Spain CTIS Part II Document Checklist

Recruitment arrangements

Mandatory information. Describe how potential participants will be identified and approached, including the first act of recruitment. Upload the information in CTIS under “Recruitment arrangements,” corresponding to section K of Annex I to the Clinical Trials Regulation. The procedure may be in Spanish or English and is not signed at submission. The European recruitment and informed-consent procedure template is accepted. EudraLex highly recommends its new version 2.0 during the current transition and states that full implementation begins on 1 September 2026.

Conditional document. A separate recruitment-procedure document is not needed when the protocol fully describes the process, but the cover letter should identify where that information appears. If advertising, letters, telephone scripts, posters, websites, social media or other recruitment materials will be used, submit each proposed item and explain how and where it will be used. Participant-facing recruitment material for use in Spain should be prepared in Spanish. It is submitted as a blank approved version, not signed.

Participant information and informed consent

Mandatory. Submit every Spanish Patient Information Sheet and Informed Consent Form needed for the trial under “Subject information and informed consent form,” section L. This includes the main study document and separate versions for relevant populations, substudies or optional activities. Use clear descriptive titles with version and date.

These are blank forms at CTIS submission. The participant, parent, representative, witness and investigator sign only when consent is obtained. AEMPS Annex VIIIA is the national model. AEMPS Annex VIIIB provides text for biological samples. The Spain patient information and informed consent guide explains the main document, and the Spain minor consent guide covers child and parent versions.

Conditional. Add distinct consent materials when the trial includes adults unable to consent, emergency enrollment, an impartial-witness process, pregnancy follow-up for a participant's partner, optional substudies or secondary use. Do not hide independent choices inside one general acceptance statement. The Spain patient-facing document QC checklist helps test whether every population and pathway is covered.

Principal investigator suitability

Mandatory for each principal investigator. Upload a current curriculum vitae in the CTIS “Investigator CV” subsection. The European CV template is accepted. The CV may be in Spanish or English, should show suitable clinical-trial and Good Clinical Practice experience and must have been updated within the previous two years. AEMPS does not require the EU trial number in the CV and its CTIS table does not require a signature at submission.

Mandatory even when no conflict exists. Upload a Declaration of Interest in the CTIS “Suitability of the investigator” subsection. Use the European declaration template. It may be in Spanish or English, must have been updated within the previous year and should state either the relevant interests or that none exist. The AEMPS CTIS table does not require a signature at submission.

Site suitability

Mandatory for each site. Upload one site-suitability statement under the applicable CTIS facility and site-suitability fields, corresponding to M64 and N. Spain accepts the European site-suitability form or AEMPS Annex IV in Spanish or English.

This document is signed at submission by the director of the healthcare site or institution, or a delegated person. It should identify the trial, department, site, planned participant number and any collaborating departments, and confirm that the site has the required staff, equipment, facilities and expertise.

Insurance or financial guarantee

Mandatory for trials other than low-intervention trials. Upload proof of insurance or an equivalent financial guarantee under section O. The document must be in Spanish. AEMPS Annex VA is the standard insurance-certificate model. It lists each participating site and principal investigator and reflects the Spanish statutory coverage limits.

The AEMPS insurance models contain a signature line for the insurer, sponsor or site representative. Submit the completed, executed certificate or commitment. A separate CTIS electronic signature is not required.

Conditional for policies with problematic exclusions. A CEIm may accept the additional sponsor responsibility commitment in AEMPS Annex VB when an international policy contains exclusions that may not meet Spanish coverage rules. Acceptance is for the CEIm to decide.

Conditional for non-commercial clinical research. A qualifying non-commercial sponsor may initially submit the signed commitment in AEMPS Annex VI. The insurance certificate must then be provided within 30 calendar days. The trial cannot start until the CEIm confirms that the required insurance or guarantee is in place.

Conditional for low-intervention trials. A trial-specific policy is not required when the site's professional civil-liability coverage protects against trial-related harm. Submit the signed certificate from the site or organisation representative using AEMPS Annex VII. If the sponsor buys a specific trial policy instead, submit Annex VA.

Financial and other arrangements

Mandatory. Submit one financial budget for the trial under section P. It may be in Spanish or English and does not need to be signed at CTIS submission. Spain accepts a single budget with variable site amounts or the set of individual site budgets.

The budget should cover the cost of additional tests, cost per visit and recruited participant, indirect and administrative costs to be specified in site contracts, free supply of the investigational medicinal products, any additional participant cost and all planned participant and investigator compensation. The amount, nature and payment procedure for participant compensation must be clear.

Conditional. The European compensation-for-participants template may be used when helpful, but it does not replace the Spanish financial budget. Site contracts are required before site initiation but are not submitted as Part II documents.

Data-protection information

Mandatory within the participant information. Include the AEMPS Annex VIIIA personal-data appendix in the Spanish participant document. Upload it only under “Subject information and informed consent form.” Do not duplicate it as a separate national data-protection document.

The CTIS Form also includes the EU statement of compliance with Regulation (EU) 2016/679. That statement sits outside the Part II document placeholders but remains part of the application. The participant appendix must identify the sponsor and site roles, processing purposes, confidentiality protections, retention, rights, contacts, sharing and international transfers where applicable.

Biological samples

Conditional. When the trial collects new samples, uses archived material, stores samples or plans future use, complete the Part II biological-sample information. Spain accepts AEMPS Annex XIII in Spanish or English. It does not need a signature at submission.

Describe the samples, quantities, collection procedures, responsible entity, analysis and storage locations, retention, coding, access, transfers, future use, recontact and handling of findings. The matching Spanish participant text should follow AEMPS Annex VIIIB. Optional future use needs separate consent logic. The Spain secondary and future use guide explains the difference between trial use and later research.

Application support items outside the Part II placeholders

Mandatory. Identify the agreed assessing CEIm in the cover letter. Before submission, contact a CEIm that participates in CTIS work and confirm that it is available on the proposed dates.

Mandatory unless exempt. Upload proof of the AEMPS assessment fee in the CTIS Form. A sponsor claiming the non-commercial exemption described by AEMPS should upload the required signed declaration instead. The selected CEIm must be identified during fee payment.

Final document check before submission

Confirm that every document has a stable descriptive CTIS title, the correct version and date, and the correct country placement. Confirm that Spanish participant documents match the protocol and are not signed in advance. Confirm that every site has its own signed suitability form and appears on the applicable insurance document.

Use the Spain CTIS Part II guide hub to open the population-specific drafting guides before final QC.