The c4c Academy Platform provides educational courses and training materials tailored to the needs of all the c4c beneficiaries involved in the conduct of paediatric clinical trials. Through these courses, c4c beneficiaries will gain greater insight and expertise into all relevant aspects of the organisation, implementation and delivery of paediatric clinical trials, including those focused on regulatory approval of new paediatric drugs.

The following courses are all available through the c4c Academy Platform.

The courses are exclusively reserved for the c4c Consortium, kindly contact your National Hub, if you wish to participate.

Accredited Courses

Advanced Course on Paediatric Clinical Trials & Paediatric Drug Development

This course aims to educate healthcare professionals about the scientific, methodological and practical issues of the design, conduct, analysis & management of clinical trials in paediatrics.

Enrol: 1st April – 15th May 2023

Paediatric
GCP Course

This basic online course addresses the core elements of GCP, including issues specific to paediatric clinical trials.

Enrol Anytime! 

Paediatric GCP
Refresher Course

The course is designed for clinical research personnel, who have already taken the c4c GCP Course to refresh their knowledge.

Enrol Anytime! 

Good Clinical Practice related courses

Audit & Inspection Readiness

This course is on how an inspection (or an audit) should be prepared for and conducted by staff of a clinical trial site.

Enrol: 11th Sept to 14th Jan 2024

Essential Documents

The course is designed to familiarise you with the essential documents needed for a Clinical Trial, following the guidelines of Good Clinical Practice.

Enrol: 26th Feb – Mar 17 2024*

*”extraordinary enrolment phase” from March 18th to Apr 7th

Ethics Committee Evaluation

This course focuses on the evaluation of paediatric clinical trials by an Ethics Committee, following the guidelines of Good Clinical Practice.

Enrol: 9th Oct to 29th Oct 2023*

*”extradionary enrolment phase” from 30th Oct to 12th Nov 2023

Monitoring Paediatrics Trials

This course focuses on the monitoring aspects of paediatric clinical trials, including the role of the monitor (CRA), site staff responsibilities, monitoring plans and study specific procedures (SSP).

Enrol Anytime! 

Obtaining Informed Consent & Assent

This course focuses on the process to obtain informed consent and assent during paediatric clinical trials.

Enrol: 18th Sept 2023 to 4th Feb 2024

The Role of Research Nurses

The course focuses on the role of Research Nurses in paediatric clinical trials.

Enrol: 8th Jan – 18th Feb 2024!

Safety Reporting Data

The course focuses on safety data reporting in paediatric clinical trials, following Good Clinical Practice and Good Pharmacovigilance Practice guidelines.

Enrol between 8th Jan & 18th Feb 2024

Trial Start Up

This course provides a general overview of activities required to start paediatric clinical trials in sites, in line with international and European standards, taking into account the specific guidelines for trials involving children.

Enrol Anytime! 

c4c Academy - Short Courses

Developmental Pharmacology

This course will present the key aspects of developmental pharmacology, covering the impact of growth and maturation on drug disposition, effects on dosage selection and evaluation in the different paediatric age groups.

Enrol Anytime! 

Elements of Clinical Trial Methodologies

This course provides the basic elements of clinical research methodologies focusing on understanding clinical research results and learning the basics of writing research papers.

Enrol between 6 Nov 2023 & 14 Jan 2024! 

Gene Therapy Trials

This self-learning course gives an overview of some key features of gene therapy clinical trials and how the set-up of these trials can differ from other clinical trials.

Enrol Anytime! 

Innovative Clinical Trial Design

This course provides an introduction to various types of innovative clinical trial design, including adaptive designs, platform trials & precision medicine approaches.

Enrol Anytime! 

Involving Children & Families
in Clinical Trial Design

This course aims to enable students to identify activities in the development of clinical trials in which patients can contribute. Students will learn about the design of appropriate methodology and impact assessment.

Enrol Anytime! 

Investigational Medicinal Product Supply

This  course introduces key aspects of investigational medicinal product supply planning, including regulatory requirements, blinding, placebo supply, and forecasting.

Enrol Anytime

Issues in Adolescent Clinical Trials

This course provides an opportunity to learn how to deal with the most important issues in adolescent clinical trials.

Enrol between 11th Dec 2023 & 31st Jan 2024

Paediatric Investigation Plans

This course provides the learner with knowledge of the key concepts of a Paediatric Investigation Plan (PIP).

Enrol Anytime! 

Registries in Paediatric Drug Development

This course will explain how registry data can be used within all phases of paediatric clinical trials, the ethical and legal aspects of using registry data and how regulatory level data can be generated.

Remote & Hybrid
Paediatric Clinical Trials

This one day Live course will provide an opportunity to learn how to conduct remote and hybrid clinical trials and manage emergency situations that may arise during home therapy.