title: Improved quality monitoring of multi-center acupuncture clinical trials in China.
abstract: BACKGROUND
  In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs).
  
  
  METHODS
  A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy.
  
  
  CONCLUSIONS
  The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency.
  
  
  CONCLUSIONS
  Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.
authors.affiliation: College of Acupuncture and Massage, Chengdu University of TCM, Chengdu, Sichuan 610075, China. ling94@163.com
authors.forename: Ling
authors.initials: L
authors.lastname: Zhao
authors.forename: Fan-rong
authors.initials: FR
authors.lastname: Liang
authors.forename: Ying
authors.initials: Y
authors.lastname: Li
authors.forename: Fu-wen
authors.initials: FW
authors.lastname: Zhang
authors.forename: Hui
authors.initials: H
authors.lastname: Zheng
authors.forename: Xi
authors.initials: X
authors.lastname: Wu
mesh_terms: D015670:Acupuncture Therapy; D002681:China; D006801:Humans; D008485:Medical Audit / Q000379:methods / Q000458:organization & administration; D008516:Medicine, Chinese Traditional; D015337:Multicenter Studies as Topic / Q000592:standards*; D015397:Program Evaluation; D011785:Quality Assurance, Health Care / Q000379:methods / Q000458:organization & administration*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*