OpenClinica: User Types and Roles

OpenClinica has two sets of user privileges – global privileges which are determined by User Type, and study/site privileges, which are determined by User Role.

  • User Type controls the user’s access to administrative screens/functions for creating new studies, and managing user accounts, CRFs, and Subject records in the system. A User Type is assigned when the user account is created.
  • User Role controls the user’s access to functionality for a particular study (or site in a multi-site study). User Roles are assigned when a user is added to the study

This approach is designed to enable a scaleable and flexible model for large and small sites. Responsibility may be centralized or spread across multiple administrators, PIs, and coordinators. An account’s User Role for a Study or Study Site is independent of the account’s User Type.

User Type

User Types in OpenClinica are as follows:

  • User – Normal user accounts that may be assigned roles in individual studies and study sites

  • Business Administrator – User accounts with access to the Business Admin module.
    Business Administrators are able to:
    - View/Create/Edit/Remove/Restore User Accounts (including viewing user audit logs
    - View/Create/Edit/Remove/Restore User Role assignments for existing Users
    - View/Edit/Remove/Restore Global Subject Records
    - View/Create/Edit/Remove/Restore Studies
    - View/Create/Edit/Remove/Restore Site Information
    - View/Create/Edit/Remove/Restore Case Report Forms

  • Technical Administrator
    - Technical Administrators have all the privileges of Business Administrators as well as the capability to manage other Technical and Business Administrator accounts. Business Administrators may not create, modify, or remove Technical Administrator accounts.

User Role

A User must granted a User Role to access a study. The User Role may be granted at the Study level or Site level. Users assigned to multiple studies may be granted a different User Role for each Study or Site. Users who are assigned Roles at the Study level will have access to study data acrosss all Sites in the Study and may also access any single Site within the Study individually. Users who are assigned Roles at the Site level will only have access to study data from the particular Site to which they have been assigned. The User Roles in OpenClinica reflect increasing levels of access: Each user role inherits the permissions and privileges of the roles before it (i.e. the Investigator role includes all the capabilities of the CRA). So while Users have primary functions, they will also have the ability to perform functions of the User Roles with lesser capabilities. The User Roles in OpenClinica, from most privileged to least privileged, are as follows:

User RolePrimary Functions Accessible Modules
Data Manager-Create & Manage CRFs
-Create & Manage Event Definitions
-Create & Manage Rules
-View & Manage Events
-Create & Manage Sites
-Manage Subjects
-Manage Study
-Extract Data
-Manage Study
-Build Study
-Extract Data
-Submit Data
Study Director-Create & Manage CRFs
-Create & Manage Event Definitions
-View & Manage Events
-Create & Manage Sites
-Manage Subjects
-Manage Study
-Submit Data
-Sign Subject Data
-Extract Data
-Manage Study
-Build Study
-Extract Data
-Submit Data
Data Specialist -View Datasets
-Create Datasets
-Extract Data
-Submit Data
Monitor-Source Data Verification
-View All Subjects
-View Events
-Notes & Discrepancies
-View/Create Datasets
-Submit Data (read only)*
-SDV
-Extract Data
Data Entry Person -View All Subjects
-Add Subjects
-Add New Study Events
-View Study Events
-Enter CRF Data
-Notes & Discrepancies
-Submit Data

Site Level User Roles

User RolePrimary Functions Accessible Modules
Investigator -Import Data
-View Datasets
-Create Datasets
-Sign Subject Data
-Submit Data
-Extract Data
Monitor (site)-Source Data Verification
-View All Subjects
-View Events
-Notes & Discrepancies
-View/Create Datasets
-Submit Data (read only)*
-SDV
-Extract Data
Clinical Research Coordinator -View All Subjects
-Add Subjects
-Add New Study Events
-View Study Events
-Enter CRF Data
-Notes & Discrepancies
-Submit Data

* Monitor is a read-only role and may not enter, modify, or remove subject or CRF data. The monitor may create and annotate notes and discrepancies.


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