Clinical Data Quality Management

Course ID
6 CFU (3 + 3)

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 otìrganized into two modules

Clinical Monitoring

Teacher: Paolo Primiero

General context and Regulations. Feasibility and Site Selection Visit.  Approvals in Clinical Trials. Site Initiation Visit (SIV). Site Staff Training. Safety Information. Site Staff Training. Case Report Form (CRF). Site Staff Training. Informed Consent. Site Staff Training. Trial Master File (ISF). Monitoring Ongoing/Interim Monitoring Visit (MOV/IMV). Close Out Visit (COV). Monitoring report.  Monitoring Report Issues. Monitoring issues management. Risk Based Monitoring (RBM)


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); introducion 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 and Pharmacovigilance in clinical trials.

Suggested textbooks Materials provided by the teachers


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