Circular 03/2012/tt-Byt: Guidance On Clinical Drug Trials

Original Language Title: Thông tư 03/2012/TT-BYT: Hướng dẫn về thử thuốc trên lâm sàng

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Pursuant to the law on Pharmacy 14/06/2005 and Decree No. 79/2006/ND-CP dated 09/08/2006 detailing the Government's implementation of some articles of the law on Pharmaceuticals;
Pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health, the Department of health guidance on clinical drug trials as follows: chapter I GENERAL PROVISIONS article 1. Scope this circular instructions on the medicine to try long clinical trial, clinical, provided a number of clinical trials stage; clinical drug test conditions; registration, evaluation, approval of drugs on clinical trial, the clinical drug trial phases; the rights and obligations of the related objects; monitoring, inspection, evaluation test results of clinical drug trial in Vietnam for research, allowing the circulation of drugs pharmaceutical chemistry, biological medicine, Oriental medicine, vaccines and medicines from medicinal herbs used in the diagnosis, treatment and prevention is directly on the person (hereinafter referred to collectively as drugs).
Article 2. Explanation of terms In this circular, the terms below are interpreted as follows: 1. Water is a reference in the Britain, France, Germany, America, Japan, Australia, Canada or the management of health products in Europe (European Medicines Agency-EMA).
2. multi center study is a clinical trial was conducted in two research centres to ensure the universality of the number of participants in clinical drug trials, the demographic factor or anthropology.
3. Agencies, organizations, individuals with clinical reagents are the agencies, organizations, individuals have the function of research, production, import, export, distribute medication needs his medicine on the clinical trial.
4. the receiving organization to try smoking on clinical medical institutions can function in scientific research, are qualified professional manpower, facilities, equipment for making drugs on clinical testing and evaluation, Ministry of health allows.
5. Participants in clinical drug trials are patients or healthy volunteers willing to participate in the study.
6. clinical research organization (Contract Research Orgnization: CRO) is the organization with legal personality, whose competences match according to the regulations of the Ministry of health, independent of the agencies, organizations, individuals with clinical trial drugs, organized, individual drugs in clinical trials contracted to perform the work support for the study as written research outline monitoring, research, data analysis.
7. Governing the research location (Site Management Organization: SMO) is the organization with legal personality, capable of according to the regulations of the Ministry of health, independent of the agencies, organizations, individuals smoking in clinical trials, the organization received drugs on clinical trial be held, individuals have clinical reagents or organization receiving the drug on clinical trial contracts to perform the support work for the management of the research location.
8. the foreign clinical data as the method, the results of clinical studies have been performed abroad.
9. the race factor is the factor related to the large population groups that share the characteristics of heredity, culture, customs and Habitat.
10. international regulations about clinical drug trials are recognized by the Ministry of health is the Guide to good practice on clinical drug trials of block areas in the International Conference on harmonization on the use of pharmaceuticals (ICH) and the Guide to good practice on clinical drug trials (Good Clinical Practice GCP-) of the World Health Organization (WHO).
Article 3. Principles of clinical medicine test 1. The clinical drug trial have to in accordance with the provisions of this circular, the provisions of the law on Science and technology, good practice to try smoking on clinical and international treaties to which Vietnam is a member.
2. Participants in clinical drug trials must be selected in accordance with the principles of ethics in biomedical research.
Article 4. The prohibited acts 1. Research on clinically when the Ministry of health.
2. Arbitrary modification, additional content profile, outline of the study has been approved by the Ministry of health.
3. The use of drugs in clinical testing on other purposes.
4. Forced audience participation in research or concealed information or not providing the information prescribed for research participants.
Chapter II the SMOKING MUST TRY clinical, CLINICAL TRIAL EXEMPTION and the EXEMPTION of SOME CLINICAL TRIAL STAGE article 5. The drug must complete clinical trial phase 1. As for smoking, health food chemistry: a chemical substance-containing pharmaceutical Drugs) new, smoking has a new combination of medicinal substances were circulating.
b) B. medical products were first invented or new combinations of ingredients that have been circulating.
c) Smoking health products, pharmaceutical goods overseas have been floated but not enough for 5 years in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows).
d) Smoking health products, pharmaceutical chemistry have clinical trials prior to the time this circular effect but do not meet the rules of good practice to try smoking on the Ministry of health or clinical guidelines on good practice to try smoking on health are clinically recognized.
2. for vaccines: a new vaccine research), production and was first used.
b) vaccine has been floated but not enough for 5 years in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows).
c) vaccines in clinical testing prior to the time this circular effect but do not meet the rules of good practice to try smoking on the Ministry of health or clinical guidelines on good practice to try smoking on health are clinically recognized.
3. for Oriental medicine, the drug from medicinal herbs: a) containing new medicinal Drugs first used on people.
b) clinical testing of drugs prior to this circular effect but do not meet the rules of good practice to try smoking on the Ministry of health or clinical guidelines on good practice to try smoking on health are clinically recognized.
Article 6. Free clinical trial drugs 1. For Chemistry, medical products: a) the original name chemistry Drug (generic drugs).
b) foreign Drug has not yet been granted registration number circulating in Vietnam but has been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows) and the competent State authorities of the country that confirmed to be safe and effective , has the same roads, and content specified in Vietnam like specify in that country.
c) foreign Pharmacies have been given the registration number circulating in Vietnam, but there are changes or additions of new roads, new designation, the dosage like new, used, dosage of the medication that has been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows).
2. for vaccines: a) has granted foreign vaccines registered in Vietnam is still in force, were imported into Vietnam to complete the box, labeled phase.
b) vaccine registration in Vietnam due to expire the registration number and without any changes.
3. for Oriental medicine, medicines from medicinal herbs: a) the article Oriental medicine is recognized by the Ministry of health.
b) Oriental medicine, medicinal drugs from abroad has not been granted registration number circulating in Vietnam but has been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows) and the competent State authorities of the country that confirmed to be safe and effective , has the same roads, and content specified in Vietnam like specify in that country.
Article 7. Free drug clinical trial stage some 1. For Chemistry, medical products: Medicines abroad had registered in Vietnam but there are changes or additions of new roads, new designation, the new form other than specified, the road user, the dosage of the drug is being lawfully in circulation for at least 5 years in the country of origin (or country of reference if the international treaties to which Vietnam is a Member allow) to make: a Clinical Trial) reviews of security;
b) Clinical Trial evaluation of effectiveness in case not yet clinical trial evaluation of the effectiveness of clinical testing or evaluation of effectiveness but do not meet the rules of good practice to try smoking on the Ministry of health or clinical guidelines on good practice to try smoking on health are clinically recognized.
2. for vaccines: a) Clinical Trial safety assessment with regard to:-the foreign vaccine has not yet been issued the registration number circulating in Vietnam, has been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows) and the competent State authorities of the country that confirmed as safe and effective, have the same use, and content specified in Vietnam like specify in that country.
-Vaccines made in Vietnam made from packed lounges products imported from foreign countries which finished products of vaccines that have been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows).
-Vaccines have been given the registration number circulating in Vietnam but change or supplement excipients, preservatives, change production base (do not change the production process).
b) Clinical Trial evaluation on the safety and immune properties in phase 3 for:-foreign vaccines have been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows) technology transfer made in Vietnam.
-Vaccines produced in Vietnam are made from imported intermediate products that the products of the vaccines that have been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows).

-Vaccines have been given the registration number circulating in Vietnam but change or supplement a of the content: production process, dosage form, specify, use object (age, gender, race), the road user, the dosage, the vaccination schedule.
3. for Oriental medicine, medicines from medicinal herbs: Clinical Trials evaluation of safety for drugs have been circulating registration level in Vietnam and the article Oriental medicine is recognized by the Ministry of health but there are changes or additions on the specified path, using the formula, the other form with the specified roads, formula, the dosage of the drug have been circulating for at least 10 years lawfully in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows).
Article 8. Try smoking on clinical in some special cases, involving emergency health security the Minister of health to review the decision to exempt some drugs on clinical trial phase on the basis of the advice of the Advisory Council of the level of drug circulation and Registration Board of ethics in biomedical research-Ministry of health for the following cases : 1. Drugs used in special cases, involving emergency health security include: a) Smoking health products, pharmaceutical chemistry, the vaccine has been floated but not enough for 5 years in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows) , there have been multiple clinical trial data center are conducted in Vietnam and Asia, results of studies prove safe and effective, gaining the same amount, specified and used in Vietnam indicated that the country's like.
b) Chemistry Medicine, Oriental medicine, medicines from medicinal herbs to meet the requirements of special treatment, in the category of rare drugs by the Ministry of Health issued, there is a special form in the country have not produced, yet there are alternative medications without the drugs that will affect the patient's life, have not yet been issued the registration number circulating in Vietnam , was released but not yet enough for 5 years in the country of origin (or country of reference if the international treaties to which Vietnam is a member allows) and the competent State authorities of the country that confirmed to be safe and effective, have the same use, and content specified in Vietnam like specify in that country.
c) vaccines used to prevent infectious diseases new dangers arise unknown pathogens or infectious disease especially dangerous are likely spread quickly, spread wide and high mortality, have yet to be given the registration number circulating in Vietnam, has been circulating legally but not sufficient for 5 years in the country of origin (or country of reference if the Convention of the national which Vietnam is a member allows) and be competent State agencies of that country confirmed as safe and effective, have the same use, and content specified in Vietnam like specify in that country.
2. Smoking has had research results from the research level or equivalent and above was made prior to the time this circular effect that has been made in accordance with the provisions of this circular and the Guide to good practice on clinical drug trials, the Council of science and technology Ministerial level or equivalent or higher experience gained in love review and the proposal to allow widely applied.
Chapter III CONDITIONS of CLINICAL TRIALS on DRUGS article 9. Conditions of clinical reagents for clinical reagents must ensure the following requirements: 1. Have been studied in clinical stage, has the documents to prove the safety of the experiment to the next stage.
2. Have the formula, dosage and manufacture process stability.
3. research results of clinical trials the previous phase if the proposed drug testing on the next phase of clinical.
4. quality standards according to the registration records of clinical drug trials.
5. the clinical trial drug Labels "production for clinical trials. All spaces used for other purposes ".
Article 10. Conditions on resumes to try smoking on clinical drug trial registration profile on clinically by Vietnamese (1 original, signed, stamped and 3 copies) are: 1. drug testing form on the Agency's clinical, organizational, individual drugs in clinical trials (annex 1 attached to this circular).
2. product profile for research staff by Vietnamese or English accompanied by Vietnamese summary (Appendix 2 attached to this circular).
3. Application assessment, review of drug trial research outline on the receiving organization's clinical trial (Appendix 3 attached to this circular).
4. collaborative research contract to try drugs on between clinical, organizational, individual and the receiving organization to reagent test and the contract of cooperation between agencies, organizations, individuals with reagents to clinical research organizations, governing the location of research if (Appendix 3 attached to this circular).
5. Demonstration outline of clinical trials Research (Appendix 5 attached to this circular).
6. Curriculum vitae and certificate of good practice to try smoking on clinical research fellow/project by the Ministry of health or because the organizations are recognized by the Ministry of health.
7. A provide information on research and the vote volunteer researched (annex 6 attached to this circular).
8. Report on the evaluation of the surface science and ethics in research of the Council of ethics in biomedical research base level (the receiving organization to try smoking on clinical).
9. The text confirm involvement of research institutions to study the multi-center in Vietnam.
10. Written approval to participate in research of people's Committee of the central cities, for the studies in the field.
11. The document on the drug in clinical trials, including: a study of smoking materials): recipe ingredients, manufacturing processes, quality standards, drug testing (voucher for Chemistry medicine, Oriental medicine, medicinal drugs from the Agency's testing: testing the central drug or manufacturer's standard drug good manufacturing practices (GMP) for vaccines : test votes the Agency's quality national accreditation or certification issued for batches of vaccines, products of the national drug agency country).
b) clinical study documents of the drug need to try: a report of research on pharmacological effects, toxicity, safety, suggestions on dosage, route, using.
c) drug testing research papers on the clinical stage (if suggested clinically drug testing in the next phase).
