DECISION

ON PROMULGATION OF "THE REGULATION ON CLINICAL TRIALS FOR MEDICAL EQUIPMENT”

MINISTER OF HEALTH

Pursuant to the Government’s Decree No. 49/2003/ND-CP dated May15, 2003 on functions, missions, authority and organizational structure of the Ministry of Health;

Pursuant to the Prime Minister’s Decree No. 12/2006/ND-CP dated January 23, 2006 on details for implementation of the Commercial Law with regard to international trading of goods and agencies' trading, processing and transit of goods for foreign partners;

At the requests of the Head of the Department of Science and Training, Head of the Department of Medical Equipment and Works and Head of the Department of Legal affairs.

DECISION:

Article 1. This Decision is enclosed with "the Regulation on clinical trials for medical equipment".

Article 2. This decision comes into force 15 after the date that it is published on the Official Gazette.

Article 3. Chief of Office, Chief of Inspectorate, Heads of departments under Ministry of Health, Head of Drug Administration of Vietnam, Head of Food Hygiene and Safety Administration, Head of General Department of Preventive Medicine, Head of Vietnam Administration of HIV/AIDS Control, Directors of provincial Departments of Health, Heads of medical agencies and other units under Ministry of Health shall be responsible for implementing this Decision. /.

REGULATION

CLINICAL TRIALS FOR MEDICAL EQUIPMENT
(Enclosed to the Decision No. 36/2006/QD-BYT dated November 14, 2006 by Minister of Health)

Chapter I

GENERAL

Article 1. Scope

This regulation defines principles, requirements, applications, procedures, authority to verify plans, research organization, quality inspection, finances, acceptance formalities, announcement of results of clinical trials for medical equipment, rights and responsibilities of entities in possession of equipments, organizers of trials and participants in clinical trials for equipment.

Article 2. Regulated entities and scope of application

This regulation applies to:

1. Entities in possession of medical equipment to be tested, organizers of trials and participants in clinical trials for medical equipment in accordance with this Regulation.

2. Medical equipment to undergo clinical trials consists of:

a) Medical equipment that newly derives from domestic studies and is subjected by competent state management authorities to clinical trials.

b) Medical equipment initially imported into Vietnam and subjected by competent state management authorities to clinical trials.

Article 3. Terminology

In this regulation, the following words and phrases are construed as follows:

1. Medical equipment includes:

a) Machines, devices, system of devices, materials and apparatus for prevention, diagnosis, treatment of diseases and rehabilitation for human beings.

b) Machines, apparatus and materials transplanted or inserted into human body for prevention or treatment of diseases or rehabilitation.

2. Clinical trials for medical equipment (referred to as trials) mean the process of research and assessment of safety and efficiency of medical equipment on human.

3. Preclinical trials for medical equipment refer to studies done on experimental animals or biological fluids to evaluate biological interaction, toxicity and effects of medical equipment.

4. Entities in possession of medical equipment to undergo clinical trials mean organizations and individuals that study, produce, import, export or distribute medical equipment.

5. Organizers of clinical trials for medical equipment refer to health facilities that conduct scientific research and meet infrastructural requirements for performance of clinical trials for medical equipment in conformity to assessments and approvals by the Ministry of Health.

6. Participants in clinical trials are patients or healthy volunteers who participate in trials.

Article 4. Principles of clinical trials for medical equipment

1. Clinical trials for medical equipment shall adhere to procedures for management of science, technology and ethics in medical and biological research.

2. Participants in clinical trials shall be selected in safe and confident manners according to ethical principles in medical and biological research.

3. Data and findings from clinical trials shall only be published after assessed and approved by competent government authorities.

Chapter II

REQUIREMENTS FOR CLINICAL TRIALS FOR MEDICAL EQUIPMENT

Article 5. Requirements for medical equipment

1. Equipment produced domestically:

a) Have passed research on design, engineering, technical features and production technology.

b) Have passed inspections and assessments of technical specifications of the equipment for guaranteed quality and safety.

c) Have passed evaluation tests regarding biological interaction.

