SAFETY

Contains a cumulative list of ADRs that are expected for the investigational product being administered to participants in a clinical trial. Refer to ICHE2F

if it is suspected to be medicinal product-related with a high level of certainty, it should be included in the RSI and/or IB.

An adverse reaction that meets three criteria: suspected, unexpected and serious.The nature or severity of the serious ADR is not consistent with the applicable product information.

It may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety and relevant efficacy data, and to recommend to the sponsor whether to continue, modify or stop

Any unfavourable medical occurrence that is considered serious at any dose if it is life-threatening, Requires extended hospitalisation or results in persistent disability ting hospitalis

A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human participants