12. certified copies of certificates of product (CPP) license or circulate (FSC) and the standard certificate of good manufacturing practices (GMP) of the State administration organs competent for these drugs suggest that clinical trial research reviews about computer safety, clinical trial stage 4.
13. the study medication Label as specified in clause 5 article 9 of this circular and the snapshot model smoking research.
Article 11. The condition of the receiving organization try, the main researcher and research participants in clinical drug trials 1. The receiving organization to try the drug on to clinical criteria for good practice in clinical drug trial (GCP); economic independence, organizational personnel with respect to individuals, the organizations that have the drug in clinical trials and the commitment to complete clinical trials do not have any conflict of interest between the parties involved.
2. the main researcher on clinical drug trial must have deep knowledge about the level of specialization, clinical experience, practical capacity ensure the principles of good practice in clinical drug trials, master the rules try smoking on clinical, capable of implementing the outline of the study was approved by the full , true progress, GCP certification by the Ministry of health or because the organizations are recognized by the Ministry of health.
3. the researcher must have appropriate professional knowledge, was training on the content and skills necessary to perform the study, GCP certification by the Ministry of health or because the organizations are recognized by the Ministry of health.
Article 12. Condition of participants in clinical drug trials 1. Participants in clinical drug trials to be volunteers, respond to requests for expertise and commitment to sign with the organization receiving the drug on clinical trials, unless the person with limited capacity for civil acts, lost the capacity for civil acts or doesn't have the capacity for civil acts.
2. where the participants in clinical drug trials have yet to be 18 years old, with limited capacity for civil acts, lost the capacity for civil acts or doesn't have the capacity for civil acts it must be consent of the representative in accordance with the law.
3. where people try drugs clinically was pregnant or are breastfeeding: research profile must specify the reason for selecting this object and must be approved by the Minister of health on the basis of review, evaluation outline study on computer science, computer ethics of the Council of ethics in Biomedical Research-Department of health.
Article 13. Conditions of funding clinical research 1. Funding should be enough to complete the activities in the whole process of drug clinical trial (including the items: funding study; the cost of management, monitoring, inspection) by the Agency, organization, individual smoking need clinical trials provided by contract research between individuals, institutions, and organizations receiving reagents for clinical testing.
2. With regard to the study medication due to the program, the subject of using the State budget or the subject of cooperation with organizations, individuals and foreign funding, and the organization received drug test on funding provisions need clinical clinical trials in total funding granted for research.
3. the receiving organization to try smoking on clinical and research members are responsible for managing the funds allocated to the study of the right content and costs as provided by law or the contract has been signed between the two sides.
Chapter IV registration, assessment, APPROVAL of the DRUG in CLINICAL TRIALS RESEARCH on article 14. Registration of clinical trials on drugs research

1. The Agency, organization, individual drug clinical trials registration filing include the documents defined in paragraph 1, item 2 article 10 of this circular to the Ministry of health.
2. Within 15 working days from the receipt of the registration records, the Ministry of health have written answers as a basis for the agencies, organizations, individuals with clinical reagents deployment next steps.
Article 15. Build the profile of research based on the text approved by the Health Ministry, agency, organization, individual drug clinical trials in collaboration with the principal researcher and the organization received drug test on building clinical research drug test records on clinically include: 1. The Agency individuals, organizations, clinical reagents provided the documents specified in paragraphs 1, 2, 7, 11, 12 and 13 article 10 of this circular for the main researcher and the receiving organization to try smoking on the clinical.
2. main researcher coordinate agencies, organizations, individuals have the reagents on clinical and research team members to design the outline of research, fully prepared dossier according to the provisions of article 10 of this circular.
Article 16. Applying study on clinical drug trial 1. The research profile of clinical drug trials as defined in article 10 of this circular posted on the Ministry of health as the basis for the evaluation, review and approval.
2. Submission of the Health Ministry before April 20 will be reviewed during appraisal. The records, filed after the time limit on will switch to evaluation in the next month.
3. information related to the registration, filing and building are accessible in the electronic portal of the Ministry of Health www.moh.gov.vn or through the website of the Council of ethics in biomedical research www.iecmoh.vn the Ministry of health.
