APPLICATION
News
19.12.2025
Guidance Austria concerning Part II / Subject Information and Informed Consent Form, in the expanded Version 4, was published on December 19, 2025 (see menu item Part II / Participant Information).
New in version 4:
- Transfer of pseudonymized data to the third country USA
- Collection of data on ethnic origin
- Use of pseudonymized data for the development of new technologies (secondary use of data)
07.08.2025
The Guidance Austria regarding Part II / Subject information and Informed Consent Form, in extended version 3 was published on 07.08.2025 (see item Part II / Participant information)
New in version 3:
- General information on the involvement of third-party providers in clinical trials
- Involvement of third-party providers for home nursing/homecare visits
- ICF for combination studies
- Data protection clause—legal basis for the processing of personal data
General
It is essential to comply with the statutory provisions of the CTR.
Applications are made in CTIS (euclinicaltrials.eu).
All communication takes place within CTIS. For inquiries, the ethics committees involved offer a national point of contact.
Language requirements
According to § 31 Abs. 2 AMG, the application dossier for multinational clinical trials must be in English. Applications for mononational clinical trials can be submitted in either English or German.
The following details and documents must (also) be submitted in German:
- The “full” and “public” study titles.
- Note: The full study title must match the documents in Part II (e.g., ICF, insurance).
- Synopsis of the trial protocol (Pkt. D Z 24 of Annex I of Regulation (EU) No. 536/2014). This must cover all key aspects of the clinical trial.
- Documents intended for the trial participants. These include:
- Part I: Patient Facing Documents (materials used in connection with endpoints during the clinical trial) according to Eudralex Vol.10 Q&A 1.24.
- Part II:
- All materials covered by Section K (Procedure for recruiting trial participants) and L (Trial participant information, informed consent, and procedure for obtaining informed consent) of Annex I of Regulation (EU) No. 536/2014.
- Insurance documents.
Documents which are not classified as Patient Facing Documents, but are intended for use by participants during the trial: there is no legal basis for these to be requested. However, it is important to note that it is the sponsor’s responsibility to ensure that these documents are only used after a certified translation has been created.
Trial participants who are not fluent in German:
If a participant who is not sufficiently fluent in German is to be included a certified translation of all patient facing documents must be made available.
Part I
Synopsis
The application must include a German summary (Synopsis) of the trial protocol according to Pkt. D. Z 24 of Annex I of Regulation (EU) No. 536/2014. This must include all essential points within the protocol. An additional lay synopsis is not required.
Patient Facing Documents
Definition of Patient Facing Documents according to Eudralex Vol.10 Q&A 1.24: Documents handed out to study participants during the study (e.g., questionnaires, diaries, etc.).
Patient Facing Documents, used in connection with endpoints during the clinical trial must be submitted together with the protocol in Part I of the application dossier.
There is no legal basis for requesting documents that are not Patient-Facing Documents but are intended for the trial participants during the Clinical Trial. However, we explicitly point out that it is the sponsor's responsibility to use these documents only after creating a valid translation. This can be checked during an inspection (by BASG).
If trial participants are included in the clinical trial at a local trial centre who are not sufficiently fluent in German, all documents must be available in a certified translation in the language the trial participant understands.
GDPR Compliance
For the privacy statement (Statement of compliance with General Data Protection Regulation), this template should be used ("Template statement on compliance Regulation (EU) 2016/679").
This template for compliance with VO (EU) 2016/679 must include a clause confirming compliance with national data protection regulations. Alternatively, an additional confirmation of compliance with all national laws and guidelines on data protection can be submitted in Part II.
CRF (Case Report Form)
Submitting a CRF is not mandatory according to VO (EU) 536/2014. However, the ethics committees request it be submitted (Part I Section "Protocol") as it is considered an essential part of the study documents.
Part II
Guidelines for Harmonized Documents
For the following FORM section and Part II documents, the templates published by the Commission in (Eudralex Vol. 10, Chapter 1 - https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en) are accepted/recommended:
- Declaration of Interest
- Compliance with applicable rules for biological samples
- Informed consent and patient recruitment procedure
- Compensation for trial participants
- Investigator Curriculum Vitae
Note: The CV must be dated and not older than one year. A signature is not required.
Note: The signed and dated CV must be stored in the Trial Master File/Investigator Site File.
In case other templates are used, those should include as a minimum the information of the templates by the Commission.
Participant Information and Consent Form (ICF)
General:
Use of the national template which has been created by the ethics committees and includes all the required points is recommended. If the national template is not used, the information for trial participants must cover all topics listed in the national template.
Guidance ICF AustrianEthics AND Sample ICF
The insurance and data protection points in the sample text must, however, be used verbatim, as they have been developed in conjunction with legal experts and contain all legal points in understandable language. Text can be added at the end of the section, but only if this does not lead to contradictory or redundant statements.
When designing patient information, please consider the following:
- Ensure that the information is presented in a way understandable to laypeople. Avoid jargon and technical terms, if these cannot be avoided they must be fully explained. If possible, include graphics and/or tables for better presentation/visualization.
- Avoid redundant content.
- To simplify changes to contact information, we recommend using placeholders. If this is done, site-specific data should be provided in a separate document labelled "not for publication."
Contact Information:
Contact information is an integral part of patient information. For multicentre studies it can be submitted in the form of a "contact list". This document should be listed as “not for publication”. The respective placeholders must be included in the patient information.
The following site-specific data must be provided:
- Full centre name
- Name and contact details (phone, email, etc.) of the PIs and, if applicable, Deputy PIs
- 24-hour emergency number
- Contact details for the centre’s data protection officer (email address is sufficient; a functional email address should be used rather than a personal email addresses.) In order to assist you, a list of Data Protection Officers for the Austrian hospitals is available via this link (data supplied without liability).