Results of such processes must be verified, evaluated and endorsed, by at least a ministerial-level Council of Science and Technology, for subsequent clinical trials.

2. Medical equipment required to undergo clinical trials:

Pursuant to legal regulations on importation of medical equipment and to requests by state management authorities.

Article 6. Requirements for organizers of clinical trials for medical equipment

1. Have scientific research function, be independent and have no economic connection with entities in possession of medical equipment to undergo clinical trials.

2. Have sufficient human resources to perform research:

a) Principal investigator of a clinical trial for medical equipment must possess adequate qualities and expertise concerning the research field, experience in clinical practice and use of medical equipment, solid knowledge of regulations on management of science, technology and ethics in research, and abilities to undertake the research and trial.

b) Researchers possess adequate qualities and expertise pertinent to requirements of the research and have undergone relevant training in knowledge and skills related to the research.

3. Have infrastructures and medical equipment adequately qualified for the research to proceed in scientific, safe and efficient manners for good clinical practice.

4. Undergo assessments by Ministry of Health and obtain its approval for trials.

Chapter III

APPLICATION, PROCEDURE AND APPROVAL OF CLINICAL TRIALS FOR MEDICAL EQUIPMENT

Article 7. Application for clinical trials for medical equipment

An application includes:

1. The written request by the entity in possession of the equipment for clinical trial for medical equipment (Appendix 1);

2. The filled-out form of application by the clinical trial organizer for clinical trial for medical equipment (Appendix 2);

3. The plan of clinical trial for medical equipment (Appendix 3);

4. The scientific resume of the principal investigator and lead researcher;

5. The written undertaking of research ethics;

6. The written request for evaluation of research ethics;

7. Technical documents of the medical device to undergo clinical trial:

a) Technical standards and quality inspection papers from competent authorities;

b) The description of technical features and guidelines for installation and use;

c) Documents concerning biological assessment studies on animals, blood or biological products; drugs, devices or techniques in need for the process of the trial;

d) For products studied and made domestically:

- Factory certificate

- Written record of verification and evaluation by the competent Scientific Council of technical features, product quality and preclinical trial result. The conclusion of such Council must specify the quality and safety of the product and endorse the clinical trial on human.

dd) For medical equipment imported:

- Certificate of quality (ISO, FDA, EC or equivalent);

- License for sale in the country of production (original or valid copy);

- Information on safety and performance in the last 2 years from the issue date of the request.

 - Other details as requested by competent statement management authorities.

Such papers must be enclosed with a translation and a notarized and consular legalized copy.

8. The research contract between the entity in possession of the medical device and the organizer of the clinical trial;

9. The written record of the approval by the Science Council at the grassroot level of the scientific and ethical aspects of the research.

The application shall be presented in Vietnamese and in 2 original sets.

Article 8. Application processing

1. Department of Science and Training shall take in applications and assess conditions for clinical trials and legality of such applications.

2. If conditions and the application for clinical trial abide by Article 5, 6, 7 of this Regulation, the Head of the Department of Science and Training shall report to the Minister of Health after 15 working days for the latter to establish a Council of Science and Technology under Ministry of Health, which reviews and verifies the research proposal, and to form a Council of Ethics in medical and biological research, which reviews ethical aspect of the research, according to current regulations. Subsequently, such councils shall provide their meeting records to the Minister for approval of the research.

Article 9. Approval of research title

Minister of Health shall consider and decide to approve a clinical trial upon satisfaction of these requirements:

1. The application for clinical trial for medical equipment suffices according to Article 7 of this Regulation.

2. Council of Science and Technology under Ministry of Health has assessed and unanimously endorsed the research proposal and the principal investigator and lead organization have adopted revisions as per the Council's recommendations (if any).

3. Council of Ethics in medical and biological research has approved the ethical aspect of the research in writing. The written record of the Council's meeting must be available.

Chapter IV

PERFORMANCE OF CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Article 10. Design of research

1. A clinical trial for medical equipment shall be open, with or without comparators. Council of Science and Technology shall provide specific counsels to each study with regard to sampling size, research time, crucial trial phases and assessment of such phases.

