Ethical Approval

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 sites. The list of sites, Ethical Committees, approval numbers and approval dates can be found below:

Country	City	Insitute	Ethical Commitee	Number Approval	Date Approval
Austria	Vienna	Medizinische Universität Wien - Universitätsklinik für Unfallchirurgie	Ethikkommission der Medizinischen Universität Wien	1646/2014	03-MAY-2016
Austria	Innsbruck	Medizinische Universität Innsbruck Universitätsklinik für Neurologie	Ethikkommission der Medizinischen Universität Innsbruck	AN2014-0336   343/4.22	01-DEC-2014
Belgium	Antwerp	Antwerp University Hospital	Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen	B300201422714	17-NOV-2014
Belgium	Liège	CHR Citadelle	Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen	B300201422714	17-NOV-2014
			Comité d'Ethique 412	1427	25-NOV-2014
Belgium	Liège	CHU	Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen	B300201422714	17-NOV-2014
			Comité d'Ethique hospitalo-facultaire niversitaire de Liège (707)	B707201422102 / 2014-244	07-OCT-2014
Belgium	Leuven	UZ Leuven	Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen	B300201422714	13-JUN-2015
			Comissie Medische Ethiek UZ KU Leuven / Onderzoek	B322201523981 / S57019 (ML11365)	10-JUL-2014
Denmark	Odense	Odense Universiteitshospital - Neurokirurgisk afdeling	De Videnskabsetiske Komitéer for Region Syddanmark	S-20140215	16-MAR-2015
Denmark	Copenhagen	Region Hovedstaden Rigshopitalet	De Videnskabsetiske Komitéer for Region Syddanmark	S-20140215	16-MAR-2015
Finland	Turku	Turku University Hospital	Varsinais suomen sairaanhoitopiirin kuntayhtyma - Eettinen Toimikunta	95/1801/2014	24-OCT-2014
Finland	Helsinki	Helsinki University Central Hospital	Varsinais suomen sairaanhoitopiirin kuntayhtyma - Eettinen Toimikunta	95/1801/2014	24-OCT-2014
France	Paris	APHP	Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM	141421B-31	19-DEC-2014
France	Besançon	CHRU de Besançon	Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM	141421B-31	19-DEC-2014
France	Lille	Lille University Hospital	Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM	141421B-31	19-DEC-2014
France	Grenoble	University Hospital of Grenoble	Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM	141421B-31	19-DEC-2014
France	Nancy	University Hospital Nancy	Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM	141421B-31	19-DEC-2014
France	Poitiers	CHU Poitiers	Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM	141421B-31	19-DEC-2014
Germany	Heidelberg	Universitätsklinikum Heidelberg Neurochirurgische Kliniki	Ethikkommission Medizinsche Fakultät Heidelberg	S-435/2014	27-MAY-2015
Germany	Berlin	Charité | Campus Virchow Klinikum	Ethikkommission an der Medizinsche Fakultät Der rheinsch-Westfälischen Technischen Hocgschule Aachen	1098/15	26-FEB-2016
Germany	Aachen	Uniklinik RWTH Aachen	Ethikkommission an der Medizinsche Fakultät Der rheinsch-Westfälischen Technischen Hocgschule Aachen	EK 174/15	02-JUL-2015
Germany	Ludwigsburg	Klinikum Ludwigsburg	Ethikkommission Medizinsche Fakultät Heidelberg	S-435/2014	29-JAN-2016
Hungary	Pecs	Pecsi Tudomanyegyetem Klinikai Kozpont	ETT TUKEB Egészségügyi Tudományos Tanács	42558-3/2014/EKU	02-OCT-2014
