About RDC Onsite User Roles

Your user role, together with privileges granted to you, determine your activities with RDC Onsite. Your user role defines what you can and cannot do in the RDC Onsite application. For example, your user role may let you enter data, modify data, and resolve discrepancies, but not let you verify or approve the data.

By default, RDC Onsite includes the following pre-defined user roles:

• Site user
• Investigator
• Clinical Research Associate (CRA)
• Data manager

In addition, your sponsor can create and define various other user roles for your instance of RDC Onsite. The following sections describe the default user roles.

Site User

A site user enters patient data into electronic Case Report Forms (CRFs). Site users can start to enter data after the database development is complete, and the study is underway. Entering data and addressing system-generated discrepancies take place simultaneously. Persons with this user role include study coordinators, site coordinators, nurses, research assistants, and data entry personnel.

Investigator

The investigator is the physician responsible for the study at a particular site. The investigator approves CRFs and sometimes also enters data.

After data for a patient is entered and reviewed, and all discrepancies are resolved, the investigator electronically signs the forms, confirming the veracity of the entered data.

Clinical Research Associate (CRA)

As soon as possible after data is saved at the site, the Clinical Research Associate (CRA) reviews study data and addresses issues, performing source data verification either remotely or during a site visit. The CRA, commonly called a clinical monitor or monitor, is an employee of the sponsor or the Clinical Research Organization (CRO).

After data for a patient is entered and reviewed, and all discrepancies are resolved, the CRA has the privileges to electronically verify the forms, confirming that all information has been reviewed.

Data Manager

The data manager is a member of the study team and works at the sponsor site. The data manager uses RDC Onsite to monitor enrollment, track study progress, and review the data for overall quality, patterns, and trending. In addition, the data manager may enter, review, and resolve discrepancies.