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. 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. From January 31, 2022, European Union Clinical Trial Information System (EU CTIS) has become functional, and Clinical Trials Regulation (Regulation (EU) No 536/2014) is now applicable. EU CTIS will support both protocol registration and results posting activities for clinical trials conducted in EU/EEA.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| EU CTIS | Not Applicable | Competent authority, Sponsor | Clinical Trial Application |
Interventional (Phase 1-4) |
English |
| 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 CTIS | Registration |
Yes |
Prior to enrollment |
| Results |
Yes |
Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies) | |
| 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.
- Results will now be required to be posted on EU CTIS per Regulation (EU) No 536/2014.
Registry Updates
- March 2023: CTIS Newsflash - On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
- March 2023: CTIS Newsflash - On March 03, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
- February 2023: Clinical Trials Highlights - On February 20, 2023, EMA published the thirteenth issue of the Clinical Trials Highlights. All Clinical Trials Highlights updates are posted on the Development of the Clinical Trials Information System page. Starting from January 31, 2023, sponsors are required to submit their initial clinical trial applications through CTIS. EMA has resolved a considerable number of … Continue reading "February 2023: Clinical Trials Highlights"
References
- 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.
- 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.
- 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.
- Clinical Trials Regulation. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation#transition-period-for-clinical-trial-sponsors-section.
- Clinical Trials Information System: training and support. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support.