Factors affecting the causality assessment of adverse events following immunisation in paediatric clinical trials: An online survey
Background Serious adverse events (SAEs) in clinical trials require reporting within 24 h, including a judgment of whether the SAE was related to the investigational product(s). Such assessments are an important component of pharmacovigilance, however classification systems for assigning relatedness vary across study protocols. This on-line survey evaluated the consistency of SAE causality assessment among professionals with vaccine clinical trial experience.
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- Peer review status:
- Peer reviewed
(Accepted manuscript, 720.7KB)
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- Elsevier Ltd
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- Copyright © 2015 Elsevier Ltd. All rights reserved.
- This is the accepted manuscript version of the article. The final version is available online from Elsevier at https://doi.org/10.1016/j.vaccine.2015.10.126
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