User Roles

Roles are pre-defined user access levels. Customised roles can also be created.

Data monitors are responsible for reviewing and verifying data. They only require the ability to review data and raise queries, and do not normally need to edit patient data. The data monitor is responsible for locking forms once all queries have been resolved by site coordinators, project managers or investigators. In smaller projects, data monitoring may be performed a project manager of administrator and custom user rights will need to be created.

Data managers are involved in setting up and maintaining the project, and have full access to all study data. The data manager has the ability to program data quality rules and raise queries, reports.

Project managers are members of the primary study team and have a senior administrative role. Project managers can assign existing users to data access groups, raise queries, edit reports and records. They have full access to study data but can download only de-identified data.

Investigators have full user rights and can lock records with an electronic signature if required.

Access level	Site data entry	Site Coordinator	Project manager	Investigator	Data manager	Central data entry	Data monitor	Statistician
Assign to DAG	Yes	Yes	No	No	No	No	No	No
Project design and set up	No	No	No	Yes	yes	No	No	No
User rights	No	No	No	Yes	Yes	No	No	No
DAG rights	No	No	Yes	Yes	Yes	No	No	No
Data export	No	No	De-identified	Full	Full	No	No	De-identified
Logging	No	Yes	Yes	Yes	No	No	Yes	No
Data Quality	No	Execute	Execute	Create, edit, execute	Create, edit, execute	Execute	Execute	Create, edit, execute
Add/Edit Reports	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Queries	Respond	Respond	Open close respond	Open close respond	No	Respond	Open close respond	Open close respond
Stats & Charts	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Calendar	Yes	Yes	Yes	Yes	No	No	No	No
File repository	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Data comparison	No	No	No	Yes	Yes	No	Yes	Yes
Create Records	Yes	Yes	Yes	Yes	Yes	Yes	No	No
Rename Records	No	Yes	Yes	Yes	Yes	No	No	No
Delete Records	No	No	No	Yes (but turn off)	Yes (but turn off)	No	No	No
Lock/unlock records	No	No	No	Yes	No	No	Yes	Yes
Lock all records at once	No	No	No	Yes	No	No	Yes	No
Lock records with e-signature	No	No	No	Yes	No	No	No	No
Data entry rights	View & Edit	View & Edit	View & Edit	View & Edit	View & Edit	View & Edit	View	View
Edit surveys	No	Yes	yes	Yes	No	No	No	No

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User Roles