Process of Managing Clinical Trials

This topic details sample tasks that administrators and end users often perform when managing clinical trials. Your company might follow a different process according to its business requirements.

Perform the tasks in this topic in the order presented. For example, a protocol must exist before you can create its subject visit template.

Administrator Procedures

The following list shows the 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 the tasks CRAs (clinical research associates) typically perform at the site level to manage a clinical trial:

1. (Optional) "Creating Accounts and Contacts for Clinical Trials"

2. "Creating Sites for Clinical Trials"

3. (Optional) "Creating Satellite Sites for Clinical Trials"

4. "Associating Sites with Accounts"

5. "Risk Assessments for Clinical Trials"