Clinical Trial and Clinical Research Unit

Developed by: Instituto de Investigación Sanitaria del Hospital Ramón y Cajal (IRYCIS)

Description

Keywords:

Clinical trials, phase I studies, phase II, phase III clinical research protocols, CRD

Summary:

IRYCIS has a Clinical Trials and Clinical Research Unit (UCICEC) with the infrastructures and common services for the proper conduction of clinical trials and other clinical research studies.

Scientific Coordinator: Mª Angeles Gálvez Múgica, Clinical Pharmacology.

Contact: 91 336 8825, mariaangeles.galvez(ELIMINAR)@salud.madrid.org

The Clinical Trials Unit is ready for admission of patients or healthy volunteers. It can perform the following tests:

1. Phase I clinical trials: first study of drug administration in humans, pharmacokinetic (PK) and pharmacodynamic (PD) interactions studies with drugs or foods, studies evaluating biomarkers and pharmacogenetics, security drugs studies and bioequivalence.

2. Clinical Trials Phase II and III: monitoring in collaboration with researchers from hospital services. Examinations, tests, blood samples described in the study protocol.

3. Designing clinical research: studies requiring blood sampling or other tests that should be carried out under hospitalization, studies evaluating non-drug interventions as diagnostic products or therapeutic techniques.

4. Supporting the design of the protocol, CRDs and patient information sheets.

5. Submission to the Competent Authority and RECs.

6. Monitoring of clinical trials and observational studies.

7. Collaboration in the preparation of annual and final reports.

8. Pharmacovigilance activities: assessment and reporting serious adverse events if applicable.

9. Support in the publication of study results.

The UCICEC follow the rules and security measures of "Technical and health requirements of the units where early stage drug clinical trials are conducted in the Community of Madrid" and British ABPI Guide for Phase I studies and work according to Standards of Good Clinical Practice and Good Laboratory Practice. The Clinical Trials Unit Phase I has been certified by the General Office of Evaluation and Control of the Ministry of Health of the Community of Madrid.

The UCICEC is located at Ramón y Cajal Hospital, and has:

• Two wards with 4 beds / 8 recliners, with shots of medical gases, blood pressure monitors with centralized record heart rate, ECG, O2 saturation and temperature.

• Medical consultation: with equipment needed for full medical examination.

• Laboratory: sample processing and storage.

• Polyvalent room: meetings, patients / volunteers resting, conferences, television and Internet access.

• All Security facilities for patients / healthy volunteers: defibrillator, trolley stop, synchronized clocks, camera system continuous monitoring, central monitoring, backup files and control of temperature and system alarm in freezers and refrigerators.

Contact
Mª Ángeles Gálvez Múgica 
(Phone. /email): 91 336 88 25 // mgalvez.hrc@salud.madrid.org