Paediatric Clinical Research
Infrastructure Network

PedCRIN Tools

Collection, storage and use of biological samples and related data in paediatric clinical trial
Viviana Giannuzzi, Adriana Ceci, Lucia Ruggieri, Rossella Conte, Donato Bonifazi, Mariagrazia Felisi, Cristina Manfredi, Evelyne Jacqz-Aigrain, Beate Aurich, Salma Malik, Christine Kubiak, Andrea Wutte

Abstract: A checklist developed to help researchers, sponsors, and other affiliated personnel actors to verify that all key aspects required to properly manage samples and related data in the context of paediatric trials are taken into consideration

V1, 02 APRIL 2021

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Causality assessment of adverse events in paediatric clinical trials
Donato Bonifazi, Mariagrazia Felisi, Cristina Manfredi, Louise Braken, Matthew Peak, Mark Turner, Rosella Conte, Lucia Ruggieri , Evelyne Jacqz-Aigrain, Beate Aurich, Salma Malik, Christine Kubiak

Abstract: A visual algorithm based on the Naranjo scale and specifically adapted for the paediatric population to help researchers in their assessment of causality of adverse events occurring during a clinical study

V1, 02 APRIL 2021

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Format PedCRIN Patient meeting guide for children
Cor Oosterwijk, Eric Vermeulen, Mariette H E Driessens

Abstract: This tool is a basic guide about the way children/youth can be ‘consulted’ about a paediatric clinical study. ‘Consultation’ is asking children/youth for input about the study. The tool describes a specific way of consultations: a ‘focus group’, a face-to-face meeting. 

V1, 06 APRIL 2021

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Format PedCRIN meeting guide for Adults
Cor Oosterwijk, Eric Vermeulen, Mariette H E Driessens

Abstract: This tool is a basic guide about the way parents can be ‘consulted’ about a paediatric clinical study. ‘Consultation’ is asking parents for input about the study. The tool describes a specific way of consultations: a ‘focus group’, a face-to-face meeting. 

V1, 06 APRIL 2021

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