• Chapter

Post-Authorization Safety Studies for medical devices and combination products

A prospective study analyzes prospective experiences of a cohort following the instant when the cohort is defined, e.g., the start of a medicinal product, which involves forming a cohort of subjects at the index date and observing the over a future period. Prospective studies need to be disambiguated with longitudinal studies where subjects, exposures, and outcomes are studied over time, and information is collected at multiple intervals (in contrast with cross-sectional studies where data collection is restricted to a single point in time). Longitudinal studies can be prospective or retrospective and can involve primary data collection or existing data.

Citation

Jalbert, J. J., Lystig, T. C., Ritchey, M., & Ali, A. K. (2018). Post-Authorization Safety Studies for medical devices and combination products. In A. K. Ali, & A. G. Hartzema (Eds.), Post-Authorization Safety Studies of Medicinal Products: The PASS Book (1st ed., pp. 277-292). Cambridge, MA: Academic Press. DOI: 10.1016/C2015-0-04472-0, 10.1016/C2015-0-04472-0

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