Helmrich, Isabel R. A. Retel http://orcid.org/0000-0001-5257-395X
van Klaveren, David
Dijkland, Simone A.
Lingsma, Hester F.
Polinder, Suzanne
Wilson, Lindsay
von Steinbuechel, Nicole
van der Naalt, Joukje
Maas, Andrew I. R.
Steyerberg, Ewout W.
,
Funding for this research was provided by:
Seventh Framework Programme (602150)
ZNS - Hannelore Kohl Stiftung
OneMind
Integra LifeSciences Corporation
Article History
Accepted: 25 June 2021
First Online: 30 July 2021
Declarations
:
: The authors declare that there is no conflict of interest.
: The CENTER-TBI study (EC Grant 602150) has been conducted in accordance with all relevant laws of the EU 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, accordingly to the local legislations, for all patients recruited in the Core Dataset 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.