Paediatric Clinical Research
Infrastructure Network

PedCRIN Tools

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PedCRIN tools for the empowerment of paediatric community

PedCRIN developed a series of tools (WP3) and procedures to support the setup and the management of multinational neonatal and paediatric clinical trials in Europe. These tools are developed to train and support researchers and clinicians so they can establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective and easier way. The removal of barriers to trial management will speed up the evaluation of new and improved therapies.

Collection, storage and use of biological samples and related data in paediatric clinical trial
Authors: 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
Authors: 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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Neonatal trials and informed consent: Points to consider
Authors: Evelyne Jacqz-Aigrain, Beate Aurich, Eric Vermeulen, Valéry Elie, Naura Mahmoudi

ContributorsDonato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool provides a check list of practical points to consider when talking to parents about the possible inclusion of a neonate into a clinical trial

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Informed consent

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Enrolment into neonatal trials:Points to consider during protocol development
Authors: Beate Aurich, Eric Vermeulen, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsDonato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool provides a list of points to consider during protocol development for improving the enrolment of neonatal trials

Keywords: Neonatal trial, Protocol development, Guidance document, Tool

V 1.0, 22 March 2021

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Sampling techniques for neonatal pharmacokinetic studies: Points to consider
Authors: Evelyne Jacqz-Aigrain, Beate Aurich,Valéry Elie, Naura Mahmoudi

ContributorsSaskia De Wildt, Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool provides practical points to consider for neonatal pharmacokinetics studies

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Pharmacokinetics

V 1.0, 22 March 2021

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Feasibility assessment of neonatal studies and selection of investigator sites/ study centres: Points to consider
Authors: Beate Aurich, Valéry Elie,Naura Mahmoudi, Evelyne Jacqz-Aigrain 

ContributorsPascale Wenger, Mark Adams, Pirrko Lepola, Jaana Kallio, Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool lists examples of points to consider for the feasibility assessment and selection of neonatal centres

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Feasibility

V 1.0, 22 March 2021

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Feasibility assessment of neonatal studies and study population: Points to consider
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsPascale Wenger, Mark Adams, Pirrko Lepola, Jaana Kallio, Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool provides points to consider for the feasibility assessment of neonatal study populations

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Feasibility

V 1.0, 22 March 2021

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Neonatal trials and standard age groups: Points to consider
Authors: Evelyne Jacqz-aigrain, Beate Aurich, Valéry Elie, Naura Mahmoudi

ContributorsAndres Rane, Estelle Naumburg, Pascale Wenger, Mark Adams, Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool summarises the definitions of commonly used terms for neonatal age-groups

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Age groups

V 1.0, 22 March 2021

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Neonatal trials and data collection by age groups: Points to consider
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

Contributors:Andres Rane, Estelle Naumburg, Pascale Wenger, Mark Adams,Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool summarises the definitions of commonly used terms for neonatal age-groups

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Age groups, Data collection

V 1.0, 22 March 2021

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Neonatal trials and data analysis by age group: Points to consider
Authors: Beate Aurich, Valéry Elie,Naura Mahmoudi, Evelyne Jacqz-Aigrain

Contributors:Andres Rane, Estelle Naumburg, Pascale Wenger, Mark Adams,Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool proposes a check list for the analysis of age-related data in neonatal trials

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Age groups, Data analysis

V 1.0, 22 March 2021

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Formulations used in neonatal trials: Points to consider
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

Contributors:Pascale Wenger, Mark Adams ,Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool includes a check list of points to consider for neonatal formulations

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Formulation

V 1.0, 22 March 2021

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Excipients in neonatal medicines: Points to consider
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

Contributors: Pascale Wenger, Mark Adams,Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool provides a check list of points to consider for excipients in neonatal formulations

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Excipients

V 1.0, 22 March 2021

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Examples of guidance documents by health authorities and institutional bodies on neonatal formulations
Authors: Beate Aurich, Valéry Elie,Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsPascale Wenger, Mark Adams,Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tools lists examples of documents published by regulatory authorities and institutional bodies concerning neonatal formulations

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Formulations, Regulations

V 1.0, 22 March 2021

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Protocol development for neonatal trials: Points to consider for pharmacovigilance
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsDonato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool gives points to consider concerning pharmacovigilance and risk managment at the time neonatal protocol development

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Drug safety

V 1.0, 22 March 2021

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Safety data analyses of neonatal trials: Points to consider
Authors: Beate Aurich, Valéry Elie,Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsAndres Rane, Estelle Naumburg, Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool provides practical points to consider when planning for the analysis of neonatal safety data

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Safety data collection, Safety data analysis

V 1.0, 22 March 2021

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Potential confounders and risk factors for adverse events in neonatal trials: Points to consider
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

Contributors: Andres Rane, Estelle Naumburg, Donato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool gives examples of potential confounders and risk factors for adverse events/ outcome in neonatal trials

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Outcome

V 1.0, 22 March 2021

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Exclusion criteria in neonatal trial protocols: Points to consider
Authors: Beate Aurich, Valéry Elie,Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsDonato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool illustrates in a worked example how existing safety data from the product label/ summary of product characteristics can inform exclusion criteria of a neonatal protocol

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Drug safety

V 1.0, 22 March 2021

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Outcome in neonatal trials and data collection and analysis:Points to consider
Authors: Beate Aurich, Valéry Elie,Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsDonato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool provides examples of data which may inform the planning of data collection and analysis of neonatal outcome

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Outcome data collection, Outcome data analysis

V 1.0, 22 March 2021

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Assessment of short outcome of neonatal trials: Points to consider
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsDonato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool lists examples of data items for the assessment shortterm efficacy and safety outcome of neonatal trials

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Short-term outcome

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Assessment of long-term outcome of neonatal trials: Points to consider
Authors: Beate Aurich, Valéry Elie, Naura Mahmoudi, Evelyne Jacqz-Aigrain

ContributorsDonato Bonifazi, Salma Malik, Christine Kubiak

Abstract: This tool lists examples of data items for the assessment longterm efficacy and safety outcome of neonatal trials

Keywords: Neonatal trial, Protocol development, Guidance document, Tool, Long-term outcome

V 1.0, 22 March 2021

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Format PedCRIN meeting guide for Adults
Authors: 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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Format PedCRIN Patient meeting guide for children
Authors: 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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