|
MINISTRY OF
HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------
|
|
No. 36/2006/QD-BYT
|
Hanoi, November
14, 2006
|
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".
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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. /.
FOR MINISTER
DEPUTY MINISTER
Le Ngoc Trong
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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;
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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).
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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./.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
FOR MINISTER
DEPUTY MINISTER
Le Ngoc Trong
(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:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
Medical equipment that come into indirect
contact
.............
Medical equipment that come into direct
contact
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Surface contact
.............
- Invasive contact
.............
- Transplant
.............
- Support of body functions
.............
3. Clinical trial is requested from: ............
to: .............
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
+ 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);
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
The organization’s verification
(if a representative lodges this request for
clinical trial)
We assign ... as our representative and
request Ministry of Health to approve the clinical trial for our medical
device.
Head of the
organization
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
(Local authority’s verification of the
individual in possession of the medical device)
People’s Committee of Ward ... verifies that
Mr/Ms. ... is residing in ward ... in permanent/ temporary residence.
FOR PEOPLE’S
COMMITTEE
(Sign and seal)
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------
……….… [place], …
… … [date]
Name of the
organizer of the clinical trial for medical equipment:
Address:
Telephone:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Email:
We apply for the clinical trial for medical
equipment:
1. Name of the
medical device:
2. Type:
3. Use:
4. Batch no:
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 no … dated … (specify the issue date of the quality
inspection sheet)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
Head
of the applicant
(sign and seal with full name)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
MINISTRY OF HEALTH RESEARCH PROPOSAL CLINICAL TRIAL
FOR MEDICAL EQUIPMENT
1. Research topic
2. Code (as given by the supervisory authority)
3. Duration:
(From … [month]/ …. [year] to … [month]/
... [year])
4. Supervisory level
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Province
5.
Outlay
Total:
from the …
(specify the source of finances: Science and Technology
Fund, sponsorship, self-financed money, etc.)
6.
Origin of the research topic:
6.1. Research: - Accepted; - Not yet accepted
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Result of the acceptance or evaluation by
Science and Technology Council formed by Ministry of Health (specify:
approval or disapproval of the clinical trial, request of repetition of
experiments or preclinical trials, etc.)
6.2. Preclinical trial for medical equipment:
- Preclinical trial performed: ........................................................................................
- Accepted or evaluated by Science and
Technology Council under Ministry of … or by government agency ...
Result of the Council’s evaluation:
.....................................................................................
. Phase accepted:
......................................................................................
. Request of permission for the preclinical
trial for medical equipment at phase: ...........................................................
7
Topic of the preclinical trial for medical
equipment in the phase (in detail):
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
8
Principal investigator}
Full name:
Academic title/ academic degree:
Academic rank:
Telephone: (Office)/ (Home) Fax:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Email:
Office address:
Home address:
9
The organizer of the clinical trial for medical
equipment (Lead organization)
Name of the organization in science and
technology:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Address:
10
Organization or individual in possession of the
medical device clinically tried (the entity permitted to use the copyright of
the device pre-clinically tried and the result of the preclinical trial to
proceed to production, real-life deployment or subsequent research)
Name of the organization
Telephone: Fax: Email:
Office address:
Full name (of the individual)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Academic rank:
Telephone: (Office)/ (Home) Fax:
Mobile:
Email:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Home address:
(Explanation of sections as per the
Preclinical trial guideline for contents of the proposal at various phases)
11
Objective:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Local and overseas clinical trials for the
medical device
·
Research topic
New
Following the study finished at the previous phase
·
Description of the medical device (technology, technical features, product
quality, process of use and operation, evaluation method, possible risks and
hazards and safety measures for participants or organizers)
·
Overview of clinical trials for the medical device:
Overseas:
Local:
· List clinical trials
related to the medical device, which have been announced in the last 10
years.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
13
Approach, research method, techniques (elucidate
the approach, research design, sampling, sample size, criteria for research subjects,
research methods, techniques to be employed - in comparison with equivalent
methods, research values, technical means, equipment for determination of
research figures, originality, uniqueness and creativity of the design and
methods of this study)
14
Research content (list and describe contents to
be studied, indicate new and suitable contents to solve questions
and attain research objectives, cooperation activities expected to transfer
research findings to users)0}
15
International cooperation
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Detail
16
Progress
No.
Main contents and tasks
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Outcome desired
Time
(Start - End)
Person, organization in charge
1
2
3
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
5
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
17
Form of research result desired
¨ Graph
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
¨ Analysis report, conclusions
regarding the effect, suitability and safety of the medical device
¨ Forecast for
subsequent clinical trials for the medical device
¨ Directions for
use of the medical device
¨ Procedure for use
¨ Other outcomes
18
Requirements for outcomes
No.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Scientific
requirement
Note
(1)
(2)
(3)
(4)
1
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
2
3
4
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
19
Method for transfer of research findings
20
Effect of research findings (apart
from those declared in Section 18)
· Training of
personnel in science and technology
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
· On economy - society:
21
Activities of organizations that cooperate
to perform the research
(Indicate all organizations that cooperate to
perform the research and their tasks)
No.
