everything.study
HLTH 5814

Assessment and Patient Safety for Clinical Trials

0.5 credit · Graduate

The importance of efficacy and safety measurements, biosamples, pharmacokinetics, pharmacodynamics, drug mechanism of action, reporting of harm, Data and Safety Monitoring Board, pharmacovigilance, consideration of special populations. Good clinical practice, good medical practice, and good laboratory practice.

2026

Topics

  • Fall Orientation
  • Clinical Research and Patient Safety safety failures.
  • Ethical & Regulatory Foundations of Regulatory frameworks, global regulatory systems
  • Safety (ICH, FDA, EMA, Health Canada), GCP/GxP
  • Division 5, protocol structures.
  • Foundations of Efficacy, Safety, and Defining efficacy/safety/tolerability, phases of
  • Benefit–Risk development, risk–benefit analysis, signal detection.
  • Scientific Foundations of Safety and PK/PD, Mechanism of Action, biomarkers
  • Risk Planning: Pharmacologic preclinical predictors.
  • Principles & Mechanistic
  • Understanding
  • Designing Protocols for Safety: Protocol safety design, safety endpoints, stopping
  • Prospective Safety Planning rules, DSMPs, IBs.
  • Ecpectedness & Causality causality (Naranjo, WHO-UMC), MedDRA.
  • Non-Serious AEs & Real-World Data Non-serious AEs, RWD, Health Canada AE
  • reporting, NHP/vaccine safety.
Sources