Module 17 2024

05/12/2024

Chapter 7: Clinical Investigations

Modifications to clinical investigations The regulations will set out the procedures that should be followed in cases where a sponsor intends to introduce modifications to a clinical investigation Recording and reporting of adverse events that occur during clinical investigations The regulations will require the sponsor to fully record, for clinical investigations, all of the following: a. Any adverse event of a type identified in the clinical investigation or performance study plan as being critical to the evaluation of the results of that clinical investigation or performance study b. Any serious adverse event

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Chapter 7: Clinical Investigations

c. Any medical device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate d. Any new findings in relation to any event referred to in points (a) to (c). Types of clinical investigations and exemptions/authorizations The regulations will include exemptions from some of their requirements for certain clinical investigations. However, all studies must still be registered with the MHRA before taking place.

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