Alla fine del corso gli studenti avranno le conoscenze di base sia teoriche che pratiche per comprendere e implementare attività di ricerca clinica. Il corso è inteso in particolare per formare personale coinvolto in tutti gli aspetti della ricerca clinica come study coordinators, data managers, e clinical research associate.
Prerequisiti
Ottima conoscenza della linga inglese
Metodi didattici
Il corso è organizzato in: lezioni frontali, svolte con presentazioni (PowerPoint proiettate su Schermo) tramite le quali il discente acquisirà le nozioni teoriche necessarie per comprendere i principi di base della ricerca clinica.
Verifica Apprendimento
Esame scritto con domande a risposta multipla (tipicamente il primo appello dell'anno) o esame orale.
Testi
Lessons from a Horse Named Jim: A Clinical Trials Manual from the Duke Clinical Research Institute. AUthor: by Margaret B. Liu, Kate Davis
Contenuti
The course has a strong focus on clinical research and intend to provide not only the theoretical basis to understand, operate, and design clinical research but also to bridge the theory to practice bridge. The course is specifically intended to train personnel involved in clinical research operations, such as academic study coordinators, data managers, and clinical research associate.
Founding Principles of Clinical Research o The ABC of Clinical Research o Key Personnel involved in Clinical Research o Interactive Discussions and Practical Example
Basic Methodology of Clinical Research
o Statistical and Methodological Principles o Interactive Discussions and Practical Example
Clinical Research Operations: Data Management
o Study Coordinator’s roles o Data Management and relevance of Data Quality o Data Structure and reporting: The Case Report Form
Clinical Research Operations: Monitoring
o GCP o Principle of Monitoring o The Role of The Monitor (CRA, Clinical Research Associate) o Monitoring Profit and non-Prof RCTs
Clinical Research Operations: Safety Reporting
o Safety Desk & Pharmacovigilance o Adverse Event Assessment and Reporting