Translational Research

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Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional)

Published by NIH

Career Development ProgramClinical ResearchResearch TrainingTranslational Research

The National Center for Advancing Translational Sciences (NCATS) will award Institutional Research Career Development (K12) programs through the Clinical and Translational Science Awards (CTSA). The purpose of this Funding Opportunity Announcement (FOA) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare an outstanding heterogeneous pool of promising later stage postdoctoral fellows and junior faculty scholars in clinical and translational science who have made a commitment to independent research careers (i.e., tenure-track or equivalent faculty positions), and to facilitate their timely transition to more advanced support mechanisms, e.g., K08, K23, R01, R03, etc. Applicants must submit both a UM1 application to PAR-21-293: Clinical and Translational Science Award and a K12 application to this FOA.

This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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Research Management Manual

Published by EATRIS

Project ManagementResearch and Drug DevelopmentTranslational Research

The EATRIS Research Management Manual provides general guidance on how to structure and run a translational research project, from project initiation to project closure, to optimize the translational feasibility of your project. It also provides the necessary tools and templates, based on best practice experience and established project management methodologies.

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European Paediatric Translational Research Infrastructure (EPTRI)

Published by EPTRI

Drug DevelopmentpaediatricRegulatory Affairsresearch infrastructureTranslational Research

The EPTRI Centralised Services are provided by the EPTRI CMO and dedicated experts. These services include:
*Providing access to paediatric patients’ cohorts
*Providing access to paediatric samples and related data
*Advice on in-vivo / in-silico non-clinical study design
*Advice on in-vivo / in-silico clinical study design
*Advice and document preparation for regulatory and ethics procedures
*Advice on preparing HTA reports for paediatric medicines, diagnostics, and medical devices
*Advice on data and sample sharing preparation
*Support with applications to public and private funding opportunities

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European Commission. Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified. Version 5. November 2021

Published by European Commission (EC)

Clinical TrialsGMOGood PracticeTranslational Research

Guideline on Clinical trials with medicinal products that contain or consist of GMOs must also comply with applicable requirements under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms

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Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

Published by United Nations

Genetic ResourcesNagoya ProtocolTranslational Research

The Protocol  provides
a strong basis for greater legal certainty and transparency for both providers
and users of genetic resources. It also promotes the use of genetic resources and associated traditional knowledge,  strengthens the opportunities for fair and equitable sharing of benefits from their use. 

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Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

Published by Official Journal of the European Union

Data ProtectionProcessing of Personal DataTranslational Research

The protection of natural persons in relation to the processing of personal data is a fundamental right. This Regulation is intended to contribute to the accomplishment of an area of freedom, security and justice and of an economic union, to economic and social progress, to the strengthening and the convergence of the economies within the internal market, and to the well-being of natural persons.

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