Clinical Studies Unit (CSU)

Clinical Studies Unit (CSU)

  • PRESENTATION
  • SERVICES
  • SPACES AND RESOURCES
  • RATES
  • TEAM MEMBERS
  • CONTACT

The Clinical Studies Unit (CSU) is a cross-cutting platform to support health research belonging to the Pere Virgili Institute for Health Research (IISPV). It manages and promotes biomedical research and is made available to all researchers, in the environment of the Health Institutions of Tarragona (800,000 inhabitants).

It includes the Joan XXIII University Hospitals (Tarragona) and Sant Joan (Reus), Pere Mata Institute Monographic University Hospital (Reus), Verge de la Cinta Hospital (Tortosa), Santa Tecla Tarragona Hospital) among others.

 

Unit management

Hospital Universitari Sant Joan (Reus): Dr Lluís Masana. Professor of Medicine. Director of Research of the HUSJR.

Hospital Universitari Joan XXIII: Dr Ricardo Closa. Professor of Pediatrics. Senior Consultant of Pediatrics HJ23.

The UEC offers services to researchers who want to carry out clinical research studies, in compliance with the legislation and rules of Bona Pràctica Clínica (BPC).

  1. Processing / Coordination-Management / Monitoring / Pharmacovigilance.

  2. Support in the elaboration of the scientific report in competitive calls for research.

  3. Advice on methodological and regulatory aspects of clinical research studies.

  4. Nursing support:

    • Research management activities and logistics support at the UEC.
    • Database preparation and management.
    • Care activity (Collaboration with the evaluation of patients, Collection of anthropometric data, Vital constants, Complementary tests (ECG).
    • Extraction of biological samples. Processing and handling of samples to send to biobank and central laboratories.
    • Data manager tasks. Trainings. Recruitment Systems (IWRS). Control of clinical study files and documents.
    • Management of spaces and equipment dedicated to research.
    • Support in monitoring activities.
    • Advice on methodological and regulatory aspects of clinical research studies.
  5. Administrative support:

    • Management from the beginning of the procedure until the signing of the clinical trial and study contracts.
    • Management of documentation permits and CEIM resolutions.
    • Billing Management of Clinical Trials and Studies.

The UEC has specific spaces and infrastructures at the University Hospital of Tarragona Joan XXIII (HJ23):

  • Nursing consultation
  • Consultation of long-term tests
  • Work Office
  • Monitoring area
  • Keep custody of closed files
  • Clinical Trials Start Classroom
  • BioBanc for the processing and storage of samples with centrifuges and freezer -80ºC
  • Pharmacy space
  • Kits and study files storage area

The UEC has specific spaces and infrastructures at the Sant Joan de Reus University Hospital (HUSJR):

  • In-house nursing consultation. Consult 83 yellow color (8.00h – 11.00h)
  • Own nursing office: from 11.00 IISPV
  • Monitoring and custody area of OPEN study files (classroom 6 teaching area)
  • Classroom teaching area for meetings to start clinical trials. Book in advance.
  • Area in hospital emergency laboratory to process samples and store them (centrifuge and freezer -80ºC)
  • Area to study medication storage pharmacy (refrigerator or environment as needed)
  • Passive archive area of the hospital for custody of closed files (floor -1)

The aim of the platforms is to provide a quality scientific, technical and methodological support service for internal and external researchers at the IISP.

Global coordination:

Dr. Ramon Bosch
Hospital Universitari Joan XXIII Tarragona.

Dr. Lluis Masana
Hospital Universitari Sant Joan Reus.

 

Clinical research support nursing:

Anna Varela
UEC Nursing Coordinator. Location and main activity at HUSJR.

Judit Borràs
UEC’s own nursing. Location and main activity in HJ23.

 

Administrative staff:

Elisabet Serralvo
Economic Management Unit

Neus Rodríguez
Project Unit, Pre-Award

Institut d’Investigació Sanitària Pere Virgili

Hospital Universitari Sant Joan de Reus
Planta 0. Secció de Color Taronja
Avda. Josep Laporte, 4
43204 Reus

A/e: anna.varela@iispv.cat

Parc Sanitari Joan XXIII
C/ Doctor Mallafrè Guasch, 4
43005 Tarragona

A/e: judit.borras@iispv.cat