Functions
The Central Clinical Research and Clinical Trials Unit (UICEC Sant Pau) provides comprehensive support to researchers in the development of independent research projects (not sponsored by the pharmaceutical industry) on the methodological, regulatory, administrative, economic and practical aspects, subject to compliance with the ethical, good clinical practice and legislation.
UICEC Sant Pau is part of the Spanish Clinical Research Network (SCReN), a functional organization network to support the conduction of multi-center clinical trials and participates in the SCReN Platform (Spanish Clinical Research Network ISCIII)
Knowledge management
- One-stop information for independent research group projects.
- Comprehensive assessment and project coordination.
- Point of communication between researchers and technical units.
- Pharmacovigilance activities for trials including drugs or medical devices.
- Knowledge management::
- Study of dimensionality and feasibility of projects.
- Identification of each project needs.
- Advice on the preparation of documentation: protocol, annexes, monitoring report, final report.
- Advice on the submission of documentation to Spanish Agency for Medicines and Medical Devices (AEMPS), Clinical Research Ethics Committee (CEIC), Autonomous Communities (CCAA) and other relevant authorities.
- Advice on project registration in public databases.
- Identification of spinoff projects.
- Advice on the presentation of research results..
Methodological and statistical support unit
- Advice on study design.
- Data entry.
- Data processing.
- Development of statistical reports.
- Electronic CRFs validation and management.
- Documentation and reports.
Documentation, archiving, monitoring and follow-up unit
- Support in document creation: EudraCT form and annexes / application forms / evaluation forms follow form.
- Support in the processing of initial applications, clarifications and amendments: AEMPS, CEIC, other health authorities regarding clinical trials, and other post-authorization studies.
- Comprehensive monitoring of clinical trials and observational studies.
- Management of initial, follow-up and final reports.
- Development and file custody promoter (Master File), file preparation investigator.
- Other communications to CEIC, autonomous communities and competent authorities.
Unit of management and financial management
- Management of clinical trials contracts with participating centers.
- Management of collaboration agreements with laboratories / companies for funding.
- Management of clinical trial-related contracts (CRO’s, E-CRDs, statistics, etc.). Management of clinical trial-related client and supplier invoices.
- Management of clinical trial insurance policies.
- Preparation of financial reports for the submission of studies to ethics committees.
- Management of payment of fees to the competent authorities.
