Paediatric Good Clinical Practice Online Training Course is now open.
Title of Course: Paediatric Good Clinical Practice Course
Edition of the course: 5th periodic edition
Course Duration: 4-5 hours
Course start date: 1st Dec 2020
Course end date: 30th Apr 2024
Course enrollment: Enrollment is open from 01/12/2020 until the end of this edition of the course (5th)
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.
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
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
