CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.
Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.
Leistungen
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 (öffnet in neuem Fenster)Governing documents detailing the mandate for each of the trial committees and boards.
UNITY Data Transfer and user Agreements templates (öffnet in neuem Fenster)Template for agreements governing the data sharing/integration
Guidelines on how to implement a centralised pharmacovigilance system (öffnet in neuem Fenster)Describes how a centralised pharmacovigilance system is implemented
Study initiation package EPOXI (öffnet in neuem Fenster)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 (öffnet in neuem Fenster)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 (öffnet in neuem Fenster)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
Veröffentlichungen
Autoren:
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
Veröffentlicht in:
Wellcome Open Research, 2023, ISSN 2398-502X
Herausgeber:
London: Wellcome Trust
DOI:
10.12688/WELLCOMEOPENRES.19616.1
Autoren:
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
Veröffentlicht in:
Nature Medicine, 2023, ISSN 1078-8956
Herausgeber:
Nature Publishing Group
DOI:
10.1038/s41591-023-02393-6
Autoren:
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
Veröffentlicht in:
Eurosurveillance, Ausgabe 29, 2024, ISSN 1560-7917
Herausgeber:
European Centre for Disease Control and Prevention (ECDC)
DOI:
10.2807/1560-7917.ES.2024.29.38.2400575
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