Portugal Patient-Facing Document QC Checklist

Trial content checks

Confirm the study title, short title, EU trial number, sponsor, site and principal investigator.
Confirm the medicine name, formulation, dose, route and schedule are described consistently and at an appropriate level for participants.
Confirm the purpose, phase and experimental status are accurate.
Confirm randomization, blinding, placebo and comparator information.
Confirm visit frequency, treatment duration, follow-up and total participation time.
Confirm all participant procedures, samples, questionnaires, digital tools and record reviews.
Confirm which procedures are standard care and which occur only because of the trial.
Confirm that alternatives to participation are described without steering the decision.

Protocol-to-document consistency

Map every protocol procedure and risk to the relevant participant document.
Reconcile the schedule of activities with the visit table, diaries and appointment information.
Reconcile pregnancy testing, contraception, breastfeeding and donation restrictions.
Reconcile sample type, volume, frequency, storage, testing and future use.
Reconcile remote visits, home nursing, direct-to-participant shipment and electronic consent if used.
Reconcile stopping rules, rescue treatment, safety follow-up and post-trial access.
Check that no recruitment claim overstates likely benefit or understates burden.

Consent logic checks

Keep main-trial consent separate from optional future research, extra sampling, genetic testing and biobanking.
Provide a yes and no choice for each optional activity.
State that refusal of an optional activity does not affect main-trial participation.
Make sure the person signing has authority for that decision.
Use a separate consent for a pregnant partner whose data or records will be collected.
Do not treat an impartial witness as a legally authorized representative.
Explain withdrawal separately for treatment, follow-up, data and stored samples.
Do not promise deletion of records that must be retained for trial integrity or legal compliance.

Population and document coverage

Confirm whether the trial needs each of the following Portugal-specific variations:

For minors, confirm that the documents reflect the Portuguese age rules. A capable child under 16 is asked for assent. A participant aged 16 or 17 must assent in addition to representative consent. A participant who reaches 16 during the trial gives written assent. A participant who reaches 18 gives written informed consent to continue.

For an adult unable to consent, confirm that the legal-representative pathway and EU protective conditions apply. Institutional residence has an additional Portuguese restriction.

Data privacy checks

Identify the controller or joint controllers correctly.
Describe purposes, categories, coded identifiers and recipients accurately.
Explain who may review source medical records and why.
Identify international transfers and safeguards where relevant.
State retention periods or clear retention criteria.
Provide usable privacy and data-protection contacts.
Describe participant rights with any trial-law limits.
Align the wording with the sponsor's GDPR statement submitted in CTIS.
Confirm that electronic tools, vendors and remote monitoring are described when they change the participant experience or data flow.

Biological-sample and secondary-use checks

Identify every sample and collection time point.
State the primary-trial purpose separately from optional future use.
Identify the storage institution and location.
State whether samples are coded, identifiable or irreversibly anonymized.
State the storage duration or a justified criterion.
Explain genetic testing and possible incidental findings when relevant.
Explain transfers to other institutions or countries.
Explain withdrawal and destruction rights without overpromising.
Confirm that the Part II biological-sample template matches the participant wording.
Confirm that a repository or biobank consent includes the additional information required by Portuguese law.

Country-specific regulatory checks

Participant documents and recruitment materials are in Portuguese.
The protocol synopsis is in Portuguese.
The CEIC adult ICF model is treated as optional guidance, not a fixed mandatory form.
Every patient card, leaflet, guide, brochure, instruction, questionnaire and appointment document has been included.
Insurance wording matches the valid policy and Portuguese damage-compensation route.
Trial medicines, auxiliary medicines, administration devices and protocol-only procedures are described as free to participants.
Post-trial medicine wording matches the Portuguese continuation rule and financial agreement.
Reimbursement and compensation match the Part II financial arrangements.
Site and contact details match the site-suitability documentation.

Signature, version and administrative checks

The submitted PIS, ICF and assent forms are blank.
Every document has a unique title, version and date.
Headers, footers and page numbers are consistent.
Signature blocks identify the participant, representative, interviewer and witness only when applicable.
The form provides separate signature and date fields for each required signatory.
The participant receives a copy of the signed consent form.
Re-consent triggers are defined for new information, amended documents and changes in age or capacity.
CTIS metadata and filenames match the visible document version.
Superseded versions are not included as current documents.

Readability and Portuguese language checks

Use natural European Portuguese regulatory and clinical terms.
Avoid literal translation of protocol language.
Define technical terms at first use.
Use short paragraphs, active sentences and descriptive headings.
Present risks by likelihood and seriousness when reliable information supports it.
Use neutral language and avoid promotional claims.
Make age-specific assent documents suitable for the intended child or adolescent.
Check fonts, spacing, contrast, tables and form fields for accessibility.
Verify that translated text, numbers, units, dates and contact details were not altered.
Complete independent proofreading by a qualified Portuguese reviewer.

Final approval check

Complete a side-by-side review of the protocol, CTIS data, PIS and ICF, recruitment procedure, insurance, financial arrangements, GDPR statement and biological-sample template. Record each discrepancy and its resolution. The Portugal Part II document checklist provides the final dossier-level check.

Return to the Portugal CTIS hub for the complete guide series.