Austria CTIS Part II Clinical Trial Guides

Austria CTIS guide directory

Austria CTIS Part II Document Checklist

Use this guide to identify the Part II documents, Austria-specific templates, language rules and signature requirements that apply at initial submission.

Read the Austria CTIS Part II Document Checklist

Austria CTIS Patient Information and Consent Requirements

Use the main consent guide for the standard German Patient Information Sheet and Informed Consent Form, including Austria's mandatory insurance and data-protection wording.

Read the Austria CTIS Patient Information and Consent Requirements

Austria CTIS Patient-Facing Document QC Checklist

Use this checklist before submission to test protocol consistency, consent logic, population coverage, privacy, biosamples, versions, signatures and Austrian national requirements.

Read the Austria CTIS Patient-Facing Document QC Checklist

Austria Healthy Volunteer Consent Requirements

Use this guide when a trial enrolls healthy volunteers and the participant information must address reimbursement, lack of therapeutic benefit where applicable and Austria-specific insurance and privacy content.

Read the Austria Healthy Volunteer Consent Requirements

Austria Minor Consent and Assent Requirements

Use this guide for children and adolescents, including Austria's age-specific participant documents and the additional consent requirement for decision-capable minors.

Read the Austria Minor Consent and Assent Requirements

Austria Limited-Capacity and Legal Representative Consent Requirements

Use this guide when adults cannot provide valid consent themselves and a legally designated representative or later post-hoc consent process is required.

Read the Austria Limited-Capacity and Legal Representative Consent Requirements

Austria Emergency Enrollment Consent Requirements

Use this guide for emergency trials that rely on the narrow deferred-consent pathway in Article 35 of the Clinical Trials Regulation and Austria's required post-hoc document.

Read the Austria Emergency Enrollment Consent Requirements

Austria Impartial Witness Consent Requirements

Use this guide when a participant can consent but cannot write and an impartial witness is needed to document consent under Article 29 of the Clinical Trials Regulation.

Read the Austria Impartial Witness Consent Requirements

Austria Pregnancy Follow-Up Consent Requirements

Use this guide when the trial plans pregnancy follow-up, post-birth child data, physician contact or other pregnancy-related data collection in Austria.

Read the Austria Pregnancy Follow-Up Consent Requirements

Austria Secondary and Future Use Consent Requirements

Use this guide for optional future research using data or biological samples, including Austria's rules on restricted research fields, optional consent and secondary use for new technologies.

Read the Austria Secondary and Future Use Consent Requirements

Main Austrian differences to plan for

German participant-facing documents

For multinational trials, the core dossier can be English, but Austria requires the full and public titles and protocol synopsis in German. Materials used before inclusion under Part II Sections K and L must be German. Insurance documents intended for participants are also subject to the German-language rule. When non-German-speaking participants are planned, certified translations into a language they understand must be available. The Austria patient information and consent guide explains the participant-document rules in detail.

Austria-specific site suitability

Austria requires its national Trial Site Suitability Form for Austrian sites. The form must be signed by the site-specific responsible person. For Austrian healthcare facilities, the ethics committees and BASG expect the medical director, deputy medical director or equivalent functionary, subject to any institution-specific signature rule. Wet-ink, advanced electronic and qualified electronic signatures are accepted for the site-suitability form. A pasted scanned signature is not accepted. The Austria Part II document checklist places this in the CTIS upload structure.

National consent wording

The national Austrian ICF template is recommended rather than mandatory as a whole. If another format is used, it must cover the topics in the Austrian template. Austria is stricter for two sections. The insurance and data-protection passages from the national sample text must be used verbatim, with additions only where they do not create contradictions or repetition. The Austria patient-facing document QC checklist includes checks for these passages.

Insurance evidence

Austrian law requires no-fault personal injury insurance for trial participants. The ethics platform requires the insurance policy, the applicable terms and conditions and the insurance confirmation, including the required investigator liability and criminal legal-protection coverage information. Coverage must span the planned trial duration and cover at least the higher Austrian participant number shown across site-suitability forms or in the CTIS Member State Concerned data.

Population-specific documents

Austria requires separate documents for several populations. For minors aged 8 and above, the ethics platform expects separate parent or legal-guardian consent and age-appropriate child or adolescent information and consent. For adults unable to consent, a separate legal-representative document is required. Temporarily incapacitated and emergency-trial participants require an additional post-hoc information and consent form when capacity returns. Use the population guides above rather than adapting the standard ICF without a separate review.