Module 15 Presentations

10/04/2024

Annex XV Clinical Investigations

Annex XV CLINICAL INVESTIGATIONS ● Chapter I. General Requirements ● Chapter II. Documentation Regarding The Application For Clinical Investigation ● Chapter III. Other Obligations Of The Sponsor

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Chapter I

General requirements Ethical Principles – ensure that the study is carried out in accordance to recognised Ethical principals. Methods: • Clinical Investigation will be performed based on latest scientific and technical knowledge and conducted according to the CIP. • Procedures and methodologies are appropriate to the device under investigation. • Endpoints shall be clinically relevant, using scientific methodologies. • Investigator will have access to all the technical and clinical data (IB). • Clinical Investigation Report shall contain critical evaluation and list all findings, even if negative.

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