Study User

Site User

Admin

Home Page

 Data
Manager		 Study
Director		 Data
Entry
Person		 Data
Specialist		 Monitor Clinical
Research
Coordinator		 Investigator Monitor Technical
Admin
User		 Business
Admin
User
Summary Current Study/Site x x             Role Dependent Role Dependent
  Enrollment by Site x x            
Subject Enrollment x x            
Study Progress x x            
Subject Status Count x x            
Source Data Verification table         x     x
  SDV View by event CRF         x     x
SDV View by Subject ID         x     x
Subject Matrix     x x   x x  

Submit Data

 Data
Manager		 Study
Director		 Data
Entry
Person		 Data
Specialist		 Monitor Clinical
Research
Coordinator		 Investigator Monitor Technical
Admin
User		 Business
Admin
User
  SubjectMatrix View x x x x x x x x Role Dependent Role Dependent
Edit Subject Study record x x   x     x  
Remove/Restore a Subject x x   x     x  
Reassign a Subject x x            
View Subject: Enter Data into CRFs x x x x   x x  
View Subject: Reassign CRF Version x x            
Sign Subject       x     x  
Add Subject x x x x   x x  
Notes and Discrepancies View x x x x x x x x
Download and Print Discrepancy note x x x x x x x x
Query Set to New x x     x     x
Query Set to Updated x x x x x x x x
Query Set to Proposed Resolution x x x x   x x  
Query Set to Closed x x     x     x
Create Discrepancy Note: Failed Validation Check, Annotation, Reason for Change x x x x   x x  
Set Discrepancy Note: Failed Validation Check to Updated x x x x x x x x
Set Discrepancy Note: Failed Validation Check to Resolution Proposed x x x x   x x  
Set Discrepancy Note: Failed Validation Check Set to Closed x x     x     x
Schedule Event Add New Event x x x x   x x  
View Events Filter x x x x x x x x
Edit Event x x x x   x x  
Lock/unlock Event x x            
Remove/Restore Event x x            
Set Event to Complete, Data Entry Started, Stopped, Skipped x x x x x x x x
Sign Event       x     x  
Lock Study Event x x            
Import Data x x x x   x x  

Monitor and Manage Data

 Data
Manager		 Study
Director		 Data
Entry
Person		 Data
Specialist		 Monitor Clinical
Research
Coordinator		 Investigator Monitor Technical
Admin
User		 Business
Admin
User
  Source Data Verification View x x     x     x Role Dependent Role Dependent
SDV by Event CRF x x     x     x
SDV by Study Subject x x     x     x
Study Audit Log View x x     x     x
Rules View x x            
Run Rules x x            
Remove/Restore Rules x x            
Test Rules x x            
Download XML x x            
Access Rule Designer for Rule - Enterprise x x            
View Audit Logs Rules x x            
Groups View x x            
CRFs View x x            
Create/Upload New CRF x x            
View, Print, Metadata for CRFs x x            
Edit CRF Description x-owner x-owner            
Replace CRF x-owner x-owner            
Remove or Restore CRF x-owner x-owner            
Create and view new CRF Versions x x            
Download CRF versions x x            
Remove or Restore CRF Versions x-owner x-owner            
Delete CRF Versions                

Extract Data

 Data
Manager		 Study
Director		 Data
Entry
Person		 Data
Specialist		 Monitor Clinical
Research
Coordinator		 Investigator Monitor Technical
Admin
User		 Business
Admin
User
  View Data Sets View x x   x x   x x Role Dependent Role Dependent
Edit DataSets x x   x-owner x   x x
Export User Created Data Sets x x   x x   x x
Remove/restore data sets user created x x   x-owner x-owner   x-owner x-owner
Remove/restore sets Others created x x            
Create Data Sets x x   x x   x x

Study Setup

 Data Manager Study Director Data Entry Person Data Specialist Monitor Clinical Research Coordinator Investigator Monitor Technical Admin User Business Admin User
  View Study View x x             Role Dependent Role Dependent
Print x x            
Metadata x x            
Build Study Access x x            
View study x x            
Edit study x x            
Set Study Status x x            
Create/Upload New CRF x x            
View, Print, Metadata for CRFs x x            
Edit CRF Description x-owner x-owner            
Replace CRF x-owner x-owner            
Remove/Restore CRF x-owner x-owner            
Create and view new CRF Versions x x            
Archive CRF Version                
Download CRF versions x x            
Remove/Restore CRF Versions x-owner x-owner            
Delete CRF Versions                
View, Create and Edit Event definitions x x            
Remove/Restore Study Event definition x x            
View, Create and Edit Group Classes x x            
Remove/Restore Group Classes x x            
Create and edit Rules x x            
Run Rules x x            
Remove/Restore Rules x x            
Test Rule x x            
Download Rule xml x x            
Access Rule Designer for Rule - Enterprise x x            
View, Create and Edit Sites x x            
Remove/Restore Sites x x            
Users Access x x            
View User roles x x            
Assign Users to study x x            
Set/Remove User Role x x            

Administration Mode

 Data
Manager		 Study
Director		 Data
Entry
Person		 Data
Specialist		 Monitor Clinical
Research
Coordinator		 Investigator Monitor Technical
Admin
User		 Business
Admin
User
  Studies Access                 x x
View and Create New Studies                 x x
Remove/Restore Studies                 x x
Users Access                 x x
Create New user                 x x
Set user type to 'T echnical Admin'                 x  
View and Edit User Account (Site or Study level)                 x x
Set User Role                 x x
Remove/restore User Account (Site or Study level)                 x x
Remove/Restore Technical Administrator User Account                 x  
Configure Lock Out                 x x
Audit User Activity                 x x
Manage Password complexity                 x x
CRFs View                 x x
Create/Upload New CRF                 x x
View, Print, Metadata for CRFs                 x x
Edit CRF Description                 x x
Replace CRF                 x x
Remove/Restore a CRF                 x x
Create and View new CRF Version                 x x
Archive CRF Version                 x x
Remove/Restore CRF Version                 x x
Delete CRF Version                 x x
Download CRF version                 x x
Jobs View                 x x
Create new Exports                 x x
Edit Data Exports                 x x
Remove/Restore Export Jobs                 x x
Delete Export Jobs                 x x
Create New Imports                 x x
Edit Data Imports                 x x
Remove/Restore Import Jobs                 x x
Delete Import Jobs                 x x
View currently executing jobs                 x x
Cancel currently executing jobs                 x x
Subjects View                 x x
View Subject Global/Study record                 x x
Edit Subject                 x x
Remove/Restore Subject                 x x

Other

 Data
Manager		 Study
Director		 Data
Entry
Person		 Data
Specialist		 Monitor Clinical
Research
Coordinator		 Investigator Monitor Technical
Admin
User		 Business
Admin
User
  UpdateProfile x x x x x x x x x x
  Logout x x x x x x x x x x