Fondazione Gianni Benzi, together with Consorzio per Valutazioni Biologiche e Farmacologiche and the European Clinical Research Infrastructure Network (ECRIN) published the article “PedCRIN tool for the biosamples management in paediatric clinical trials”.

Internationally agreed guidelines and recommendations on paediatric studies are available. In addition, specific tools and services on biobanking have been developed within existing initiatives, but they do not include any guidance on the management of biological samples in paediatrics.

Within the EU funded project PedCRIN, 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.

A checklist of the key items to be considered was prepared. It is publicly available on the PedCRIN website. 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.

Discover more by reading the full article here!