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 decision on an application (initial application or substantial modification) is made by the Federal Office for Safety in Health Care after the procedure has been completed. In the Clinical Trials Information System (CTIS), this corresponds to the completion of the "Authorize" task.

According to Regulation (EU) 536/2014, the completion of this task is sufficient as a decision on the application. In the case of an authorization or an authorization with non-suspensive conditions, the clinical trial can be started or the requested change can be implemented, respectively.

Article 8
Decision on the clinical trial
1. Each Member State concerned shall notify the sponsor via the EU portal whether it authorizes the clinical trial, authorizes it subject to conditions or refuses authorization.

In addition, the following documents will be generated:

• a confirmation letter on the completion of the "Authorize" task, which is transmitted via CTIS upon completion
• a National decision letter, which is sent outside CTIS by post to the sponsor or national applicant within the next 14 days

The approval covers the data status in CTIS, including registered centres and uploaded documents. For this reason, no list is included in the confirmation letter or the National decision letter.

Part I and Part II assessment report are no decision letter and should not be treated as such.

In case the application is authorised, the positive decision does not have to be awaited, especially as there may be administrative or postal delays.

In case the application is not authorised, the negative decision is the basis for any appeal proceedings.

Regulation (EU) 536/2014 no longer provides for a national applicant. The applicant according to the regulation is the sponsor, the application is submitted via the Clinical Trials Information System (CTIS).

Nevertheless, a national contact point for the delivery of the legal decision and the invoice is both useful and necessary. Otherwise, these can only be sent to the (often international) sponsor.

The national contact point should therefore be communicated to the BASG with each initial application via the "proof of payment" document.

Both the invoice and the national legal decision (by mail) are then sent to this address.

The responsibility for payment applies to all applications for the trial that are subject to fees, including the fee for the annual safety report (development safety update report, DSUR).

The application dossier must be submitted in English for multinational clinical trials and in German or English for purely national clinical trials.

Full title and public title of the clinical trial must also be provided in German. The full title must correspond to the title on Part II documents (e.g. patient information or confirmation of insurance).

The content description of the labeling of the investigational product according to Annex VI must also be provided in German. Labeling in English is acceptable if it is stated in the cover letter and protocol that the medication will be administered exclusively by healthcare professionals who are proficient in English.

A German language version of the submitted summary (synopsis) of the protocol according to point D. Z 24 of Annex I of Regulation (EU) No 536/2014, which covers all important points of the protocol, must be attached to the application. An additional synopsis in layman's terms is not required.

In any case, the documents intended for the subjects shall be submitted in German.

This includes

• in Part II materials used as information material prior to inclusion in the study (Sections K and L of Annex I of Regulation (EU) No. 536/2014), and
• in Part I, materials used during the clinical trial in connection with endpoints ("patient facing documents") according to Eudralex Vol.10 Q&A 1.24.

For other documents intended for subjects during the clinical trial, there is no basis in Regulation (EU) No. 536/2014 for submission as part of the submission. Nevertheless, the sponsor has to ensure that these documents are only used in valid translation. This can be verified during an inspection.

If the inclusion of subjects who do not speak German is planned, documents for these subjects must also be available in a certified translation into a language that the subject understands.

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") are accepted/recommended.

In case other templates are used, those should include as a minimum the information of the templates by the Commission.

• Template statement on compliance Regulation (EU) 2016/679*

*A statement should 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 and declaration of interest should be dated and up-to-date. 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.

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
  ("ius practicandi").
• 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.

Deputy Investigator:

• 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.
• When submitting documents on the deputy of the investigator, the name of the deputy must be blacked out in the "for publication" version to ensure data protection.

Investigator Team:

• 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.

The billing address should 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. Otherwise, the invoice will go to the sponsor. Since it is a document for information, a resubmission for a substantial modification is not required, unless the billing information itself needs to be updated.

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 recht@basg.gv.at.

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

1. revert its decision
2. amend its decision (e.g., on the basis of new documents submitted in the appeal)
3. 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.