Module 15 Presentations

10/04/2024

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)

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Chapter III

Other Obligations Of The Sponsor

• Making available all documentation to the NCAs listed in Chapter II • Ensure any SAE’s (or other events in Article 80(2)) are reported to the sponsor in a timely manner • Ensure all documents listed in Annex XV are held for the following time:  10 years after the clinical investigation has completed, or  10 years after the last device is placed on the market, 15 years for implantable. • Ensure an appropriate monitor is appointed (independent from the site). • Ensure the follow up of investigation subjects • Ensure (and be able to prove) the clinical investigation is conducted to Good Clinical Practice • Prepare a Clinical Investigation Report covering all essential items.

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