Portugal Patient Information and Consent Requirements

Language and document set

Mandatory. Submit Portuguese versions of the PIS and ICF. The same rule applies to assent forms, legal-representative information, recruitment materials, patient cards, instructions, diaries, questionnaires and other participant-facing material. CEIC may approve another language only in an exceptional and justified case.

Mandatory. Create a separate document or clearly identified version for every group whose information or decision pathway differs. Do not ask an adult participant, parent, adolescent, legal representative or pregnant partner to sign a form written for another role.

At minimum, assess whether the trial needs:

• competent-adult PIS and ICF
• healthy-volunteer PIS and ICF
• parent or legally authorized representative information and consent
• adolescent and child assent material
• adult limited-capacity participant information
• emergency subsequent-consent material
• impartial-witness wording
• pregnancy follow-up information and consent
• optional future-use consent for data or samples

The Portugal Part II document checklist shows where each item belongs in CTIS.

Readability and presentation

Write for a person who has not read the protocol. Use short sentences, familiar words, descriptive headings and enough white space. Explain unavoidable medical terms immediately. Keep the consent declaration short and put the explanation in the information section.

The PIS should identify the study and version clearly. Use the same study title, EU trial number, sponsor, investigator and site details as CTIS. Add page numbering and a footer with the document title, version and date.

The information must be understandable to the intended population. A technically accurate translation is not enough if the Portuguese text reads like a literal translation of the protocol. The CEIC model emphasizes health literacy, clarity, autonomy and participant-centered communication.

Core information to include

Study purpose and voluntary choice

Explain why the study is being done, why the person is invited, whether the medicine is experimental and what assignment to treatment means. State clearly that participation is voluntary, refusal will not affect normal care and consent may be withdrawn.

Procedures, visits and duration

Describe screening, randomization, placebo or comparator use, treatment, samples, questionnaires, remote activities, record review, follow-up and the participant's expected time commitment. Distinguish routine care from procedures performed only for the study.

Risks, burdens and benefits

Present reasonably foreseeable risks in plain Portuguese, including medicine risks, procedural risks, reproductive risks, privacy risks and burdens such as extra visits. Do not imply personal benefit when none is expected. Describe alternatives to participation and available standard treatment.

Pregnancy and contraception

When relevant, explain known and unknown reproductive risks, contraception and pregnancy-testing requirements, prohibited donation, what to do if pregnancy occurs and what follow-up is proposed. A pregnant partner needs her own information and consent if the sponsor will collect her data or access her records. See the Portugal pregnancy follow-up guide.

Biological samples and genetic information

Explain what samples are collected, their purpose, coding, storage location, retention, testing, transfers, possible genetic analysis and destruction. Separate trial-required use from optional future research. If samples will enter a repository or biobank, include the additional information required by Portuguese law. See the Portugal secondary-use consent guide.

Personal data and medical-record access

Identify the controller or controllers, purposes, data categories, recipients, coded-data process, authorized direct access, international transfers, safeguards, retention and privacy contacts. Explain relevant participant rights accurately. Do not promise deletion where clinical-trial law requires data to be retained.

If monitors, auditors, regulators or ethics bodies may review source records, explain who may access them, why and under what confidentiality controls. Keep the privacy wording aligned with the sponsor's GDPR statement in CTIS.

Costs, expenses, compensation and insurance

State that trial medicines, auxiliary medicines, administration devices and protocol-only tests or consultations are provided without cost to the participant. Explain reimbursement or compensation, including how it is calculated and whether payment is prorated after withdrawal.

Describe the insurance and injury-compensation route in understandable terms. Do not ask the participant to waive legal rights. If post-trial treatment may be clinically indispensable, explain the Portuguese continuation pathway without promising access that the protocol and law do not support.

Withdrawal and end of participation

Explain how to withdraw, what trial procedures will stop, what safety follow-up may still be requested and what happens to data and samples already collected. Distinguish withdrawal from treatment, withdrawal from follow-up and withdrawal of optional future-use consent.

Contacts and results

Provide Portuguese site contacts for study questions, medical emergencies, participant rights and privacy. Explain how the participant will be informed of information that may affect willingness to continue and how the lay summary of results will be made available.

Consent choices and structure

The main decision to participate must be clear and unambiguous. Do not combine it with optional future research, optional genetic testing, biobanking, extra samples or unrelated contact. Each optional choice should have its own yes and no response and declining it must not affect main-trial participation.

Use separate declarations where another person is the data subject. A trial participant cannot consent on behalf of a pregnant partner. A legal representative consents for the person only when authorized by Portuguese law and the trial meets the protective conditions for that population.

Population-specific pathways are covered in the following guides:

• Portugal healthy volunteer consent requirements
• Portugal minor consent and assent requirements
• Portugal limited-capacity and legal-representative consent requirements
• Portugal emergency enrollment consent requirements
• Portugal impartial witness consent requirements

Signature and dating

Mandatory when consent is obtained. The participant or legally authorized representative and the person who conducted the consent interview sign and date the ICF. Give the participant or representative a copy of the signed form.

Record signatures and dates at the time of consent. Do not pre-date forms or ask a participant to confirm information that was provided later. If new information may affect continued participation, provide the approved update and obtain re-consent when required.

When a participant can consent but cannot write, use the alternative process in the EU Regulation and have an impartial witness present. The Portugal impartial witness guide explains the signature record.

For minors, Portuguese law distinguishes assent under age 16, assent at ages 16 and 17, written assent when a participant turns 16 during the trial and written consent on reaching 18. Do not use the adult signature block without adapting it. See the Portugal minor consent guide.

What is signed at CTIS submission

The PIS and ICF are submitted blank. Do not place participant, representative, witness or interviewer signatures on the submitted model.

Investigator declarations, the declaration of interests, the site-conditions declaration and the insurance certificate have their own submission-time signature rules. They are separate Part II documents and should not be merged into the consent form.

Final QC

Before upload, confirm that:

• every participant group has the correct Portuguese document
• risks, visits and samples match the protocol
• optional choices are separate from main consent
• pregnancy, contraception and partner follow-up are consistent
• privacy wording matches actual data flows and the GDPR statement
• insurance, expenses and post-trial treatment match the Part II documents
• contacts are local and usable
• document titles, versions and dates match CTIS
• signature blocks match the participant's role and legal pathway
• no participant-facing content remains only in English

Use the Portugal patient-facing document QC checklist for a full cross-document review. Return to the Portugal CTIS hub for the complete guide series.