Article 17. Appraisal, approval of the test drugs on clinical research 1. Appraisal records research: within 30 working days after receiving the application, as defined in article 10 of this circular, the Ministry of Health held a meeting of the Council of ethics in biomedical research.
2. reporting results: within 15 working days, after the results of the evaluation of the Board of ethics in biomedical research, science and training will synthesize, complete records and notified in writing to the Agency, organization, individual drugs in clinical trials the receiving organization, clinical drug trial.
3. Approved: within 15 working days, after the announcement of the results and receive additional profile is complete (if any), the science and training will presenter, General Secretary of the Ministry of health for approval.
Chapter V the STAGES of CLINICAL TRIALS on the DRUG and CONDUCT TESTING of 18 Thing. The test phase of the drug chemistry, clinical health products 1. Stage 1: a) Is the first phase of tested new active substances or new formulations of the drug in humans (often done in healthy volunteers).
b) study phase 1: preliminary assessment in order to establish safety and early reviews pharmacokinetics and pharmacodynamics of active substances in humans.
c) sample size: need careful consideration based on the results of a clinical study, the sample size of 10-30 objects.
2. Phase 2: a) is the phase of testing was conducted on the number of sick people.
b) study phase 2: aims to evaluate the effectiveness of therapy, the safety of active substances on the patient, determine the dosage and dose regimen use appropriate to devise the optimal therapy for clinical trials.
c) sample size: a minimum of 50 people.
3. Phase 3: a) is the testing phase was research on the number of sick people. The conditions of clinical trials in this stage is conducted close to the normal conditions of use. Often conduct multi-center, random, group.
b) study phase 3: to determine the stability of the formula, calculation, short and long term effect of the active ingredient, evaluate the effectiveness of therapy in the overall price level. The study of harmful reactions often occur, detect the special characteristics of the products of research.
c) sample size: a minimum of 200 sick people.
4. Stage 4: a) Is the clinical study was conducted after the drug was put into circulation. Design research can vary but the scientific and moral standard identical to standard before smoking.
b) stage 4 study purposes: this stage clinical trials are conducted on the basis of the characteristics of the product have been allowed to circulate, often in the form of the following monitoring circulating or evaluate the effectiveness of therapy or evaluate treatment strategies.
c) sample size: a minimum of 1,000 patients.
Article 19. The stages of clinical trials on vaccines 1. Stage 1: a) Is the first phase of tested new vaccines in small scale to assess the level of safety of the vaccine through the acquisition of preliminary information about the ability to tolerate the drug. Usually the stage 1 is performed on a healthy volunteer adults, at risk of infection and complications is lower before use for the target audience.
b) phase 1 is usually the open research, not random group placebo syndrome can be done with some age or population groups to determine dosage, safety, vaccine, vaccination schedule of vaccines.
c) These vaccines live off pathogenic (virus or bacterium) infection is likely for the person receiving or exposure must be assessed and closely monitoring about dosage, clinical signs of infection and cause response (instant, early and late). Phase 1 studies can provide preliminary information about dispersal, the independent recovery characteristics, transmission for the exposure and genetic stability of vaccine strains.
d) sample size: need careful consideration based on the results of a clinical study, the sample size of 30-50 objects.
2. Phase 2: a) was conducted after the completion of phase 1 with the result being the Council of ethics in biomedical research-Ministry of Health approved. The purpose of phase 2 to prove properties of immune components are active, the safety of the vaccine trial on the destination object. Phase 2 study evaluating the immune response capability related to age, race, gender. Design research group and random.
b) for live vaccines reduce pathogenic, in addition to the monitoring of parameters such as phase 1 needs attention to the emergence and existence: antibody titer neutralizing antibodies or antibody discontinued the cross-or cell-mediated immunity and those interactions affect the immune system (for example : antibodies exist previously, inoculation with vaccines or other drugs).
c) sample size: a minimum of 200 objects.
3. Phase 3: a) phase 3 study was conducted on a large scale, multi center to evaluate the effectiveness of protection (efficacy) and safety of the ingredients that are in the vaccine immunity on the destination object.
b) sample size: a minimum of 500 objects.
