Module 5 Presentations

05/07/2024

Risk mitigation measures

Investigator: responsible for clinical management of trial participant. Sponsor of the trial: legal responsibility, safety oversight of the entire trial.

SUSARs SAEs RSI USMs DSUR

IB SmPC

Literature

The Organisation for Professionals in Regulatory Affairs

19

Risk mitigation measures (2)

• Change to eligibility criteria • Prohibited medications • Safety monitoring • Adverse events of special interest • Risk adapted-approach

The Organisation for Professionals in Regulatory Affairs

20