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|
|Design and set up||No||No||No||Yes||yes||No||No||No|
|Data Quality||No||Execute||Execute||Create, edit, execute||Create, edit, execute||Execute||Execute||Create, edit, execute|
|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|
|Delete Records||No||No||No||Yes (but turn off)||Yes (but turn off)||No||No||No|
|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|