Clinical Trials Support Unit
- Presentation
- Services
- Contact
The Clinical Trials Support Unit (USAC) is created for the purpose of promoting and facilitating clinical research at the institution.
In order to carry out this objective, the USAC is made up of a team of professionals in charge of carrying out the clinical trials: study coordinators, nursing staff, data managers and administrative staff. In a coordinated way they are responsible for logistics, coordination, data management and all those activities to launch a study until its completion.
The purpose of this joint work is to launch the study as soon as possible, ensuring the quality and reliability of the data obtained in the study and comply with the agreements with the promoters.
The services provided by the USAC are:
Start-up (start-up)
- Review of the economic report and the protocol
- Contact with promoters, sending the initial documentation.
- Support in the process of feasibility
- Pre-study visit
- Suitability of the facilities
- Monitoring the signing of contracts
- Support in the presentation of the study to the local CEI
- Schedule of the start visit
- Receipt of study material
Study coordination
- Initiation and monitoring visits
- Management and monitoring of the study in coordination with the promoters of the study
- Coordination of communication to all staff and services involved in the study
- From Training
- Update of study databases
- Preparation, realization and follow-up of patient visits
- Medication management
- Management of the collection and processing of biological samples
- Resolution of queries
- Reporting and Monitoring of Serious Adverse Events (SAEs) and Special Interest Events (AESI)
- Billing
- Source document file
Closing of the study
- Closing visit
- Billing review
- Obtaining the closing documentation
- Study documentation file
- Attention to audits and inspections
Clinical Trials Support Unit
Santi Esteva Gras
Head of the Clinical Trials Support Unit
Parc Taulí Research and Innovation Institute
USAC, Parc Taulí, 1
Taulí Building, floor -1
08208 Sabadell
- 93 723 66 73