Paediatric Good Clinical Practice Course

Paediatric Good Clinical Practice Basic Online Training Course is now open.

Edition of the course: 5th periodic edition

Course enrollment: Enrollment is open from 01/12/2020 until the end of this edition of the course (5th)

Course start date: 1st Dec 2020

Course end date: 31st Dec 2021

To enrol in this course, please contact your National Hub who will supply you with the course password.

Your National Hub’s Referent Person for Training and Education will verify your eligibility to enroll to the Course and provide you with the Course’s enrolment password.

Once you receive this Course’s Enrolment Password from your National Hub, please log in on  c4c Academy Platform.

If you don’t have an account yet, click on Create new account and follow the instructions.

 

Who is the course for?

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

 

Max. number of persons that each national hub can enrol: Unrestricted

 

Bloom’s taxonomy level of the course:

General Description:

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

Each module will include:

  • a set of slides to download
  • 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.

 

Programme:

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

 

Faculty:

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