Quality Mangament of Clinical Trial Center (CTC). What are the important subgroups of organization?
Trials performed at the CTC. There is no difference between sponsored clinical research and investigator initiated research (ITT). ITT means investigator initiated trials which are performed with industry support (= sponsored trials).
Which trials are performed?
PHASE 1 = safety and toxicity.
The important questions adressed are: is dosage safe? How should drug be administered? How is the body affected?
PHASE II = therapeutic explorative. The important questions adressed are: Is the treatment working and how is the body affected?
PHASE III = therapeutic confirmative. The most important question wich is addressed: Risk vs. benefit?
PHASE IV = post marketing authorisation
Which are the types of clinical trials?
Pre-Clinical development is the first stage in drug development. Which is true about it?