Austria CTIS Patient Information and Consent Requirements

German language requirements for participant documents

Mandatory. Participant-facing materials submitted in Part II Sections K and L must be German. The full and public trial titles and the protocol synopsis must also be available in German, and the full title must be consistent with the title shown on the ICF and insurance materials.

Conditional. If an Austrian site plans to enroll a participant who does not sufficiently understand German, all participant-facing documents for that participant must be available as a certified translation into a language the participant understands. Do not treat an English master ICF as a substitute for the German Austria version.

Participant-facing endpoint documents used during the trial, such as questionnaires or diaries, may belong in Part I under current EU guidance. Austria still applies the participant-language rule to their use.

Use of the Austrian national ICF template

Recommended. Use the national Austrian Patient Information and Informed Consent template as the starting structure. AustrianEthics states that it contains the required topics. A sponsor-developed template can be used only if it covers the same topics.

Mandatory. Use the national sample wording for the insurance section and the data-protection section verbatim. AustrianEthics states that these passages were developed with legal experts and should not be linguistically rewritten. Necessary additions can be placed at the end of the relevant section only if they do not create contradictory or repetitive statements.

This distinction matters in QC. The overall template is recommended, while the specified insurance and privacy passages are mandatory text.

What the standard Austrian participant information should cover

The document should explain the trial in language that a lay participant can understand. AustrianEthics asks sponsors to avoid unexplained technical terms and redundant content and encourages graphics or tables when they genuinely improve understanding.

The standard information set should cover the elements required by the Clinical Trials Regulation and the Austrian template, including:

• the nature and purpose of the trial
• study procedures, treatment allocation and expected duration of participation
• foreseeable risks, inconveniences and burdens
• potential benefits without overstating therapeutic benefit
• relevant alternative treatment options
• the participant's right to refuse or withdraw without disadvantage
• what happens after treatment or participation is stopped
• compensation and reimbursement arrangements
• the Austrian no-fault participant insurance and the insurance contact point
• collection and processing of personal data, including the Austrian mandatory privacy wording
• access to source records where applicable
• biological-sample collection, storage and use where applicable
• pregnancy, contraception and pregnancy follow-up where relevant to the protocol
• study, site, emergency, data-protection and patient-advocacy contacts
• how and where trial results will become available under the CTR

Optional services, optional genetic investigations, future research, secondary data use and other choices should not be buried inside the main participation decision. Use separate consent choices or separate documents where the Austrian guidance requires them.

Site-specific contact information

Mandatory content. Contact information is an integral part of Austrian participant information. For multicentre trials, AustrianEthics permits a separate site contact list marked “not for publication” while the master ICF contains placeholders.

The current national platform asks the site-specific information to include the full centre name, PI and any deputy PI contact details, a 24-hour emergency number, the site's data-protection officer contact and patient-advocacy contact details. The participant information should also contain the national contact point for insurance questions.

Using placeholders avoids a full ICF amendment when a site contact changes, but the corresponding site contact document must remain current.

Consent, signature and dating

Mandatory when consent is obtained. Regulation (EU) No 536/2014 requires informed consent to be written, dated and signed by the person conducting the consent interview and by the participant or, where applicable, the legally designated representative. The participant or representative receives a copy.

The Austrian national requirements portal states that informed consent signatures use wet ink or qualified electronic signature. Do not apply the wider advanced-electronic-signature rule used for the Austrian site-suitability form to participant consent.

The ICF uploaded at CTIS submission is a blank controlled template. Participant signatures are collected later, before trial participation unless a valid CTR emergency pathway applies.

If the participant can consent but cannot write, the CTR impartial-witness process applies. The Austria impartial witness consent guide explains that procedure.

Withdrawal and continued data collection

Participants can withdraw from the trial. AustrianEthics Guidance ICF Version 4 states that after a participant withdraws from the trial, new data should not continue to be collected for study purposes through study visits, follow-up visits or re-contact. Safety-reporting obligations under the CTR remain unaffected.

The Austrian Medicines Act also requires the participant or legal representative to receive explicit written information about the purpose and scope of personal-data processing and the effect of withdrawal on data already processed. The exact national sample privacy wording should be used rather than replaced with a global sponsor clause.

Population and use-case variations

The standard adult ICF is only the default document. Use a separate or adapted pathway when the trial includes one of the following situations.

• Healthy volunteers in Austria need the standard Austrian protections, with particular attention to compensation, lack of therapeutic benefit where applicable and insurance.
• Minors in Austria require age-appropriate documents and additional minor consent rules.
• Adults with limited capacity and legal representatives require a separate representative information and consent form.
• Emergency enrollment requires the Article 35 conditions and an Austrian post-hoc information and consent form when capacity returns.
• Impartial-witness consent applies when the participant is unable to write.
• Pregnancy follow-up may require a separate consent when data collection extends beyond the main ICF scope.
• Secondary and future use needs distinct optional consent logic for data and biological samples.

Genetic investigations and optional components

Conditional. AustrianEthics states that optional genetic investigations require a separate consent form. The participant information must address disclosure of results where relevant and the optional nature of the activity. Do not make optional genetic participation a condition of joining the main trial unless the protocol genuinely makes the investigation part of the trial rather than an optional add-on.

Future use of samples and secondary use of data have additional Austrian requirements. Use the dedicated Austria secondary and future use guide rather than inserting a broad one-line future-research permission into the standard signature page.