section 1. History and background -- section 2. Protocol development -- section 3. Preparation and assessment -- section 4. Legislative and regulatory issues -- section 5. Promotion and patient retention -- section 6. Active treatment -- section 7. Ancillary studies -- section 8. Off-treatment follow-up -- section 9. Data management and reporting -- section 10. Quality management -- section 11. Professional development -- section 12. International consideration.