2. When performing the research at various facilities, the organizer of clinical trials for medical equipment shall form a general management team composed of the principal investigator, heads of branch subjects and representatives of lead organizations in order to reach unanimity in goals, research details, assessment indices, plans and schedule.

Article 11. Collection of data

1. The process of a clinical trial must be recorded into sheets of clinical trial for medical equipment (Appendix 5). Such sheets shall record every information gained during the trial and be used for supervision, acceptance and evaluation of the research. The sheets are deemed as original papers that are retained in long term.

2. Originals of relevant materials necessary for clinical assessment must be photocopied precisely, traced and stored as per regulations. Such materials include test reports, radiographs, medical record and other relevant papers.

Article 12. Storage of data and research documents

1. Data, original documents, test reports, written materials related to the trial, councils’ meeting minutes, supervision records, progress reports, research proposals and other papers shall be retained in full at the research facility in at least 5 years from the end of the trial.

2. The principal investigator shall be held liable fully for the retention of the research's documents and be responsible for presenting the documents requested for purpose of inspection.

Article 13. Reporting

Reports must indicate methodology, clinical trial progress, medical equipment's operations, data analysis and assessment of findings. Reports must provide accurate, honest and unbiased conclusions. Content of reports must be pertinent to the goals and content of the research as shown in the proposal approved.

The principal investigator shall be held liable for the scientific nature and accuracy of data, conclusions, remarks, confidentiality and other matters of reports.

Chapter V

QUALITY INSPECTION AND HANDLING OF ANOMALIES DURING THE TRIAL

Article 14. Inspection and supervision of quality

1. Quality is inspected and supervised to sustain the rights, interests and health of participants in clinical trials and to assure that the research is recorded in adequate, precise and timely manners in conformity to the research proposal approved.

2. Minister of Health shall supervise trials and conduct regular and ad-hoc inspections on case basis.

3. Entities in possession of clinically tested equipment can assign individuals to supervise the research and to assume liabilities to the laws for such entities' activities.

4. The organizer of clinical trials and principal investigator shall be responsible for supporting supervisory individuals to perform their tasks and read data upon requests.

Article 15. Credibility of data

In each phase of the research, all (original) clinical data and test figures gained shall be examined when recorded. Conclusions in a research finding report must be deduced from original data.

Councils for acceptance at different echelons may summon specialists to supervise findings, examine original data and assess the research's products, if deemed necessary/

Article 16. Handling of anomalies

Anomalies during the research shall be handled as follows:

1. If complications occur and menace the life of clinical trial participants, the principal investigator and organizer of the clinical trial shall terminate the process immediately, give emergency aids, cope with problems, make written records and report to competent state management authorities in an urgent manner.

2. If a test damages the health of clinical trial participants, the principal investigators shall halt the research to have them treated and monitored. Subsequently, the clinical trial shall be reviewed to proceed or to discontinue.

3. If anomalies are expected and settled effectively, the clinical trial shall continue.

Chapter VI

RIGHTS AND RESPONSIBILITIES OF ENTITIES IN POSSESSION OF MEDICAL EQUIPMENT, ORGANIZERS CLININCAL TRIALS FOR MEDICAL EQUIPMENT AND PARTICIPANTS

Article 17. Rights of entities in possession of medical equipment clinically tried

1. Organizations and individuals in possession of medical equipment clinically tried can select organizations that have adequate facilities and specialist personnel from the Ministry of Health's list to conduct the clinical trial for medical equipment.

2. Organizations and individuals in possession of medical equipment clinically tried can use the copyright of the findings of the clinical trial. They shall be entitled to request confidentiality of their products and relevant research findings.

Article 18. Responsibilities of entities in possession of medical equipment clinically tried

1. Be held liable to the laws for the quality and safety of the medical device tested.

2. Provide adequate medical equipment to be tested and relevant technical documents as requested by the organizer (instructions for installation and operation of medical equipment, issue-handling procedures, requirements for maintenance and use, reuse, safety check before and during use).

3. Fund the clinical trial for medical equipment as per the proposal approved by the Ministry of Health (and for any damages) according to the contract between the entity in possession of the medical device clinically tried and the organizer of such clinical trial.

