Issued by the state administration

of traditional Chinese medicine

on the national office of traditional

Chinese medicine

Clinical research base clinical research norms

Construction instruction opinion "(try the line) of notice

congress

Countries do science and technology of Chinese medicine [2011] no. 35

The provinces, autonomous regions, municipalities directly under the central government health TingJu, administration of traditional Chinese medicine, the units directly under the bureau, Beijing university of Chinese medicine, Chinese medicine clinical research base for each country construction unit, the national Chinese medicine clinical research base DuDaoZu members:

For the purpose of further regulating the national Chinese medicine clinical research base clinical research work, according to the 2011 national Chinese medicine clinical research base business construction work, the overall arrangement &fishery administration formulated by the Chinese clinical research base of national standard clinical research guiding opinion on construction (trial implementation) (hereinafter referred to as the "opinions"), hereby printed and distributed to you, and notify relevant matters are as follows:

A, please according to the opinions of the base request, unifies the actual situation of the work unit, key disease clinical research on the different requirements and links in clinical research, a systematic quality management process, and on the basis of this base formulates the clinical study of standard system. These guiding opinions attached "national Chinese medicine clinical research base clinical research standard document framework", "make standard operating procedures (SOP) standard operating procedures" and "clinical research scheme design norm" as the only standard reference for base.

Second, the base in the standard system, after the completion of training should be strengthened, and in clinical research in the actual process carried out seriously standard, well written records, make it become the guarantee the quality of clinical research the important means. The base construction unit standard system completion status and executive records will be as part of the 2012 base business construction supervision the important content.

Three, the base in formulating and implementing standard process, technical problems related to our Chinese clinical research can be key research laboratory consultation method. In the opinions of the implementation process any comments and Suggestions, please inform our congress.

Four, contact and telephone:

Traditional Chinese medicine (base of statistics of congress office)

WangSiCheng Chen army (010-59957712)

Traditional Chinese medicine clinical research key research laboratory

HuJingQing (010-88001294)

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