↓ Skip to main content

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

Overview of attention for article published in Trials, March 2011
Altmetric Badge

Mentioned by

blogs
1 blog
wikipedia
1 Wikipedia page

Citations

dimensions_citation
60 Dimensions

Readers on

mendeley
149 Mendeley
citeulike
3 CiteULike
You are seeing a free-to-access but limited selection of the activity Altmetric has collected about this research output. Click here to find out more.
Title
Standard requirements for GCP-compliant data management in multinational clinical trials
Published in
Trials, March 2011
DOI 10.1186/1745-6215-12-85
Pubmed ID
Authors

Christian Ohmann, Wolfgang Kuchinke, Steve Canham, Jens Lauritsen, Nader Salas, Carmen Schade-Brittinger, Michael Wittenberg, Gladys McPherson, John McCourt, Francois Gueyffier, Andrea Lorimer, Ferràn Torres, the ECRIN Working Group on Data Centres

Abstract

A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials.

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 149 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Germany 4 3%
Switzerland 3 2%
United Kingdom 3 2%
Tanzania, United Republic of 1 <1%
Malaysia 1 <1%
Finland 1 <1%
Belgium 1 <1%
Denmark 1 <1%
Russia 1 <1%
Other 0 0%
Unknown 133 89%

Demographic breakdown

Readers by professional status Count As %
Researcher 36 24%
Student > Master 22 15%
Other 17 11%
Student > Ph. D. Student 15 10%
Student > Bachelor 12 8%
Other 30 20%
Unknown 17 11%
Readers by discipline Count As %
Medicine and Dentistry 42 28%
Computer Science 20 13%
Business, Management and Accounting 9 6%
Agricultural and Biological Sciences 9 6%
Biochemistry, Genetics and Molecular Biology 9 6%
Other 37 25%
Unknown 23 15%