PI and PA to remove any users that leave the university or no longer work on the project.
Research Data Stored in WashU REDCap
Research data stored in REDCap is subject to the Washington University Research Data and Materials Policy. Any project that is part of a research project that has IRB approval should have this included within the REDCap project.
REDCap Project PI Departing University
If the PI of a REDCap project leaves the university, research please follow the PI Departure Process. Research data in REDCap can be transferred only with prior approval from a Dean, Department Chair, or Director ( as specified in the PI Departure Process).
Transferring REDCap Data to another Institution
If a PI would like to transfer data from a REDCap project to another institution, please follow the PI Departure Process. If any other study team member leaves the university (another faculty memberfor example, a student or trainee , etc.) they must be treated as an external collaborator. First, the any individual leaving the university must still be on the research team in the approved IRB protocol. Then, they must receive a guest WUSTL Key and be added to the project with the guest WUSTL Key by a PAis graduating and moving to another university and would like to take the data with them), they will need to complete a Data Transfer Agreement (DUA) and, if needed, a Materials Transfer Agreement.
Transferring a REDCap Project to another WashU PI
If the PI is departing the university, follow the PI Departure Process. If a project with research data needs transferred for any other reason, i.e., the current PI is going to clinic full time and will no longer conduct research, you must make a modification in the IRB and Submit a REDCap Ticket with the approval letter that contains the name of the new PI and IRB number.