Common use of Causality Assessment Clause in Contracts

Causality Assessment. Trial investigators are required to provide an assessment of causality for all adverse events (serious and non-serious) observed during this trial. This assessment will provide a determination of whether, in the investigator’s judgment, there exists a reasonable possibility that the investigational product caused or contributed to an adverse event. For this assessment, investigators must categorize the causality as either “related” or “not related.” For an adverse event to be considered “related” to the trial treatment, there should be evidence that the event follows a reasonable temporal sequence from the administration of trial treatment or that the event follows a known response pattern to the drug. Causality would be further confirmed by improvement in the adverse event upon stopping the trial treatment and reappearance of the event upon rechallenge.

Causality Assessment. Trial investigators ‌ Investigators are required to provide an assessment of causality for all adverse events (serious and non-serious) observed during this trialstudy. This assessment will provide a determination of whether, in the investigator’s judgment, there exists a reasonable possibility that the investigational product caused or contributed to an adverse event. For this assessment, investigators must categorize the causality as either “related” or “not related.” ”. For an adverse event to be considered “related” to the trial study treatment, there should be evidence that the event follows a reasonable temporal sequence from the administration of trial treatment study treatment, or that the event follows a known response pattern to the drug. Causality would be further confirmed by improvement in the an adverse event upon stopping the trial study treatment and reappearance of the event upon rechallenge.