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Clinical trial application
procedures are comparable to those of other EU countries.
Ethics Committee approval is required before a clinical trial can
commence.
The Forum of Austrian Ethics Committees, a voluntary union founded
in 1997, serves to harmonise the working methods of the Austrian Ethics
Committees and provides standardised application forms.
The Austrian competent authority has enacted a decree concerning ethical
committees in multicentre studies (Leit-Ethikkommissions-V) in May
2004, by which the respective requirements of Directive 2001/20 EC
have been implemented in national law. ECs are bound to publish the
schedule of meetings and respective time limits for the submission
of documents in the internet. Set aside the short version of the study
protocol and the patient information and informed consent form, the
ECs are to accept documents in German and in English language as well.
The provisions of the CT Directive are fully implemented, application
for the authorisation of a clinical trial is made out following CT1.
The principles of the Declaration of Helsinki and the ICH GCP
Guidelines must be observed, as well as the regulations of the Austrian
Pharmaceuticals Act ("AMG").
 Health
Care System |
Austria's health care system
is organised on a decentralised basis and is mainly managed
by the provincial authorities of the nine Austrian provinces.
The federal authorities are responsible for the basic legislation.
There is a compulsory social insurance system providing cover
for almost all of the population (approx. 8 million). Supplementatry
private health insurance is taken out by a large proportion
of the population.
Primary health care is provided to a great extent by physicians
in single-handed practices. Group practices are practically
nonexistent. Most of the practitioners have contracts with social
health insurances. A large number of outpatient clinics play
an important role in Austria; and inpatient medical care is
provided by approximately 325 hospitals. |
| Why
with ECRON? |
The language is German,
so no translation is needed if a study is planned for Germany.
The area is covered by German monitors from the Konstanz office
(western part) and from the Bratislava office by German speaking
monitors (Vienna and eastern part of Austria). |
| Authorities |
Ministry
of Health (Bundesministerium für Gesundheit und Frauen)
Ethics
Committees in Austria |
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AUSTRIA
