Austria CTIS Patient-Facing Document QC Checklist

Trial content checks

[ ] Confirm the German full study title on participant documents is identical to the German full title entered for Austria in CTIS.
[ ] Confirm study purpose, treatment groups, randomisation, blinding and treatment duration match the protocol.
[ ] Confirm all participant procedures, visits and study-specific tests are described at the level needed for informed consent.
[ ] Confirm the stated risks and burdens reflect the current protocol and current safety information used for the submission.
[ ] Confirm expected benefit is not overstated and alternatives are described where relevant.
[ ] Confirm pregnancy, contraception and pregnancy follow-up language matches the protocol.
[ ] Confirm reimbursement and compensation amounts, methods and conditions match the Part II financial-arrangements information.

[ ] Compare visit frequency, sample collection, imaging, biopsies, homecare, digital tools and optional procedures against the protocol line by line.
[ ] Confirm every optional activity is clearly separated from mandatory trial procedures.
[ ] Confirm patient-facing endpoint materials that belong in Part I have been identified and the German language requirement has been applied to their use in Austria.
[ ] Confirm the participant document does not promise procedures, access, treatment or follow-up that the protocol does not support.
[ ] Confirm withdrawal language does not imply that routine study visits or new study-purpose data collection continue after full trial withdrawal.

[ ] Confirm the main trial participation decision is distinct from optional choices.
[ ] Confirm optional genetic investigations use a separate consent form where required by AustrianEthics.
[ ] Confirm optional third-party services include the information and explicit choice required by the current Austrian ICF guidance.
[ ] Confirm future research, sample anonymisation and new-technology secondary use use clear yes or no options where required.
[ ] Confirm the signer logic matches the population. The standard adult participant signs for themselves. A legally designated representative signs when the participant cannot validly consent. An impartial witness signs only in the CTR situation where the consenting person cannot write.
[ ] Confirm the person conducting the consent interview also signs and dates the informed consent document.

[ ] Confirm the standard adult German PIS and ICF is present for the main population.
[ ] For healthy volunteers, apply the Austria healthy volunteer consent requirements.
[ ] For minors, apply the Austria minor consent and assent requirements and confirm age-appropriate documents are present.
[ ] For adults unable to consent, apply the Austria limited-capacity and legal representative requirements.
[ ] For temporary incapacity or emergency research, apply the Austria emergency enrollment requirements and confirm the post-hoc document is present.
[ ] If a participant may be unable to write, apply the Austria impartial witness requirements.
[ ] If pregnancy follow-up is planned, apply the Austria pregnancy follow-up requirements.
[ ] If data or samples may be used beyond the main trial, apply the Austria secondary and future use requirements.

[ ] Confirm the Austrian national sample data-protection passage is reproduced verbatim.
[ ] Confirm any added privacy wording is placed after the required passage and does not contradict or repeat it.
[ ] Confirm the participant or representative is expressly informed in writing about the purpose and scope of personal-data collection and processing.
[ ] Confirm the document explains the effect of withdrawal on data already processed in line with Austrian law and the current national wording.
[ ] If pseudonymised data will be transferred to the United States, confirm the current AustrianEthics Guidance Version 4 transfer information has been addressed.
[ ] If data on ethnic origin will be collected, confirm this special-category data collection is explicitly described.
[ ] If pseudonymised trial data will be reused to develop artificial intelligence, machine learning or other new technologies, confirm the separate understandable description, commercial nature where relevant and optional yes or no consent are present.

[ ] Confirm the main study explains which samples are collected for protocol-defined trial purposes.
[ ] If residual or additional samples will be stored for future research, confirm the future research field is restricted rather than described as unlimited research.
[ ] Confirm the document identifies which samples will be retained, storage location and duration, and who is responsible for storage and destruction.
[ ] Confirm participants can refuse optional future use without losing access to the main trial.
[ ] For pseudonymised samples, confirm the right to request destruction is explained.
[ ] If later anonymisation is proposed, confirm it is separately optional and that the loss of the ability to request destruction after anonymisation is clearly explained.

[ ] Confirm all Part II Sections K and L participant-facing documents are German.
[ ] For a planned non-German-speaking participant population, confirm certified translations into a language understood by participants are available.
[ ] Confirm the national Austrian ICF template was used or every topic in it has been covered.
[ ] Confirm the insurance passage from the Austrian sample ICF is reproduced verbatim.
[ ] Confirm the participant information includes a national insurance contact.
[ ] Confirm site-specific contact information includes the centre, PI and deputy PI where applicable, 24-hour emergency number, site data-protection officer and patient-advocacy contact.
[ ] If placeholders are used in the master ICF, confirm the site contact list is current and marked “not for publication” in CTIS.

[ ] Confirm the CTIS submission contains blank controlled consent templates rather than signed participant copies.
[ ] Confirm each document has a clear version and date that match the application package.
[ ] Confirm the consent process is designed for wet-ink or qualified electronic signature in line with the Austrian national requirements portal.
[ ] Confirm no pasted scanned signature is being used where the Austrian site-suitability form requires wet ink, advanced electronic or qualified electronic signature.
[ ] Confirm all population-specific consent documents use consistent titles, protocol identifiers, sponsor details and contact logic.

[ ] Use plain German that the intended participant population can understand.
[ ] Explain unavoidable medical and regulatory terminology at first use.
[ ] Remove repeated explanations that lengthen the ICF without helping consent.
[ ] Use headings, short paragraphs and, where useful, simple tables or graphics to make complex procedures understandable.
[ ] Keep optional decisions visually distinct from the main study-consent signature.