Supplementary material

European Clinical Research Infrastructures Network (ECRIN) - transnational working groups (TWG) - 2008 reports:

  • Deliverable 1 - Securing participant’s autonomy and interacting with ethics committees. View.
  • Deliverable 2 - Clinical Research in Europe: interaction with ethics committees before, during and after a clinical trial. View.
  • Deliverable 3 - Potential publications. View.
  • Deliverable 4 - Clinical research in Europe: national differences in legislative and regulatory frameworks. View.
  • Deliverable 5 - Meetings on the legislative and regulatory frameworks for clinical research in Europe. View.
  • Deliverable 6 - Regulatory requirements for adverse reporting in ECRIN countries. View.
  • Deliverable 7 - Establishment of network for the development of EU-wide postmarketing surveillance studies. View.
  • Deliverable 8 - A report on the computerization of adverse event reporting. View.
  • Deliverable 9 - Survey on data management, tools and procedures within ECRIN. View.
  • Deliverable 10 - GCP-compliant data management in multinational clinical trials. View.
  • Deliverable 11 - Identification, evaluation and prioritization of possible common or compatible GCP-compliant data management tools for multinational trials. View.
  • Deliverable 12 - Survey on existing strategies for monitoring and risk definition. View.
  • Deliverable 13-14 - Development of a risk assessment tool, assessment of its reliability and definition of a common monitoring strategy and report. View.
  • Deliverable 15 - Specification of quality based Standard Operating Procedures design to address the issues and needs of transnational projects. View.
  • Deliverable 16 - Standard Operating Procedure Development, review, approval and management of SOPs. View.
  • Deliverable 17 - Final report on quality assurance. View.
  • Deliverable 18 - Standard Operating Procedures on Ethics. View.
  • Deliverable 19 - Standard Operating Procedures on Regulation and interaction with competent authorities. View.
  • Deliverable 20 - Standard Operating Procedures on adverse event reporting. View.
  • Deliverable 21 - Standard Operating Procedures on monitoring. View.
  • Deliverable 22 - National reports for new networks connecting to ECRIN. View.
  • Deliverable 23 - ECRIN Website (www.ecrin.org). View.
  • Deliverable 24 - Survey on existing education programmes within the ECRIN member states. View.
  • Deliverable 25-26 - Material for European and national educational programs. View.

 

Feinberg J, Nielsen EE, Korang SK, Halberg Engell K, Nielsen MS, Zhang K, Didriksen M, Lund L, Lindahl N, Hallum S, Liang N, Xiong W, Yang X, Brunsgaard P, Garioud A, Safi S, Lindschou J, Kondrup J, Gluud C, Jakobsen JC. Nutrition support in hospitalised adults at nutritional risk. Cochrane Database of Systematic Reviews 2015, Issue 3. Art. No.: CD011598. DOI: 10.1002/14651858.CD011598. View supplementary material.

 

CLASSIC Trial - Conservative vs. Liberal Approach to fluid therapy of Septic Shock in Intensive Care - Statistical Analysis Plan for the Classic Trial. Valid from December 2nd 2015. View supplementary material.

 

Almdal TP, Boesgaard TW, Breum L, et al. The CIMT Trial: Quality of Life and clinical outcomes in the CIMT-Trial. 2015. View supplementary material

 

Bjelakovic G, Nikolova D, Wetterslev J, Gluud C. Comment to: ‘Meta-analysis of long-term vitamin D supplementation on overall mortality’. PLOS ONE. 2014. View supplementary material.

 

Nielsen N, Wetterslev J, Cronberg T, et al. Targeted temperature management at 33 degrees Celsius versus 36 degrees Celsius after cardiac arrest. N Engl J Med. 2013. View supplementary material.

 

Hemmingsen B, Lund SS, Gluud C, Vaag A, Almdal TP, Hemmingsen C, Wetterslev J. Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus. Cochrane Database of Systematic Reviews. 11 nov 2013, 11, s. CD008143. View supplementary material.

 

Bjelakovic G, Gluud LL, Nikolova D, Whitfield K, Wetterslev J, Simonetti RG, et al. Vitamin D supplementation for prevention of mortality in adults. Cochrane Database of Systematic Reviews. 2014, 1, s. CD007470. View supplementary material.

 

Jakobsen JC. Treatment manuals for the MIPSY trial. 2010. View supplementary material.

 

Rambaldi A, Saconato HH, Christensen E, Thorlund K, Wetterslev J, Gluud C. Glucocorticosteroids for alcoholic hepatitis - a Cochrane Hepato-Biliary Group systematic review with meta-analyses and trial sequential analyses of randomized clinical trials. Aliment Pharmacol Ther. 2008; 27(12): 1167-78. View supplementary material.

 

Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative metra-analysis. J Clin Epidem 2008: 61(1): 64-75. View supplementary material.

 

Bjelakovic G, Nikolova D, Gluud LL, Simonetti RG, Gluud C. Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis. JAMA 2007; 297(8): 842-57. View supplementary material.

 

Kruse A, Gluud LL, Rossel P, Krogsgaard K, Holm S, Mortensen EL, Gluud C, and the INFO II Trial Group. A randomised trial on the effects of written and oral information on nurses' knowledge about and attitude towards clinical research. Not published 2005. View supplementary material