Clinical Trials

Points to be considered for the application of clinical trials

• Each submitted clinical trial application (CTA) requires a EudraCT number.
• The application to the ethics committee concerned can be submitted prior to or simultaneously with the application to the BASG (Federal Office for Safety in Health Care; Bundesamt für Sicherheit im Gesundheitswesen), but not following thereafter.
• The list of the required documentation can be found on the BASG website (L_W021_List of Documents required).
• The EudraCT Application form (pdf print-out) and the documents required for the assessment shall be submitted in a folder as a single printed copy. It is obligatory to submit the application form as xml file on CD-ROM or disc.
• The additional submission of all relevant documents (protocol, IB, IMPD) in electronic form is not obligatory, but appreciated by the Austrian Competent Authority.
• An automatic confirmation of receipt is sent by e-mail for the following procedures: Initial application, substantial and non-substantial amendment and annual safety report. These e-mails are addressed to the applicant listed in the CTA-file.
• The first action by the authority is to validate the dossier for formal completeness. Clear arrangement of all documents will support an efficient and fast validation.
• The date of receipt of the formally complete (or completed) dossier defines the clock start for the 35 (calendar-) day period of scientific assessment. The confirmation of formal completeness is sent to the sponsor (or named representative) by FAX.
• The clinical trial application can be considered as approved if the BASG has not communicated an objection within the 35 day period stated on the confirmation of formal completeness (silent approval).
• To initiate any clinical trial, the silent approval by the competent authority and the positive opinion by the ethics committee are obligatory.
• Since November 2008 the following fees have been established for initial clinical trial applications: 2500 € for clinical trials Phase I-III and 1500 € for clinical trials Phase IV. Academic clinical trials are exempted from fees.
• Amendments are free of charge.  Changes to the dossier need to be made apparent to the assessor (e.g. summaries, track-changes) and essential modifications (e.g. dose, study design) need to be appropriately justified.
• The above described procedures are different with regard to Advanced Therapies. More details are described in the Guidance for the submission of Clinical Trials with Advanced Therapy Medicinal Products (ATMPs).