- Contact details for patient advocacy groups (Patient Representatives)
Patient Information for patients unable to give informed consent/Emergency Medicine Studies
- If patients unable to provide informed consent are to be included in the study, a separate information and consent form for their legal guardian must be submitted.
- If patients who are temporarily unable to provide informed consent are to be included, or the trial is part of Emergency Medicine, an additional post-hoc information and consent form must be submitted. This must be given to participants once they regain their ability to provide informed consent.
Patient Information for Minors
If the trial includes minors aged 8 years and above separate consent must be obtained from both the parents/legal guardians and the children/adolescents. The linguistic level of understanding of the children/adolescents should be considered, and the information and consent should be age-appropriate (8-9 years, 10-13 years, and 14-17 years).
Recommendations for linguistic design and sample information can be found here.
Patient Information for Genetic Investigations
For applications involving genetic investigations or analyses, or those including an optional component, the following guidelines regarding disclosure and consent must be followed. Special attention should be given to result disclosure. Optional components require a separate consent form. (Link to Guidelines)
Trial Site Suitability Form (SSF)
For Austrian centres, use the national Trial Site Suitability template is MANDATORY: (SSF Link)
"The Trial Site Suitability Forms have to be signed by the site-specific responsible person."
The CTR ethics committees and the BASG, assume that the signature of the respective Medical Director (or Deputy Medical Director) or the equivalent functionary must appear on the completed SSF for all Austrian healthcare facilities. Some federal states or healthcare facilities have specific regulations for the signing of the SSF – you can find a list of specific regulations here. Signature requirements: wet ink or advanced (AES) or qualified (QES) electronic signature (a pasted scanned signature is NOT sufficient).
Requirements for Investigators or Investigational Teams
Requirements for the Investigator:
- According to the current version of § 43 of the Medicines Act (AMG) the investigator must be a licensed physician or dentist authorized to practice independently in Austria.
- The investigator must demonstrate:
1) Appropriate knowledge and experience in the field of clinical drug trials,
2) Appropriate knowledge and experience in the intended indication area, and
3) Knowledge in relevant areas of non-clinical medicine, especially biometrics. - Evidence of the listed criteria must be provided by the investigator to the reviewing ethics committee and the sponsor. If the investigator does not have the required knowledge and/or experience in one of the areas specified in Z 3, relevant experts must be consulted alongside the investigator.
- The evidence listed above must be evident from the investigator's CV, which must be dated and not older than 1 year
- The evaluating ethics committee recognizes training courses such as the ÖÄK course for clinical investigators, postgraduate programs, or topic-specific seminars upon submission of the respective certificates/participation confirmation documents. Proof of completed ICH-GCP training is required. This can be evidenced by the provision of a training certificate indicating that the training meets the minimum requirements of the "TransCelerate Mutual Recognition Program" for mutual recognition of GCP basic requirements. The ICH-GCP training must be refreshed every 3 calendar years and documented by a training certificate if there has been no active participation in the conduct of clinical trials during this period.
Deputy Investigator:
- Regulation (EU) 536/2014 does not explicitly require the provision of a deputy investigator. However, it is recommended that a qualified deputy be provided along with the investigator in the initial application
- Providing a deputy investigator means that any unnecessary stress and delays caused by the unplanned departure of the principal investigator can be avoided. If a deputy investigator is not provided and the investigator leaves unexpectedly, a substantial modification must be submitted to register the new investigator. This process takes time and may cause delays to the trial.
- When submitting documents for the deputy investigator, their name should be redacted in the "for publication" version to ensure data protection.
- The deputy investigator must meet the same qualification requirements as the investigator.
Investigation Team:
- The requirements for the investigator according to Regulation (EU) 536/2014 and AMG apply only to the principal investigator and their deputy, not to the entire investigation team.
- Other individuals involved in the clinical trial must be sufficiently qualified through education, training, and experience to perform their respective roles.
- If their role involves medical activities, they must be qualified as a physician according to Austrian professional law (= licensed physician or physician in training).
Insurance
The sponsor must obtain insurance that complies with the requirements of § 40 AMG.
The responsible ethics committee must review the documents in accordance with its legal mandate. All insurance documents must be made available to assess whether these comply with the legal requirements.
The following insurance documents must be submitted:
- The insurance policy
- The insurance terms for:
- No-fault personal injury insurance ("subject insurance")
- Extended liability insurance for the investigator
- Extended criminal law protection insurance for the investigator - Insurance confirmation
Insurance documents should be submitted without redactions. Redactions are only permissible for information that is irrelevant to the insurance content, such as premiums paid by the policyholder. However, it must be clear what is being redacted (e.g., it is permissible to redact the premium amount itself, provided it is evident that the redaction is limited to that). Redactions beyond this scope cannot be accepted because the ethics committee cannot verify whether the redaction covers fields which should not be redacted. If there is any doubt regarding the nature of the redaction, completely unredacted insurance documents must be submitted to the ethics committee.
Please note the following additional review criteria:
- The entire planned duration of the clinical trial must be covered by insurance.
- At a minimum, the number of insured people must be equal to the sum of all planned trial participants in all trial centres as indicated in the Site Suitability Forms (Planned number of subjects / patients in total) or the information in the MSC tab in CTIS, whichever is higher. A higher number of insured people is permissible.
National Compliance with GDPR
The template "Template statement on compliance Regulation (EU) 2016/679" can be used for the data protection statement (Statement of compliance with General Data Protection Regulation).
This compliance template for Regulation (EU) 2016/679 must include a provision stating that additional national data protection regulations will also be complied with, or an additional confirmation of compliance with all national data protection laws and regulations must be submitted in Part II.