Regulatory Reporting Requirements for SAEs. Prompt notification of an SAE by the Investigator to the Sponsor is essential so that legal obligations and ethical responsibilities towards the safety of patients and the safety of a study medication under clinical investigation are met. The Sponsor has a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of a study medication under clinical investigation. The Sponsor will comply with country-specific regulatory requirements relating to safety reporting to the regulatory authority, IRBs/ IECs, and Investigators. Suspected unexpected serious adverse reactions (SUSARs) must be reported according to local regulatory requirements and Sponsor policy and forwarded to Investigators as necessary. An Investigator who receives an Investigator safety report describing an SAE or other specific safety information (eg, summary or listing of SAEs) from the Sponsor will review and then file it along with the Investigator’s Brochure and will notify the IRB/IEC, if appropriate according to local requirements.
Regulatory Reporting Requirements for SAEs. Prompt notification of an SAE by the Investigator to Xxxxxxx is essential so that legal obligations and ethical responsibilities towards the safety of participants and the safety of a study intervention under clinical investigation are met. • Xxxxxxx has a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of a study intervention under clinical investigation. Xxxxxxx will comply with country-specific regulatory requirements relating to safety reporting to the regulatory authority, IRBs/ IECs, and Investigators. • Suspected unexpected serious adverse reactions (SUSARs) must be reported according to local regulatory requirements and Alexion policy and forwarded to Investigators as necessary. • An Investigator who receives an Investigator safety report describing an SAE or other specific safety information (eg, summary or listing of SAEs) from Alexion will review and then file it along with the IB and will notify the IRB/IEC, if appropriate according to local requirements.
