GCP courses

Who is this course for?

The Pediatric 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 (BO course)

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

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 BO course will have a duration of around 4.5 hours.

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

Advanced Online modules (AO modules)

The AO modules will address in detail the specifics of PCTs in relation to GCP conduct and the features of the different roles of personnel involved in a trial. AO modules will look into particular aspects of GCP, taking into account job functions and adapted to the personnel’s roles and responsibilities in a PCT.

The AO modules will be accessible once the BO course has been completed and its final exam passed. The AO 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 BO 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

BO course

The BO 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

AO modules

The AO modules will be developed at a later stage of the c4c project, once the BO course has been copmpleted.

Faculty

Teachers/Trainers of the BO Course and of the AO 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.