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.[issue article order] supervisory management board of national provision medicines and chemical reagents makes the 5th
.[issue date] 2004-01-17
.[effective date] 2004-04-01
.[date of failure]-----------
.[what belong to a category] state law code
.[file origin]-----------
Clinical trial sets medical devices(National provision medicines and chemical reagents supervises management board to make the 5th)
" clinical trial sets medical devices " supervised joint hearing of Wu of management board bureau to discuss via national provision medicines and chemical reagents on December 22, 2003 through, grant to release now. This provision applies since April 1, 2004.
Director: Zheng Xiaoyu
24 years on January 17
Clinical trial sets medical devicesGeneral principles of the first chapterThe first is the management that strengthens clinical to medical devices trial, safeguard suffer rights and interests of the person that try, make sure clinical trial result is true, reliable, basis " medical devices monitors regulation " , make this provision. The 2nd medical devices is clinical of the experiment carry out reach supervisory examination, ought to according to sets originally. What this the 3rd regulation calls medical devices clinical trial is to point to: Obtain medical devices the medical establishment of clinical trial qualification (weigh medical establishment below) the process that the security that the medical devices that registers to application issues in normal use condition and effectiveness have try out or test and verify according to the regulation.
Medical devices is clinical the purpose of the experiment is the evaluation suffers try a product to whether have expectant security and validity. Clinical trial ought to abide by the 4th medical devices " Helsinki of world medicine congress is enunciative " (accessory 1) moral principle, character of just, esteem, do one‘s best makes suffer the person that try to the oldest rate is benefited and avoid to harm as far as possible. Clinical trial divides the 5th medical devices medical devices is clinical try out and medical devices are clinical test and verify.
Medical devices is clinical try out is to point to through clinical use come test and verify is principle of theory of this medical devices, basic the element such as structure, function whether assure security effectiveness.
Medical devices is clinical test and verify is to point to through clinical use come test and verify this medical devices and already appeared on the market the element such as the main structure of the product, function whether materiality is equal, whether to have same security, validity.
Medical devices is clinical the limits of try out: Had not have appeared on the market, the medical devices that security, effectiveness remains to affirm.
Medical devices is clinical the limits of test and verify: Congener product already appeared on the market, its security, effectiveness needs the medical devices that affirms further. The 6th medical devices is clinical the premise condition of the experiment:
(one) this product has what check passes to register product standard or corresponding country, occupation standard;
(2) this product is had measure a report oneself;
(3) this product has medicines and chemical reagents of food of the State Council to supervise management department to supervise what the branch approbates to detect jointly with technology of quality of the State Council orgnaization report of issued product type test, and conclusion is qualification;
(4) suffer try a product to be the medical devices that is used at embedded human body first, the animal test that ought to have this product reports;
Other need is affirmed by animal experiment the product is clinical to human body the product of experiment security, also ought to submit animal experiment report.
The 2nd chapter suffers the safeguard of rights and interests of the person that tryClinical trial does not get the 7th medical devices to get fee of collection of the person that try. The 8th medical devices is clinical experiment controller or its client ought to to suffer the person that try or its are legal agent defines as follows item:
(one) suffer the person that try to attend clinical trial of one‘s own accord, authority is exited in any phase of clinical trial;
(2) the individual data that gets the person that try is confidential. Ethical committee, (food) the supervisory management department of medicines and chemical reagents, person that carry out can consult the data that gets the person that try, but must not disclose its content external;
(3) medical devices is clinical test program, especially clinical trial purpose, process mixes medical devices deadline, anticipate the risk that bears the person that try to be benefited possibly to arise with the likelihood;
(4) medical devices is clinical during the experiment, medical establishment is accountability to the information data that gets the person that try to offer as clinical as this trial to concern;
(5) try product reason to cause because of sufferring suffer the person that try to damage, the person that carry out ought to give get the compensation with the corresponding person that try; About compensation matters concerned ought to be in medical devices carries in clinical trial contract bright. The 9th suffers the person that try to be in sufficient understanding medical devices is clinical on the foundation of experiment content, obtain " know the inside story agrees with a book " . " know the inside story agrees with a book " except outside ought to including to stipulate the 8th place lists each originally, still ought to include the following content:
(one) medical devices is clinical experiment controller autograph and autograph date;
(2) suffer the person that try or its are legal procuratorial autograph and autograph date;
(3) medical establishment in medical devices the discovery in clinical trial suffers try a product to expect the clinical impact beyond, must be opposite " know the inside story agrees with a book " relevant content undertakes modification, endure the person that try or its are legal procuratorial new sign one‘s name affirms.
