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As well as being associated with specific studies and sites, each user is assigned to a role. Activities in the OutcomeLogix application are restricted to users who are assigned to specific roles. The OutcomeLogix application ships with the following default roles.
Default roles
User Types | Role | Description |
|---|---|---|
Site Users | Clinical Research Coordinator (CRC) | An assistant to the investigator at a site. |
| Investigator | The clinician who is responsible for treating subjects, executing the protocol of a study at a specific site, and filling out forms for subjects. |
Sponsor | Sponsor | The organization that has commissioned the study or a contract research organization (CRO) conducting a study for a sponsor. |
| Clinical Research Associate (CRA) | A person hired by a sponsor to supervise and monitor the progress of sites that are participating in a study. |
| Clinical Data Manager (CDM) | A person responsible for preparing and maintaining a study database and reviewing data. The CDM can view all patient data but cannot see patient-identifying information. |
| Medical Monitor | A person who designs the study protocol and reviews data. The medical monitor can view all patient data but cannot see patient-identifying information. |
| Sponsor Help Desk | Support personnel provided by Oracle or the sponsor. Typical OutcomeLogix operations performed include adding sites and users and resetting passwords. |
| Call Center Manager | The Call Center manager performs administrative tasks, assigns patients to Call Center staff, and has all of the rights of Call Center staff. |
| Call Center Staff | Call Center staff are responsible for interacting with patients enrolled in the study. They manage the call queue and help patients complete surveys, log patient calls, report major medical events, fill in ePRO forms on behalf of patients, and manage patient contact information. |
Patient | Patient | A study participant. |
| Observer | A person who assists a study participant during the study, typically a parent or guardian. |
Oracle or System Users | OLX Read Only | This role provides Oracle staff with access to view a study in read-only mode. Users can view all patient data but cannot see patient-identifying information. |
| OLX Help Desk | The Oracle Tier 1 Support users. Typical OutcomeLogix operations performed include adding sites and users and resetting passwords. Users can view all patient data but cannot see patient-identifying information. |
| Study Administrator | This superuser initially sets up Help Desk users (so that the Help Desk users can set up the other users in the study). This role terminates when the study goes live. |
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