The Clinical Pharmacology Service is organized into the following areas:

Clinical Trials Unit (CTU). This unit provides methodological support to researchers in tasks related to the sponsorship of clinical trials (RCTs) with drugs and medical groups, especially in multicenter clinical studies, to ensure regulatory compliance, GCP compliance and quality assurance. Its activity is dedicated to the design, coordination, monitoring, analysis and presentation of phase II-IV multicenter clinical trials in various fields, especially in infectious diseases, AIDS, neurology, cardiovascular, nephrology, gastroenterology, liver diseases, cancer and nutrition. In the last 20 years, it has participated in the management of more than 120 RCTs with medicines and medical groups that have signed up nearly 10,000 patients in Spain and other European countries. The Unit is part of the Spanish (SCReN) and European (ECRIN) research platforms.

IDIBAPS Medical Statistics Platform. The Medical Statistics platform, created in 2007, is an IDIBAPS platform that provides methodological and statistical support to the research projects of IDIBAPS and related institutions. Depending on the projects and availability, it also supports external, public and private entities. The main objective is the promotion of clinical research of excellence and facilitating the obtaining of resources.

The Research Ethics Committee (CEIm). This is a multidisciplinary group of people who, following the international recommendations on ethics in research and the legislation currently in force, have as their main function to ensure the protection of the rights, safety and well-being of the people who participate in clinical trials and research projects . For this reason, each year 850 projects and 400 amendments are evaluated and a total of 1,500 documentary records are collected (security reports, project status reports and results reports). It also offers advice and guidance to researchers on ethical, methodological, statistical and administrative issues.

The Technical Secretariat of the CEIM is integrated within the Technical Secretariat for Research Support (Medicine Area). Within its functions, it aims to offer advice and guidance to researchers on ethical, methodological, statistical and administrative issues.

Research projects are only accepted in electronic format through the Online Evaluation Request Form. It is available on the CEIM website: https://www.clinicbarcelona.org/ceim

On the CEIm website you can consult all the requirements and assessment fees. It is also possible to request the suitability management of facilities for clinical trials.

Pharmacovigilance Technical Committee (CT-FV): The mission of this committee is to ensure the safety of patients and contribute actively to European surveillance systems in the field of drug safety. After a first phase of initiation and consolidation and the creation of the CT-FV, more than 250 notifications of adverse drug reactions have been received and evaluated, and the system of detection, diagnosis, management, prevention and registration of RAMs has been improved throughout the Hospital with the formation of a multidisciplinary group that includes all care areas. The CT-FV has participated in more than twenty training actions aimed at HCB faculty and new residents.

The Service also participates in the following Working Groups:

• Content Quality and Security Working Group in Clinical History.Representatives of the Pharmacovigilance Group also participate in the Working Group on Content Quality and Safety in Clinical History to ensure that patient medical records meet the minimum quality requirements, especially with regard to the record of adverse drug reactions in their medical history, an essential part to prevent adverse events with medicines.