Final answer:
An investigator must notify the sponsor of serious adverse events within 24 hours as per ICH E6 Section 4.11.1. This process is a critical part of postmarket safety surveillance and may be followed by additional studies or risk management plans mandated by the FDA.
Step-by-step explanation:
According to ICH E6 Section 4.11.1, an investigator is required to notify the sponsor of serious adverse events (SAE) within 24 hours. This timeframe is critical to ensure that patient safety is monitored appropriately and that the sponsor can undertake necessary steps in response to the SAE. Sponsors are in turn responsible for reviewing these reports and submitting necessary documentation to regulatory bodies such as the FDA, which also receives reports through its MedWatch program.
Postmarket safety surveillance plays a pivotal role in the ongoing assessment of a drug's safety profile. Following NDA approval, additional requirements such as conducting Phase IV trials or implementing risk management plans may be mandated, ensuring continued vigilance in monitoring drug safety and effectiveness in real-world settings.