Module 17 2024

05/12/2024

Chapter 7: Clinical Investigations

The regulations also detail specific requirements for: • The methods for conducting a clinical investigation • Detailed requirements for the clinical investigation plan (CIP) • Requirements that must be met for performing a clinical investigation The regulations will document participants' rights to withdraw from a clinical investigation, making this clear to subjects/participants and sponsors. The regulations will define requirements for clinical investigation investigators and personnel involved in clinical investigations, with supplementary guidance providing additional detail. This information was not presently documented in the consultation document.

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Chapter 7: Clinical Investigations

Informed consent Requirements for obtaining informed consent from individuals participating in a clinical investigation will be introduced. The developed regulations will supplement legislative provisions with clear guidance. In addition, they will reflect the need for alignment with requirements for medicines. The regulations will also document the circumstances in which requirements for informed consent might be waived. Additional requirements for clinical investigations on minors are documented in the regulations. Additional requirements for clinical investigations or performance studies on pregnant or breastfeeding women are also documented in the regulations

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