The 3rd chapter medical devices is clinical test programThe 10th medical devices is clinical test program is to clarify the file of the content such as method of analysis of experiment purpose, risk, overall design, experiment and measure. Experiment plan ought to be made before clinical trial begins medical devices, medical devices is clinical the experiment must undertake according to this test program. Eleventh medical devices is clinical test program ought to suffer rights and interests of the person that try, safety and health to be first principle with utmost ground safeguard, the format that ought to press a regulation with the person that carry out by the medical establishment of responsible and clinical trial (accessory 2) collective design is made, after ethical committee is approbated, the newspaper is carried out; If have,revise, must agree via ethical committee. Dozenth inside the 3rd kind of when have not appear on the market embedded body or the medical devices that uses theory of doctor of traditional Chinese medicine to be made, clinical trial program ought to judge an orgnaization to put on record to careful of technology of medical devices. Thirteenth the congener medical devices that already appeared on the market appears undesirable incident, or the medical devices with ambiguous curative effect, national provision medicines and chemical reagents controls management board but the regulation of the clinical trial program with unified formulate.
Begin the clinical trial of this kind of medical devices, the person that carry out, medical establishment and clinical trial personnel ought to implement the provision of unified clinical trial program. Clinical trial program ought to be aimed at the 14th medical devices specific suffer the character that tries a product, determine number of clinical trial routine, duration and clinical evaluation level, make test result has statistical sense.
Plan of clinical try out ought to prove medical devices suffer the basic case that tries the element such as product theory principle, basic structure, function and accept the security validity that tries a product.
Plan of clinical test and verify ought to prove medical devices suffer try product and already appeared on the market the element such as the main structure of the product, function whether materiality is equal, whether to have same security, validity. Clinical trial program ought to include the 15th medical devices the following content:
(one) the title of clinical trial;
(2) the purpose of clinical trial, setting and content;
(3) clinical evaluation standard;
(4) the risk of clinical trial and be benefited analysis;
(5) full name of clinical trial personnel, post, title and hold a post branch;
(6) overall design, include the possibility analysis that succeed or fails;
(7) clinical trial duration reachs his to decide reason;
(8) every disease is planted number of clinical trial routine reachs his to decide reason;
(9) the ground that chooses amount of target range, object and option, contrast when necessary the setting of the group;
(10) remedial sex product ought to have get used to disease or suitable scope clearly;
(11) the assessment technique of clinical function and statistical processing technique;
(12) side-effect is forecasted reach the step that ought to take;
(13) suffer the person that try " know the inside story agrees with a book " ;
(14) each duty. The 16th medical establishment signs the clinical trial program that both sides agrees with with the person that carry out, sign clinical trial contract. Clinical trial ought to be in the seventeenth medical devices two above (contain two) medical establishment undertakes.
The 4th chapter the person that clinical trial carries out medical devicesThe 18th person that carry out is in charge of initiating, carry out, organization, aid financially and inspect is clinical experiment. The person that carry out registers the unit of product of this medical devices for application. Duty of the 19th person that carry out:
(one) choose medical establishment lawfully;
(2) offer to medical establishment " medical devices is clinical experiment notice " ;
(3) as collective as medical establishment design, make medical devices clinical trial program, the medical devices that signs both sides to agree is clinical test program and contract;
(4) offer freely to medical establishment suffer try a product;
(5) personnel of clinical to medical devices trial undertakes grooming;
(6) offer to medical establishment assure;
(7) produce serious side effect ought to according to the facts, part in time to the province that accepts this medical devices to register application, municipality, municipality directly under the Central Government (food) report of supervisory management board of supervisory management department of medicines and chemical reagents and national provision medicines and chemical reagents, at the same time to undertake the other medical establishment of clinical trial reports this medical devices;
(8) medical devices of break down of the person that carry out is clinical before the experiment, ought to inform medical establishment, ethics of committee and the province that accept this medical devices to register application, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents and national provision medicines and chemical reagents control management board, show reason;
(9) suffer those who try a product to be damaged to sufferring the person that try to cause, the person that carry out ought to press medical devices clinical trial contract gives get compensation of the person that try. The 20th " medical devices is clinical experiment notice " ought to include the following content:
(one) suffer try product principle specification, get used to disease, function, anticipate achieved use goal, use interpellate, installation interpellate;
(2) get the technical index that tries a product;
(3) supervisory management department of medicines and chemical reagents of food of the State Council supervises what the branch approbates to detect jointly with technology of quality of the State Council orgnaization issue suffer try report of product type test;
(4) the risk that produces possibly, recommend be on guard reach urgent processing technique;
(5) the confidential issue that involves possibly.
