This unit provides technical and administrative support to the centre’s ethics committees. (Ethics Committee for Research involving medicinal products, ETHICS COMMITTEE ON ANIMAL EXPERIMENTATION and ETHICS COMMITTEE FOR HEALTH CARE) and is in charge of the entry process for the evaluation and implementation of research projects to be carried out at the Hospital Clínico San Carlos.
Mª Mar García Arenillas
ceic.hcsc@salud.madrid.orgLourdes Cabrera García
Berta Orellana Suárez
Elena Sánchez García
Mª Ángeles Torres Mora
4th North
Hospital Clínico San Carlos
C/ Profesor Martín Lagos s/n.
28040 Madrid
Information to patients on their participation in clinical trials: Information is provided, and questions are answered to potential participants in research projects who contact the unit for information on the clinical research process.
Counselling to IdISSC researchers on consultations carried out and for the drafting, execution, and implementation of research protocols: Providing assistance to researchers who request it on queries submitted in relation to the preparation of the protocol, the design of the study or the implementation of the study and counselling on documentation and the authorisation process for research projects to be carried out at IDISSC.
Counselling and consultancy for sponsors and start-up units external to IdISSC on consultations carried out and for the drafting, execution, and implementation of research protocols: To provide assistance and resolve queries on methodological, ethical and legal aspects of research projects that have been submitted or are to be submitted for evaluation by the Ethics Committee for Research involving medicinal products of the Hospital Clínico San Carlos.
Processing of entry, validation and administrative management of research projects carried out at the HOSPITAL CLÍNICO SAN CARLOS and outside the HOSPITAL CLÍNICO SAN CARLOS that are submitted for evaluation by the Ethics Committee for Research involving medicinal products: Processing of the entry process for the evaluation and implementation of research projects to be carried out at the Hospital Clínico San Carlos: Clinical Trials, Research Projects with Medical Devices, Observational Studies, Other research projects (Epidemiological, End-of-degree/Master’s Degree Projects, Theses, Surveys, etc.).
Processing of modifications to previously authorised research projects: Registration, evaluation and processing of reports corresponding to relevant amendments to projects previously authorised by the Ethics Committee for Research involving medicinal products of the Hospital Clínico San Carlos.
Monitoring of research projects: Processing of notifications of the start of the centre, closure of the centre, patients included, adverse reactions, annual follow-up reports and final report and results of projects previously authorised by the Ethics Committee for Research involving Medicinal Products of the Hospital Clínico San Carlos.
Processing of entry, validation and administrative management of research projects carried out at the HOSPITAL CLÍNICO SAN CARLOS that are submitted for evaluation by the ETHICS COMMITTEE ON ANIMAL EXPERIMENTATION: Processing of the entry process for the evaluation and implementation of pre-clinical research projects to be carried out at the Hospital Clínico San Carlos.
Administrative support to the Authorised Body of the Ethics Committee on Animal Experimentation: Processing of the entry process for the evaluation of pre-clinical research projects requesting evaluation by the Authorised Body of the Ethics Committee on Animal Experimentation.
Researchers from outside the HCSC linked to IDISSC:
Pharmaceutical industry
CRO and Commissioning Units
Foundations and other research groups
Any researcher, sponsor or start-up unit belonging to any centre in Spain and wishing to carry out a clinical research project that is evaluated by the Ethics Committee for Research involving medicinal products of the Hospital Clínico San Carlos.
The Biobank is attached to 2 external committees:
