Aims: The aim of the course is the learning of principal characteristics of a proper Quality System applied to clinical studies, so that it can guarantee the trustability of data as requested by the Good Clinical Practices.
The course is organized into two modules
Clinical Monitoring
Teacher: Martina Gravina
“The objective of this Course is to learn the main topics about clinical trials monitoring of drugs such as different types of visits on trial site (site selection visit, site initiation visit, monitoring ongoing visit, close out visit) and related activities, as preparation and Follow up of the visit and final monitoring report. Furthermore, during the Course, new risk – based approach to monitoring (centralized/remote monitoring) will be illustrated.”
Program:
General context
• From feasibility to Site Initiation Visit (SIV)
• Site Initiation Visit – General activities
• Site Initiation Visit – Training for trial staff – Study Protocol
• Site Initiation Visit – Training for trial staff – Safety management
• Site Initiation Visit – Training for trial staff – Case Report Form (CRF)
• Site Initiation Visit – Training for trial staff – Investigator Study File (ISF) • Site Initiation Visit – Training for trial staff – Informed Consent
• Monitoring Ongoing Visit (MOV) – General activities
• Monitoring Ongoing Visit (MOV) – Source Data Verification (SDV)
• Close Out Visit (COV)
• Risk Based Monitoring
• Monitoring reports
Clinical Research quality management
Teacher: Annamaria Paparella
General overview of main Quality requirements, with particular reference to ISO. Quality in Pharmaceutics; Risk Based Approach. Good x Practices (GxP); introduction to Good Clinical Practices (GCP). Quality at the Sponsor; Quality Assurance and Quality Control. Organization and Training of GCP personnel. Documentation System; selection of a Contract Research Organization (CRO). Data Quality; Data integrity. Handling of Quality events; management of Corrective and Preventive Actions (CAPA). Audit activities. Managing of inspections. Quality in handling of an Investigational Medicinal Product. Quality tollerance limits and risks indicators in clinical trials .
Suggested textbooks Materials provided by the teachers
