Best practices for role, site, and depot assignment
Users with different responsibilities require different roles. For example, some users need the ability to add users to a study. Some need to only add to add site and depot users.
When you create a user and assign a study role to them, you must take into consideration all three modes of a study. Moreover, you must also assign each user to sites and depots in all three study modes, depending on what type of access they should get.
The guidelines in this chapter help you assign the appropriate study roles to each user in each mode, as well as assign them to the correct sites and depots. However, it is ultimately up to you to make a decision on what roles a user must get in a certain mode or what sites and depots they should be assigned to.
- Assignments for user administrators
After a delegated administrator creates accounts for all of the users at an organization, a user administrator must add these users to the study and assign them to individual sites and depots. - Assignments for study team members
As a user administrator, you must assign the appropriate study role to each study team member, in each mode (Study Design, Testing, Training, or Production mode). Moreover, you must assign each study team member to the appropriate sites and depots in a study. - Assginments for site and depot users
As a user administrator, you must assign the appropriate study role to anyone who needs to work at a site or depot during the study conduct period. Moreover, you must assign them to the appropriate sites and depots for each mode (Testing, Training, and Production).
Related Topics
Parent topic: Study roles in Oracle Clinical One Platform
Assignments for user administrators
After a delegated administrator creates accounts for all of the users at an organization, a user administrator must add these users to the study and assign them to individual sites and depots.
Even though you may have one or more global users at your organization, you must have an user administrator assigned in each study.
Note:
Typically, an user administrator in Study Design mode is also a site administrator in Production, Testing and Training modes.Table 4-1 Study roles, site, and depot assignments for user administrators
Job role | Study role assignment | Site assignment | Depot assignment |
---|---|---|---|
User administrator |
Note: Even though an user administrator is typically the site administrator, you may have different study roles assigned for Production, Testing and Training modes. |
For all three categories of sites (Production, Testing, and Training Sites), select the checkbox for any site where the user administrator must be able to assign other users. For example, if the user administrator must assign users to Hospital Roma (a site created in Testing mode), then the user administrator must also be assigned to Hospital Roma in Testing mode. |
For all three categories of depots (Production, Testing, and Training depots), select the checkbox for any depot where the user administrator must be able to assign other users. For example, if the user administrator must assign users to the Canada Depot (a depot created in Production mode), then the user administrator must also be assigned to the Canada Depot in Production mode. |
Assignments for study team members
As a user administrator, you must assign the appropriate study role to each study team member, in each mode (Study Design, Testing, Training, or Production mode). Moreover, you must assign each study team member to the appropriate sites and depots in a study.
Table 4-2 Study roles, site, and depot assignments for study team members
Job role | Study role assignment | Site assignment | Depot assignment |
---|---|---|---|
Clinical supply manager | For Testing, Production, and Training mode, select the Clinical Supply Manager role. | Choose All Sites. | Choose All Depots. |
Statistician | For Testing, Production, and Training mode, select the Statistician role. | Choose All Sites. | Assign no depots. |
Study designer |
For Study Design Mode, select the Study Designer role. For Testing mode, depending on what other tasks the
study designer might need to perform, select one of the
following study roles:
For Training and Production mode, depending on what
other tasks the study designer might need to perform, select one
of the following study roles:
|
|
Assign no depots. |
Study manager | For Testing, , Production, and Training mode, select the Study Manager role. | Choose All Sites. | Assign no depots. |
Clinical Research Associate (CRA) | For Testing, Production, and Training mode select the CRA role. | If the CRA is responsible for site management,
choose All Production Sites and
All Training Sites.
Otherwise, select only the Production and Training sites that the user manages as well as any Testing sites that the user will work in. |
Assign no depots. |
Data manager | For Testing, Production, and Training mode, select the Data Manager role. | Choose All Production Sites and All Training Sites. | Assign no depots. |
Safety monitor | For Testing, Production, and Training mode, select the Medical Monitor role. |
|
Assign no depots. |
Production administration | For Testing, Production, and Training mode, select the Production Admin role. |
|
Assign no depots. |
Assginments for site and depot users
As a user administrator, you must assign the appropriate study role to anyone who needs to work at a site or depot during the study conduct period. Moreover, you must assign them to the appropriate sites and depots for each mode (Testing, Training, and Production).
The table below describes typical study role, site, and depot assignments for every site and depot user.
Table 4-3 Study roles, site, and depot assignments for site and depot users
Job role | Study role assignment | Site assignment | Depot assignment |
---|---|---|---|
Site user | For Testing, Production, and Training mode, select
the:
|
|
Assign no depots. |
Pharmacist | For Testing, Production, and Training mode, select the Pharmacy study role, particularly if the user is responsible for dispensing Unblinded Pharmacist kits in a study. |
|
Assign no depots. |
Depot user |
For Testing mode, choose no roles unless the user is involved in the verification of the study. For Production andTraining mode, select the Unblinded Depot User role. |
|
|