Portugal CTIS Part II Document Checklist

Folder K: Recruitment arrangements

Mandatory. Submit a description of the recruitment procedure when it is not already described adequately in the protocol. Use the current EudraLex recruitment and informed-consent procedure template. Portugal recommends the EU template. It is not signed by participants at submission. Upload it under Recruitment arrangements.

Conditional. Submit every recruitment item that will be used, including advertisements, letters, scripts, social-media text, referral material and pre-screening information. Participant-facing versions must be in Portuguese. Identify each item by title, version and date. These are blank approved materials, so participant signatures are not expected at submission.

Make sure the recruitment description explains who identifies potential participants, who makes the first contact, whether medical records are reviewed before contact, what pre-screening data are collected and how undue influence is avoided.

Folder L: Subject information and informed consent form

Mandatory. Submit the Portuguese Patient Information Sheet (PIS) and Informed Consent Form (ICF) for every participant group and consent pathway. Examples include competent adults, healthy volunteers, parents or guardians, adolescents, younger children, adults with limited capacity and pregnant partners. Upload blank version-controlled documents under Subject information and informed consent form. They are signed later when consent or assent is obtained, not at CTIS submission.

Mandatory. Submit every other participant-facing item required by the trial, such as patient cards, dosing or device instructions, visit schedules, diaries, questionnaires, guides, brochures and appointment information. Portuguese is required unless CEIC grants an exceptional justified language waiver.

The CEIC adult ICF model published in January 2026 is optional. It is a drafting aid, not a mandatory template. The Portugal patient information and consent guide explains the content, consent choices and signatures.

Folder M: Suitability of the investigator

Mandatory. Provide a current curriculum vitae for the principal investigator at each Portuguese site. Portugal recommends the EudraLex CV template. The national checklist expects the CV to be current, signed and dated. Include the investigator's relevant education, clinical-trial experience and ability to conduct the protocol.

Mandatory. Provide a declaration of interests for the principal investigator at each site. Use the EudraLex declaration-of-interest template. The investigator signs and dates it before submission.

Conditional. Provide a Good Clinical Practice certificate when competence is not sufficiently documented in the CV or when requested by the Portuguese checklist. The MedEthicsEU Portugal overview accepts GCP information in the CV. Keep the site name, investigator identity and estimated participant number consistent across CTIS, the CV, the site declaration and the financial documents.

Folder N: Suitability of the facilities

Mandatory. Provide a site-suitability form for each site. Portugal accepts the EudraLex site-suitability form but requires national site detail in addition. The declaration should cover the site's infrastructure, equipment, human resources, expected recruitment and ability to perform the protocol.

Mandatory. Include authorization to conduct the trial in the relevant service and authorization for the composition of the research team. The Portugal checklist expects the declaration to be authored and signed by the Director of Service. Submit the signed and dated declaration at Part II submission.

Mandatory. Include a declaration from the pharmaceutical services and a description or declaration of the investigational-medicinal-product circuit. State how receipt, storage, preparation, dispensing, return and destruction will be controlled.

Conditional. If a study coordinator is provided by an external entity or does not sit clearly within the site's hierarchy, include the supporting employment, authority, confidentiality and institutional-agreement evidence requested in the CEIC checklist.

Conditional. When an external facility will perform protocol tests or assessments, identify it, explain why it is needed, describe it in the site declaration, provide licensing evidence where applicable, extend insurance coverage to it and provide the relevant financial agreement. A later material change to the external provider may require a substantial modification.

Folder O: Proof of insurance cover or indemnification

Mandatory. Submit a valid insurance certificate that identifies the trial, insurer, insured party, policy number, type of insurance, coverage and validity. The Portugal checklist expects the certificate to be dated and signed by the insurer and valid at submission.

The sponsor must maintain civil-liability coverage appropriate to the nature and extent of the risk. The national checklist states that cover should remain valid during the trial and for 12 months after the last participant completes the study in Portugal. Portuguese law presumes that health damage arising during participation or in the following year was caused by the trial, unless the legal presumption is rebutted. CEIC may set a longer period for a particular trial.

Conditional. For a low-intervention trial, CEIC may dispense with a separate trial-specific policy if the sponsor presents evidence that existing civil-liability insurance covers the statutory damage. Do not assume that low intervention removes the insurance requirement. Obtain CEIC acceptance.

