SUSARs in Clinical Trials: managing the unexpected for patient safety
- ClinOpsHub
- 6 mag
- Tempo di lettura: 2 min
Ensuring the safety of participants is a fundamental responsibility for Sponsors and Investigators in clinical trials. One of the most urgent and critical safety concerns are SUSARs - Suspected Unexpected Serious Adverse Reactions. Their identification and management are essential not only for protecting trial subjects but also for maintaining compliance with the regulatory frameworks.
Defining SUSARs in the Clinical Trial setting
A SUSAR arises when a trial participant experiences an adverse reaction that meets three specific criteria:
Serious: the event results in death, is life-threatening, requires (or prolongs) hospitalization, causes significant disability, or is medically significant.
Unexpected: the nature or severity of the event is not consistent with the safety information outlined in the Investigator’s Brochure or SmPC.
Suspected: there is a reasonable possibility that the investigational drug contributed to the reaction.
Identifying such events is a key component of ongoing risk assessment during the clinical development of new therapies.
Managing SUSARs: responsibilities and workflow
When a SUSAR is suspected, the trial sponsor must initiate a structured safety evaluation. This involves:
Immediate case assessment by the pharmacovigilance team, evaluating seriousness, expectedness, and causality.
Unblinding, where necessary, limited to the affected subject only, to determine drug exposure.
Accurate coding using MedDRA terminology and data entry into validated safety databases.
This process ensures timely communication with stakeholders without compromising the scientific integrity of the study.
Regulatory Timelines and Reporting Channels
EU Regulation no. 536/2014 mandates strict reporting timelines:
SUSARs that are fatal or life-threatening must be reported within 7 calendar days from awareness, with any follow-up submitted within 8 additional days.
All other SUSARs must be reported within 15 calendar days.
Reports are submitted electronically via EudraVigilance (within the European Economic Area - EEA), and communicated to Ethics Committees, Investigators, and Competent Authorities as required. Adherence to these timelines is essential for regulatory compliance and ethical oversight.
Partner with Us for End-to-End SUSAR Compliance
From accurate case evaluation to compliant submissions and regulatory correspondence, our ClinOpsHub Pharmacovigilance team ensures every safety event is handled with precision and efficiency.
Contact us today to learn how we can help you navigate safety reporting requirements and uphold the highest standards of patient protection in your clinical trials.
Learn more by taking the course “La Farmacovigilanza alla luce del Regolamento EU n. 536/2014” on demand and anytime at the following link with a special discount of 50%:
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