Application form „Antragsformular of Forum Oesterreichischer Ethik-Kommissionen“ + attached the Patient information/ Informed consent – tacked with paper clip (!)
3 x
Clinical trial protocol + one copy on CD-ROM (for studies according the Drug Act "Arzneimittelgesetz")
1 x
Investigator’s Brochure + one copy on CD-ROM(for studies according the Drug Act "Arzneimittelgesetz")
1 x
Case Report Forms (if applicable)
1 x
List of Study centers
(for studies according the Drug Act “Arzneimittelgesetz”)
1 x
Curriculum Vitae (CV), Specialists certificate, Publication list
1 x
Approval of other Ethics-Committees (if applicable)
If you submit studies according the Drug Act, you have to attach the documents according to the EU-Directive 2001/20/EG
Submission