Insurance and compensation wording must match the PIS and ICF. Review the Portugal patient-facing document QC checklist before submission.

Folder P: Financial and other arrangements

Mandatory. Provide financial arrangements for each site. Portugal accepts a final contract, the agreed contract model or a document containing the mandatory minimum information for initial validation. A definitive contract should identify the sponsor, site, principal investigator and any other party, and it should be signed by all parties before it takes effect.

The document should state the remuneration and functions of the research team consistently with the site declaration. It should also address site costs, investigator payments, participant expenses or compensation, external providers and the free supply of trial-related medicines and procedures.

Portuguese law requires the sponsor to provide the investigational medicinal product, auxiliary medicines, administration devices and protocol-only consultations or tests without cost to the participant. It also establishes a post-trial continuation pathway when the investigator considers the medicine indispensable and there is no comparably effective and safe alternative. Align the financial agreement and participant information with that pathway.

Conditional. If participants receive reimbursement or compensation, describe the amounts, calculation, payment schedule and any conditions. Use the EudraLex participant-compensation template if useful. Portugal does not make that EU template mandatory. Avoid completion bonuses or payment structures that could pressure a participant to remain in the trial.

Folder Q: Fee evidence

Conditional. Portugal charges the applicable national clinical-trial fee unless an exemption applies. Since 2 December 2025, payment or exemption is handled through an electronic process after CTIS submission. The CTIS contact receives the relevant links by email. Follow the current CEIC and INFARMED instructions rather than uploading an unsupported payment document before the process is issued.

Folder R: Compliance with data-protection rules

Mandatory. Provide the sponsor statement that personal data will be handled in accordance with the General Data Protection Regulation and applicable Portuguese law. The EudraLex GDPR-compliance statement submitted in the CTIS Form section is acceptable for Portugal and does not need to be duplicated under Part II when it covers the Portuguese trial activities.

The statement is a sponsor declaration, not a participant-signed document. The PIS and ICF still need a clear privacy section covering controllers, purposes, data categories, legal basis, recipients, coded data, transfers, retention, rights and contacts.

Folder S: Compliance with rules for biological samples

Mandatory when biological samples are collected, stored or used. Submit the current EudraLex template on compliance with Member State rules for the collection, storage and future use of human biological samples. The MedEthicsEU Portugal overview identifies this EU template as mandatory. Complete the Portugal-specific information rather than uploading a generic statement.

State what is collected, why, where it is stored, whether it is coded or anonymized, how long it is kept, who may receive it and whether future use is optional. Genetic research, biobanks and use for a new purpose trigger additional Portuguese consent and governance rules. The Portugal secondary-use consent guide explains these distinctions.

Population-specific and use-case documents

Add the following only when they apply:

• Healthy volunteers: a Portuguese PIS and ICF that states there is no expected therapeutic benefit and clearly explains payment, restrictions and risk. Use the healthy volunteer consent guide.
• Minors: parent or representative information and consent, plus age-appropriate assent materials. Use the minor consent and assent guide.
• Adults unable to consent: participant information adapted to capacity and a legal-representative consent pathway. Use the limited-capacity guide.
• Emergency enrollment: an ethics-approved prior-consent exception and prompt subsequent-consent materials. Use the emergency enrollment guide.
• Participant unable to write: an impartial-witness process and signature field. Use the impartial witness guide.
• Pregnancy follow-up: separate materials for a pregnant participant and a pregnant partner when their data or records are collected. Use the pregnancy follow-up guide.
• Optional future use: a separate optional choice for secondary use of data or samples. Use the secondary-use consent guide.

Final submission checks

• Use Portuguese for all participant-facing material and the protocol synopsis.
• Use Portuguese or English for other dossier documents.
• Confirm every document title, version and date against CTIS.
• Submit signed investigator, interest, site and insurer declarations where required.
• Do not pre-sign blank participant consent forms.
• Keep site names, investigators, team functions and participant estimates consistent.
• Confirm that the site declaration includes pharmacy and investigational-product circuit information.
• Confirm that insurance covers every Portuguese site and applicable external facility.
• Use the current EudraLex recruitment procedure and biological-sample templates.
• Remove documents that are not required by the Clinical Trials Regulation or Portuguese guidance.

Return to the Portugal CTIS Part II guide hub for the full guide series.