Issued by the state bureau of

traditional Chinese medicine

Chinese medicine clinical research base construction four specifications

China's traditional Chinese medicine for dispatch (reporter to the good) July 7,, issued by the state administration of traditional Chinese medicine "Chinese medicine clinical research ethics review platform construction norms," and "national Chinese medicine clinical research base clinical research standardization of construction instruction opinion", "the national Chinese medicine clinical research base of traditional Chinese medical treatment and the clinical scientific research information sharing system construction basic requirements", "the national Chinese medicine clinical research base clinical scientific research ability training program of backbone four standard for the guidelines. Four specifications (guide) reflects the base appoaches to the overall thinking, the base construction, increasing deepening business clinical scientific research ability has guiding significance.

Construction ethics review platform

To ensure the country's traditional Chinese medicine clinical research base in scientific research project more standard, research results are more likely to be approved, the state administration of traditional Chinese medicine ethics review into the first standard, has formulated the Chinese medicine clinical research ethics review platform construction standard ". The move is to protect the rights and interests of the subjects and health, and promoting the quality of high clinical research important measures.

The "standard" clear requirements in Chinese medicine clinical research organization, must according to the related laws and regulations, and the ethical guidelines, is responsible for establishing the protection of human research subjects organization management system, make clear the related departments and personnel duties, and ensure that this organization, and take in the organization of the implementation of all of the people involved in biomedical research projects submitted to ethics review, subjects were protected, and ensure that the ethics committee to perform function independently.

The detailed provisions in the "code for the Chinese medicine clinical research ethics review platform construction quality assessment main point, base on the DuDaoZu business construction at the base of the implement supervision inspection. In addition, the base unit ethics review platform construction work, the ethics committee members, the relevant system and operation will also regularly submit to the state administration of traditional Chinese medicine.

Ensure the quality of clinical research

The national Chinese medicine clinical research base clinical research standardization of construction in order to ensure the guiding opinions of traditional Chinese medicine clinical research base clinical research quality, promote the discipline construction, improve the clinical research standard system.

"Opinions" clearly put, clinical research must comply with the regulations legitimacy, scientific, systematic and controllable and adaptability five principles, clinical studies standard system should include at least management system, responsibilities, standard operating procedure, technical specifications and emergency plan etc five parts content. The opinions of the 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 code" is formulated as the base of the reference standard. 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. It is reported, the base construction unit standard system completion status and executive record, will become 2012 base construction supervision is an important content of the business.

Set up information sharing system

The national Chinese medicine clinical research base of traditional Chinese medical treatment and the clinical scientific research information sharing system construction basic requirements in order to make full use of clinical practice produce a large amount of information of high quality research, innovation in Chinese medicine clinical scientific research organization model, to construct the characteristics of the traditional Chinese medicine, and to further improve the research methods of traditional Chinese medicine of traditional Chinese medicine clinical research base country clinical research ability and efficiency.

Build "of traditional Chinese medical treatment and the clinical scientific research information sharing system", is to follow the traditional Chinese medicine clinical research, in view of the characteristics of the actual data base clinical research, the construction of the key problems of clinical data collection, management and utilization of the technical support system, and realize medical and clinical research information sharing, thus improving TCM clinical research base overall ability and efficiency.

Base to set up sharing system construction leading group, group leader by the hospital as the main leadership, members shall include key research disease to scientific research, information, and the person in charge of the medical department functions such as director. Leading group is responsible for formulating base sharing system construction planning; Coordination and organization key research disease to technical standard system formulated and staff training, hardware construction and software system installation, information system integration and operation commissioning etc construction tasks.

Base construction DuDaoZu will be based on the business requirements of each base to timely implement supervision inspection to 2012 by the end of the year to at least in key disease research application sharing system.

Curing talents training mode

For promoting Chinese clinical scientific research personnel training standardization and the systematic, form practical and efficient training system, and promote the scientific research personnel and to enhance the ability of fast growth, the state administration of traditional Chinese medicine special formulated the "national Chinese medicine clinical research base clinical scientific research ability training program of backbone.

The outline of traditional Chinese medicine research points out, according to the national business base construction goal request for clinical research backbone should have: clinical base scientific research management knowledge system and clinical research methodology, Chinese medicine clinical research knowledge system requirements new methods and techniques, new model, Chinese herbal medicine research and development and ethics knowledge.

According to the actual demand, the outline of the basic set of implementation, including class and improve class, training project 22. According to introducing, through the implementation of the syllabus, Chinese medicine clinical research base and professional talents talents to a certain amount, to participate in training the Chinese clinical scientific research personnel not less than 1000 people; 80% of them master clinical scientific research basic knowledge and skills, of which 20% master clinical scientific research project, design, implementation, to the leader in the field of basic requirements. The outline of the cultivation plan for the implementation of the fixed number of year is expected to end in December 2012.