Spain

Spain

Spanish Registry of Clinical Studies (REec)

Verified on September 9, 2021

The Spanish Registry of Clinical Studies (REec) is not a World Health Organization (WHO) recognized primary registry but has provisions for reporting both the protocol registrations and results summary. All Phase 1-4 interventional and observational trial registration and results posting are required on REec as per Articles 47 and 48 of Royal Decree 1090/2015, of December 4. For Interventional studies, the results summary can be shared as Clinical Study Report (CSR) synopsis or as a PDF of results posting from EudraCT. The Royal Decree 957/2020, of November 3 regulates observational studies with medicines (EOm) for human use and registration, results submission is mandatory for prospective follow-up studies and is voluntary for other studies

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
EU CTR EU CTR via Clinical Trial Applications Competent authority Clinical Trial Application

Interventional

(Phase 1-4)
Spanish (only specific sections)
English
REec Mandatory National Database (includes Ethics Requirement) Sponsor Clinical Trial Application

Interventional

(Phase 1-4);

Observational

(studies with prospective follow-up drugs)
Spanish
English
EU PAS EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) Sponsor Through a dedicated registration platform (process independent from clinical trial application) Post-authorization Safety Efficacy Studies English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
EU CTR Registration

Yes

Prior to Enrollment
Results

Yes

Within 12 months of Study Completion (Non-paediatric Studies) Within 6 months of Study Completion (Paediatric Studies)
REec Registration

Yes

Interventional: Maximum of 14 calendar days from authorisation to register in the REec, but prior to first subject enrollment; Observational: Maximum 15 working days from the start date of the study
Results

Yes

Interventional: Within 6 months of the trial completion (for paediatric trial), Within 12 months of the trial completion (for adult trial); Observational: Within 12 months from study completion or within 30 working days from the date of publication of the same in scientific journals or other media, whichever is earlier
EU PAS Registration

Yes

Before Data Collection
Results

Yes

Within 12 months of End of Data Collection

Other Mandatory Requirements


  • A Clinical Trial Application (CTA) is required to be submitted to the EudraCT by the sponsor via AEMPS.
  • Results are required to be posted on EudraCT per European Directive 2001/20/EC.

Registry Updates


  • September 2021: EU CTIS Webinar - European Medicines Agency updated about the upcoming Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on September 10, 2021: The webinar will be conducted on November 29, 2021, for the small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials. The agenda of the … Continue reading "September 2021: EU CTIS Webinar"
  • September 2021: CTIS Training Update - European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021. The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial … Continue reading "September 2021: CTIS Training Update"
  • September 2021: CTIS Training Updates - European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and … Continue reading "September 2021: CTIS Training Updates"

References


  1. Annex of Royal Decree. Spanish Agency of Medicines and Medical Devices. https://www.aemps.gob.es/legislacion/espana/investigacionClinica/docs/Royal-Decree-1090-2015_4-December.pdf. Published 2015. Accessed September 10, 2018.
  2. Instruction document of the Spanish Agency of Medicines and Medical Devices for conducting clinical trials in Spain. https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/Instrucciones-realizacion-ensayos-clinicos-EN.pdf. Published April 24, 2018. Accessed November 11, 2019.
  3. Royal Decree 1090/2015, of December 4, which regulates clinical trials with medications, the Ethics Committees for Drug Research and the Spanish Registry of Clinical Studies. http://noticias.juridicas.com/base_datos/Admin/565124-rd-1090-2015-de-4-dic-regula-los-ensayos-clinicos-con-medicamentos-los-comites.html#a47. Published December 24, 2015. Accessed November 11, 2019.