CORDIS provides links to public deliverables and publications of HORIZON projects.
Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .
Deliverables
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 (opens in new window)Governing documents detailing the mandate for each of the trial committees and boards.
UNITY Data Transfer and user Agreements templates (opens in new window)Template for agreements governing the data sharing/integration
Guidelines on how to implement a centralised pharmacovigilance system (opens in new window)Describes how a centralised pharmacovigilance system is implemented
Study initiation package EPOXI (opens in new window)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 (opens in new window)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 (opens in new window)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
Publications
Author(s):
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
Published in:
Wellcome Open Research, 2023, ISSN 2398-502X
Publisher:
London: Wellcome Trust
DOI:
10.12688/WELLCOMEOPENRES.19616.1
Author(s):
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
Published in:
Nature Medicine, 2023, ISSN 1078-8956
Publisher:
Nature Publishing Group
DOI:
10.1038/s41591-023-02393-6
Author(s):
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
Published in:
Eurosurveillance, Issue 29, 2024, ISSN 1560-7917
Publisher:
European Centre for Disease Control and Prevention (ECDC)
DOI:
10.2807/1560-7917.ES.2024.29.38.2400575
Searching for OpenAIRE data...
There was an error trying to search data from OpenAIRE
No results available