Karten 22 Karten
Lernende 1 Lernende
Sprache English
Stufe Universität
Erstellt / Aktualisiert 25.05.2014 / 01.06.2014
Lizenzierung Keine Angabe
0 Exakte Antworten 0 Text Antworten 22 Multiple Choice Antworten
Fenster schliessen

Quality Mangament of Clinical Trial Center (CTC). What are the important subgroups of organization? 

Regulatory Affairs


Data Management & IT-Coordination

Project Management (Trial Unit and Phase-1-unit)


Fenster schliessen

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?

ITT and NCT (non-commercial trials)

epidemiological and observation trials

trials for medical devices

clinical trials in other areas (e.g. surgery)


Fenster schliessen

PHASE 1 = safety and toxicity.
The important questions adressed are: is dosage safe? How should drug be administered? How is the body affected?



healthy volunteers

10-50 participants

always symptomatic healthy volunteers

Fenster schliessen

PHASE II = therapeutic explorative. The important questions adressed are: Is the treatment working and how is the body affected?

proof of concept

dose optimizing

side effects

50-200 participants

there is no control group

Fenster schliessen

PHASE III = therapeutic confirmative. The most important question wich is addressed: Risk vs. benefit?


statistic significant group: 200-1000 participants

dose optimizing

control group

it is not trying to imitate real conditions

Fenster schliessen

PHASE IV = post marketing authorisation

first: approval by health authorities is required

long-term safety has to be assured

short-term safety has to be assured

focus is on effectivness


Fenster schliessen

Which are the types of clinical trials?

Treatment & Prevention

Screening & Diagnostics


Quality-of-life / supportive care

Palliative care

Fenster schliessen

Pre-Clinical development is the first stage in drug development. Which is true about it?

takes 3-4 years

one part: selection

one part: pre-clinic

takes 4-5 years

use in galenics, pharmacology and toxicology