Paediatric Good Clinical Practice Refresher Course


Title of Course: Paediatric Good Clinical Practice Refresher Course

Edition of the course: First Regular Edition

Course Duration: 2 hours

Course start date: 1st Oct 2023

Course end date: 30th April 2025

Course enrollment: Enrollment is open from 1st Oct 2023 until 30th April 2025.

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

Your National Hub’s Representative 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 course is designed to assist clinical research personnel, who have already taken the c4c GCP Course or similar, refresh their knowledge of the basic principles of GCP and more specifically, how these principles can be applied in the pediatric research setting.

The course includes new and revised content relating to current regulations and guidelines for pediatric clinical trials in Europe.

It is addressed to all clinical research personnel (Investigators, Study Coordinators, Data Managers etc.) who have previously completed a Basic GCP course (not necessarily the c4c one) and are encouraged to refresh their training in line with EU GCP regulations (e.g. every 2-3 years).


Programme:

The course, which is self-learning, consists of 5 modules and it will take approximately 2 hours to complete – based on the assumption of prior GCP knowledge.

  1. ICH GCP Requirements

  2. Investigator’s Responsibilities

  3. Informed Consent

  4. Safety Management

  5. Records, Reports & Essential Documents

The student can start the course whenever suits and there is no time limits to complete it, until April 30th 2025.


Who is the course for?

The course is addressed to health care professionals involved in clinical trials regarding neonates, children and adolescents and is accessible to those who have already carried out a Basic GCP course (not necessarily the c4c one). Your National Hub may require evidence of other GCP course completion.


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


Bloom’s taxonomy level of the course:

Faculty:

Kristin Marx (Servier), Pavla Pokorna (CUNI), Annalisa Landi (FGB), Lucia Ruggieri (FGB), Alpha Diallo (INSERM), Melanie Figarella (INSERM) and Lea Levoyer (INSERM)

Certificate

If the student answers correctly to the 10 questions at the end of each of the 5 modules (3 attempts for each question and at least 80% of correct answers) and fills in the satisfaction questionnaire at the end of the course, a certificate of completion of a GCP course, accredited by Transcelerate, can be downloaded from the platform.