Good Clinical Practice Courses

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

 

Name of the course: Paediatric Good Clinical Practice (GCP) Basic Online Training Course

Edition of the course: 2nd periodic edition

Course enrollment: Wednesday 1 April – Wednesday 22 April 2020

Course start date: 4th May 2020

Course end date: 1st June 2020

 

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.

Access to this second edition will be prioritised for participants in the not-for-profit c4c Proof of Viability Clinical Trials (namely TREOCAPA, KD-CAAP and cASPerCF).

 

Max. number of persons that each national hub can enrol: 10

 

Bloom’s taxonomy level of the course:

 

General Decription:

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.