4. Be responsible for handling consequences and making amends to clinical trial participants if menaces ensue due to the use of the medical device tested according to the laws.

5. Cooperate with principal investigators and organizers of clinical trials to supervise the clinical trial for medical equipment in a strict manner to maintain contents and schedule as shown in the proposal approved.

Article 19. Rights of the organizer of clinical trial for medical equipment and the principal investigator

1. An organizer of a clinical trial for medical equipment shall have all rights and interests similar to those gained upon its leading of other studies in science and technology.

2. A principal investigator in a clinical trial for medical equipment shall have all rights similar to those in other studies in science and technology. He can design the research, select collaborators, organize relevant units during the research and allocate research funds in active and effective manner as per regulations.

Article 20. Responsibilities of the organizer of clinical trial for medical equipment and principal investigator

1. An organizer of a clinical trial for medical equipment shall be responsible for:

a) Instructing the principal investigator and research team to conduct tests as per the proposal and plan of research, safeguarding the health of participants, adopting emergency measures to overcome consequences of risks and providing guidelines for spending as per regulations;

b) Supervising clinical trials, managing the medical device received for tests, securing information on research findings for entities in possession of medical equipment clinically tried.

c) Signing and ending clinical trial contracts with entities in possession of equipment to be tested;

d) Organizing research acceptance at grassroot level and reporting research findings for ministerial-level acceptance as per regulations.

2. A principal investigator shall be responsible for:

a) Organizing and implementing research plans and assuming liabilities to the laws and state management authorities for research findings, data accuracy and report integrity;

b) Managing and retaining research documents, managing assets, devices, drugs and materials used for the research as per regulations.

c) Maintaining confidentiality of clinical trial results for participants and overcoming problematic consequences to safeguard the health and life of participants.

Article 21. Rights of participants in clinical trial for medical equipment

1. Clinical trial participants shall be given adequate information on medical equipment and details of the test process, such as time, purpose, benefit and risk.

2. Clinical trial participants’ test data shall be kept confidential. Participants shall be safeguarded and compensated for any damage caused by the test as per the laws.

3. Participants shall be entitled to refuse or quit clinical trials at any time.

4. Clinical trial participants shall exempt from all expenses related to the test.

Article 22. Responsibilities of participants in clinical trial for medical equipment

1. Participants in clinical trials for medical equipment must adhere to the test procedure as per researchers’ guidelines. They must inform researches in advance of their withdrawal.

2. When participants in clinical trials for medical equipment are not capable of making decisions, their legal representatives shall be entitled to sign test agreements.

Chapter VII

FINANCE OF CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Article 23. Funding of clinical trials for medical equipment

1. Entities in possession of medical equipment shall fund clinical trials for medical equipment.

2. Finances for clinical trials for medical equipment in state-funded programs and studies shall be allocated from the overall budget of such programs and studies.

Article 24. Spending for clinical trials for medical equipment

1. The budget of a clinical trial for medical equipment shall cover expenses of the entire test. Such expenses include: Pay to workers, purchase of research materials, assessment of applications, verification of proposals, management, supervision, inspection, evaluation and acceptance of findings, assurance of participants’ benefits, rectification of menaces and other expenses incurred during the research.

2. Spending must adhere to current regulations on spending for science and technology and meet with assent by the funding organization, the principal investigator and the organizer.

3. The principal investigator and the lead organization shall estimate budget, explain and finalize spending as per regulations.

Chapter VIII

ACCEPTANCE AND ANNOUNCEMENT OF RESULTS OF CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Article 25. Procedure for evaluation and acceptance

1. The acceptance of results of clinical trials for medical equipment shall comply with current regulations on evaluation and acceptance of science and technology studies by Ministry of Health.

2. The acceptance process shall advance at two echelons: When the research ends, the principal investigator shall be responsible for reporting to the lead organization to accept research findings at grassroot level, finalize and deliver reports to the Ministry of Health of ministerial-level acceptance.

