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.

DURATION

1 10 hours and minutes

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

TECHNICAL REQUIREMENTS:

Acrobat Reader

PDF documents are exported for version 5 but are compatible with later versions of Acrobat Reader released up to the date of update of this file.

Browser

  • Internet Explorer 10
  • Internet Explorer 11
  • Mozilla Firefox
  • Google Chrome

JavaScript enabled

Pop-up blocker disabled

Minimum video resolution

The courses are optimized for a 1024 × 768 display on PCs and tablets of at least 7 inches.

Speakers or headphones (in case of multimedia products)

DATA TRACKING METHOD: SCORM 1.2

DEVELOPMENT TECHNOLOGY:

HTML5

PRODUCED BY:

PIAZZA COPERNICO

Content edited by:

IRCCS San Raffaele Hospital

COURSE CODE:

0025_19_04