Clinical Research Support Unit (USIC)

Services

The USIC provides a portfolio of services tailored to each study according to the needs of investigators:

Methodological Support

• Design and drafting of all necessary/essential documentation for the study (Protocol, Case Report Form (CRF), Informed Consent Form, etc.).
• Design and management of electronic CRFs (REDCap).

Monitoring

• Development of a monitoring plan adapted to risk assessment.
• Monitoring at all participating sites in multicentre studies.
• Preparation, conduct and reporting of site visits.
• Review of databases and verification of source documents.
• Preparation and management of study files for investigators, sponsors and pharmacies.

Data Management

• Data entry into source documents and CRFs.
• Query management.
• Registration and updating of study information across different platforms.

Administrative Management / Regulatory Affairs

• Management of contracts with participating centres.
• Management of requests, clarifications, amendments and notifications to the CEIm and regulatory authorities.
• Arrangement of civil liability insurance policies.

Coordination and Nursing

• Participation in the selection of study sites and research teams.
• Participation in the assessment of study feasibility.
• Analysis of workflows and technical, space and staffing requirements for each clinical trial.
• Conducting meetings with investigators.
• Facilitating communication between medical services and external parties involved in the study.
• Maintaining essential study files at the site: investigator, sponsor and pharmacy files.
• Facilitating patient recruitment and the informed consent process.
• Oversight and management of nursing procedures and complementary tests.
• Coordination of study visits and follow-up assessments.
• Comprehensive support in patient care.
• Pharmacovigilance: management of adverse events.
• Management of potential audits.
• Maintenance and custody of clinical trial documentation.
• Liaison with monitors and preparation of documentation for external monitoring.

Laboratory Technician

• Processing of biological samples and management of their shipment to the central laboratory.