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Current issues
The whole process is critical but the sponsor has no certainty at all that the IC was signed BEFORE the patient was selected; his full responsibility relies on doctors perfectly respecting the rules. High control responsibility carried by the CRA. The IC topic is systematically audited by the FDA/EMEA/agency.
Benefits of Kayentis solution
• Instant IC (best in class solution to ensure compliance to predicate rules)
• Secured system (embedded encryption system)
• Instant consistency checks
• Instant alert if patient selected and no IC signed
• Provide direct status report in an easily readable dashboard
• Allows correct tracing of consecutive versions of IC forms
• Patient’s anonymity fully preserved
• Pay per use cost: no heavy investment; cost adapted to the size of the study
 Download PDF file Informed Consent Form
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