Getting Started in CTMS

1. Browsers - Version 3.1 is supported on current versions of popular browsers including Microsoft Internet Explorer 10 and higher. The application should work correctly with only minor cosmetic variations in the following browser versions. The eClinical Application can be used with future versions of the five supported browsers (Microsoft Internet Explorer, Apple Safari, Google Chrome, Microsoft Edge, and Mozilla Firefox) but a warning will be displayed on the Login Page to indicate that the version is not yet supported.

• Apple Safari version 5 and higher

• Google Chrome version 30 and higher

• Microsoft Edge version 20 and higher

• Microsoft Internet Explorer 7, 8 and 9

• Requires the Enable Internet Explorer Legacy Versions Configuration Variable under the Application configuration group to be set to True

• Requires the Internet Explorer Browser to be set to Compatibility Mode

• Mozilla Firefox version 3 and higher

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

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

2. Review System Tables and add data as needed

3. Finance and Budgets

• Budget Categories

• Budget Line Items

4. Document Management

• Document Categories

• Document Types

• Document Extensions

• Document Trial Master File Templates

5. Site Visits

• Site Visit Categories

• Site Visit Types

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

• Site Visit Report Templates

6. Project

• Test Articles

• Therapeutic Groups

• Project Groups

• Project Event Groups

• Project Event Types

7. Add a New Domain and/or Project

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

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

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

• Protocol Version

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

• Protocol Visits

• Protocol Visit Schedule

• Add Site Visit Report Template Maps

• Subject Discontinuation Reasons

• Subject Screen Failure Reasons

11. Add Sites to Project

12. Assign Site Staff and Site Team members

13. Enroll Subjects

14. Budgets and Finance

• Add Budget Template

• Map Budget to Protocol Version

• Add Site Budgets