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 | |||||||
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 |