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Process of Managing Clinical Trials

This topic details sample tasks often performed by administrators and end-users when managing clinical trials. Your company might 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 Clinical Protocol.
3. Tracking and Revising Team Assignment History
4. Creating and Revising Protocol Versions.
5. (Optional) Setting Up Clinical Regions.

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 a Clinical Trial Account and Contacts.
2. Creating a Clinical Trial Site.