1. PRE-SCREENING
Initial conversation by phone, or in the clinic with a team member of the study team,
to tell you about the study opportunity.
2. INFORMED-CONSENT
Form that explains your rights and obligations as a participant in the study.
3. SCREENING
Do you meet the basic study requirements? Vitals, labs, medical history, exams or
other procedures may be conducted.
4. ENROLLMENT/ RANDOMIZATION
You are assigned to a treatment course, which could be a placebo. You and your doctor
may not know what you receive.
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5. STUDY VISITS
These may be days, week or months apart. The study protocol outlines what may happen
at each visit, such as labs, physical exam, questionnaires or other tests/ procedures.
6. END OF STUDY TREATMENT
At this point you may no longer receive treatment or placebo.
7. FOLLOW-UP PERIOD
The study team may call you, or you may have occasional appointments, to assess how
you are doing after ending study treatment.
8. COMPLETION
Your participating in the study has ended.
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