Clinical Research Support Unit (USIC)

To this end, it has a multidisciplinary team of professionals with experience in the comprehensive management of clinical studies and an infrastructure equipped with facilities to support clinical research:

• Fully equipped medical offices.
• Reception and waiting room for participants and family members.
• In-house laboratory equipped with all the necessary equipment for processing biological samples.
• Pharmacy for clinical trials.
• Ambient medication storage room with restricted access and controlled temperature.
• Refrigeration equipment room with monitored alarm systems and centralised temperature control.
• Stores for consumables and materials.
• Meeting area available for monitoring clinical trials and/or external audits.
• Archive of active clinical trials.
• External archive for the custody of documentation in accordance with current regulations.
• Offices for trial coordination.

Services

The mission of the Clinical Research Support Unit is to provide efficient support and advice to researchers at our centres for the conduct and development of clinical studies, providing specialisation, experience and knowledge.

To achieve this objective, the Unit has a portfolio of services adapted to each study based on the needs of the researchers.

• METHODOLOGICAL SUPPORT
  • Design and drafting of all the documentation necessary for the study (protocol, data collection notebook (CRD), informed consent, etc.).
  • Design and management of the electronic CRD (REDCap).
• MONITORING
  • Preparation of the monitoring plan adapted to the risk assessment.
  • Monitoring of all sites participating in multicentre studies.
  • Preparation, development and reporting of site visit reports.
  • Database review and verification of source documents.
  • Preparation and maintenance of necessary files: investigator, sponsor, pharmacy.
• DATA MANAGEMENT
  • Recording of data in source document and CRD.
  • Query management.
  • Recording and updating of study information to different platforms.
• ADMINISTRATIVE / REGULATORY MANAGEMENT
  • Management of contracts with participating centres.
  • Management of requests, clarifications, amendments and notifications to IRB/IEC and regulatory agencies.
  • Application for civil liability insurance policy.
• COORDINATION AND NURSING
  • Participate in the selection of the centre and the research team.
  • Participate in the evaluation of the feasibility of the study.
  • Analysis of the technical, space and personnel circuits and needs of each clinical trial.
  • Conducting meetings with investigators.
  • Facilitating the communication of the medical services involved in the study and external stakeholders.
  • Maintaining necessary files: investigator, sponsor, pharmacy.
  • Facilitating the recruitment and informed consent process
  • Control and management of nursing procedures and complementary tests.
  • Coordination of follow-up visits and controls.
  • Comprehensive patient care support.
  • Pharmacovigilance: management of adverse events.
  • Management of possible audits.
  • Custody of clinical trial documentation.
  • Contact with monitors and preparation of documentation for external monitoring.
• LABORATORY TECHNICIAN
  • Processing of biological samples and management of their shipment to the central laboratory.
• PHARMACY
  • Management and preparation of study medication.

Who we are

The professional team of the Clinical Research Support Unit is a functional unit made up of specialised professionals accredited in Good Clinical Practice Standards who carry out the following tasks: study coordinator, study nurse, data manager, CTA, monitor, sample processing and pharmacy.

All the staff have experience in a wide variety of clinical research protocols in different medical areas, which allows them to understand the needs of each research team, adapting the services to the procedures set out in the protocol