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CLINICAL DATA MANAGEMENT
Background
"Clinical data management" is a profession with increasing importance in product research and development process. It is now firmly established discipline in its own right, and is becoming an area that researchers know about and can progress their careers within. The term "data management" in clinical trials become a very general term that covers the procedures both for collection of data at clinical sites and for the quality control of those data after they have been submitted to a statistical or coordinating centre. Clinical data management team are charged with producing high quality databases that meet clinical and regulatory requirements. The quality of a clinical trial determines the acceptability of the results and care must be taken to ensure that high standards of quality are present both in the clinical trial design and in the integrity and interpretation of data. To this end, all participants in the clinical trial have a role to play in safeguarding data integrity. Data validation activities start at the investigator site and end with a statement in clinical or expert reports to indicate that the clinical trial was conducted in accordance with "Good Clinical Practice" (GCP) and that the report provides a complete and accurate account of the data collected during the trial. Procedures should be established for managing the trial data, and steps taken to ensure that the quality of data is high throughout a trial. Effective project management also requires key communication skills, closing the feedback loop and ensuring that all involved in the process flow actively participate in the reduction of process cycle times.
UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) has recognised the importance of Clinical Data Management in supporting the GCP clinical trials and has put efforts on establishing the Clinical Data Management Centres in Asia (1 in Japan, 2 in India, 1 in China and 2 in Thailand), Africa (I in Ethiopia) and South America (1 in Colombia). The ‘Brainstorming Meeting on Clinical Data Management’ was held at the Faculty of Allied Health Sciences, Thammasat University, Thailand during 26-26 November 2002. This was followed by ‘Clinical Data Management Workshop’ held at the same place during 24-29, March 2003. A series of training course/meeting has now being planned, i.e., ‘WHO/TDR Training Course on Clinical Data Management Software’ (to be held at Thammasat University, Thailand, during 22-26, September, 2003), and ‘WHO/TDR Workshop on Standard Operating Procedures (SOPs) for Clinical Data Management’ (to be held at Thammasat University, Thailand, during 28-30, September). It is expected that by the end of this year (December 2003), all ‘TDR Clinical Data Management Centres’ would have some progress in the clinical data management activities at their centres.
Objective
The objective of the ‘WHO/TDR Annual Meeting on Clinical Data Management’ is to assess and follow up with the progress in clinical data management activities in the eight ‘TDR Clinical Data Management Centres’. Data management teams from the involved centres will have opportunity to present their activities and exchange experiences with other teams. |
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Last Update: September 21, 2006
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