2. Study Design and Planning.
3. Data Definition, Forms and Database Design.
4. Computer Systems for Data Management and Data Entry.
5. Patient Registration.
6. Local Data Management Systems.
7. Central Quality Control of Data.
8. Data Management and Good Clinical Practice.
9. Software Tools for Trials Management.
10. Follow-Up and Close-Out Phase.
11. Training, Education and Documentation.
12. Clinical Trials Collaboration Models.