			Pécsi Tudományegyetem	5421	28-MAR-2015
Hungary	Szeged	zegedi tudományegyetem orvostudományi kar Szent Györgyi Albert Klinikai Központ	ETT TUKEB Egészségügyi Tudományos Tanács	42558-3/2014/EKU	2-OCT-2014
			Szegedi Tudományegyetem	3803	23-MAY-2016
Israel	Haifa	Rambam Medical Center	Helsinki Committee, Rambam Health Care Campus	RMB 373-14	22-JUL-2015
Israel	Jeruzalem	Hadassah-hebrew University Medical Center	Hadassah Medical Organization IRB	0590-16 HMO	06-DEC-2016
Italy	Milan	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Direzione Scientifica Comitato Etico	542/2014	20-OCT-2014
Italy	Milan	Ospedale San Raffaele	Comitato Etico - Ospedale San Raffaele	217/2014	10-APR-2015
Italy	Torino	AOU Città della Salute e della Scienza di Torino	Comitato Etico Interaziendale A.O.U. Città della Salute e della Scienza di Torino - A.O. Ordine Mauriziano - A.S.L.	0015269	15-FEB-2016
Italy	Cesena	Bufalini Hospital	Comitato Etico IRST IRCCS AVR	1675/2015 I.5/207	18-MAR-2015
Italy	Padova	Azienda Ospedaliera Università di Padova	Comitato Etico - Ospedale San Raffaele	217/2014	10-APR-2015
Italy	Monza	San Gerardo Hospital/ASST	Comitato Etico Della Provincia Monza Brianza	1978/2014	22-DEC-2014
Italy	Novara	Maggiore Della Carità Hospital	Comitato Etico Interaziendale A.O.U. 'Maggiore della Carità'	CE 46/15	03-JUL-2015
Italy	Milan	Niguarda Hospital	Comitato Etico - Ospedale Niguarda Ca' Granda	636-122015	23-DEC-2015
Latvia	Riga	Pauls Stradins Clinical University Hospital	Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society	171215-1E	17-DEC-2015
Latvia	Riga	Riga Eastern Clinical University Hospital	Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society	171215-1E	17-DEC-2015
Latvia	Rezekne	Rezekne Hospital	Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society	171215-1E	17-DEC-2015
Lithuania	Vilnius	Vilniaus Universiteto Ligonine	VILNIAUS REGIONINIS BIOMEDICININIŲ TYRIMŲ ETIKOS KOMITETAS	158200-15-801-323	06-OCT-2015
Lithuania	Kaunas	LSMUL Kauno klinikos Skubio pagalbos skyrius	KAUNO  REGIONINIS BIOMEDICININIŲ TYRIMŲ ETIKOS KOMITETAS	BE-2-6	06-JAN-2015
Netherlands	Leiden	Het Leids Universitair Medisch Centrum te Leiden	Leids Universitair Centrum - Commissie Medische Ethiek	P14.222/NV/nv	03-DEC-2014
Netherlands	Rotterdam	Erasmus MC	Leids Universitair Centrum - Commissie Medische Ethiek	P14.222/NV/nv	03-DEC-2014
Netherlands	The Hague	Medisch Centrum Haaglanden	Leids Universitair Centrum - Commissie Medische Ethiek	P14.222/NV/nv	03-DEC-2014
Netherlands	The Hague	Het Haga Hospital	Leids Universitair Centrum - Commissie Medische Ethiek	P14.222/NV/nv	25-NOV-2015
Netherlands	Nijmegen	Radboud UMC	Leids Universitair Centrum - Commissie Medische Ethiek	P14.222/NV/nv	02-JUL-2015
Netherlands	Tilburg	St. Elisabeth Ziekenhuis	Leids Universitair Centrum - Commissie Medische Ethiek	P14.222/NV/nv	02-JUL-2015
Netherlands	Groningen	UMC Groningen	Leids Universitair Centrum - Commissie Medische Ethiek	P14.222/NV/nv	03-DEC-2014
Norway	Tromso	Universitetssykehuset Nord-Norge	Regional komité for medisinsk og helsefaglig forskningsetikk REK midt-Norge (REK midt)	2014/1454	23-MAR-2015
