7.2 Permissions for User Roles and Types
The OpenClinica features you can access depend on your User Type and Role. When your User Type or Role does not have permission for a module or feature, OpenClinica does not present it as an option. If you are trying to use a module or feature in OpenClinica but cannot find it where the User Documentation indicates it should be, it's probably because your User Role or Type does not have permission for it.
To see the modules and main features that a User Role has permissions for, refer to the table in Summary of Features Available to User Roles or view the User Matrix.
To see which users have permission to use a module, and to see further restrictions of features within a module, see the section for that module on this page.
7.2.1 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:
- Add and Manage Subjects
- View, Schedule, and Enter Data into CRFs for Events
- No Waiting to Perform Double Data Entry After Initial Data Entry
- Import Data
- Notes and Discrepancies
Monitor and Manage Data:
- Study Audit Log and Source Data Verification
- Manage Groups
- Create, Edit, and Manage CRFs
- Rules
Extract Data
Study Setup:
- View and Build Study
- Assign Users
Home page presents summary of current Study or Site.
Study Director Submit Data:
- Add and Manage Subjects
- View, Schedule, and Enter Data into CRFs for Events
- No Waiting to Perform Double Data Entry After Initial Data Entry
- Import Data
- Notes and Discrepancies
Monitor and Manage Data:
- Study Audit Log and Source Data Verification
- Manage Groups
- Create, Edit, and Manage CRFs
- Rules
Extract Data
Study Setup:
- View and Build Study
- Assign Users
Home page presents summary of current Study or Site.
Data Specialist Submit Data:
- Add and Manage Subjects
- View, Schedule, and Enter Data into CRFs for Events
- Import Data
- Notes and Discrepancies
Sign Subject data
Extract Data
Monitor Monitor and Manage Data:
- View Subjects
- View Events
- Study Audit Log and Source Data Verification
- Notes and Discrepancies
Extract Data
Data Entry Person Submit Data:
- Add and Manage Subjects
- View, Schedule, and Enter Data into CRFs for Events
- Import Data
- Notes and Discrepancies
Summary of Available Modules and Features for User Roles at the Site Level
User Role Modules and Main Features Investigator Submit Data:
- Add and Manage Subjects
- View, Schedule, and Enter Data into CRFs for Events
- Import Data
- Notes and Discrepancies
Sign Subject Data
Extract Data
Monitor (site) Monitor and Manage Data:
- View Subjects
- View Events
- Study Audit Log and Source Data Verification
- Notes and Discrepancies
Extract Data
Clinical Research Coordinator Submit Data:
- Add and Manage Subjects
- View, Schedule, and Enter Data into CRFs for Events
- Import Data
- Notes and Discrepancies
Data Entry Person
(Same as Clinical Research Coordinator; use to differentiate office job titles for similar job function if necessary.)
Submit Data:
- Add and Manage Subjects
- View, Schedule, and Enter Data into CRFs for Events
- Import Data
- Notes and Discrepancies
7.2.2 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.
7.2.3 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. 7.2.4 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.
- To remove or restore dataset definitions you created, your User Role must be Data Manager.
7.2.5 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.
- Only users whose User Type is "business administrator" or "technical administrator" can edit, remove, restore, or delete CRFs.
7.2.6 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.
7.2.7 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.
Approved for publication by Benjamin Baumann (bbaumann), Principal. Signed on 2014-03-24 9:45AM
Not valid unless obtained from the OpenClinica document management system on the day of use.
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- OpenClinica 3 User Documentation
- Overview of OpenClinica 1 Overview of OpenClinica
- Submit Data2 Submit Data
- Monitor and Manage Data3 Monitor and Manage Data
- Extract Data4 Extract Data
- Study Setup5 Study Setup
- Rules6 Rules
- Users and Roles7 Users and Roles
- About User Roles and Types7.1 About User Roles and Types
- Permissions for User Roles and Types7.2 Permissions for User Roles and Types
- Summary of Features Available to User Roles7.2.1 Summary of Features Available to User Roles
- Submit Data Module - Permissions7.2.2 Submit Data Module - Permissions
- Monitor and Manage Data Module - Permissions7.2.3 Monitor and Manage Data Module - Permissions
- Extract Data Module - Permissions7.2.4 Extract Data Module - Permissions
- Study Setup Module - Permissions7.2.5 Study Setup Module - Permissions
- Administration Module - Permissions7.2.6 Administration Module - Permissions
- Module for Other Features - Permissions7.2.7 Module for Other Features - Permissions
- View, Assign, and Modify Users and Roles7.3 View, Assign, and Modify Users and Roles
- Light Weight Directory Access Protocol(LDAP) Users7.4 Light Weight Directory Access Protocol(LDAP) Users
- User Matrix7.5 User Matrix
- Administration8 Administration
- Printing CRFs9 Printing CRFs
- OpenClinica Participate10 OpenClinica Participate
- OpenClinica Randomize11 OpenClinica Randomize
- OpenClinica Installation and Upgrade Guides12 OpenClinica Installation and Upgrade Guides
- Glossary13 Glossary
- Knowledge Articles14 Knowledge Articles
- OpenClinica Community Tools and Tips15 OpenClinica Community Tools and Tips
- OpenClinica Conference Presentations16 OpenClinica Conference Presentations