Austria CTIS Part II Document Checklist

K. Recruitment arrangements

Mandatory. Submit the recruitment procedure in CTIS Section K. If advertisements, invitation letters, scripts, social-media materials or other recruitment materials will be used before a participant decides whether to join, submit the applicable materials as well. Participant-facing recruitment content must be German in Austria. A certified translation is also needed when recruitment is directed to a planned participant population that does not sufficiently understand German.

These documents are not participant-signed at CTIS submission. The current European Commission “Informed consent and patient recruitment procedure” template v2.0 applies to new Part II submissions. On the review date of this guide it is in the final transition period before full implementation on 1 September 2026. Use the current v2.0 format for new work rather than starting from the superseded version.

CTIS naming: K1 Recruitment arrangements and K2 Recruitment material description. The Austria patient-facing document QC checklist is useful before upload.

L. Participant information and informed consent

Mandatory. Submit the German Patient Information Sheet and Informed Consent Form for the standard adult population in CTIS Section L. The national Austrian ICF template is recommended. If another structure is used, it must still address all topics in the national template. The insurance and data-protection passages from the Austrian sample text are mandatory verbatim.

The submitted ICF is the blank controlled document used later to obtain consent. It is not signed by participants at CTIS submission. When consent is obtained, Regulation (EU) No 536/2014 requires the consent to be written, dated and signed by the person conducting the consent interview and by the participant or legally designated representative. The Austrian national requirements portal states that informed consent uses wet ink or a qualified electronic signature.

Conditional. Submit separate or additional Section L documents when the trial includes minors, adults unable to consent, temporary incapacity, emergency enrollment, an impartial-witness procedure, pregnancy follow-up requiring separate consent, optional genetic investigations or optional secondary and future use. Austria specifically requires a legal-representative form for adults unable to consent and a post-hoc form for temporarily incapacitated or emergency participants. For minors aged 8 and above, separate parent or guardian and age-appropriate child or adolescent documents are expected.

CTIS naming: L1 SIS and ICF description and L2 other subject information material description. The Austria patient information and consent guide explains the core ICF and links to every population variation.

M. Investigator suitability

Mandatory. Provide the principal investigator curriculum vitae and Declaration of Interest for each Austrian site in CTIS Section M. The CV must show the qualifications required under section 43 of the Austrian Medicines Act, including authority to practise independently in Austria and relevant clinical-trial and indication experience. AustrianEthics states that the CV must be dated and not older than one year. Evidence of completed ICH Good Clinical Practice training is required.

The European Commission templates are accepted and recommended. BASG states that the CV and Declaration of Interest should be dated and current and does not require a signature at submission. A signed and dated CV must still be archived in the Trial Master File or Investigator Site File.

CTIS naming: M1 CV Investigator and M2 Declaration of Interest.

N. Facility suitability

Mandatory. Use the national Austrian Trial Site Suitability Form for every Austrian centre. Austria does not accept the generic EU site-suitability form as a substitute for this national requirement.

The completed form must be signed before CTIS upload. AustrianEthics states that the site-specific responsible person must sign it and that, for Austrian healthcare facilities, the expected institutional signatory is the medical director, deputy medical director or equivalent functionary. Some hospitals and federal states have additional signature specifications, so check the current institution-specific list before collecting signatures.

The site-suitability form accepts wet-ink, advanced electronic or qualified electronic signatures. A pasted scanned signature is not sufficient.

CTIS naming: N1 Site suitability form. National template: Austrian Trial Site Suitability Form.

O. Insurance or indemnification

Mandatory. Austrian Medicines Act section 40 requires no-fault personal injury insurance for participants. AustrianEthics requires the insurance policy, the insurance terms and conditions and the insurance confirmation. The submitted insurance material must allow the ethics committee to assess participant insurance, extended investigator liability insurance and extended investigator criminal legal-protection insurance.

Insurance documents should be unredacted except for information irrelevant to the insurance assessment, such as a clearly identified premium amount. Coverage must extend across the full planned trial duration. The insured participant number must be at least the higher of the sum planned across Austrian site-suitability forms or the number entered for Austria in the CTIS Member State Concerned data.

Participant-facing insurance information must follow the Austrian language rule. The participant information must also include a national contact point for insurance questions.

CTIS naming: O1 Trial participant insurance certificate and O2 proof of coverage where needed.

P. Financial and other arrangements

Mandatory. Describe participant compensation, investigator compensation, funding and other relevant financial arrangements in CTIS Section P. Austria accepts and recommends the European Commission compensation template. Do not present reimbursement of reasonable expenses as an incentive to participate.

When Austrian sites use different reimbursement methods, the Austrian ICF guidance asks the master participant information to show all options available at participating Austrian sites. If more than one method is available at a site, include a choice in the consent form. Additional rules apply when reimbursement is handled by an external service provider.

CTIS naming: P1 Compensation trial participants, investigator, funding and other arrangements. The Austria healthy volunteer consent guide covers reimbursement language where it is especially relevant.

R. National data-protection compliance

Mandatory. The European Commission GDPR compliance statement must include confirmation that Austrian national data-protection rules will also be followed. AustrianEthics permits this national statement within the Commission template or as an additional Part II confirmation.

This Part II compliance document is separate from the participant-facing data-protection section of the ICF. Under section 41 of the Austrian Medicines Act, the participant or legal representative must receive explicit written information on the purpose and scope of personal-data collection and processing and must consent to that processing. The Austrian sample ICF data-protection wording is mandatory verbatim.

CTIS naming: R1 Compliance on the collection and use of personal data.

S. Biological samples

Conditional. When biological samples are collected, stored or used, submit the Part II compliance information in Section S. Austria accepts and recommends the European Commission “Compliance with applicable rules for biological samples” template.

If samples will also be stored for optional future research, the main study sample-compliance document is not enough by itself. Austria requires the future research field to be delimited and the participant information to explain which samples will be kept, where and for how long, who is responsible for storage and destruction, and the participant's choices. Use the Austria secondary and future use consent guide for that document logic.

CTIS naming: S1 Compliance on the collection, use and storage of biological samples.

Austria items outside the Part II K to S list

Mandatory for the application. A German protocol synopsis is required, even though it belongs with the Part I protocol package rather than Part II. A separate lay synopsis is not required by Austria.

Administrative. BASG asks sponsors to upload a national contact and billing address in the CTIS “Proof of Payment of Fee” area so the invoice and national decision can be delivered correctly. Actual proof of payment is not part of a valid submission because BASG bills separately from the application assessment.

Final Austria submission check

• Confirm the German full and public titles match the title on the ICF and insurance materials.
• Confirm all participant-facing K and L materials are German.
• Add certified translations for any planned non-German-speaking participant population.
• Use the Austrian national site-suitability form for every site and verify the correct local signatories.
• Confirm each investigator CV is dated and no more than one year old.
• Submit the complete insurance evidence and reconcile the insured participant number with the higher Austrian total in the site forms or CTIS.
• Confirm the Austrian national data-protection statement is present.
• Confirm every special population has the separate participant document required for that pathway.
• Use the current EU v2.0 informed-consent and recruitment-procedure template for new Part II work.