Page tree

Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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.Yes

In small projects, study management, data management and data monitoring roles may be shared.  

 

Access levelSite
data entry
RA

Site Coordinator

Project manager
Study ManagerInvestigatorData
managerCentral data entry
ManagerData EntryData
monitor
MonitorStatistician
Assign to DAGYesYesNoNo
No
YesNoNoNo
Design and set upNoNoNo
Yes
NoyesNoNoNo
User rightsNoNoNo
Yes
NoYesNoNoNo
DAG rightsNoNo
Yes
No
YesFull
NoYesNoNoNo
Data exportNoNo
De-identified
Deidentified/ taggedIdentifiedFullNoNo
De-identified
Deidentified/ tagged
Add/Edit Reports
Yes
No
Yes
NoYesYesYes
Yes
No
Yes
NoYes
Stats & ChartsYesYesYesYesYes
Yes
NoYesYes
 Manage survey participants No No
Survey ToolsNoNoYes Yes Yes No No No 
Calendar
No
YesYesYesYes
No
YesNoNoNo
 Import
Import toolNo 
No 
NoNo Yes Yes No No No 
Data comparisonNoNoNoYes
LoggingYes
No
YesYes
LoggingNo
YesYes
YesNo
NoYesNo
Data comparisonNoNoNo
Yes
NoYesNoYesYes
File repositoryYesYesYesYesYesYesYesYes
Data Quality
No
ExecuteExecuteExecuteCreate, edit, executeCreate, edit, execute
Execute
NoExecuteCreate, edit, execute
Data
Queries / data resolution
Open
RespondOpen, respond, closeOpen, respond, closeOpen, respond, closeOpen, respond
No
Open, respondOpen, respond, close
, respond
Open
, close
, respond
API
No 
NoNoNoNoExport, Import/UpdateNoNo No 
Mobile App
No 
NoNoNoNoNoNoNo No 
Data resolutionRespondRespondOpen close respondOpen close respondNoRespondOpen close respond
Open close respond
Create RecordsYesYesYesYesYesYesNoNo
Rename RecordsNo
Yes
No
Yes
No
Yes
NoYesNoNoNo
Delete RecordsNoNoNo
Yes (but turn off)
NoYes (but turn off)NoNoNo
Lock/unlock recordsNoNo or YesYesYesNoNoYes
Yes
No
Lock all records at onceNoNo
Yes
NoYesNoNoYesNo
Lock records with e-signatureNoNoNoYes, if required, otherwise just lock/ unlockNoNoNoNo
Data entry rightsView & EditView & EditView & EditView & EditView & EditView & EditViewView
Edit surveysNoYesyesYesNoNoNoNo