TMF CITADEL

1. General All Zones

1.1. Communications

1.2. Tracking information

1.3. Meeting material

1.4. Filenote

2. Statistics

2.1. Statistics Oversight

2.2. Analysis

2.3. Report

3. Data Management Zone

3.1. Data Management Oversight

3.2. Data Capture

3.3. Database

3.4. EDC Management

4. Third Parties Zone

4.1. Third Party Oversight

4.2. Third Party Set-up

5. Safety Reporting Zone

5.1. Safety Documentation

5.2. Trial Status Reporting

6. IP and Trial Supplies Zone

6.1. IP Documentation

6.2. Interactive Response Technology

7. Site Management Zone

7.1. Site Selection

7.2. Site Set-up

7.3. Site Initiation

7.4. Site Management

8. IEC/IRB Approvals Zone

8.1. Trial Approval

8.2. Other Committees

8.3. Trial Status Reporting

9. Regulatory Zone

9.1. Trial Approval

9.2. Trial Status Reporting

10. Trial Management Zone

10.1. Trial Oversight

10.2. Trial Team

10.3. Trial Committee

10.4. Meetings

11. Central Trial Document Zone

11.1. Product and Trial Documentation

11.2. Subject Documentation

11.3. Reports