...
Once a user with a WUSTL Key and password logs in to REDCap v13, they can begin creating REDCap Projects on the WUSTL REDCap Instance. Projects are in Development Status by default when a project is created. Development Status allows for easy building, testing, and modifying in order to tailor the project for the specific needs of your study. Data collected and stored in a project that is in Development Status is not considered HIPAA compliant. Therefore, collection and/or storage of PHI or other sensitive data ("real data") are not permitted while the project is in Development Status. In addition, data are not backed-up when the project is in Development Status so you are at risk of permanent data loss. Projects must be moved to Production Status before collecting after the project has been thoroghouly thoroughly tested AND the IRB has approved the protocol for the study(ies) which data will stored in REDCap. An IRB Approval Letter will be requested and required in order for the project to be moved to the production server. Multiple REDCap Projects can be created for a single study as long as each is moved to Production Status and the IRB Approval Letter is uploaded for each individual REDCap Project.
...
It is important to note that you can still make modifications to your project in production status. Some modifications may require administrator review in order to prevent data loss or project corruption.
...
IRB Approval
I2DB is not responsible for granting, approving, or waiving IRB project approvals. We also are not responsible for determining whether a project is in compliance with an IRB protocol. Please contact the HRPO and or the IRB with questions regarding IRB compliance. WashU HRPO and IRB offer HRPO Help Services to provide guidance on:
SWAT On-Call Service: 314-747-6800
All research projects on the Production server must obtain an IRB approval or waiver before the project will be granted access. The Project PIs are responsible for ensuring that their project protocols allow for data capture, storage and retrieval on our REDCap instance. HRPO’s recommendation is for Quality Improvement project researchers to contact the Expedited Review Manager and request a determination on what approval is needed for their data collection. Determinations are made on a case by case basis.
User Rights
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.
Data
Research data stored in REDCap is subject to the Washington University Research Data and Materials Policy. If the PI leaves the university, 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). If any other study team member leaves the university (another faculty member, 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 PA.