LI Hongjiao, HE Liyun, ZHANG Xin, et al. Content and Methods of Quality Control for a Large Sample,Multicenter,Randomized,Double-blind Controlled Trial of Chinese Medicine Treatment of Cold[J]. Journal of Traditional Chinese Medicine2015, 56(16): 1374-1377.
LI Hongjiao, HE Liyun, ZHANG Xin, et al. Content and Methods of Quality Control for a Large Sample,Multicenter,Randomized,Double-blind Controlled Trial of Chinese Medicine Treatment of Cold[J]. Journal of Traditional Chinese Medicine2015, 56(16): 1374-1377.DOI: 10.13288/j.11-2166/r.2015.16.008.
Because of the influence of subjects’ poor compliance
failure to record the combined drugs and other factors
it is difficult to make quality control during the large sample multicenter
randomized
double-blind controlled trials of Chinese Medicine treatment of cold
which finally will affect the authenticity and scientific nature of the study results. To ensure research implementation quality
in a multicenter
randomized
double-blind controlled trial including 3000 cases of cold treated with antiviral oral liquid
the quality control method of field distance interaction was adopted. The advantage of field quality control was researchers( implementation interveners and effect evaluators) and subjects could meet face to face. Thus it was appropriate to develop interview of research related personnel and to study the information origins. The advantage of distance quality control was real-time. Quality control personnel could know study progress
adverse events and other situations by distance quality control instantly and meanwhile adjust check frequency of field quality control according to evaluation results of distance quality control
so that to save quality control cost
and at the same time ensure research quality. The content and methods of quality control did well control the quality of research
and it provided references for quality control in randomized controlled trials of Chinese Medicine treatment of cold.