Good Clinical Practice Courses

The Good Clincial Practice Basic Online Course is now open. If you would like to register, please contact your National Hub.

 

Who is this course for?

The Paediatric Good Clinical Practice (GCP) Training course is addressed to healthcare professionals involved in clinical trials regarding neonates, children and adolescents.

General Description

The c4c Paediatric GCP Training course will be based on a combination of a Basic Online course and Advanced Online modules.

Basic Online course

The basic online course is divided into different modules addressing the core elements of Good Clinical Practice (GCP), including issues specific to Paediatric Clinical Trials.

Each module will include:

  • a set of downloadable slides
  • a downloadable script of the lesson
  • a recording of the lesson;
  • videos and animations (embedded into the lessons)
  • post-lesson downloadable material (papers, guidelines, documents etc.)
  • self-assessment test

The entire course will have a duration of around 4.5 hours.

A final exam of the entire course will be administered in the form of questions with multiple-choice answers. Passing it will be mandatory in order to receive the c4c Paediatric GCP Course Certificate, accredited by Transcelerate.

Advanced Online modules

The advanced online modules will address in detail the specifics of Paediatric Clinical Trials in relation to GCP conduct and the features of the different roles of personnel involved in a trial. The advanced online modules will look into particular aspects of GCP, taking into account job functions and adapted to the personnel’s roles and responsibilities in a Paediatric Clinical Trial.

The advanced online modules will be accessible once the basic online course has been completed and its final exam passed. The advanced online modules do not constitute a course as a whole, but rather can be chosen singularly by the trainers according to their educational needs.

The different modules will have the same didactic structure as the basic online course but will also have sessions of interactive learning:

  • case studies discussion in focus groups
  • simulation of hypothetical case scenarios
  • role-playing
  • group exercises
  • small group interactive sessions

A self-assessment test will conclude each module.

A certificate by the c4c Paediatric Academy will be provided to participants according to the specific modules taken.

 

Programme

Basic Online course

The basic online course is divided into 9 modules:

  1. Introduction to ICH-GCP in paediatric clinical research
  2. Research ethics and Independent Ethics Committees
  3. Investigators
  4. Informed consent and assent
  5. Sponsors
  6. Monitoring, auditing and inspections
  7. Clinical trial protocol
  8. Recording and reporting and safety data
  9. Essential documents

Advanced online modules

The advanced online modules will be developed at a later stage of the c4c project, once the basic online course has been completed.

Faculty

Teachers/Trainers of the basic online course and of the advanced online modules are international experts of Paediatric Clinical Trials belonging to c4c consortium. They will be selected by the organizers of the Paediatric GCP Training Course, both from Academy and Industry.