TMF CITADEL

1. General All Zones

1.1. Communications

1.2. Tracking information

1.3. Meeting material

1.4. Filenote

2. Trial Management Zone

2.1. Trial Oversight

2.2. Trial Team

2.3. Trial Committee

2.4. Meetings

3. Central Trial Document Zone

3.1. Product and Trial Documentation

3.2. Subject Documentation

3.3. Reports

4. Regulatory Zone

4.1. Trial Approval

4.2. Trial Status Reporting

5. IEC/IRB Approvals Zone

5.1. Trial Approval

5.2. Other Committees

5.3. Trial Status Reporting

6. Site Management Zone

6.1. Site Selection

6.2. Site Set-up

6.3. Site Initiation

6.4. Site Management

7. IP and Trial Supplies Zone

7.1. IP Documentation

7.2. Interactive Response Technology

8. Safety Reporting Zone

8.1. Safety Documentation

8.2. Trial Status Reporting

9. Third Parties Zone

9.1. Third Party Oversight

9.2. Third Party Set-up

10. Data Management Zone

10.1. Data Management Oversight

10.2. Data Capture

10.3. Database

10.4. EDC Management

11. Statistics

11.1. Statistics Oversight

11.2. Analysis

11.3. Report