BACKGROUND: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. METHODS: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. RESULTS: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. CONCLUSION: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.
Clinical Trials Data Monitoring Committees* ; Europe ; Humans ; Korea

OBJECTIVETo ensure and enhance the quality of multi-central large sample clinical trials of acupunc ture and moxibustion.

METHODSTake the multi-central clinical trials supported by National Key Technology R &- D Program of "the 11th Five-year Plan" as an example to introduce the duty of monitors and simply describe the formulation of the monitoring plan, the monitoring procedure and contents of the monitoring plan and treatment of the commonly-seen problems.

CONCLUSIONQuality monitoring work in multi-central large sample clinical trials of acupuncture and moxibustion is equally serious and scientific with clinical medical trials and it is an important way to guarantee the credible results.

Acupuncture Therapy ; Clinical Trials Data Monitoring Committees ; Clinical Trials as Topic ; Humans ; Quality Assurance, Health Care