Leistungen
Communication and dissemination plan: Details on the dissemination strategyand action plan including analysis of stakeholder groups, identification of keyevents and activities
Project Quality Plan (PQP): rules for meetings management, documents naming and storage, deliverables preparation and quality reviewProject Quality Plan (PQP): rules for meetings management, documents namingand storage, deliverables preparation and quality review
Study initiation package – RISPStudy initiation package-RISP (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory 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.)
Midterm recruitment report – PREVALUNG ETOILEMidterm recruitment report-PREVALUNG ETOILE: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Project Management Plan (PMP): organisation, scope of work, Master Plan, Project Action List, risk registerProject Management Plan (PMP): organisation, scope of work, Master Plan,Project Action List, risk register
First meeting of the PAB minutesReport on the status of posting results in a repository – FLEMENGHO
Report on the status of posting results in a repository-FLEMENGHO. Irrespective of the successful completion of the clinical study, summary results must be posted in the applicable registry/ies (where the study was registered) even if the timing of posting of results falls outside of the grant period. The report is to be scheduled for the time results posting is expected or for the last months of the project, whichever comes earlier.
Midterm recruitment report – SUMMITMidterm recruitment report-SUMMIT: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Management Board charts signed by membersMidterm recruitment report – PREVALUNG
Midterm recruitment report- PREVALUNG: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Midterm recruitment report – ROBINSCAMidterm recruitment report-ROBINSCA: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Study initiation package – SUMMITStudy initiation package-SUMMIT (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory 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.)
Study initiation package – FLEMENGHOStudy initiation package-FLEMENGHO (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory 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.)
Study initiation package – PREVALUNG ETOILEStudy initiation package-PREVALUNG ETOILE (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory 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.)
Study initiation package – ROBINSCA•Study initiation package-ROBINSCA (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory 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.)
Study initiation package – NCL TLHCStudy initiation package-NCL TLHC (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory 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.)
Study initiation package – PREVALUNGStudy initiation package- PREVALUNG (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory 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.)
Midterm recruitment report – FLEMENGHOMidterm recruitment report-FLEMENGHO: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Visual identity, website and social media: Project branding, introductory projectmaterials, video, infographics, logo are available, website is published andsocial media accounts operative
Veröffentlichungen
Autoren:
Shuai Zhang, Liwei Zhao, Mengfei Guo, Peng Liu, Sijing Li, Wei Xie, Ai-Ling Tian, Jonathan G Pol, Hui Chen, Hui Pan, Misha Mao, Yumei Li, Laurence Zitvogel, Yang Jin, Oliver Kepp, Guido Kroemer
Veröffentlicht in:
Journal for ImmunoTherapy of Cancer, Ausgabe 11, 2023, ISSN 2051-1426
Herausgeber:
BMJ Publishing Group Ltd & Society for Immunotherapy of Cancer
DOI:
10.1136/jitc-2023-006785
Autoren:
Marine Fidelle, Deborah Suissa, Roxanne Birebent, et al
Veröffentlicht in:
Journal for immunotherapy of cancer, Ausgabe 11, 2023, ISSN 2051-1426
Herausgeber:
BMJ Publishing Group Ltd & Society for Immunotherapy of Cancer
DOI:
10.1136/jitc-2023-SITC2023.1510
Autoren:
Marine Fidelle, Ai-Ling Tian, Laurence Zitvogel, Guido Kroemer
Veröffentlicht in:
Oncoimmunology, Ausgabe 12, 2023
Herausgeber:
Taylor & Francis Group
DOI:
10.1080/2162402X.2023.2224672
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