Module 15 Presentations

10/04/2024

Clinical Investigation: Elements of the CIP / ISO

Subjects Number, period, Inclusion, Exclusion Criteria, Milestones Procedure Description of investigation related procedures Monitoring Plan Outline of monitoring plan Statistical Consideration Design, Sample Size, level of significance, power, drop out rate, pass/failure criteria, interim analysis, final analysis Data Management Data review, electronic data system, data retention, QA

Protocol/CIP deviations Not allowed except for emergency, recording of PDs, notification requirements, CAPA, PI disqualification criteria Device accountability Description of procedure Compliance statement Adherence to Decl.o. Helsinki, ISO, local regulations, approval, EC/Regulatory Auth. Requirements, Insurance Informed Consent Description of process, emergency treatment AE, ADE, Device Deficiency Definitions, reporting, DMC

Administrative Info Title, Version, Sponsor, PIs Overall Synopsis Summary of investigation Device Description Manufacturing, Identification, training, Intended purpose Justification of design Evaluation report: Pre-clinical, clinical data Risk Benefit Clinical benefits, adverse device effects, residual risk Objective and hypothesis Objective, hypothesis, claims, residual risks to be assessed Design Type of investigation, type of measurements, endpoints, device & comparator (incl. justification

Vulnerable Subjects Description, ICF process, EC

Suspension/ Premature termination Criteria for termination, Breaking the blind, Subject follow-up Publication Policy Statement result publication Bibliography List of references relevant for investigation

CIP Amendment Procedure for CIP amendments

The Organisation for Professionals in Regulatory Affairs

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Annex H: Application of ISO 14971 to clinical investigations

Figure H.1 —Application of ISO 14971 to the management of potential safety concerns in a clinical investigation

The Organisation for Professionals in Regulatory Affairs

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