Spain CTIS Part II Patient Information and Consent Requirements

What the Spanish PIS/ICF must do

The PIS should let a potential participant understand why they are being invited, what will happen, which risks and burdens are added by the trial and what choices they have. The ICF records the decision without repeating the whole information sheet.

The document must match the protocol, Investigator's Brochure and other participant materials. A technical statement may be correct but still unacceptable if a participant cannot understand it. Explain trial concepts in ordinary language. For example, explain random allocation and placebo instead of relying on those terms alone.

Spanish language and document design

Mandatory. Submit the participant-facing PIS/ICF in Spanish. AEMPS states that Part II documents addressed to trial participants and assessed by the CEIm must be written only in Spanish. If a participant needs another language, the sponsor is responsible for providing an accurate translation. Those additional translations do not need to be submitted to the CEIm under the national instruction.

Recommended by AEMPS. Keep the model document to no more than 15 pages, including the ICF. Use Arial or Times New Roman at 11 points or larger, line spacing of at least 1.5 and normal margins. The personal-data appendix should not exceed two pages and follows the same minimum font and spacing rules.

Use headings, short paragraphs and a simple visit schedule where it helps. Do not paste the protocol schedule into the PIS. AEMPS recommends a simpler patient-facing table and advises against repeating routine details or the same discomfort under several sections.

Identification and introduction

Mandatory. Identify the study title, study code, EU trial number, sponsor, principal investigator and site. AEMPS allows the principal investigator and site fields to remain blank in the model so each site can complete them before use.

The introduction should state that participation is being offered in a research study, that the study has received the required CEIm and AEMPS review, and that the person should read the information, ask questions and consult others if desired.

Voluntary participation and withdrawal

Explain why the person is being invited. State that participation is voluntary, refusal will not affect care and consent can be withdrawn at any time without penalty or loss of the normal relationship with the treating team.

Do not make a signed revocation form a condition for withdrawal. AEMPS states that signing a withdrawal document is not mandatory. If the protocol includes such a form, the PIS and the form should say clearly that withdrawal remains valid without signing it.

Explain what happens to data and samples after withdrawal. Data already collected may need to be retained and used to preserve trial validity and meet legal duties. Under Spanish clinical-trial rules, data and samples obtained under the withdrawn consent should not be used in later analyses or studies after the withdrawal date unless another lawful route or new consent applies. The wording must distinguish leaving trial visits, withdrawing trial consent and withdrawing optional future-use consent.

Study purpose, design and activities

Describe the main study question in plain language. Avoid a full inclusion and exclusion list. Explain the intended population, total planned participant number, study treatments, treatment groups and the chance of receiving each option. Where applicable, explain random assignment, blinding and placebo in simple terms.

State the total participation period and separate treatment from follow-up. Give the number and frequency of visits, tests and procedures. Make clear which activities are part of normal care and which are added by research. Explain any home activities, digital tools, travel to another site or access to medical records.

If the study has an optional substudy open to all participants, it may be described in a separate section of the main PIS with a clear yes or no choice. If only a defined subpopulation will be invited, AEMPS advises a separate information and consent document.

Risks, burdens and participant responsibilities

State whether the study medicine is authorised and whether its use is within the authorised indication. Summarise the most frequent and most serious known risks in language a participant can understand. State that unknown risks may exist. Describe added risks and discomforts from procedures such as biopsies, imaging, extra blood collection or extended visits.

Explain participant responsibilities, including attending study activities, reporting adverse events and medication changes, and consulting the study doctor before changing medicines or herbal products except in an emergency.

Benefits and alternatives

Describe expected direct benefit only when supported. State that the participant may receive no health benefit. AEMPS says that free medicine, test results and closer follow-up should not be presented as benefits of participation.

List the main effective treatment alternatives, including the option of not joining. If the same medicine may be available in normal care, say so. The investigator can offer further detail, but the PIS should still give a short useful summary.

Pregnancy, contraception and breastfeeding

When participants or their partners could become pregnant, add a specific section on pregnancy and breastfeeding. Explain known fetal risks or state that they are unknown. Describe protocol-required contraception without adding requirements that are absent from the protocol.

Tell participants to inform the investigator promptly about pregnancy. Explain what pregnancy and infant data will be collected and for how long. When the pregnant person is the partner of a male trial participant, AEMPS requires a specific consent from that partner. The Spain pregnancy follow-up guide explains the separate document pathway.

Biological samples and optional research

Describe every sample, collection procedure, quantity, purpose, coding method, analysis location, storage period and transfer that affects the participant. State whether a biopsy or other collection is mandatory or optional and explain its risks.

AEMPS Annex VIIIB provides paragraphs for trial-purpose samples and excess samples. Samples remaining after the trial are destroyed unless the participant agrees to storage and future research. Future use should identify the applicable Spanish biobank, collection or foreign repository route and give a separate yes or no choice. The Spain secondary and future use guide covers the consent and withdrawal rules.

Data protection

Include the AEMPS Annex VIIIA Appendix 1 as part of the Spanish participant document. It should identify the sponsor and site and explain their respective processing roles. The site retains identifying medical-record information. The sponsor normally receives coded or pseudonymised study data.

Explain the legal basis and purposes, confidentiality, who may access identifiable information, retention, rights and limitations, data-protection contacts, result publication, data sharing and transfers outside the European Economic Area. Describe outsourced activities that require direct participant data, such as travel or reimbursement services, by purpose. AEMPS does not require the names of each service company.

Do not describe trial data processing that is legally required for the study as if it depended entirely on an optional GDPR consent. Optional future data uses beyond the drug development programme or unrelated disease area need their own choice.

Costs, compensation, insurance and treatment after the trial

State that the participant will not pay for study medicines or trial-specific tests and should not incur added costs beyond normal care. Explain reimbursement and any compensation, including the amount or calculation, payment method and proportional payment when participation ends early. AEMPS advises participants that compensation is treated as income for Spanish tax purposes.

When trial-specific insurance applies, explain that the sponsor has cover meeting Royal Decree 1090/2015 and how the participant can obtain more information. Explain whether and under what conditions the study treatment may remain available after participation ends.

Contacts and new information

Give the study doctor's name, service, telephone number, availability and any site contact for participation questions. Direct urgent medical issues to the appropriate usual or emergency care route. Tell participants to disclose trial participation when receiving care elsewhere and to carry any trial card provided.

State that new information that could affect willingness to continue will be communicated promptly. Explain the circumstances in which the sponsor or investigator may stop participation and what follow-up may continue if visits stop without consent being withdrawn.

Consent and signature structure

At CTIS submission. Upload a blank Spanish ICF. No participant or investigator signs the form before submission.

When consent is obtained. The participant and investigator sign and date the ICF. The participant should receive the PIS and a signed and dated copy of the ICF. AEMPS asks for handwritten name, signature and date in its model. The consent form should confirm that the participant read the PIS and data-protection appendix, could ask questions, received enough information, understood voluntariness and agrees to participate.

Use separate signature logic when another person gives consent or witnesses the process. The Spain limited-capacity and legal representative guide covers adults unable to consent. The Spain impartial witness guide covers participants unable to read or write.

Population and use-case variations

The standard adult PIS/ICF is only the starting point. Prepare the variation that matches the protocol:

• Healthy volunteer consent in Spain for trials without expected therapeutic benefit.
• Minor consent and assent in Spain for parent consent and age-adapted child or adolescent documents.
• Emergency enrollment consent in Spain when prior consent cannot be obtained under the approved emergency pathway.

Use the Spain CTIS guide hub to review the full country document set around the participant form.