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Process of Managing Clinical Trials

This section details sample tasks often performed by administrators and end-users when managing clinical trials. Your company may follow a different process according to its business requirements.

In the following examples, tasks are carried out in the order presented. For example, a protocol must exist before its subject visit template can be created.

Administrator Procedures

The following list shows tasks administrators typically perform to manage a clinical trial. These tasks are typically performed in the following order:

1. Creating a Clinical Program.
2. Setting Up a Protocol.
3. Creating and Revising Protocol Versions.
4. (Optional) Setting Up Regions.
5. Defining a Subject Visit Template.

End-User Procedures

The following list shows tasks end users typically perform when managing a clinical trial. The procedures are performed by the CRA at the site level and are typically performed in the following order:

1. (Optional) Creating an Account and Contacts (End User).
2. Creating a Site (End User).
3. Creating a Subject and Setting Up Visits and Visit Activities (End User).
4. Applying Protocol Amendments (End User).
5. Monitoring Subject Status and Enrollment Rates (End User).