| 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
The data shown below were compiled from readership statistics for 151 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 | 135 | 89% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 36 | 24% |
| Student > Master | 23 | 15% |
| Other | 17 | 11% |
| Student > Ph. D. Student | 15 | 10% |
| Student > Bachelor | 12 | 8% |
| Other | 31 | 21% |
| Unknown | 17 | 11% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 42 | 28% |
| Computer Science | 20 | 13% |
| Biochemistry, Genetics and Molecular Biology | 9 | 6% |
| Agricultural and Biological Sciences | 9 | 6% |
| Business, Management and Accounting | 9 | 6% |
| Other | 39 | 26% |
| Unknown | 23 | 15% |