The 5th chapter medical establishment and medical devices are clinical experiment personnelThe 21st assumes medical devices the medical establishment of clinical trial, it is to show medicines and chemical reagents of food of course the State Council monitors the drug that management department holds jointly with service of sanitation of the State Council clinical trial base. Clinical trial personnel ought to have the 22nd medical devices the following condition:
(one) have the professional specialty that assumes this clinical trial, qualification and capacity;
(2) the concerns with clinical trial material that is familiar with place of the person that carry out to offer and document. The 23rd responsible medical devices is clinical the medical establishment of the experiment and duty of clinical trial personnel:
(one) the concerned data that ought to be familiar with the person that carry out to offer, familiar suffer those who try a product to use;
(2) as collective as the person that carry out design, make clinical trial plan, both sides signs clinical trial program and contract;
(3) according to the facts to suffer specification of the person that try to get the detailed case that tries a product, before clinical trial is carried out, must give suffer the time with the sufficient person that try to consider to whether attend clinical trial;
(4) record according to the facts accept the side-effect that tries a product and undesirable event, analyse a reason; Produce undesirable incident and serious side effect, ought to according to the facts, part in time to the province that accepts this medical devices to register application, municipality, municipality directly under the Central Government (food) report of supervisory management board of supervisory management department of medicines and chemical reagents and national provision medicines and chemical reagents; Produce serious side effect, ought to report inside 24 hours;
(5) when producing side effect, clinical trial personnel ought to make clinical judgement in time, take step, protection gets benefit of the person that try; When necessary, ethical committee has right instantly break down is clinical experiment;
(6) of clinical trial break down, ought to inform suffer committee of the person that try, person that carry out, ethics and the province that accept this medical devices to register application, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents and national provision medicines and chemical reagents control management board, show reason;
(7) offer clinical trial report, be in charge of to the validity of the report and dependability;
(8) right the data that the person that carry out provides has confidential obligation. The medical establishment of clinical trial ought to chair the 24th responsible medical devices certainly the professional technology personnel of clinical trial regards clinical trial as chief. Clinical trial controller ought to be had advocate the title that treats doctor above.
The 6th chapter medical devices is clinical test reportAfter clinical trial finishs the 25th medical devices, the medical establishment that assumes clinical trial ought to press medical devices the format of the requirement of clinical trial program and regulation (accessory 3) issue clinical trial to report. Medical devices is clinical test report ought to be signed by clinical trial personnel, dated, sign order of opinion, dated, lot by the clinical trial management department in the medical establishment that assumes clinical trial. Clinical trial report ought to include the 26th medical devices the following content:
(one) the disease of the experiment is planted, analyse of constituent of the sexual distinction of gross of case of illness and case of illness, age, cent, contrast the setting of the group (when necessary) ;
(2) clinical trial method;
(3) uses statistical method and assessment technique;
(4) clinical evaluation standard;
(5) clinical trial result;
(6) clinical trial verdict;
(7) the undesirable incident that discovers in clinical trial and side-effect and its processing circumstance;
(8) analysis of clinical trial result;
(9) get used to disease, suitable scope, no-no disease and note;
(10) existence problem and improve a proposal. The 27th medical devices is clinical test data appropriate is saved and ought to manage. After medical establishment ought to save clinical trial data to be stopped to the experiment 5 years. After the person that carry out ought to save the product investment that clinical trial data comes to be produced finally to use 10 years.
Supplementary articles of the 7th chapterThis the 28th regulation supervises management board to be in charge of explaining by national provision medicines and chemical reagents. This the 29th provision applies since April 1, 2004.
Accessory: 1. Helsinki of world medicine congress is enunciative
2. Medical devices is clinical test program (slightly)
3. Medical devices is clinical the experiment reports (slightly)
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