Recommendations for roles managed

When you set up a role on the Manage Roles page, you can set up the other roles that are managed by a role.

For detailed descriptions of recommended role assignments by IRT function, see the Roles and permissions matrix.

This table lists the features that are affected by the Roles managed function.

This table provides suggestions for the roles managed list and notes for roles that are unique to IRT.

Category	Roles managed	Notes
Oracle user
Oracle Admin User	All roles	Complete access to all aspects of the system. Typically includes Oracle Program Managers, Study Designers, Second Level Support, and Third Level Support.
First Level Support	All roles except Oracle Admin user.	Initial line of support for questions about IRT.
Sponsor users
Unblinded Approver	Self	Reviews the randomization and drug upload list to ensure the information is accurate. Authorizes the use of the randomization and drug schedules that are uploaded into IRT.
Field Monitor	Self
Medical Monitor	Self
Study Manager	Everyone except Oracle Admin and First Level Support.
Statistician	Self
Unblinded Clinical Supply Manager	Self Depot User DDF User
Global Safety user	Self
Site users
Investigator	Self
Study Coordinator	Self
Site Unblind Once	Self	Unblinds a subject during a serious adverse event (SAE). If a subject experiences a SAE and requires medical attention, the Principal Investigator (or other designated person at the site) must unblind the subject to make sure emergency treatment does not conflict with study meds. This action removes the subject from the trial.
Depot user
DDF User	Self
Depot User	Self