What is a Suspected Unexpected Serious Adverse Reaction (SUSAR)?

A Suspected Unexpected Serious Adverse Reaction (SUSAR) is an adverse event that occurs during a clinical trial and is characterized by being suspected to have a reasonable causal relationship with the investigational medicinal product (IMP), being unexpected in nature or severity based on the reference safety information (e.g., Investigator’s Brochure), and meeting the criteria for seriousness, such as being life-threatening, fatal, requiring hospitalization, or causing significant disability or congenital anomalies. Typically, fatal or life-threatening SUSARs must be reported to the relevant authority within 7 days, with additional information submitted within 8 days, while other SUSARs should be reported within 15 days. This reporting process is crucial for ensuring the safety of participants and facilitating timely regulatory oversight duringclinical trials.

What is the significance of reporting Suspected Unexpected Serious Adverse Reaction?

Patient Safety:Reporting and monitoring SUSARs are essential for ensuring the safety of participants in clinical trials. They help identify potential risks associated with new drugs that may not have been evident during earlier phases of development.

Regulatory Compliance:Regulatory authorities require timely reporting of SUSARs to facilitate ongoing safety assessments. Failure to report these reactions can lead to regulatory sanctions and jeopardize future clinical trials.

Data Integrity:Accurate documentation and reporting of SUSARs contribute to the integrity of clinical trial data, enabling sponsors and regulatory bodies to make informed decisions regarding the continuation or modification of studies.

What are the regulatory requirements for reporting Suspected Unexpected Serious Adverse Reaction (SUSARs)?

Timelines:SUSARs must be reported to the relevant regulatory authorities (e.g., FDA , EMA, UK MHRA, etc) and ethics committees within 7 days of identification. If the event results in death or is life-threatening, it must be reported within 7 calendar days. For less severe events, the reporting period is extended to 15 days.

Documentation:All SUSARs must be documented thoroughly, including details about the nature of the reaction, its severity, and any potential relationship to the investigational drug. This information must be communicated promptly to all investigators involved in the trial.

Submission Requirements:Typically, SUSARs must be reported electronically through systems- in the EU this would be Euravigilance, and in the U.S, the FDA Adverse Event Reporting System (FAERS) is typically used. Sponsors must submit SUSARs using the required formats i.e., CIOMS form, or local equivalents like Eudravigilance in the EU or MedWatch in the USA, which facilitates efficient data collection and analysis by regulatory authorities.

DDReg’ capability

A crucial component of clinical trials is managing suspected unexpected serious adverse reactions (SUSARs), which ensures participant safety and compliance with regulatory standards. We at DDReg offer complete assistance for SUSAR reporting, from accurate documentation and submission via global platforms to making sure all deadlines and regulatory requirements are accomplished. Sponsors may concentrate on their trial goals while we manage the intricacies of safety reporting owing to our experience.