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Journal article

Factors affecting the causality assessment of adverse events following immunisation in paediatric clinical trials: An online survey

Abstract:

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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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1016/j.vaccine.2015.10.126

Authors


More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Paediatrics
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDM
Sub department:
Jenner Institute
Role:
Author
Publisher:
Elsevier Publisher's website
Journal:
Vaccine Journal website
Volume:
33
Issue:
51
Pages:
7203-7210
Publication date:
2015-11-06
Acceptance date:
2015-10-28
DOI:
ISSN:
0264-410X
Source identifiers:
571890
Language:
English
Keywords:
Pubs id:
pubs:571890
UUID:
uuid:f36b5cc4-0052-49d1-8aa5-82585dd4da47
Local pid:
pubs:571890
Deposit date:
2015-11-02

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