5.2.1 Summary of Features Available to User Roles
The following tables summarize the modules and features available to each of the User Roles at the Study and Site levels.
Summary of Available Modules and Features for User Roles at the Study Level
User Role | Modules and Main Features |
Data Manager | Submit Data:
Monitor and Manage Data:
Extract Data Study Setup:
Home page presents summary of current Study or Site. |
Study Director | Submit Data:
Monitor and Manage Data:
Extract Data Study Setup:
Home page presents summary of current Study or Site. |
Data Specialist | Submit Data:
Sign Subject data Extract Data |
Monitor | Monitor and Manage Data:
Extract Data |
Data Entry Person | Submit Data:
|
Summary of Available Modules and Features for User Roles at the Site Level
User Role | Modules and Main Features |
---|---|
Investigator | Submit Data:
Sign Subject Data Extract Data |
Monitor (site) | Monitor and Manage Data:
Extract Data |
Clinical Research Coordinator | Submit Data:
|
Data Entry Person (Same as Clinical Research Coordinator; use to differentiate office job titles for similar job function if necessary.) | Submit Data:
|
5.2.2 Submit Data Module - Permissions
To access the Submit Data module, your User Role cannot be Monitor. Restricted features in the Submit Data Module for other User Roles are listed here.
Subject Features
- To remove a Subject from a Study or Site or to restore a Study Subject, your User Role cannot be Data Entry Person or Clinical Research Coordinator.
- To assign a Subject to another Site within the Study, your User Role must be Data Manager or Study Director.
Signing Events and Subject Casebooks
- To sign a Study Event or a Subject casebook, your User Role must be Investigator or Data Specialist.
CRF Data and Event Features
- To remove and restore Study Event CRFs, remove and restore Study Events, or delete Study Events, your User Role must be Study Director or Data Manager.
- To delete Study Event CRFs, your User Type must be “business administrator” or “technical administrator.”
- To set Study Event Status to “locked,” your User Role must be Data Manager or Study Director, or your User Type must be “business administrator” or “technical administrator.”
Notes and Discrepancies Features
- To set the status of a Discrepancy Note to “closed,” your Role must by Data Manager, Study Director, or Monitor.
For information about features in the module, see Submit Data.
5.2.3 Monitor and Manage Data Module - Permissions
To access the monitoring features in the Monitor and Manage Data module, your User Role must be Monitor, Data Manager, or Study Director. For information about features in the module, see Monitor and Manage Data.
The features within the module that you can access depend on your User Role and User Type:
Role | Features | Notes |
Monitor | Subject Matrix | Can only view. Cannot make changes to information. |
View Events | Can only view. Cannot make changes to information. | |
Source Data Verification | No restrictions. | |
Study Audit Log | No restrictions. | |
Notes and Discrepancies | Can create only the Query type of Discrepancy Note. Can only update or close an existing Discrepancy Note. | |
Study Director or Data Manager | Source Data Verification | No restrictions. |
Study Audit Log | No restrictions. | |
Rules | Study level only. | |
Group | Study level only. | |
CRFs | Study level only. User Type must be “business administrator” or “technical administrator” to edit, remove, restore, or delete CRFs. |
5.2.4 Extract Data Module - Permissions
To access the Extract Data module, your User Role cannot be Data Entry Person or Clinical Research Coordinator. Other restricted features in the Extract Data are listed here:
- To remove or restore dataset definitions you created, your User Role must be Data Manager.
- To remove or restore dataset definitions you did not create, your User Type must be “business administrator” or “technical administrator.”
For information about features in the module, see Extract Data.
5.2.5 Study Setup Module - Permissions
To access the Study Setup module, your User Role must be Data Manager or Study Director.
- Only users whose User Type is “business administrator” or “technical administrator” can edit, remove, restore, or delete CRFs.
For information about features in the module, see Study Setup.
5.2.6 Administration Module - Permissions
To access the Administration module, your User Type must be “business administrator” or “technical administrator.” You can access all the features in the Administration module no matter what your user Role is. For more about Administration module permissions, see User Types.
For information about features in the module, see Administration.
5.2.7 Module for Other Features - Permissions
No features in the Other module are restricted based on User Role or Type. All users can change their own profile and log out.
For information about the features in the module, see Getting Started with OpenClinica.