Article 26. Documents for evaluation and acceptance

The following documents shall be sent to Ministry of Health to conduct ministerial-level evaluation and acceptance:

1. The proposal (approved) of the research.

2. The decision on approval of the research title.

3. The decision on formation of the grassroot Council for evaluation and acceptance.

4. The meeting record of the grassroot Council.

5. Original figures and data of the research (copy)

6. The full report of the research’s findings (Appendix 4), which has been revised as per the grassroot Council's opinions.

7. The lead organization’s request for ministerial-level acceptance.

8. Records of inspections and supervision by managing authorities (if any).

Article 27. Announcement of research findings

1. Results of a clinical trial for medical equipment shall only be announced after accepted by the Council of Science and Technology of the Ministry of Health.

Results of a clinical trial for medical equipment shall be announced upon assent by the entity in possession of the medical device or its representative, the organizer of the clinical trial and the principal investigator.

 2. Research findings announced must be genuine and accurate in unison with the conclusion by the Council for acceptance and by unanimous consent of the entity in possession of the medical device and the organizer of the clinical trial.

Chapter IX

IMPLEMENTATION

Article 28. Assignment

Minister of Health assigns:

1. Department of Science and Training:

a) To take in applications and provide guidelines for entities in possession of medical equipment clinically tried to abide by this Regulation.

b) To assess applications.

c) To assess and recommend research grounds.

d) To supervise the research and conduct regular or ad-hoc inspections.

dd) To assess research findings.

2. Department of Medical equipment and Works to propose the list of medical equipment subject to clinical trial, to supervise and inspect the research, to obtain clinical trial results as scientific grounds for importation and sale of medical equipment.

3. Department of Treatment, Department of Maternal health, Department of Traditional medicine, Food safety and Hygiene Administration, General Department of Preventive Medicine, within authority, to receive feedbacks from actual operation of medical equipment and to report systematic problems during use to Minister of Health for discontinuation and remedial actions./.

APPENDIX 1

(The form of request by the entity in possession of the medical device for clinical trial)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------

… [place], … … … [date]

REQUEST FOR CLINICAL TRIAL FOR MEDICAL EQUIPMENT

To: MINISTRY OF HEALTH

Name of the organization:

Address:

Telephone: Fax:

Email:

Account No.

This is to request the Ministry of Health to approve the clinical trial for medical equipment

1. Name of the medical device:

2. Type: Pursuant to TCVN 7391-1:2004 on biological evaluation of medical devices

3. Clinical trial is requested from: ............ to: .............

4. Specify the type of medical equipment to be clinically tried:

+ The role of the medical device in diagnosis, prevention, control, treatment or mitigation of diseases. Compensation for injuries or disabilities, replacement, modification, surgery or contraception.

+ Does the medical device sustain or support life?

5. Use (Describe the medical device and substances that come into contact with tissues or body parts)

6. The medical device has passed: Research, preclinical research.

7. The device has been accepted at the level of grassroot, city, institute, ministry or industry:

8. Performance (specify the level of evaluation and conclusion according to the acceptance record: passed, excellent, good or …)

9. Enclosed with:

The application for clinical trial for medical equipment (Appendix 2);

The proposal of the clinical trial (Appendix 3);

Documents related to the medical device clinically tried as per Section f, Article 7 of this Regulation;

Documents that substantiate the legality of the medical device, with notarized translations.

The contract between the entity in possession of the medical device and the principal investigator/ the organization leading the clinical trial;

01 set of sample stickers for the medical device as per regulations.

The record of the grassroot Council’s assessment of the scientific and ethical aspects of the research.

We request the Ministry of Health to consider and approve the clinical trial for the said product.

APPENDIX 2

(The form of application by the organizer for the clinical trial for medical equipment)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------

……….… [place], … … … [date]

APPLICATION FOR CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Name of the organizer of the clinical trial for medical equipment:

Address:

Telephone:

Fax:

Email:

We apply for the clinical trial for medical equipment:

1.      Name of the medical device:

2.      Type:

3.      Use:

4.      Batch n^o: Code:                 Expiry:

5.      The device made in quantity for clinical trial according to these standards (specify TCVN, TCN, TCCS)

6.      Quality of the device has been inspected by ..., which is the authority competent to inspect quality as per standards enclosed to this application.

