18.1 Active monitoring phase (compliance with test schedule)

18.11   On-study materials

             Complete these materials and mail to the Operations              Office within 2 weeks of registration:

             a.     Patient questionnaire (Appendix I), Questions 1 - 8                      only).
             b.     Quality-of-life questionnaire - FAACT (not available                      Online)
             c.     Protocol-specific flow sheet.

18.12   Follow-up records

             Complete these materials and mail to the Operations Office              monthly:

             a.     Protocol-specific flow sheet
             b.     Patient questionnaires (Appendix I)
             c.     Quality-of-life questionnaire - FAACT
             d.     Weight monitoring record (Appendix II).

18.12  Research specimen submission

            See the test schedule (Section 4.0) and MML procedures
            (not available on this website) for submission requirements.

18.2    Event-monitoring phase (completion of active-monitoring
            phase)

            Submit an event-monitoring form (survival status only)             after discontinuation of drug every 6 months for 2 years
            from on study.