Maas, Andrew I. R. http://orcid.org/0000-0003-1612-1264
Ercole, Ari
De Keyser, Veronique
Menon, David K.
Steyerberg, Ewout W.
Funding for this research was provided by:
FP7 Health (602150)
ZNS - Hannelore Kohl Stiftung
Integra LifeSciences
NeuroTrauma Sciences
Article History
Received: 3 December 2021
Accepted: 11 February 2022
First Online: 18 March 2022
Declarations
:
: All authors were involved in the CENTER-TBI study, primarily supported by the FP7 program of the European Union. The authors report no relevant conflicts of interest.
: CENTER-TBI adhered to ethical guidelines, IRB approvals were obtained in all participating centers, and consent was obtained from all participants or their proxies according to national and local regulations. The CENTER-TBI study (grant 602150) has been conducted in accordance with all relevant laws of the European Union, if directly applicable or of direct effect, and all relevant laws of the country where the recruiting sites were located, including, but not limited to, the relevant privacy and data protection laws and regulations (the “Privacy Law”), the relevant laws and regulations on the use of human materials, and all relevant guidance relating to clinical studies from time to time in force, including, but not limited to, the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (“ICH GCP”) and the World Medical Association Declaration of Helsinki entitled “Ethical Principles for Medical Research Involving Human Subjects.” Informed consent by the patients and/or the legal representative/next of kin was obtained, according to the local legislations, for all patients recruited in the core data set of CENTER-TBI and documented in the e-CRF. Ethical approval was obtained for each recruiting site. The list of sites, ethical committees, approval numbers, and approval dates can be found on the website: ExternalRef removed. We note, however, that the current review article did not make use of individual patient data.