CRED Understanding Clinical Development 2024

09/10/2024

Causality

• The CT directive states that individual AEs should be evaluated for causality and seriousness by the investigator • Is there a reasonable possibility that the event may have been caused by the trial therapy • The investigator should provide an assessment of causality for any SAE • The sponsor should also provide a causality assessment for any SAE • Causality assessment should be carried out by a medically qualified doctor.

The Organisation for Professionals in Regulatory Affairs

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Expectedness

• SAEs that are considered to be related to the IMP (SARs) need to be assessed for expectedness against the Reference safety information (RSI) • This determines if the SAR is reported to regulatory agencies and ethics committees as a SUSAR (Serious unexpected suspected adverse reaction)

• In the EU, SUSARs should be unblinded before submission

The Organisation for Professionals in Regulatory Affairs

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