National rules and regulations New
National contact point and concerned ethics committees
The national legislation supplementing Regulation (EU) 536/2014 ("Clinial Trials Regulations", "CTR") are contained in the Austrian Medicines Act (AMG), Federal Law Gazette I No. 8/2022.
The competent authority in terms of the CTR is the Federal Office for Safety in Health Care (BASG).
Ethics Committees acting under the CTR are organised in a national platform and published on the website of the Ministry of Social Affairs, Health, Care and Consumer Protection.
Currently, these are...
- the Ethics Committee of the Medical University of Graz
- the Ethics Committee of the Medical University of Innsbruck
- the Ethics Committee of the Medical Faculty of the Johannes Kepler University Linz
- the Ethics Committee for the Province of Salzburg
- the Ethics Committee of the Medical University of Vienna
The BASG and the platform of Ethics Committees will define the details of their cooperation in an agreement. This agreement will be published shortly.
The application dossier should be submitted in English for multinational clinical trials and in German or English for purely national clinical trials.
The application must be accompanied by a German-language version of the scientific synopsis of the protocol in accordance with point D. line 24 of Annex I of Regulation (EU) No. 536/2014.
The documents intended for the trial subjects shall be submitted also in German. This includes both the information material used prior to inclusion in the trial (Sections K and L of Annex I of Regulation (EU) No 536/2014) and materials used during the clinical trial in connection with endpoints ("patient facing documents" according to Eudralex Vol.10 Q&A 1.24).
Document templates for FORM section and national aspects ("Part II")
Harmonized Templates and Documents:
For the following FORM section and Part II documents, the templates published by the Commission in Eudralex Vol. 10 ("Chapter I") should be used:
- Template statement on compliance Regulation (EU) 2016/679*
*A statement schould be included that also the National rules and regulations for data protection will be adhered to.
- Declaration of Interest
- Compliance with applicable rules for biological samples
- Informed consent and patient recruitment procedure
- Compensation for trial participants
- Investigator curriculum vitae**
**The investigator curriculum vitae should be dated and not older than 1 year. A signature is not required. Sponsor and Investigator are responsible for archiving the signed CV in the Trial Master File/Investigator Site File.
National Templates and Documents:
Information for Trial Subjects and Informed Consent Form
- Use of the national template is recommended. If the national template is not used, the subject information must address all topics listed in the national template.
- To facilitate changes to contact information, we recommend using placeholders in the consent form. In this case, site-specific data (e.g., name and phone number of responsible physician, site-specific contact person, patient advocate, national insurance contact...) should be submitted in a separate document marked "not for publication" in CTIS.
Site suitability form
- The template of the Site Suitability Form to be used for Austrian centers can be found here.
Proof of insurance
- The proof of insurance according to Section O of Annex 1 of Regulation (EU) 536/2014 requires the policy as well as the terms and conditions.
- Insurance documents for the subject shall be provided in accordance with the language above.
- A (national) contact point for questions regarding insurance should be included in the subject information.
National regulations and recommendations Part II
Requirements for the investigator:
- According to Section 43 of the Austrian Medicines Act (AMG), as amended, the investigator must be a licensed physician or dentist who is authorized to practice independently in Austria
- The investigator must have
1) appropriate knowledge and experience in the field of clinical trials of medicinal products,
2) appropriate knowledge and experience in the intended indication, and
3) knowledge in the relevant fields of non-clinical medicine, including in particular biometry/statistics.
- Proof of the aforementioned suitability criteria must be provided by the investigator to the evaluating ethics committee and to the sponsor. If the investigator does not have the appropriate knowledge and experience in one of the sub-areas according to point 3, he/she must involve relevant experts in a co-responsible manner.
- The evaluating ethics committee recognizes training courses such as the Austrian Chamber of Physicians (ÖAK) course for clinical investigators, postgraduate programs or topic-specific seminars upon presentation of the corresponding certificates or confirmations of participation. In any case, proof of completed ICH-GCP training must be provided by a training certificate showing that this training meets the minimum requirements of the "TransCelerate Mutual Recognition Program" for mutual recognition of GCP basic requirements.
- Regulation (EU) 536/2014 does not explicitly require for a deputy investigator be established and notified. However, it is recommended that a qualified alternate be submitted with the initial application along with the investigator.
- Otherwise, if the investigator is unavailable, the clinical trial must be stopped at the site until a replacement is approved via substantial modification.
- The requirements for the investigator according to Regulation (EU) 536/2014 and AMG only apply to the principal investigator and his deputy, but not to the entire trial team.
- Other persons involved in the clinical trial must be sufficiently qualified by education, training and experience to perform their activities.
- For medical procedures or medical care reserved for a physician a qualification as a physician according to Austrian professional law must be available (= licensed physician or physician in training).
Member States may charge fees for the performance of the activities resulting from Regulation (EU) 536/2014. However, Member States should avoid having to make multiple payments in a single Member State to different bodies involved in the assessment of the clinical trial application.
Therefore, fees for activities under Regulation (EU) 536/2014 are collected by the Federal Office for Safety.
In accordance with Article 86 of Regulation (EU) 536/2014, these fees are set according to the principle of cost recovery and published in the fee tariff of the BASG. The fees for the competent ethics committee are already included in this tariff.
The billing is carried out independently of the processing and in most cases in the later course or after completion of the procedure. Proof of payment is not part of the valid submission.
Billing is made to the organization registered as the point of contact for the Union. If other billing roles (e.g., other billing recipient, other payer) are desired, they must be communicated to BASG in a document to be uploaded in the "Proof of Payment of Fee" section of the Clinical Trials Information System (CTIS). This is only an information document and not a confirmation of payment.
According to Regulation (EU) 536/2014, an appeal procedure should be provided by the member state for the refusal of approval of a clinical trial or of substantial modification. For Austria, the appeal procedure is governed by the General Administrative Procedure Act (AVG).
The entire appeal procedure takes place outside of CTIS!
An appeal against a decision of the BASG can be lodged with the Federal Administrative Court (BVwG) within four weeks of service.
The appeal must contain the name of the contested decision, the name of the authority against which the appeal has been lodged, the grounds on which the allegation of illegality is based, the request and the information required to assess whether the appeal has been lodged in time.
The complaint should be made in writing and submitted to the address of BASG, Traisengasse 5 in 1200 Vienna, or by e-mail to the address firstname.lastname@example.org.
The BASG can then either issue a preliminary decision on the complaint itself within 2 months or forward the complaint directly to the Federal Administrative Court (BVwG) for a decision on the complaint.
In its preliminary appeal decision, the BASG may
- revert its decision
- amend its decision (e.g., on the basis of new documents submitted in the appeal)
- reject the complaint either for formal reasons (rejection) or for its legal content (dismissal).
This preliminary appeal decision can, in turn, be challenged by filing a request for referral to the Federal Administrative Court (BVwG).
The final decision is then implemented in CTIS through the "Revert Decision" action (if necessary). This allows a negative decision to be converted into an approval or an approval with conditions. The latter may include the need for the subsequent submission of a substantial modification.