4. Stage 4: a) stage 4 studies conducted after the vaccines circulating levels allowed. Stage 4 was seen as surveillance after the license or license the following research with the aim of identifying harmful reaction and follow up the effectiveness of protection after the vaccine is widely used in the community under the conditions of use. Stage 4 can be held to evaluate:-optimal conditions for use of the vaccine (optimal age for vaccination, using at the same time with a different vaccine and other conditions).
-Effective protection in risk groups (elderly people, sick people hurt, sick people).
-Maintain the level of protection and safety.
b) sample size: a minimum of 10,000 objects.
Article 20. The test phase of Oriental medicine, the drug from clinical medicine 1. Stage 1: a) research is often conducted on volunteers to meet eligible clinical trials with the aim of determining the safe dose (the maximum dose is that with that dose did not cause the severe side effects), in particular: b) the first dose is 1/3 to 1/5 the dose estimated from clinical study. From the first doses to the maximum dose that can split into multiple doses. This stage ends when determining the safe dose.
c) sample size: need careful consideration based on the results of a clinical study, the sample size of 10-30 objects.
2. Phase 2: a) evaluation studies on the safety and effectiveness of drugs. Design research group, incidentally, each team a minimum of 25 patients.
b) dosage treatment: medications used during this period are based on the results of phase 1 studies.
c) sample size: a minimum of 50 people.
3. Phase 3: a) To confirm the safety and effectiveness of the drug in terms of expansion. Research object are selected by random methods are confronting or confronting.
b) sample size: minimum 100 people sick.
4. Stage 4: a) apply as for smoking medicinal chemistry.
b) sample size: a minimum of 200 sick people.
Article 21. Research on the clinical at many different base 1. When deploying research at several different establishments, organizations receive the drugs on clinical trial is needed to establish the common Steering Committee including principal researcher, the main researcher of the branches and representatives of the host unit to research the objective, content, evaluation criteria , the plan and the progress of the research.
2. for the multinational clinical studies, of which Vietnam is a member join the procedure according to the provisions of this circular. The goal, contents of research trials in Vietnam, deployment coordination activities with national research must be performed more in the outline of the study.
Article 22. The goal, contents and sample size studied the Health Minister decided to target specific content and research sample size be specified in Articles 18, 19, 20, 21 of this circular on the basis of the Advisory opinion of the Council of ethics in biomedical research for each case profile , outline the research.
Article 23. Handle cases of accidents in time trial on clinical medicine treats the abnormalities in the research process is performed as follows:

1. The event of a dangerous hazard, threat to life of participants in clinical drug trials, the primary researcher and organization received the clinical trial must stop experimenting on that test participants, the emergency organisation, fix and resolve the consequences, setting the minutes, at the same time an emergency report to the Ethics Board level The ethical Council, Ministry of health, science and training, the Ministry of health.
2. Test cases resulting in injury to the health of participants in clinical drug trials, the primary researcher must stop the research to treat and monitor the health and performance of clinical trial participants and to consider, decide to continue or stop the clinical trial.
3. abnormal case was expected before and have adopted effective processing measures shall continue to conduct clinical trials on the drug.
Article 24. Collect information, figures 1. The information recorded in the course of research on clinical drug trials is recorded in medical research (CRFs). Medical research is considered to be the original document, preserving the archives in accordance with the regulations as a basis for monitoring, evaluating test results.
2. The documents necessary to the process of clinical assessment (test votes, results of diagnostic images, medication) are copied from the original stating they checked the name, stating the source and must be managed, stored as specified.
Article 25. Data processing 1. The figures on drug clinical trial research must be handled according to statistical methods in biology and medicine are due to an agency, independent organization with the authority, the organization received the test data processing responsible to ensure objectivity, honesty and trust.
2. The results of statistical analysis must be presented clearly to allow for the identification of differences in clinical outcomes; When evaluating the effectiveness of treatment, is based on the level of trust and the results achieved from the statistical analysis. The report concluded the last of clinical research is consistent with the results of statistical analysis.
