Siebel Clinical Trial Management System Guide > Setting Up Clinical Trials >

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.

The tasks in this topic must be performed 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:

1. Creating Clinical Programs
2. Setting Up Clinical Protocols
3. Tracking and Revising Team Assignment History
4. Creating and Revising Versions for Clinical Protocols
5. Associating Clinical Protocols with Accounts
6. (Optional) Setting Up Clinical Regions
7. Associating Clinical Regions with Accounts

End-User Procedures

The following list shows tasks end users typically perform when managing a clinical trial. The procedures are performed by the CRA (clinical research associate) at the site level:

1. (Optional) Creating Accounts and Contacts for Clinical Trials
2. Creating Sites for Clinical Trials
3. Associating Sites with Accounts