Draft a Data & Safety Monitoring Plan addendum to the IRB Application specifying AI-enabled anomaly detection protocols for placebo-controlled oncology trials using digital biomarkers

Generate draft a data & safety monitoring plan addendum to the irb application specifying ai-enabled anomaly detection protocols for placebo-controlled oncology trials using digital biomarkers for Scientific Research and Development Services industry

Scientific Research and Development Services

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Upload the current IRB application and any existing Data & Safety Monitoring Plan to serve as the baseline document
Specify the trial phase and specific design characteristics that will influence AI anomaly detection requirements
Identify the primary digital biomarker categories being employed for AI-enabled monitoring
Define specific statistical thresholds for AI-triggered alerts across different safety domains
Specify the primary regulatory authority and any co-regulatory contexts that constrain AI implementation
Identify the primary stakeholder groups who will review and approve the AI monitoring protocols
Define the required format and level of detail for the addendum based on institutional requirements
Specify additional risk mitigation strategies beyond standard clinical monitoring that are required by regulatory or institutional policy
Identify the specific quality standards or guidelines that must be incorporated into validation documentation