"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).
WHO/TDR annual meeting on clinical data management is one of the WHO/TDR routines and has important guidance to international clinical trail of drug for tropical disease. The last meetings has been held in Japan , Thailand and India .
The objective of the meeting 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.
The 2005 Annual Meeting on Clinical Data Management was held at the Second Military Medical University (SMMU), Shanghai, China during 26-28 September 2005. Attendees including Doctor Juntra Karbwang (Clinical Coordinator of WHO), Doctor Kenji Hirayama (Vice President of Nagasaki University, Japan), Kesara Na-Bangchan (Dean of the Faculty of Allied Health Sciences, Thammasat University, Thailand) and Doctor Ivan D.Velez (Director of the Programa de Estudio y Control de Enfermedades, Colombia)are all famous experts in the field of preventive medicine.The 2005 annual meeting was organized by the Department of Health Statistics (DoHS) of the Faculty of Health Service (FoHS) and the Clinical Pharmacology Center of the Second Military Medical University. They have already had many cooperative clinical trails with the WHO/TDR and established profound friendship between each other.
In the year 2003, DOHS has been set by the WHO/TDR as clinical data management center. Since its foundation, it has attended various training courses and academic exchanges sponsored by WHO/TDR which greatly enhanced its academic level on clinical experiment researching. This is the first international meeting held by FoHS of SMMU. It has active promotions in enhancing international academic exchange and subject construction and development of the FoHS. And it shall increase FoHS's influence on preventive medicine researching via famous experts attending this meeting and promote the status of SMMU in clinical data management and analysis of tropic disease in the Asia Pacific Region. |
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