...
User passwords to access a system
Two-factor authentication during log in (DUO)
Program time-outs which lock the system when not in use for an extended period of time (30 minutes)
User Roles
| Excerpt | ||
|---|---|---|
| ||
It is up to the discretion of the project PI in conjunction with the study team to set up User Rights & Roles in a project. In order for a study to be Part 11 Compliant, project sponsor / investigator roles and responsibilities must be clearly articulated to provide awareness to sponsors and investigators of responsibilities to adequately conduct clinical trials. It is important to separate roles and their designated rights in each project. The following examples would meet Part 11 compliance for separation of concerns:
 |
Note: The eConsent REDCap Template includes the Principal Investigator and Study Coordinator roles. Please add additional roles per your project needs.
...