Article 26. Data about clinical drug trials 1. The figures, the original document, slip tests, results of diagnostic imaging, the material collected is relevant to try smoking on clinical, Board meeting minutes, minutes, progress reports, monitoring, test registration records and other documents related to the study should be preserved in full , archive for at least 15 years in the research facility, calculated from the end of the study.
2. the principal researcher responsible for the whole process to preserve the archives of research material and is responsible to present when required by the Corps of inspectors, and supervision of State administration authorities.
Article 27. Report the results of research on clinical drug trial 1. Report the results of clinical trials on the drug compliance in accordance with the prescribed form (Appendix 7 attached to this circular), including full information on smoking, described the research method, test process, analyze data, evaluate the results, compared with the target research and research tasks; giving is the correct conclusion, honestly and objectively. Report content must match the objective and content of the research in the approved outline.
2. the principal researcher responsible for the computer science, accuracy, integrity of data, conclusions, and other contents of the report.
Article 28. Manage clinical reagents 1. The export and import of drugs in clinical trials should comply with current regulations on the export, import and export of drugs.
2. The management of clinical trial drugs must be done properly the current rules from the stitched samples, testing the quality, packaging, transportation, delivery, storage, labeling and distribution.
3. To have notepads to track the use of the drug for clinical trials accompanied by information about the quantity, the quality of the drug.
4. Smoking is not yet exhausted and smoking save must be closely managed, to own and preserved in accordance with the regulations. The drug is not used up must be handed over to organizations, individual reagents.
5. Smoking does not guarantee the quality must set up a treat as prescribed by the Ministry of health.
6. Samples of the drug store (the smallest packaging unit 03) must be preserved for at least three years (36 months) at the receiving organization to try smoking on the end of clinical research.
Chapter VI RIGHTS and OBLIGATIONS of the participants, who HAVE SMOKING and GET ORGANIZED to TRY SMOKING on CLINICAL Things 29. Rights of participants in clinical drug trials 1. Provided complete and truthful information before a clinical trial about the testing process and the risks that can occur.
2. Are agencies, organizations, individuals with clinical reagents in damages if due cause clinical trial.
3. Confidentiality of the personal information involved.
4. Is not responsible when the unilateral termination of the contract of participation in clinical drug trials.
5. The complaint, denouncing the violation of the law of the Organization, individuals have clinical trials medications and receive clinical drug on trial.
6. Are wellness during testing according to the outline of the study has been approved.
Article 30. The Agency's authority, organizations, individuals with clinical reagents 1. Select and propose the organization meet regulations regarding facilities and professional staff to test drugs on clinical.
2. Be owned the entire results of research of drugs in clinical trials.
3. Is entitled to recommend termination of the study if the receiving organization to try smoking serious breach of the outline.
Article 31. Obligations of the authorities, organizations, individuals with clinical reagents 1. With your permission, and was the Minister of health agreed in writing prior to clinical trials.
2. Compensation for damage to the participant to try smoking on clinical if the risk occurs due to clinical drug on trial under the provisions of the current law.
3. The contract about drug testing on the receiving organization clinical drug trials on the clinical and clinical research organizations (if any).
4. Be responsible before the law on the quality and safety of medication by themselves provide.
Article 32. The Organization's rights to receive clinical drug on trial 1. Are agencies, organizations, individuals with clinical reagents supplied drugs, funding to conduct the clinical trial in accordance with the law.
2. using the results of research on clinical drug trial under a deal with authorities, organizations, individuals with clinical reagents.
Article 33. The obligation of the organization receiving the drug on clinical trials 1. Compliance with the rules of good practice to try smoking on clinical, reporting to the Ministry of health about the process, the results of clinical trials and report irregular in case of need.
2. The contract regarding drug testing on the clinical, organizational, individual clinical trial drug and clinical trial participants.
3. Continue to follow the health and disease of clinical trial participants as agreed in the contract or the outline of the study.
Chapter VII monitoring, CHECK to ENSURE the QUALITY of RESEARCH Article 34. Monitor, test drugs on clinical trial process 1. Monitor, check to ensure that the rights, benefits, health of participants in clinical drug trials, ensure the number of records of the study are conducted in full, accurate, timely, properly regulated according to the outline of the study has been approved.
