Publications

Revising the ECRIN standard requirements for information technology and data management in clinical trials

Author(s)
Ohmann C, Canham S, Cornu C, Dreß J, Gueyffier F, Kuchinke W, Nicolis EB, Wittenberg M.
Publication date
Journal reference
Trials. 2013 Apr 5;14:97. doi: 10.1186/1745-6215-14-97.

Evaluation of data completeness in the electronic health record for the purpose of patient recruitment into clinical trials: a retrospective analysis of element presence

Author(s)
Köpcke F, Trinczek B, Majeed RW, Schreiweis B, Wenk J, Leusch T, Ganslandt T, Ohmann C, Bergh B, Röhrig R, Dugas M
Publication date
Journal reference
BMC medical informatics and decision making. 2013 Dec;13(1):37.

Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.

Author(s)
Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard AL, Fabritius ML, Mondrup F, Pott FC, Møller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group.
Publication date
Journal reference
N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Author(s)
Gluud C, Kubiak C, Whitfield K, Byrne J, Huemer KH, Thirstrup S, Libersa C, Barraud B, Grählert X, Dreier G, Geismann S, Kuchinke W, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, de Andres F, Sanz N, Kreis G, Asker-Hagelberg C, Johansson H, Bourne S, Asghar A, Husson JM, Demotes-Mainard J.
Publication date
Journal reference
Trials. 2012 Mar 27;13:27. doi: 10.1186/1745-6215-13-27.

Emerging and re-emerging infectious diseases: a continuous challenge for Europe.

Author(s)
Quaglio G, Demotes-Mainard J, Loddenkemper R
Publication date
Journal reference
Eur Resp J, 2012, 40:1312-14.

Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency

Author(s)
Dal-Ré R1, Moher D, Gluud C, Treweek S, Demotes-Mainard J, Carné X.
Publication date
Journal reference
PLoS Med. 2011 Dec;8(12):e1001149. doi: 10.1371/journal.pmed.1001149. Epub 2011 Dec 27.

A European perspective–The European clinical research infrastructures network. Annals of oncology.

Author(s)
Demotes-Mainard J, Kubiak C
Publication date
Journal reference
2011 Nov 1;22(Suppl_7):vii44-9.

A European perspective--the European clinical research infrastructures network

Author(s)
Demotes-Mainard J, Kubiak C.
Publication date
Journal reference
Ann Oncol. 2011 Nov;22 Suppl 7:vii44-vii49. doi: 10.1093/annonc/mdr425.

Precompetitive research, a synergy of public and private resources: for what purpose, how and in what framework?

Author(s)
Vassal G, Neves C, Arnaud O, Pletan Y
Publication date
Journal reference
Therapie. 2011;66(4):301.

Standard requirements for GCP-compliant data management in multinational clinical trials

Author(s)
Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, Wittenberg M, McPherson G, McCourt J, Gueyffier F, Lorimer A
Publication date
Journal reference
Trials. 2011 Dec;12(1):85.