A specialistic course for aspiring or already accredited Clinical Research Associate (CRA), providing all the necessary background to carry out the monitoring of clinical trials, in compliance with law and regulations.
The course covers topics related to the planning of a controlled clinical trial and the principles of good clinical practice.
Regulatory framework, procedural steps for the activation of the study, pharmacovigilance, and specific requirements for either investigators or clinical monitors and other people involved in the trial are all widely addressed.
The course is for health sciences university graduated only.

Argomenti

  • Drug development
  • The study protocol
  • The case report forms (CRF)
  • Randomized clinical trials (RCTs)
  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Regulatory framework (studies on drugs and biomedical devices)
  • Authorization process
  • Quality systems and quality assurance 
  • Study archives (TMF, ISF)
  • Pharmacovigilance
  • Role of the clinical monitor
  • Monitoring
  • Independent studies