CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.
I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .
Risultati finali
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 (si apre in una nuova finestra)Governing documents detailing the mandate for each of the trial committees and boards.
UNITY Data Transfer and user Agreements templates (si apre in una nuova finestra)Template for agreements governing the data sharing/integration
Guidelines on how to implement a centralised pharmacovigilance system (si apre in una nuova finestra)Describes how a centralised pharmacovigilance system is implemented
Study initiation package EPOXI (si apre in una nuova finestra)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 (si apre in una nuova finestra)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 (si apre in una nuova finestra)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
Pubblicazioni
Autori:
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
Pubblicato in:
Wellcome Open Research, 2023, ISSN 2398-502X
Editore:
London: Wellcome Trust
DOI:
10.12688/WELLCOMEOPENRES.19616.1
Autori:
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
Pubblicato in:
Nature Medicine, 2023, ISSN 1078-8956
Editore:
Nature Publishing Group
DOI:
10.1038/s41591-023-02393-6
Autori:
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
Pubblicato in:
Eurosurveillance, Numero 29, 2024, ISSN 1560-7917
Editore:
European Centre for Disease Control and Prevention (ECDC)
DOI:
10.2807/1560-7917.ES.2024.29.38.2400575
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