The mission of the CNIC is to improve the health and cardiovascular well-being of citizens through research. The Clinical Trials Coordination Unit and Clinical Research with Medicines and Sanitary Products (CTCU) will be key to CNIC to reinforce its actions in clinical research in the cardiovascular area, particularly in clinical trials. The CTCU will provide transversal support to the clinical trials led by CNIC, and will participate in external initiatives with other clinical researchers in our country. The main objective is that the CNIC serves as an element that enhances the leadership of Spain in the field of clinical trials in the cardiovascular area.

CTCU SERVICES PORTFOLIO

The CTCU may participate in all actions that are required to carry out clinical trials, which include, but are not restricted to:

• Promotion of clinical trials considered strategic,
• Evaluation of the feasibility of the trial,
• Advice (and performance if applicable) of actions to be carried out prior to the start of the projects (evaluations by ethical committees and regulatory agencies, evaluation of the need to contract civil liability insurance, ...),
• Intermediation with ethical advice and assistance in the preparation of contracts with centers participating in the trial,
• Advice on registration and follow-up of the trial in international databases (eudraCT, clinicaltrials.gov, ...),
• Advice on creation and management of electronic data collection notebook (eCRF),
• On-site monitoring of the veracity of data entered in eCRF if applicable, as well as remote management of the eCRF,
• Data entry in eCRF if applicable,
• Centralized telephone monitoring,
• Intermediation with committees to validate the events of the trials,
• Database preparation and analysis, blind opening and preparation of the results report

MAIN CLINICAL PROJECTS MANAGED BY UCEC

For more information, click on the following link: https://www.cnic.es/en/investigacion/clinica