CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.
Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .
Resultado final
Describing the data management of the UNITY and MOSA trials
A clear and prospective document detailing all statistical analyses to be performed in the trial.
TSC, TCT, DSMB and CLC Secretariat charters (se abrirá en una nueva ventana)Governing documents detailing the mandate for each of the trial committees and boards.
UNITY Data Transfer and user Agreements templates (se abrirá en una nueva ventana)Template for agreements governing the data sharing/integration
Guidelines on how to implement a centralised pharmacovigilance system (se abrirá en una nueva ventana)Describes how a centralised pharmacovigilance system is implemented
Study initiation package EPOXI (se abrirá en una nueva ventana)Registration number of the clinical study in a registry meeting WHO Registry criteria. Final version of study protocol as approved by the regulator(s) / ethics committee(s) Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)
Safety Management Plan (se abrirá en una nueva ventana)Describes the governance the safety circuit and communication of the trial The safety communication between the trial safety group InsermANRSMIE and Sponsors representatives with the trial committees TCT TSC DSMB will be described
MOSA Study initiation package (se abrirá en una nueva ventana)Registration number of the clinical study in a registry meeting WHO Registry criteria.Final version of study protocol as approved by the regulator(s) / ethics committee(s)Regulatory and ethics (if applicable, institutional) approvals required for the enrollment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)
Project website and Internal communication tools
Publicaciones
Autores:
Pesonel, E; Hoffmann, I; Guiraud, L; Bourner, J; Diallo, A; Dunning, J; Horby, P; Kali, S; Laouénan, C; Mentré, F; Merson, L; Molino, D; Palich, R; Rojek, A; Tacconelli, E; Tardivon, C; Yazdanpanah, Y; Calmy, A; Lescure, F-X; Olliaro, P
Publicado en:
Wellcome Open Research, 2023, ISSN 2398-502X
Editor:
London: Wellcome Trust
DOI:
10.12688/WELLCOMEOPENRES.19616.1
Autores:
Erica Telford, Beatriz Grinsztejn, Inge Christoffer Olsen, Nicolas Pulik, France Mentré, Skerdi Haviari, Maxime Hentzien, Olivier Ségéral, Miquel B. Ekkelenkamp, Dimie Ogoina, Nathalie Strub-Wourgaft, Alpha Diallo, Yazdan Yazdanpanah, Alexandra Calmy
Publicado en:
Nature Medicine, 2023, ISSN 1078-8956
Editor:
Nature Publishing Group
DOI:
10.1038/s41591-023-02393-6
Autores:
Leanne PM van Leeuwen, Marc C Shamier, Babs E Verstrepen, Hannelore M Götz, Katharina S Schmitz, Najlae Akhiyate, Koen Wijnans, Susanne Bogers, Martin E van Royen, Eric CM van Gorp, Marion PG Koopmans, Rory D de Vries, Corine H GeurtsvanKessel, Luca M Zaeck
Publicado en:
Eurosurveillance, Edición 29, 2024, ISSN 1560-7917
Editor:
European Centre for Disease Control and Prevention (ECDC)
DOI:
10.2807/1560-7917.ES.2024.29.38.2400575
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