Module 15 Presentations

10/04/2024

Annex I: Clinical Development Stages

Regulatory status

Pre-market

Post-market

Clinical development stage

Pilot stage (I.3.2)

Pivotal stage (I.3.3)

Postmarket stage (I.3.4)

Type of design

Exploratory or confirmatory (I.4.2)

Observational (I.4.4)

Confirmatory (I.4.3)

First in human clinical investigation (I.5.2) Early feasibility clinical investigation (I.5.3) Traditional feasibility clinical investigation (I.5.4)

Registry (a) (I.5.6) Post-market clinical investigation (a) (I.2.3)

Pivotal clinical investigation (I.5.5)

Post-market clinical investigation (I.2.3)

Descriptors of clinical investigations

Burden to subject

Non-Interventional (I.6.3)

Interventional (I.6.2)

a. Registrydatamaybeusedforpre-marketregulatorypurposes(seeI.5.6),thiscanalsoapplytothe post-market clinicalinvestigationdata

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Annex J: Clinical investigation audits

NCA’s will have the authority to conduct audits of the Clinical Investigation

Sponsor An audit of a sponsor’s organization and documents is intended to evaluate compliance with the sponsor’s own procedures, this document, and where appropriate, national regulations. Investigation Site An audit of the investigation site is intended to evaluate compliance with applicable agreements, sponsor procedures, EC requirements, the CIP, the requirements of this document, and where appropriate, national regulations.

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