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About print and distribute the medical technical operation scheme of traditional Chinese medicine clinical validation work requirements and the traditional Chinese medicine medical technical operation plan clinical validation work style of the notice

 

 

The 2013-08-13 16:13:47 reference: the department the author:

 

 

The medical administration of traditional Chinese medicine medical tube dinner-table [2013] no. 82

 

 

TCM medical technology group members units:

        According to the traditional Chinese medicine medical technological cooperation management plan "(the traditional Chinese medicine for the medical ZhengFa [2012] no. 43) and the traditional Chinese medicine medical technological cooperation work arrangements in 2013 (the medical administration of traditional Chinese medicine medical tube dinner-table [2013] no. 41) of the relevant requirements, to make medical technology of traditional Chinese medicine clinical validation work operations, we have to make the" traditional Chinese medicine medical technical operation plan clinical validation work style and the medical technical operation scheme of traditional Chinese medicine clinical validation work requirements. Hereby printed and distributed to you, please conscientiously in accordance with the relevant requirements of traditional Chinese medicine clinical validation operation plan all the work of medical treatment, and on July 31, 2013 will develop in the validation work plan submitted to the doctor of traditional Chinese medicine medical technological cooperation office for the record, on December 31, 2013 to submit periodic validation report.

        If you have any questions and Suggestions in the process of verification, please contact the doctor of traditional Chinese medicine medical technological cooperation office in time.

        Contact person and contact phone number:

        The state administration of traditional Chinese medicine department of medical administration

        Contact: wangchen Dong Yunlong fate

        Tel: 010-59957689, 59957688

        Chinese medicine medical technological cooperation office

        Contact: Chen jing Dong Jikai

        Contact phone number: 13911899974 64176177

 

 

The state administration of traditional Chinese medicine department

On July 17, 2013

 

 

Medical technology operation plan clinical validation work style of traditional Chinese medicine

 

 

        A, a verification purpose

        Determine the clinical efficacy and safety of technical operation, etc.

        Second, the test content

        1. To adapt to the disease. Treatment of the disease effectively, this technical authentication of disease to need to technological cooperation according to the technical operation of attending disease to determine.

        2. Clinical effect. Verify the clinical curative effect of this technology and the specific curative effect, clinical results and evaluation method should be determined between group members units. (curative effect evaluation to overall evaluation, including symptoms, signs, improve physical and chemical indicators, etc.)

        3. Operation method. Verify this technology commonly used instruments, operation method, contraindications and precautions such as suitability.

        4. The treatment difficulty and new growth point of technology. Treatment difficulty is found in the validation process of this technology is difficult to solve clinical problems, a new growth point is found in the validation of new curative effect of point of this technology.

        Three, to participate in the verification unit.

        Participate in each operation scheme verify unit must be more than three.

        Fourth, validation method.

        According to the different technology and prophase work, select the verification method to be suitable for:

        1. The conditional can use randomized controlled method;

        2. Adopt the methods of random parallel comparison, historical comparison, after the implementation of technical operation schemes to evaluate the curative effect of traditional Chinese medicine;

        3. With the method of clinical case reports, to a certain number of curative effect of patients after application cases were summarized and curative effect evaluation.

        Verify each technological cooperation to make a report on the case before.

        Five cases, validation

        Determine each validation shall assume the number of cases (in principle, each unit of not less than 30 cases), confirmed case validation criteria, etc.

        Six, verification time

        Verify the specific time arrangement.

        Seven, other

 

 

 

Medical technical operation scheme of traditional Chinese medicine clinical validation work requirements

 

        A, validation, organization and management

        The unified leadership of the state administration of traditional Chinese medicine department, the state administration of traditional Chinese medicine of traditional Chinese medicine medical technological cooperation office is responsible for organizing, types of collaboration, technological cooperation specific implementation.

        Validation process to give full play to the committee of experts and categories consortium led by unit, the role of technological cooperation led units, fully mobilize the enthusiasm of each member.

        Second, the validation work plan according to the procedures

        1. The technological cooperation led units proposed validation plan, listen to the views of the member units, the category group.

        2. The categories within the focal organization groups working committee and the committee of experts, to submit the validation work plan after the review, submitted to the state administration of traditional Chinese medicine of traditional Chinese medicine medical technological cooperation office for record.

        Third, the implementation of the verification work

        1. The types of consortium is responsible for the validation work within our group organization and coordination and guidance.

        2. The technological cooperation organization member of this group to determine each of the authentication.

        3. Technical training cooperative organizations involved in the validation of the unit.

        Four, verify the quality of management

        1. Verify the participation, head of the unit is responsible for the quality inspection work.

        2. The types of collaboration, the technological cooperation established inspection team, responsible for checking the validation of the member unit of work, and regularly check the authentication and records for the record.

        3. The state administration of traditional Chinese medicine department in conjunction with the provincial administration of traditional Chinese medicine is not random verification work regularly.

        Five, the time schedule

        June - July, 2013, 1.2013 years validation work plan formulation. Various technological cooperation in accordance with the requirements for validation work plan and report to categories within the audit.

        In August 2.2013 - June 2014, validation work concrete implementation phase. After categories within the audit, the technological cooperation organizations, participation units specifically responsible for the validation of this unit, ensure to finish, and submit the validation report and the data of this unit. Submit periodic report before the end of December 2013.