This WG intends to promote the harmonization of ethical/legal frameworks among countries.In particular, the working group participates the Enpr-EMA WG4 Ethics activities public consultations and aims to advice on ethical aspects on data handling and sharing.
TEDDY Network has always dealt with activities concerned with the adherence to Good Clinical Practice (GCP) in paediatric trials, also implementing the European Ethical Recommendations.
So far, documents produced include recommendations for children and adolescents, parents and doctors and health professionals, all with the objective to raise awareness on clinical research, and empower and motivate children in participating in future clinical research.
Moreover, TEDDY produces specific case by case documents (informed consents, assent forms, booklets) tailored for different age groups for each trial.
WG reference person:
Federico Martinón Torres
Cristina Serén Trasorras