I am stuck on two questions. Please let me know what you think.
1. A researcher wants to assess the safety of a new vaccine with a single time-exposure. It will be necessary to control for multiple confounders in this study design and to estimate a causal risk difference. What type of surveillance data is best suited for this type of research.
A. FDA Adverse Event Reporting System (FAERS)
B. FDA Sentinel System
C. CDC National Notifiable Diseases Surveillance Systems (NNDSS)
D. FDA MedWatch Database
E. World Health Organization Pharmacovigilance System (WHOPS
2. In order to assess predictors of increased risk for a newly developed lipid-lowering medication, a medical safety officer would like to get detailed prospective information on the medical history of individuals who might develop rhabdomyolysis. Rhabdomyolysis is an extremely rare, but very serious side effect of lipid-lowering medications such as statins and fibrates. What are the TWO best approaches to find an answer to the officer’s question? (Pick the best two options)
A. A prospective cohort study of 10,000 individuals using statins and fibrates
B. A syndromic surveillance system set up at 100 hospitals nationwide
C. FDA Adverse Drug Event Reporting System (FAERS)
D. FDA Sentinel System
E. National Notifiable Disease Surveillance System (NNDSS)