Protocol Risk Analysis Report
HPTN 084 - HIV Prevention Study • Analyzed 2024-09-15
Sample Report
Based on real validation data
87/100
Overall Risk Score
High likelihood of amendments
High Risk
Immediate attention required. High likelihood of amendments.
4
Predicted Amendments
Within 24 months
$1.2M
Estimated Cost at Risk
Total amendment costs
$1.0M
Potential Savings
By implementing fixes
Section Risk Analysis
Study Design
92
Risk Score
Complex randomization scheme may require modifications
Blinding procedures need clarification for interim analyses
Eligibility Criteria
85
Risk Score
Age range (18-45) may be too restrictive for enrollment
Contraception requirements lack specificity
Study Procedures
78
Risk Score
Follow-up schedule may be too aggressive
Sample collection procedures need standardization
Statistical Analysis
90
Risk Score
Interim analysis triggers poorly defined
Missing power calculations for secondary endpoints
Predicted Amendment Timeline
Unblinding Amendment
Efficacious treatments often require early unblinding for ethical access
75%
12-18 months
Timeline Extension
Long-term studies frequently require timeline adjustments
70%
6-12 months
Eligibility Modification
Enrollment challenges may require criteria relaxation
65%
3-6 months
Statistical Analysis Update
Interim analyses may trigger statistical plan changes
60%
9-15 months
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