According to FDA, an adverse event associated with the use of a medical product is considered serious and should be reported to the agency when the patient outcome results in: death, life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or intervention to prevent permanent impairment or damage.
Glossary
Serious Adverse Event (SAE)
02.27.12
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Breaking News | Industry News
J&J COVID-19 Vaccinations to Resume in U.S.
Recommendation from the U.S. CDC Advisory Committee followed rigorous evaluation of data relating to very rare adverse event involving blood clots.Kristin Brooks
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Clinical Trials | Drug Development | QA/QC
RBQM Comes of Age: COVID as a Catalyst for Change
Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.Kristin Brooks, Managing Editor
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Clinical Trials
The Future of Clinical Trials Series: Part II
Greater awareness will ensure diversity is no longer an afterthought and patients will be at the center of every aspect of clinical research.Jena Daniels, Rasmus Hogreffe, Ingrid Oakley-Girvan, Dr. Michelle Longmire, Medable
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Clinical Trials | Information Technology
Life Sciences Strive for Greater Agility
Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.Ronan Brown, SVP of Integrated Technology & Compliance, and Joe Rymsza, VP, Global PV & Regulatory Technology Solutions, IQVIA
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