Underscore the sponsor's paramount responsibility for the safety of clinical trial participants.
Establishing Clear Adverse Event Reporting Procedures: Discuss the sponsor's role in developing and communicating clear guidelines for the identification, documentation, and reporting of adverse events.
Timely and Accurate Reporting to Regulatory Authorities and Ethics Committees: Explain the sponsor's obligations for the prompt and accurate submission of safety information.
Ongoing Safety Monitoring and Signal Detection: Highlight the sponsor's responsibility for continuous monitoring of safety data and the detection of potential safety signals.
Implementing Risk Mitigation Strategies: Discuss how sponsor oversight contributes to the development and implementation of strategies to minimize risks to participants.
Conclusion: Reiterate the sponsor's unwavering commitment to patient safety through diligent oversight of adverse event reporting and proactive risk management.

for more: https://zenovel.com/gcp/sponsor-oversight/