Good Clinical Practice and Responsibility: updates of the Addendum
Typology: Online Course
Duration: 1 hour 10 minutes
Languages: Italian
OBJECTIVES:
The purpose of online training course is to give information on:
- Definition and objectives of the GCPs: what they are, what are its general principles, to whom they are addressed;
- Definition and modality of clinical trials;
- Description of the figures, responsibilities, systems and procedures for conducting a clinical trial;
- The need to modernize the GCPs and the specifications of the amendments to Addendum 6, in place since 2017.
RECIPIENTS:
Healthcare professionals from public and private hospitals.
CONTENTS
MODULE 1 - Definition and objectives of the Good Clinical Practices - GCP
- Screenwriting
- What are GCPs
- Fundamental concepts
- GCP priorities
- The quality of experimentation
- Chapters of the GCP
- GCP principles
- Ethical principles
- Formal principles
- The main actors
- History of the GCP
- GCP in Italy
- Profit clinical trial
- Non profit clinical trial
- Observational study
- Phases of the experiments
- Conclusion
- Learning stop
MODULE 2 - Good Clinical Practices: roles and responsibilities in conducting a clinical trial
- Screenwriting
- Figures and roles
- The promoter
- The experimenter
- The monitor
- The Ethics Committee
- Informed Consent
- The data collection card
- The original documents
- Pharmacovigilance
- Medical device supervision
- The quality
- Learning stop
MODULE 3 - Amendments to Addendum 6
- Screenwriting
- Why was an update of the GCP necessary?
- Addendum 6: updated topics
- The changes to the glossary
- The changes on the role of the investigator
- Changes on the role of the sponsor: quality management and the concept of risk
- The changes on the sponsor's role: monitoring
- Changes to essential documents
- Learning stop
- Conclusions
- The expert replies
Produced by: Piazza Copernico
Content edited by: IRCCS San Raffaele Hospital
COURSE CODE: 0025_19_04
