Spain

DCT Feasibility Assessment Spain The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Spain in relation to Decentralized Clinical Trials (“ DCT ”). It supplements the regulations and guidance applicable to the EU and EEA described in t...

2.1 Name of Regulatory Authority "Spanish Agency for Medicines and Medical Devices / Agencia Española de Medicamentos y Productos Sanitarios (“AEMPS”)" The AEMPS is the Spanish competent authority in charge of ensuring the quality, safety, eff...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.  A list of all documents required to be submitted is provided by the EU CTR 536/2014 in ...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  Under the EU CTR, the initial application for a clinical trial is divided into two parts: ...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   Yes , the investigator must be a doctor. See Art. 41.2, the Spanish RD 1090/2015 : “ 2. Only a doctor or a person practicing a r...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. The rules relating to the export of biological shipment are covered in the Royal Decree 65/2006, of January 30, which establishes requirements fo...

Section 13.1.3 “Trial Monitoring”, under section 13.1 “Decentralized Elements in Spain” within the AEMPS Instruction Document , provides the following information: “Remote verification of source data shall be considered for all ongoing clinical t...

8.1 What data privacy and/or technology regulations need to be complied with in order to run a trial in the countries of interest?   Primarily, the GDPR needs to be adhered to. The EU GDPR has been adopted in Spain through the Organic Law 3...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them  (including the language/claims used and whether or not the mention of open-...

10.1 Clinical Trial with Investigational Medicinal Product The submission process using CTIS is described in more detail below this flow chart/roadmap: Training is to be prioritized for relevant staff in Spain on the use of the Clinical Tri...

European Union (EU) EU Clinical Trials Regulation No. 536/2014 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131   Official Website of European Medicines Agency (EMA) https://www.ema.europa.eu/en/huma...

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