7.      The quality inspection sheet n^o … dated … (specify the issue date of the quality inspection sheet)

8.      The batch of the medical device has been made, sealed and stored at the organization’s warehouse or private residence.

9.      Phase of clinical trial:

10.  Expected quantity for research:

 (The label of the medical device must indicate that it is made for research and not for sale)

We apply for the clinical trial for the medical device … at …

according to the Ministry of Health’s regulations on clinical trial for medical equipment.

APPENDIX 3

MINISTRY OF HEALTH RESEARCH PROPOSAL CLINICAL TRIAL FOR MEDICAL EQUIPMENT

I. General information of the clinical trial for medical equipment

II. Content of the clinical trial for medical equipment:

 (Explanation of sections as per the Preclinical trial guideline for contents of the proposal at various phases)

III. Result of the research

IV. Participants in the clinical trial for the medical device

V. Finances and source of fund

(see the appendix)

Unit: Million dongs (VND)

......... ……… [place], ... … … [date]

Appendix

RESEARCH EXPENDITURE ESTIMATE

Unit: million dongs

EXPLANATION OF SPENDING

(million dongs)

Section 1. Fixed employment

Section 2: Materials and energy

Section 3. Special equipment and machines

Section 4. Construction and minor repair

Section 5. Other expenses

APPENDIX 4

Sample report on clinical trial for medical equipment

Cover page 1

MINISTRY OF HEALTH

REPORT ON CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Research title:

Principal investigator:

Lead organization:

Research title code (if available):

Year of …

Cover page 2

MINISTRY OF HEALTH

REPORT ON CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Research title:

Principal investigator:

Lead organization:

Supervisory level: Ministry of Health

Research title code (if available):

Duration: from … [month] … [year] to … [month] … [year]

Total expenditure: … million dongs  

From: science and technology fund: … million dongs          

Other sources (if any) … million dongs         

Year of …

Page 3

REPORT ON CLINICAL TRIAL FOR MEDICAL EQUIPMENT

1.      Research title:

2.      Principal investigator:

3.      Lead organization

4.      Supervisory organization:

5.      Secretary:

6.      Deputy principal investigator or investigation board (if any):

7.      Main performers:

8.      Branch studies (headings) of the research (if any)

 (a) Branch study 1 (heading 1)

- Name of the branch study:

- Principal investigator of the branch study:

 (b) Branch study 2

- Name of the branch study:

- Principal investigator of the branch study:

9.      Duration: from … [month] … [year] to … [month] …[year]

Page 4

ACRONYM

TABLE OF CONTENTS

Part A - Summary of prominent findings (at the discretion of the principal investigator)

1.                              Prominent findings of the research

2.                              Application into production and society

3.                              Evaluation of research performance in comparison with the proposal approved

(a)                                        Progress

(b)                                       Attainment of research objectives

(c)                                        Outcomes gained in comparison with the proposal

(d)                                       Evaluation of spending

4.                              Recommendations

Part B. Report on details of findings of ministerial-level research

1.                              Introduction:

1.1.                                    Summary of domestic and overseas studies related to the research Urgency of the research

1.2.                                    Hypotheses of the research

1.3.                                    Objectives of the research

2.                              Overview:

2.1.                                    Overseas studies in connection with the research

2.2.                                    Domestic studies in connection with the research

3.                              Subject and method of the research:

3.1.                                    Design of the research

3.2.                                    Sampling, sizing and research subject

3.3.                                    Research methodology

3.3.1.                              Research values

3.3.2.                              Method for determination of research values

3.3.3.                              Research instruments

3.4.                                    Data processing method

4.                              Research findings:

4.1 Brief description of the medical device’s intended functions, type, technology, traits and use.

4.2 Analysis of documents and data selected, advantages and disadvantages

4.3 Evaluation of relevant risks and hazards and safety measures for patients and medical personnel.

4.4 Summary of effects on health conditions of clinical trial performers.

5.                              Discussion:

6.                              Conclusion and recommendation:

7.                              Reference document:

8.                              Appendix (if any): ...

APPENDIX 5

CLINICAL TRIAL SHEET

1.                  Location of the clinical trial

-          Name of the clinical trial facility:

