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).

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 a user administrator assigned in the system, too.

If you are a user administrator, consider adding yourself to the study. A user administrator might have other roles, too. For example, a user can be a Clinical Research Associate (CRA) in Production mode, but they can also be a user administrator in Testing mode. If you are a user administrator, you can add your

The table below describes typical study role, site, and depot assignments for a user administrator.

Table 4-1 Study roles, site, and depot assignments for user administrators

Job role	Study role assignment	Site assignment	Depot assignment
User administrator	For Study Design Mode, select the User Administrator role. For Production, Testing, and Training mode, select the Site Administrator role.	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.

The table below describes typical study role, site, and depot assignments for every study team member.

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: Study Manager Clinical Supply Manager Statistician Production Admin, if the study designer is also responsible for setting up the connection to Oracle mHealth Connector Rule Designer, if the study designer is also responsible for designing rules For Training and Production mode, depending on what other tasks the study designer might need to perform, select one of the following study roles: Study Manager Production Admin, if the study designer is also responsible for setting up the connection to Oracle mHealth Connector	Choose All Testing Sites. Assign no Production or Training sites.	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.	Choose All Production Sites and All Training Sites. Select any Testing sites that the user will work in.	Assign no depots.
Production administration	For Testing, Production, and Training mode, select the Production Admin role.	Select All Production Sites and All Training Sites. Select any Testing sites that the user will work in.	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: Site User study role, if the user is only responsible for dispensation. Pharmacy User study role, if the user is responsible with dispensing Unblinded Pharmacist kits in a study.	Select only the Production and Training sites that the user works at. Choose Testing sites only if the user is involved in the verification of the study.	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.	Select only the Production and Training sites that the user works at. Choose Testing Sites only if the user is involved in the verification of the 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.	Select only the Production and Training sites that the user's depot ships to. Select no Testing sites unless the user is involved in the verification of the study.	Select only the Production and Training depots that the user works at. Select no Testing depots unless the user is involved in the verification of the study.