PedCRIN tool for the biosamples management in paediatric clinical trials.

In paediatric clinical research, it is essential to implement ethical and regulatory requirements, training and facilities to grant the proper management of specimens, considering that blood sampling may be difficult, the number of specimens is usually limited, and all efforts should be made to minimise sample volumes. In the context of the PedCRIN project, an easy-to-use tool has been developed to guide investigators and sponsors in managing specimens and associated data in compliance with the applicable European rules in the context of paediatric clinical trials. Key topics and research questions to properly manage biosamples and related data in the context of paediatric trials were identified by PedCRIN partners; the current European regulatory/ethical and legal resources were searched for and analysed; the items/measures/procedures to ensure regulatory compliance of a paediatric trial with regards to biosamples were defined. A checklist of the key items to be considered for the management of biological samples in paediatric clinical trials in compliance with the European applicable rules and legislation, was prepared. It is publicly available on the PedCRIN website https://ecrin.org/projects/pedcrin. Five different topics were covered: consent and assent; minimising harm and maximising welfare; sampling volume; skills, training and facilities required for sampling; and long-term storage of biological material. This exercise addressed a specific need in the field of paediatric research to implement ad hoc procedures for specimen handling. In fact, specific guidance on the management of biosamples in paediatrics is not available.