2. The Ministry of Health established the monitoring group, periodically check and irregular for each specific case.
3. State administration authorities, organizations, individuals with clinical reagents, clinical research organization (CRO) or management organization (SMO) study locations are the Ministry of Health approved in writing may suggest the election monitor, monitor the process of a systematic research. Who was given the task of monitoring was not a member of the research team, done right the rules about data security research and information related to clinical trial participants and the responsible authorities about his work.
4. the principal researcher and the researcher have a responsibility to create conditions for people to reference monitoring research data when required.
5. the Monitoring Group responsible for testing, the report suggested, by oversee thereon, examine the content monitoring with State administration authorities as the basis for the review, processing in accordance with the provisions of the law.
Article 35. Ensure the reliability of results of research on clinical drug trial 1. To ensure there is enough reliable research, the analysis, the conclusions about the results are derived from the original data. In each stage of research needs to examine all of the clinical data and testing criteria.
2. where necessary, the Council will invite experts reviews the results, test data, test the products of research or data monitoring Board (DSMB) as requested by the governing body.
Chapter VIII TEST REVIEWS PILLS on CLINICAL TRIAL RESULTS, Article 36. Procedure for testing drugs on clinical trial results 1. Test results on clinical drug trial research is done according to the current rules about reviews, scientific research, technology and good practice guide on clinical drug trials.
2. The trials are conducted at two levels: the level and the Ministry of health. At the end of the study, the primary researcher is responsible for reporting to the receiving organization to try smoking on clinical reviews research results at the base and improve The reporting of health records to level the sets.
Article 37. The profile level Health Ministry reports record level (1 signed original sets, stamp and 3 copies) are: 1. The text of the receiving organization to try smoking on the recommended clinical level.
2. Copy the research outline was approved.
3. Decides to approve the study.
4. the Council decided to establish the base level.
5. Board meeting minutes level basis.
6. the full text of report research results on clinical drug trials as defined and can complement other relevant information when necessary.
Article 38. End of research on clinical trials 1. Within 30 working days from the date of receiving the application proposal, the Ministry of health will organize the meeting of the Council of the results of research trials under current rules.

2. study on clinical drug trial is only considered complete when a final results report the Council reviews and accepts the addition of principal researcher according to the comments of the Board (if any).
3. The figures and the clinical trial results were announced only when it has been the Council of ethics in biomedical research-Ministry of health reviews.
Chapter IX IMPLEMENTATION Article 39. Responsible for implementing the science and training, in collaboration with the Service, the relevant Bureau: 1. Reception, check the profile registration Guide, organizations, individuals and organizations received reagents to try smoking on the clinically correct implementation of the provisions of this circular and the other provisions of the relevant laws.
2. organizations assess the conditions on resumes to try smoking on clinical, professional capacity, infrastructure and your organization legally get the drug on clinical trials, clinical research organization (CRO), venue management organization (SMO) research report headed the Ministry for permission to conduct the experiment.
3. Organization of the session of the Council of ethics in Biomedical Research-Department of health review of research assessment, outline the contents of ethics in research and science majors, reviews test results on clinical drug trial study, the General headed the Ministry for approval.
4. monitoring organization, check periodically or irregularly research process.
5. popular organizations, guide and implement the content of this circular, the good clinical practice guidelines and ethics in biomedical research for units, organizations and individuals concerned.
Article 40. The transitional provisions of the registration of clinical trials before the drug on the day this circular effect are reviewed and appraised according to the "regulations on clinical trials on drugs" was issued in accordance with decision No. 01/2007/QD-BYT on January 11, 2007 by the Minister of health.
Article 41. Effect 1. This circular has effect from the day of 20/3/2012.
2. Annul the decision No. 01/2007/QD-BYT on January 11, 2007 by the Minister of health on the issued "regulations on clinical trials on drugs" since the day this circular effect.
3. The Heads of the agencies, organizations, relevant units responsible for organizing advocacy, dissemination, implementation of the circular for the audience to know and implement.
In the process if there are obstacles, the proposal reflects the timeliness of the Ministry of health to consider additional amendments accordingly.