Serious Adverse Event Reporting for Investigators

Serious adverse events (SAEs) must be reported within 24 hours. Investigators should provide all known information related to the SAE, and follow-up reports also require a 24-hour timeframe. Investigators report SAEs to the sponsor's drug safety department. Any death of a subject must be reported to the ethics committee, regardless of the cause. SAEs affecting the study's benefit-risk profile also need to be reported to the ethics committee, and the sponsor must keep a record of each SAE.

Investigators are responsible for assessing the causality of SAEs; a study nurse is not authorized for this. Causality is typically categorized as 'not related', 'possibly related', and 'probably related'. Sometimes, 'certainly related' and 'related' are also used. 'Possibly related' and 'probably related' are automatically classified as 'related' because the sponsor must consider the worst-case scenario. Investigators often incorrectly classify events as 'possibly related' to avoid responsibility, but this category is still considered 'related'.

Investigators must judge causality very carefully. If an investigator lacks experience, they should review the investigator's brochure or consult more experienced investigators. An unexpected adverse drug reaction (one not found in the investigator's brochure) caused by the investigational product must be classified as such. There are instances where causality classifications are illogical, such as classifying an event as related before drug administration or long after treatment cessation. In such cases, the sponsor should contact the investigator for re-evaluation, although the investigator's judgment holds the highest priority.