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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
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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.
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