What You Really Need to Know About PASS

PASS protocols

What You Really Need to Know About PASS

A recent report from the Pharmacovigilance and Risk Assessment Committee (PRAC) found that in the 200+ study protocols reviewed, nearly half suffered from study design flaws. Don’t let methodological issues stall approval of your next Post-Authorisation Safety Study (PASS).

UBC’s safety study experts outline the essential protocol considerations in a new whitepaper, “Post-Authorisation Non-interventional Prospective Observational Safety Studies.”

This guide addresses the key methodological issues including:

  • Study objectives, variables and outcomes
  • Data source, study population and study size
  • Data analysis
  • Transparency requirements
  • Key timeline considerations