Getting Started

Every company’s needs are different and there are no set steps that must be taken. The following are our suggestions of the initial steps to help you get started.

1. Review the System, Domain, and Project Configuration Variables.

2. Review System Tables and add data as needed

   1. Finance and Budgets

      1. Budget Categories

      2. Budget Line Items

   2. Document Management

      1. Document Categories

      2. Document Types

      3. Document Extensions

      4. Document Trial Master File Templates

   3. Site Visits

      1. Site Visit Categories

      2. Site Visit Types

      3. Site Visit Report Fields (These are the questions that will be added to the template)

      4. Site Visit Report Templates

   4. Project

      1. Test Articles

      2. Therapeutic Groups

      3. Project Groups

      4. Project Event Groups

      5. Project Event Types

3. Add a New Domain and/or Project

4. Add Global Institutions, including Sites, IRBs, SMOs, Sponsors, and Vendors, as needed

5. Add Global Contacts, both Project contacts and Site contacts. Connect the Site contacts to the Global Institutions

6. Add Project information into the Project Tables, for example

   1. Protocol Version

   2. Project Country (must add all countries included in the project)

   3. Protocol Visits

   4. Protocol Visit Schedule

   5. Add Site Visit Report Template Maps

   6. Subject Discontinuation Reasons

   7. Subject Screen Failure Reasons

7. Add Sites to Project

8. Enroll Subjects

9. Budgets and Finance

   1. 1. Add Budget Template

      2. Map Budget to Protocol Version

      3. Add Site Budgets