The Paediatric Good Clinical Practice Basic Online Training course is addressed to healthcare professionals involved in clinical trials regarding neonates, children and adolescents.
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:
- Introduction to ICH-GCP in paediatric clinical research
- Research ethics and Independent Ethics Committees
- Investigators
- Informed consent and assent
- Sponsors
- Monitoring, auditing and inspections
- Clinical trial protocol
- Recording and reporting and safety data
- 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.
How to apply:
You can apply to the courses by sending an email to Pedmed-NL , including the following information:
- Name of the Course
- Name of Participant
- Age in years
- Institute/Hospital
- Email address
- Current position within the institute