Norway	Trondheim	St.Olavs Hospital	Regional komité for medisinsk og helsefaglig forskningsetikk REK midt-Norge (REK midt)	2014/1454	23-MAR-2015
Norway	Oslo	Oslo Universitetssykehus	Regional komité for medisinsk og helsefaglig forskningsetikk REK midt-Norge (REK midt)	2014/1454	23-MAR-2015
Romania	Timisoara	Clinica de Neurochirurgie Universitatea de Medicina si Farmacie "Victor Babes" Timisoara	Comitetului de Etica a Spitalului Clinic Judeteam de Urgenta Timisoara	N/A	16-OCT-2014
Serbia	Novi Sad	Klinidkog centra Vojvodine	Etidkog odbora Klinidkog centra Vojvodine	00-08/332	11-JUL-2014
Spain	Madrid	Hospital Universitario 12 de Octubre	Comité Etico de Investigacion Clinica del Hospital Universitario 12 de Octubre	14/262	03-NOV-2014
Spain	Barcelona	Vall d'Hebron University Hospital	Comité ético de investigación clínica y comisión de proyectos de investigación del hospital universitari Vall d'Hebron	ID-RTF080	13-NOV-2014
Spain	Bilbao	Clínico Universitario de Cruces	Comité Etico de Investigacion Clinica de Euskadi	PI2014158	24-FEB-2015
Spain	Valencia	Clínico Universitario de Valencia	Comité Etico de Investigacion Clinica del Clínico Universitario de Valencia	F-CE-GEva-15	23-APR-2015
Sweden	Stockholm	Karolinksa University Hospital	EPN (Regionala Etikprövningsnämnden i Stockholm)	2014/1473-31/4	24-SEP-2014
Sweden	Umea	Umea University Hosptital	EPN (Regionala Etikprövningsnämnden i Stockholm)	2014/1473-31/4	24-SEP-2014
Switzerland	Lausanne	Centre hospitalier universitaire Vaudois	La Commission cantonale (VD) d'éthique de la recherche sur l'être humain (CER-VD)	473/11	09-DEC-2014
UK	Birmingham	Queen Elizabeth Hospital	NHS HRA	14/SC/1370	22-DEC-2014
			UHB Research Governance Office - Queen Elizabeth Hospital	RRK5224	24-FEB-2016
UK	Cambridge	Cambridge University Hospital NHS Foundation Trust	NHS HRA	14/SC/1370	22-DEC-2014
			Research and Development Department - Cambridge University Hospital NHS Foundation Trust	AO93184	30-JAN-2015
UK	Southampton	University Hospitals Southhampton NHS Trust	NHS HRA	14/SC/1370	22-DEC-2014
			Research Governance Office - University Hospitals Southhampton NHS Trust	RHM CRI0294	13-MAR-2015
UK	Sheffield	Sheffield Teaching Hospitals NHS Foundation Trust	NHS HRA	14/SC/1370	22-DEC-2014
			Research and Development Department - Sheffield Teaching Hospitals NHS Foundation Trust	STH18187	25-MAR-2015
UK	London	Kings college London	NHS HRA	14/SC/1370	22-DEC-2014
			Research & Innovation Office - Kings college London NHS Foundation Trust	KCH15-204	30-DEC-2015
UK	Salford	Salford Royal Hospital	NHS HRA	14/SC/1370	22-DEC-2014
			Research and Development Department - Salford Royal Hospital NHS Foundation Trust	2015/025ET	27-JUL-2015
UK	Liverpool	The Walton centre NHS Foundation Trust	NHS HRA	14/SC/1370	22-DEC-2014
			Research & Innovation Office - The Walton centre NHS Foundation Trust	RG154-15	11-MAY-2015
UK	Bristol	Southmead Hospital Bristol	NHS HRA	14/SC/1370	22-DEC-2014
			Research & Innovation - North Bristol NHS Trust	3427	23-DEC-2014
UK/Scotland	Edinburgh	Lothian Health Board	NHS Scotland	14/SS/1086	23-DEC-2014
			Research and Development Department - University Hospitals Division NHS Lothian	2015/0171	19-JUN-2015