Portugal CTIS Part II Guides

Choose the Portugal guide you need

1. Portugal CTIS Part II Document Checklist

   Use this guide to identify the required and conditional documents for CTIS folders K to S, including Portugal's site, pharmacy, insurance and financial documentation.

   https://trialagents.com/ctis/portugal/en/part-ii-document-checklist

2. Portugal Patient Information and Consent Requirements

   Start here when drafting the Portuguese Patient Information Sheet (PIS) and Informed Consent Form (ICF) for an adult participant.

   https://trialagents.com/ctis/portugal/en/patient-information-consent-requirements

3. Portugal Patient-Facing Document QC Checklist

   Use this final review before submission to check protocol consistency, consent choices, translations, data wording, versions and population coverage.

   https://trialagents.com/ctis/portugal/en/patient-facing-document-qc-checklist

4. Portugal Healthy Volunteer Consent Requirements

   Use this variation for trials involving healthy volunteers, especially when there is no prospect of therapeutic benefit and compensation is offered.

   https://trialagents.com/ctis/portugal/en/healthy-volunteer-consent-requirements

5. Portugal Minor Consent and Assent Requirements

   Use this guide for children and adolescents, including the Portuguese rules at ages 16 and 18 and the role of the legally authorized representative.

   https://trialagents.com/ctis/portugal/en/minor-consent-assent-requirements

6. Portugal Limited-Capacity and Legal Representative Consent Requirements

   Use this variation when an adult cannot provide informed consent and a legally authorized representative may need to act.

   https://trialagents.com/ctis/portugal/en/limited-capacity-legal-representative-consent-requirements

7. Portugal Emergency Enrollment Consent Requirements

   Use this guide only when the protocol proposes enrollment before prior consent in a serious and immediate clinical emergency.

   https://trialagents.com/ctis/portugal/en/emergency-enrollment-consent-requirements

8. Portugal Impartial Witness Consent Requirements

   Use this variation when a participant or representative can consent but cannot write, so an impartial witness must be present.

   https://trialagents.com/ctis/portugal/en/impartial-witness-consent-requirements

9. Portugal Pregnancy Follow-Up Consent Requirements

   Use this guide when a protocol collects pregnancy, birth or infant information from a participant or from a participant's pregnant partner.

   https://trialagents.com/ctis/portugal/en/pregnancy-follow-up-requirements

10. Portugal Secondary Use Consent Requirements

    Use this variation for optional future research with data or biological samples beyond the main trial purpose.

    https://trialagents.com/ctis/portugal/en/secondary-use-consent-requirements

Main Portugal differences

Portuguese participant documents

Participant-facing documents must normally be in Portuguese. This covers the PIS and ICF, assent forms, recruitment materials, patient cards, visit information, instructions, questionnaires and other materials a participant will read or use. The Portugal patient information and consent guide explains how to build the main document set.

CEIC review and national documentation

CEIC assesses Part II. Portugal's official checklist asks for each site's investigator documentation, a detailed site-conditions declaration, authorization for the service and study team, pharmacy and investigational-product circuit information, insurance evidence and financial documentation. These requirements are mapped in the Portugal Part II document checklist.

Consent for minors and emergencies

Portuguese law now states that participants aged 16 or 17 need assent as well as consent from their legally authorized representative. A capable child under 16 must also be asked for assent. Exceptional enrollment without prior consent is possible only when all emergency conditions in Portuguese law and the EU Regulation are met. The Portugal minor consent guide and Portugal emergency enrollment guide explain the separate pathways.

Insurance and post-trial treatment

The sponsor must normally hold civil-liability insurance appropriate to the trial risk. A specific policy may be waived by CEIC for a low-intervention trial only when existing liability insurance covers the statutory damage. Portuguese law also requires free continuation of the trial medicine after participation when the investigator considers it indispensable and there is no comparably effective and safe alternative. This needs to be reflected consistently in the participant information and financial arrangements.

Data and biological samples

Portugal accepts the GDPR compliance statement used in the CTIS Form section for the Part II data-protection requirement. The EudraLex biological-sample compliance template is required for the applicable sample pathway. Optional future research needs clear separation from main-trial consent, especially when identifiable samples, genetic information or a biobank are involved. The Portugal secondary-use consent guide explains the national rules.

Other language versions

This package contains the English pages only. Link the Portuguese-language hub here after the localized guide set has been published. Do not point readers to an unpublished language version.