Roles are pre-defined user access levels. Customised roles can also be created.
Data monitors are responsible for reviewing and verifying data. They only checking data, and only require the ability to review data and forms and raise queries, and but 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, generate reports, assign user rights and export data.
Project Study managers are members of the primary study team and have a senior administrative role. Project Study 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.
In small projects, study management, data management and data monitoring roles may be shared.
data entryProject manager
managerCentral data entry monitor
|Study Manager||Investigator||Data |
|Assign to DAG||Yes||Yes||No||No|
|Design and set up||No||No||No|
|Stats & Charts||Yes||Yes||Yes||Yes||Yes||Manage survey participants|| No No|
|Survey Tools||No||No||Yes ||Yes ||Yes ||No ||No ||No |
|Execute||Execute||Execute||Create, edit, execute||Create, edit, execute|
|No||Execute||Create, edit, execute|
|Queries / data resolution|
|close||Open, respond, close||Open, respond, close||Open, ||No|
, respond, closeNo
|Open, respond||Open, respond, close|
|No||No||No||No||Export, Import/Update||No||No ||No |
|No||No||No||No||No||No||No ||No |
Yes (but turn off)
|No||Yes (but turn off)||No||No||No|
|Lock/unlock records||No||No or Yes||Yes||Yes||No||No||Yes|
|Lock all records at once||No||No|
|Lock records with e-signature||No||No||No||Yes, if required, otherwise just lock/ unlock||No||No||No||No|
|Data entry rights||View & Edit||View & Edit||View & Edit||View & Edit||View & Edit||View & Edit||View||View|