| Table
1.1 Model Study Protocol Table of Contents
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|---|
| I. Background,
rationale, and preliminary studies |
| II. Aims and
objectives |
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III. Design
A. Overview
B. Screening and enrollment
C. Intervention and control group
D. Primary and secondary outcome measures
E. Participant visit schedule
F. Measurement and data collection
G. Standard healthcare
H. Study timetable
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IV. Statistical
considerations
A. Planned
study size
B. Randomization procedures
C. Interim data analysis plan
D. Final analysis plan
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| V. Participant
orientation and informed consent |
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VI. Study
organization
A. Participating
units
B. Study administration
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VII. Policy
matters
A. Training
in human subject research
B. Conflict-of-Interest policy
C. Editorial policy
D. Participant privacy
E. Ancillary studies
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VIII. Quality
assurance
A. Training
and certification
B. Adherence aids
C. Performance monitoring
D. Performance reports
E. Site visits
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IX. Data collection
and processing
A. Data
entry
B. Inventory of forms and study materials
C. Data editing
D. Database
E. Backup procedures
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