Spain CTIS Part II Submission Guides

Choose the right Spain CTIS guide

• Spain CTIS Part II document checklist

  Use this guide to identify the Part II documents, accepted language, CTIS category, applicable Spanish template and signature requirement.

  Read the Spain CTIS Part II document checklist

• Spain patient information and informed consent requirements

  Start here when drafting the main Spanish Patient Information Sheet and Informed Consent Form, including AEMPS formatting, data protection and signature rules.

  Read the Spain patient information and informed consent requirements

• Spain patient-facing document QC checklist

  Use this before submission to compare Spanish participant documents with the protocol, consent logic, population coverage and AEMPS guidance.

  Read the Spain patient-facing document QC checklist

• Spain healthy volunteer consent requirements

  Use this for Phase I and other studies enrolling healthy volunteers, especially when compensation, inconvenience and lack of therapeutic benefit must be explained.

  Read the Spain healthy volunteer consent requirements

• Spain minor consent and assent requirements

  Use this to prepare parent or guardian consent and age-adapted documents for children and adolescents, including the Spanish rule for participants aged 12 or older.

  Read the Spain minor consent and assent requirements

• Spain limited-capacity participant and legal representative consent requirements

  Use this when an adult may need support to consent or a legally valid representative, family member or related person must provide consent.

  Read the Spain limited-capacity participant and legal representative consent requirements

• Spain emergency enrollment consent requirements

  Use this when the protocol proposes enrollment without prior consent in a medical emergency and later consent or ratification will be required.

  Read the Spain emergency enrollment consent requirements

• Spain impartial witness consent requirements

  Use this when a participant cannot read or write and the consent process must be witnessed by an impartial person who is unrelated to the study.

  Read the Spain impartial witness consent requirements

• Spain pregnancy follow-up consent requirements

  Use this for pregnancy outcome data from a trial participant or from the pregnant partner of a male participant, who requires a specific consent.

  Read the Spain pregnancy follow-up consent requirements

• Spain secondary and future use consent requirements

  Use this when data or biological samples may be used beyond the trial or drug development programme, stored after the trial or transferred for future research.

  Read the Spain secondary and future use consent requirements

The main Spain-specific differences

Spanish participant documents are not generic EU translations. AEMPS Annex VIIIA gives a national model for the Patient Information Sheet and Informed Consent Form. The combined document should not exceed 15 pages, including the consent form. It should use Arial or Times New Roman at 11 points or larger, line spacing of at least 1.5 and normal margins. Its personal-data appendix should not exceed two pages. The Spain patient information and consent guide explains the required content.

Spain has specific consent rules for minors. Parents or the legal representative consent first. A child younger than 12 must be heard when sufficiently mature. A participant aged 12 or older must also consent. One parent may sign when the other parent's express or tacit agreement is sufficiently documented. The Spain minor consent guide maps the document and signature logic.

Biological samples need their own check. Trial-purpose collection should follow the national PIS wording. Storage or future use after the trial must comply with Spanish biomedical-research and biobank rules. AEMPS Annex XIII is used in the Part II biological-sample section. The Spain secondary-use consent guide separates trial use from optional future use.

Spain also requires a financial budget and proof of insurance or an applicable alternative. The AEMPS insurance models cover standard trials, non-commercial trials and low-intervention trials. Site suitability is submitted for each site and is the Part II document that AEMPS expressly identifies as signed at submission.

Before a Spanish site can start

CTIS authorisation is not the only operational step. Before a Spanish site starts the trial, the sponsor needs the favourable CEIm opinion, the AEMPS authorisation decision, a signed contract with the site and activation of the site in the Spanish Clinical Studies Registry, REec.

Other language versions

Read this guide in Spanish.