The sponsor is primarily responsible for the ongoing safety evaluation of the investigational product (IP) throughout the clinical trial. This responsibility includes monitoring adverse events, reporting serious adverse events (SAEs) to regulatory authorities, and updating the Investigator’s Brochure (IB) with relevant safety data.
According to GCP guidelines, the sponsor must continuously evaluate safety data and report findings to regulatory bodies as necessary.
"The sponsor is responsible for the continuous safety monitoring of the investigational product and for ensuring that new safety information is communicated to investigators and regulators."
Objectives:
Ensure participant safety throughout the study.
Maintain accurate and timely reporting of safety data.
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