Guidelines for Collection, Analysis, and Presentation of Vaccine Safety Data in Pre- and Post-Licensure Clinical Studies
These guidelines, published in the journal Vaccine, seek to standardize vaccine safety assessment by improving the accuracy and completeness of collection, analysis, and presentation of information about Adverse Events Following Immunization in pre-and post-licensure clinical studies (e.g., randomized controlled trials, cohort studies, case-control studies, self-controlled case series).
Author(s): Bonhoeffer J, Bentsi-Enchill A, Chen RT, et al.
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(Located at dx.doi.org)
Bonhoeffer J, Bentsi-Enchill A, Chen RT, et al. Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems. Vaccine. 2009;27(16):2289–2297.