Module 15 2022

20/05/2022

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.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

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Chapter II

Documentation Regarding The Application For Clinical Investigation Application Form Investigator Brochure Clinical Investigation Plan General Info (sponsor details, CI identification number, PI details) often all in other

documentation, monitoring and Data Management details. Any other information (insurance, legal rep details, ICF)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

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8