Spain CTIS Part II Patient-Facing Document QC Checklist

Trial identity and document control

Confirm that every document uses the same study title, protocol code, sponsor and EU trial number as the application. Check that the title clearly identifies the population or use case. Confirm the version and date in the document and CTIS entry.

Confirm that site and investigator fields are either correctly completed or intentionally left as controlled placeholders for site completion. Check that no participant names, signatures, personal email addresses or other unnecessary personal data appear in the blank submission version.

Protocol-to-document consistency

Check the treatment groups, allocation ratio, blinding, placebo, dose, route, schedule and treatment duration against the current protocol. Check the number and timing of visits, remote contacts, hospital stays and follow-up.

Compare all trial-specific procedures, including optional procedures, biopsies, imaging, genetic tests, digital tools, home nursing and medical-record review. Mark each as routine care or research-specific where relevant. Check the PIS against protocol contraception, pregnancy testing, breastfeeding and pregnancy follow-up requirements.

Reconcile the risk section with the Investigator's Brochure or Summary of Product Characteristics and the protocol. Include the most frequent and most serious risks without pasting an exhaustive technical list. Confirm that unknown risks are acknowledged and that procedure-related risks are not omitted.

Consent logic

Confirm that every mandatory trial activity is clearly distinguished from optional research. A participant should not be able to decline a protocol-essential procedure while apparently consenting to the main trial. Optional substudies, future data use, future sample use and recontact should have separate yes or no decisions.

Check that refusing an optional activity does not imply withdrawal from the main study. Check that optional boxes are not preselected and that each choice has the correct signature logic. Confirm that withdrawal wording does not require a signed revocation form.

Use the Spain main patient information and consent guide to check the standard adult logic before reviewing variations.

Population and document coverage

Create a population matrix from the protocol and recruitment plan. Confirm a distinct, appropriate document pathway for every group that may be enrolled or followed.

• Use the Spain healthy volunteer consent guide when participants have no condition expected to benefit from treatment.
• Use the Spain minor consent and assent guide for parent or guardian consent and age-adapted child or adolescent information.
• Use the Spain limited-capacity and legal representative guide when an adult may lack capacity to consent.
• Use the Spain emergency enrollment guide only when the protocol and CEIm-approved documents contain the emergency pathway.
• Use the Spain impartial witness guide for a participant unable to read or write.
• Use the Spain pregnancy follow-up guide for pregnancy and infant outcome data, including the partner-specific consent required by AEMPS.
• Use the Spain secondary-use guide for optional future data and sample use.

Check transition points. A participant enrolled as a minor must provide adult consent when reaching legal adulthood during the trial. An adult who regains capacity should consent before continuing. A person enrolled under the emergency pathway must be informed as soon as possible and provide or ratify consent.

Spain minor-consent checks

Confirm that parents who retain parental authority or the legal representative provide prior consent. If one parent signs, confirm that the other parent's express or tacit agreement is sufficiently documented. Use the AEMPS model wording to record that both parents signed, the other parent does not object or the signer is the sole legal guardian.

For a child younger than 12, check whether the child has sufficient judgment to be heard and whether the information is adapted to the child's understanding. For every participant aged 12 or older, confirm a separate age-appropriate information and consent path in addition to parent or representative consent.

Data-privacy checks

Confirm that the AEMPS Annex VIIIA personal-data appendix is present and kept to no more than two pages. Identify the sponsor and site roles accurately. The site normally controls identifiable medical-record data and the sponsor receives coded trial data.

Check the legal basis and purposes, confidentiality, authorised access, 25-year sponsor and investigator retention, site record retention, participant rights and limitations, data-protection contacts, publications, sharing and international transfers. Describe direct-data service activities such as travel, reimbursement or home services by purpose.

Do not promise deletion of trial data when retention is required. Do not say that withdrawing from visits automatically removes data already collected. Keep optional future use separate from the processing needed for the authorised trial.

Biological-sample and secondary-use checks

Reconcile the PIS/ICF, protocol, laboratory manual and AEMPS Annex XIII. Check sample type, quantity, collection schedule, mandatory or optional status, risks, analysis locations, responsible entity, coding, storage, retention, access and transfers.

State what happens to remaining samples after the trial. If they will be stored, identify the applicable Spanish biobank, registered collection or foreign repository model. Confirm that future use, recontact and return of findings follow the participant's choices and that withdrawal of sample consent is operationally possible.

Check genetic testing separately. Explain whether testing is a trial objective, exploratory or optional. Include the participant's choice about receiving validated, health-relevant findings when applicable.

Costs, compensation and insurance checks

Confirm that trial medicines and trial-specific procedures are free to the participant. Match reimbursement and compensation wording to the financial budget. State the amount or method, payment route and proportional treatment when participation ends early.

If compensation is offered, include the AEMPS tax warning. Confirm that the amount does not create undue influence. Do not present free medicine, tests or close monitoring as a participant benefit.

Match insurance wording to the actual Spanish insurance route. Do not promise coverage broader than the policy and Spanish law. Ensure the investigator or site contact for insurance questions is usable.

Signature and dating checks

Confirm that CTIS receives blank participant forms. Check that the use copy has signature and date fields for the correct people. Standard adult consent requires the participant and investigator. Parent, representative, witness and emergency pathways require different fields.

Check that every signer receives the relevant information before signing and that the participant or representative receives a signed and dated copy. Confirm that optional choices are tied to the person entitled to make them.

Readability and document-design checks

Confirm that the Spanish text is natural and uses terminology a participant can understand. Remove unexplained abbreviations, technical protocol language, repeated risks and long legal passages.

Check the AEMPS limits and formatting recommendations: no more than 15 pages including the ICF, Arial or Times New Roman at 11 points or larger, line spacing of at least 1.5 and no reduced margins. Use a simple visit table rather than the protocol schedule where a table helps.

Confirm that contact details, emergency instructions and alternative treatments are easy to find. Test the document with a person who was not involved in drafting.

Final Spain submission check

Confirm that every participant-facing document is in Spanish and appears under the correct CTIS country and category. Confirm that recruitment materials intended for potential participants are included. Make sure the final set contains no conflicting versions.

Return to the Spain CTIS Part II guide hub to check the participant documents against the administrative package.