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.
Main menu |
Menu selection |
---|---|
Configurations |
Manage Roles |
|
Manage Permissions |
Study |
Role Notifications |
|
Edit User |
|
Link to Site/Depot |
|
User Upload |
|
Pending Users |
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 |
|