Verordnung 536/2014 - Nationale Anforderungen

Austria: National requirements applicable to clinical trials authorized under regulation EU No 536/2014


Language requirements

The following documents need to be submitted in German language, and if needed in other languages understandable for CT participants:

  • Synopsis
  • Part II: Informed Consent – subject information sheets
  • Part II: Recruiting material
  • Part II: Patient facing documents such as questionnaires, patient diary (in addition to the language requirements for patient facing documents related to part I).

Translations into other languages might be necessary for non-German speaking CT participants.


Part II application document templates

  • Compensation for trial participants – We encourage the use of the template from Eudralex -Volume X Clinical trials guidelines
  • Investigator Curriculum Vitae - We encourage the use of the template from Eudralex -Volume X Clinical trials guidelines: The current CV has to be dated (not older than 1 year), signature is not needed; however the sponsor is responsible to archive a signed CV
  • Declaration of interest - We encourage the use of the template from Eudralex -Volume X Clinical trials guidelines
  • Patient facing documents such as questionnaires, patient diary
  • Site suitability form – please use the national template. Download: Download Site suitability template for Austria - DOCX
  • Informed consent and patient recruitment procedure template - We encourage the use of the template from Eudralex -Volume X Clinical trials guidelines
    • Download national template: Download national template for Informed Consent - DOCX
  • Statement of compliance with national data protection rules (– in addition to the to the compliance statement with Regulation (EU) 2016/679 (GDPR))
  • Compliance with applicable rules for biological samples - We encourage the use of the template from Eudralex -Volume X Clinical trials guidelines
  • Statement of compliance with national data protection rules (– in addition to the to the compliance statement with Regulation (EU) 2016/679 (GDPR))
  • Informed Consent – subject information sheets Subject information should address all topics as presented in the national subject information template; to simplify changes of contact data we recommend to use a contact data form for site specific data (e.g. name and phone of PI, data protection contact at the site, Patientinnenanwaltschaft). This document should be marked as “not for publication".Subject information should address all topic as presented in the national subject information template; to simplify changes of contact data we recommend to use placeholders in the informed consent and a separate contact data form for site specific data (e.g. name and phone of PI, site specific data protection contacts, patient advocates - Patientinnenanwaltschaft, national contact for insurance matters). The contact data form should be marked “not for publication”.Note: for informed consent only wet ink or QES are acceptable

Site suitability

The CTR does not stipulate an official deputy (“Stellvertreter”). However, it is strongly recommended to appoint at least one suitably qualified person who can replace the principal investigator at any time.

Insurance

Please submit the insurance policy and terms & conditions. Terms and Conditions are relevant for participants and should be submitted in German language. A (national) contact for insurance matters should be included in the informed consent.

Investigator qualification

Pursuant to § 43 AMG, the investigator must be a licensed medical doctor or dentist authorized to carry out independent professional training in Austria. He must have the appropriate knowledge and experience in the field of clinical testing of medicinal products, knowledge and experience in the intended indication area and knowledge in the relevant areas of non-clinical medicine. Evidence of the suitability criteria mentioned must be provided. Eligibility criteria for investigators in clinical trials (principle investigator, co-investigator) are currently being developed. The criteria apply to all doctors working as investigators for the first time. Prior experience as a principle investigator or co-investigator will be considered. There is a transition period effective January 31, 2025 (end of the 3-year "transition period" from the implementation of the CTR). The evaluating ethics committee will recognize training courses such as the ÖÄK course for clinical investigators, postgraduate programs or topic-specific seminars after presentation of the relevant certificates or confirmation of participation. In any case, proof of completed ICH-GCP training must be provided by proof of training showing that this training meets the minimum requirements of the TransCelerate mutual recognition program TransCelerate mutual recognition program
TransCelerate mutual recognition program- GCP-Minimum-Criteria (PDF)

 

Zuletzt bearbeitet am  14.05.2023 von