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Protocol Development and Presentation

Key Sections of Protocol. Background and rationale for studyStudy designObjectives (primary, secondary, subgroup hypotheses)Primary and secondary endpoints (efficacy and safety)Inclusion and exclusion criteriaTreatmentsSample sizeData collection plan and follow-up scheduleData analysis plan,

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Protocol Development and Presentation

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    1. Protocol Development and Presentation Protocol 10 -12 pages. On the last page of the protocol indicate the members of the team and the sections they contributed to. Turn in by the last day of class. Presentation 15 minutes during the last 2 weeks of class, followed by questions and discussion.

    2. Key Sections of Protocol Background and rationale for study Study design Objectives (primary, secondary, subgroup hypotheses) Primary and secondary endpoints (efficacy and safety) Inclusion and exclusion criteria Treatments Sample size Data collection plan and follow-up schedule Data analysis plan, including plan for interim monitoring and guidelines for early termination

    3. Advice Elect a chairperson and rapporteur Divide up the work among all protocol team members Give each member a list of names and email addresses Plan to meet 4-5 times during the semester Plan to have 2-3 members present the protocol

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