patient registry

Four Key Considerations for Long-Term Patient Registry Design

One of the biggest operational challenges with the design of registries, also called post-approval safety studies (PASS), is understanding the differences with clinical trials. Clinical trials involve subjects with very specific inclusion/exclusion criteria and protocol procedures, but registries take “all comers” with limited inclusion/exclusion criteria seen as part of routine care. Often sponsors design what they believe is a registry but is actually a post-approval study based upon clinical trial guidelines and SOPs.

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