Risk Assessment Inputs
Upload protocol and site context to identify and prioritize potential risks impacting patient safety, data integrity, and study execution.
Clinical Trial Protocol *
Primary input for controlled risk assessment.
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Supported formats: .pdf
Site Level PD Log *
Used to contextualize historical protocol deviations at the selected site.
Lab Manual
Provides laboratory workflow context that may inform operational and data integrity risks.
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Supported formats: .pdf
Pharmacy Manual
Provides investigational product handling context that may inform safety and compliance risks.
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Supported formats: .pdf
Clinical SOP
Provides standard operating procedure context that may inform compliance and operational risks.
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Supported formats: .pdf
Governance note: Controlled, versioned inputs. Outputs require qualified human review and do not replace sponsor oversight.