-          Address:

-          Telephone:

2.                  Date that the clinical trial starts (specify the actual date but not the date that the written approval is signed)

3.                  Description of the medical device

-          Name of the medical device:

-          Feature and function:

4.                  Information of the participant prior to the clinical trial

-          Full name:                                                 Age:                            Gender:

-          Address:

-          Telephone:

-          Height:                                          Weight:

-          Blood pressure:                                                     Cardiovascular condition:

-          Initial health condition:

5.                  Diagnosis and anticipation of dosage, duration and side effect

6.                  Supportive drugs during the process

7.        Values to be monitored during the process (specify)

8.        Anomalies during the process     

9.                  Evaluation and conclusion

10.    Date that the clinical trial ends

Signature of the performer of the clinical trial

APPENDIX 6

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------

ATTESTATON OF CONSENT TO PARTICIPATE IN CLINICAL TRIAL

(Including these main details)

Party A. The facility conducting the clinical trial for medical equipment

Representative:

Address:

Telephone:

Party B. The participant in the clinical trial

Full name:

Address:

Or Legal representative

Address:

Telephone:

As summary of the research, conditions and rights of the participant in the clinical trial for medical equipment are notified adequately. The parties enter the following agreement:

Article 1. Party A is responsible for providing this information:

Purpose of the test

Duration of the test

Benefits from the test

Article 2. Party A's responsibilities

Undertake to maintain safety of participants;

Undertake to recompense as per the laws for damage caused by the clinical trial;

Undertake to maintain confidentiality of the participant/

Article 3. Party B voluntarily participates in the clinical trial.

Article 4. Party B is entitled to quit the clinical trial at any time without liability of compensation. Have the right to denounce violations of the entity testing the medical device.

APPENDIX 7

GUIDELINE FOR ASSESSMENT OF THE RESULT OF THE CLINICAL TRIAL FOR MEDICAL EQUIPMENT

1.                  Ministry of Health forms the Council that shall assess and accept the result of the clinical trial for medical equipment upon its receipt of sufficient documents as per Article 25 of the Regulation on clinical trial for medical equipment.

2.                  Upon its review of all documents, reports and relevant papers, the Science Council shall assess the research in 4 stages:

a.                                           Study documents of the clinical trial

b.                                          Assess the result of the research by criterion

c.                                           Cast vote and give grade

d.                                          Finalize and report the assessment

3.                  Criteria for assessment: five categories with the maximum grade of 50 as follows:

4.                  The research fails in one of these events:

a. Basic works under the contract are partially or entirely failed.

b. Research findings are of no use.

c. Documents or data is not credible.

d. Goals and plan change in a subjective manner.

e. Financial management rules are violated.

f. Submission of the application for acceptance is deferred for 6 months or more after the deadline of the research without permission by Ministry of Health.

5.                  Council bases on the result of grading and voting to rank the research:

             Pass: Not violating Point a, b, c, d, e or f in Section 4

The research must score at least 25

Rank A: 40 ¸ 50 points

Rank B: 30 ¸ 40 points

Rank C: 25 ¸ 30 points

            Fail: Below 25 points or violate either Point a, b, c, d, e or f in Section 4.

6.                  Council review and assess the result of the research.

            The result of the clinical trial is endorsed.

            Further clinical trial is requested.

            Other recommendations

SHEET FOR ASSESSMENT AND REMARK

RESULT OF THE CLINICAL TRIAL FOR MEDICAL EQUIPMENT

1. Research title:

Code:

2. Principal investigator:

3. Lead organization:

4. Members of the assessment Council:

a. Full name:

b. Expertise:

c. Date of receipt of the application for assessment:

d. Date of return of the application for assessment:

5. Assessment criteria:

6. General remark on the result of the research

7. Following contents are not relevant to the proposal

 (this part only applies when the research is "Failed")

8. Opinions of members of the Council on unsolved issues and their recommendations