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CLINICAL DATA MANAGEMENT

HIGHLIGHTS

   Diploma Course on Research & Development of Products to Meet Public Health Needs

Background

The mission of UNICEF-UNDP-World Bank-WHO Special Programme for Research and Training in Tropical Diseases (TDR) is to discover and develop to registration and out-license affordable products for TDR’s ten target diseases (malaria, leishmaniasis, onchocerciasis, Chagas disease, leprosy, tuberculosis, schistosomiasis, lymphatic filariasis, African trypanosomiasis and dengue).

In order to obtain regulatory approval, clinical studies of drugs/vaccines must be planned and conducted to meet relevant regulatory requirements and guidelines. Taken together, the guidelines and regulations concerning clinical research constitute what has come to be known as "Good Clinical Practice" (GCP). Compliance with GCP provides public assurance that the rights and safety of study participants have been protected and that the clinical study data are credible.

In the past years, TDR has put a lot of emphasis on capacity strengthening of the investigators and clinical monitors in disease endemic countries in GCP and complementary disciples including clinical data management. In recent years, much efforts have been put on clinical data management in supporting the GCP clinical trials.


"Clinical data management" is a profession with increasing importance in product research and development process and is considered as an integral part of clinical trials. 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 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. Involvement of clinical data management team into initial planning of the study is very essential and will lead to improvement of data quality.


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Last Update: January 17, 2011
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