Ongoing Protocol Review
Outline of items to be reviewed
Admission Data
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Screened, admitted, reported, active
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Subject eligibility
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Demographic characteristics (total, by group)
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Recruitment and retention (total, by group)
Protocol Compliance
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Expected recruitment rate
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Study drop-outs and reason
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Data QA report
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Overall data flow
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CRFs collected, received, entered, reported by relevant CRF
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Protocol deviations
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Protocol violations
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Missing data
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Staff omission
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Subject refusal to provide data
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Monitor holding/stopping rules (e.g., lower dose)
Safety Data Report (total and by group)
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Vital signs
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Any relevant medical, psychosocial or laboratory data
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AEs (summarized in tables)
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SAEs (individual reports)
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Concomitant medications
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Concomitant illnesses
Efficacy Data Report
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Total or by group
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Masked or unblinded
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With or without statistical analysis
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Primary outcome variable
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Secondary outcome variables