Lisinopril Lay Summary. Meropenem Lay Summary. POP01 Lay Summary. Click here to subscribe. Lay Summaries. Donato Bonifazi CVBF will chair the last session which will focus on the sustainability of the project and will highlight potential synergies with other existing networks and projects, such as conect4children c4c or the ERNs. PedCRIN is a European project aimed at developing capacity for the management of multinational academic paediatric clinical trials.
It is funded by the European Commission under grant agreement no. The PedCRIN project has involved six work packages, including the project coordination and implementation, the definition of the PedCRIN business strategy and governance structure, the development of tools specific for paediatric and neonatal trials adverse event reporting, biosample management, ethical and regulatory database, monitoring, quality and certification , the provision of operational support to three selected trials, and communication and patients engagement in research.
The PedCRIN project was an opportunity to develop a partnership with the paediatric research community and to better understand the needs of the paediatric community. Registrations for the final event: Link. The PedCRIN achievement: Investigator Initiated paediatric Clinical trials PedCRIN launched a call for trials in , which provided an opportunity to promote the use of PedCRIN throughout the EU paediatric and scientific community and to engage with several paediatric and neonatal networks of academic clinical investigators interested in multinational clinical trials.
Data collection and storage are governed by the General Data Protection Regulation. A Steering Committee guides the research to make sure it is relevant and of high quality. Public and patient involvement PPI may be provided by individual cohorts' own groups, as well as by the interlinked Penta organisation, which is a network of paediatricians and researchers working in infections in Europe and globally.
The PPI groups help with release of the results of the research. The Principal Investigators of cohorts which have participated in previous EPPICC data mergers will be approached to ascertain their interest in participating in future data mergers. New cohorts may also be identified and may be invited to participate.
The key inclusion criterion for a cohort to participate is enrolment of children and adolescents with the infection of interest. All cohorts who are able to commit to submitting and cleaning data, obtaining any ethical, regulatory or other approvals required locally, and completion of data sharing agreements in accordance with the project timelines will be included. For certain analyses, additional data items may be requested, and may include:.
Submitted data are subjected to a range of logic and consistency checks. Sample size calculations are carried out for specific planned analyses to ensure that sufficient participants are available to meaningfully answer each research question.
Standard statistical methods are used in the analysis of different types of exposure and outcome data. Adjustment for confounding may be achieved through multivariable modelling or using alternative approaches such as propensity scoring.
Missing data are to be expected and, depending on the analysis and the amount and likely mechanisms of missing data, may be approached using complete case analysis or techniques such as multiple imputation. Details of specific analytical approaches are included in each Concept Sheet. Previous analyses of EPPICC paediatric data have used approaches including Cox regression, linear regression, logistic regression, and propensity score matching.
Cohorts may be grouped by region as cohorts within the same region are often similar in terms of epidemiology and treatment approaches , and region is then included as a covariate in the analysis. Each cohort is responsible for ensuring compliance with local and national regulatory and ethical processes. A final copy will be sent to the study sponsor, the Penta Foundation.
The dataset will be held for a minimum of 5 years after the end of the study. All data will be handled and used in accordance with the DSA. Transfer of EPPICC data partial or complete to third party collaborators requires approval from the PIs of cohorts contributing data or authorised cohort representatives and is subject to a contract and Data Sharing Agreement, if applicable.
All data transfer is conducted through a secure process. Any data transferred to third parties must be stored by third parties in compliance with all relevant data protection regulations.
A Concept Sheet is then required, which would be circulated to and discussed with all potential contributing cohorts.
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