Clinical Trials Unit of the Clinical Pharmacology Department (CTU)
The Clinical Trials Unit of the Clinical Pharmacology Department (CTU) provides support for the design, organisation and conduct of clinical trials with medicinal products and medical devices. The CTU's objective is to collaborate with hospital researchers on the ethical, regulatory, methodological and logistical aspects they need so that studies are carried out in accordance with the required standards.
The CTU works in close coordination with the Spanish Platform of Clinical Research and Clinical Trials Units (SCReN) of the ISCIII, whose mission is to support the conduct of multicentre trials sponsored by national research groups and their integration into European projects through the European Clinical Research Infrastructure Network (ECRIN).
The Puerta de Hierro CTU has acted as national coordinator in Spain for publicly funded clinical trials (FP7, ISCIII, FIS, H2020) and provides support for clinical trials conducted in collaboration with the hospital's various clinical departments.
The CTU provides advice to researchers from the IIS Puerta de Hierro for the design and conduct of clinical research projects. For example, you can request:
1. Regulatory and ethical-legal support for clinical research projects
- Legal classification of the project, support for processing applications with the AEMPS, Committees and participating sites.
- Registration of the clinical trial in international databases (EudraCT, clinicaltrials.gov, ISCTR).
- Support for compliance with the LOPD and other applicable legislation depending on the project.
- Support for compliance with pharmacovigilance or medical device surveillance requirements.
2. Methodological and scientific support
- Support for study design: formulating the hypothesis, study design, choice of variables, population selection, sample size calculation, etc.
3. Support for conducting the clinical trial
- Trial management and coordination
- Study nursing
- Data collection
- Monitorización
- Farmacovigilancia, vigilancia de productos sanitarios y notificación de acontecimientos adversos
- Preparation of periodic or final reports
4. Phase I clinical trials unit. Pharmacokinetic and pharmacodynamic studies.
5. Support for incorporating projects into the Spanish Platform of Clinical Research and Clinical Trials Units (SCReN) or the European one (European Clinical Research Infrastructure Network, ECRIN).
- Essential support services for the design, planning and execution of national or European multicentre clinical research projects.
Clinical Pharmacology CTU
Head: Belén Ruiz Antorán (Specialist Physician, Clinical Pharmacology Department)
- Gustavo Adolfo Centeno Soto (Specialist Physician in Clinical Pharmacology, Unit Coordinator)
- Laura Vicente Izquierdo (Research Nurse)
- Silvia Paloma Rodríguez Araque (Clinical Trial Assistant CTA, Data Management
Contact:
- Tel: 91 191 6481
- Fax: 91 191 7650
- E-mail: farmacologia_clinica@idiphim.org
SCReN Platform for clinical trial support:
Head: Cristina Avendaño Solá (Specialist Physician, Clinical Pharmacology Department)
- Ana Velasco Iglesias (PhD in Biological Sciences. Project Management, Monitor)
- Sara Jerónimo Torre (Degree in Biological Sciences. Project Management, Monitor)
- Cristina Barcelona Soria (Degree in Biological Sciences. Project Management, Monitor)
- Lorena Gregorio (Grado en Farmacia. Monitor de ensayos clínicos y Farmacovigilancia)
- Carolina Mengotti Luna (Grado en CC Físicas. Diseño de CRD-RedCap y Análisis de datos)
Contact:
- Tel: 91 191 7867
- E-mail: scren@idiphim.org
- Consultations to Clinical Pharmacology by researchers from the IIS Puerta de Hierro: free of charge.
- Examples: legal classification of a project and guidance on regulatory aspects, guidance on study design or approach, assessment of incorporating a study into the national (SCReN) or European (ECRIN) support platform, preparation of a clinical trial budget.
- Tasks carried out by contracted staff, delegated by the sponsor or the research team: individual budget prepared according to workload and using established rates.