Name of the
organization
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Activity/
contribution to the research
1
2
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
....
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Connection with production and life
(Indicate producers or users of research
findings, which participate in the research and their tasks)
23
Performers of the research
(Specify at most 10 main individuals from lead
organizations, who contribute to the research)
No.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Employer
% of time spent on
the research
A
Principal investigator
B
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
1
2
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
....
Unit: Million dongs
(VND)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Spending for the research
No.
Source of fund
Total
Including
Fixed employment
Materials and
energy
Machines,
equipment
Construction,
minor repair
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
1
2
3
4
5
6
7
8
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Including:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
1
Science budget
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
2
Other sources (specify)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Self-financed
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Others (mobilized capital, etc.)
......... ………
[place], ... … … [date]
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Principal
investigator
(Sign and full name)
......... ………
[place], ... … … [date]
BY ORDER OF MINISTER
HEAD OF DEPARTMENT OF SCIENCE AND TRAINING
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Appendix
Unit: million dongs
No.
Spending
Total
Source
Amount
Ratio (%)
State budget
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Others
1.
Fixed employment
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Materials and energy
3.
Special equipment and machines
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4.
Construction, minor repair
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
5.
Others
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
EXPLANATION OF
SPENDING
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
No.
Entry
Total
expenditure
Source
State budget
Self-financed
Others
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Section 2: Materials and energy
No.
Entry
Measuring
unit
Quantity
Unit price
Amount
Source
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Self-financed
Others
2.1
Materials
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Tools
and spare parts
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
2.3
Energy and fuel
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Coal
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Electricity
kW/h
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Petrol and oil
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Other fuels
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
2.4
Water
m3
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
2.5
Purchase of boos, documents, data
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
No.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Measuring
unit
Quantity
Unit price
Amount
Source
State budget
Self-financed
Others
3.1
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
3.2
Purchase of test and measuring equipment
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
3.3
Equipment depreciation
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
3.4
Rent of equipment
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
3.5
Transport and installation
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Section 4. Construction and minor repair
No.
Entry
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Source
State budget
Self-financed
Others
4.1
Cost of construction of
m2 of factory or laboratory
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4.2
Cost of repair of m2
of factory or laboratory
4.3
Cost of installation of electrical and water
systems
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4.4
Other costs
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Total
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Section 5. Other expenses
No.
Entry
Amount
Source
State budget
Self-financed
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4.1
Business trip
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4.2
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4.3
Evaluation, inspection, acceptance
- Intermediary inspection and acceptance
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Internal acceptance
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Official acceptance
4.4
Others
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Seminar
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Printing, stationery
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
- Translation
........
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4.5
Allowance for Principal investigator
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
REPORT ON
CLINICAL TRIAL FOR MEDICAL EQUIPMENT
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Principal investigator:
Lead organization:
Research title code (if available):
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Cover page 2
REPORT ON
CLINICAL TRIAL FOR MEDICAL EQUIPMENT
Research title:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Year of …
Page 3
1. Research title:
2. Principal
investigator:
3. Lead organization
4. Supervisory
organization:
5. Secretary:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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]
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Page 4
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
(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:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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): ...
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
-
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)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Representative:
Address:
Telephone:
Party B. The participant in the clinical
trial
Full name:
Address:
Or Legal representative
Address:
Telephone:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
PARTY A’S
REPRESENTATIVE
PARTY B’S REPRESENTATIVE
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
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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:
No.
Criteria
Highest point
3.1
Fulfillment of the research's basic works
12
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Adequacy of quantity and volume of basic works
fulfilled according to the clinical trial contract (between the entity in
possession of the medical device and the organizer of the test)
4
b
Research method (sampling, sizing, techniques, experimental
authenticity, representativeness of tests, figures, etc.)
4
c
Completeness of science reports (statement,
summary report, document, data, clinical trial record, preclinical trial
record, other papers, duration, progress and expenditure)
4
3.2
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
12
a
Attainment of goals of the clinical trial
+ Result of the test method planned with clinical
reality
+ Does result of the clinical trial indicate full
evaluation and anticipation of risks and adverse effects of the device and
solutions?
4
b
Assessment of latent risks and recommendation of
safety measures for patients, medical personnel and individuals concerned
4
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Ethical assessment
+ Health condition of performers of the clinical
trial after their use of the device
+ Expertise and experience of performers of the
clinical trial
4
3.3
Scientific value of the result of the clinical
trial
8
a
Scientific value, originality and creativity of
the research
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
b
Announcement of research findings (on newspaper
and publications)
4
3.4
Practical value of the result of the clinical
trial
8
a
Practical applicability of research findings
4
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Economic - social effects of the research
4
3.5
Assessment of organization and management,
training and other contributions
10
a
Assessment of research organization and
management
4
b
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4
c
Other contributions
2
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Further clinical trial is requested.
Other recommendations
SHEET FOR ASSESSMENT AND REMARK
RESULT OF THE CLINICAL TRIAL FOR MEDICAL
EQUIPMENT
Defender
Member
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
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:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Criteria
Highest point
Points given by
specialists
5.1
Fulfillment of the research's basic works
12
a
Adequacy of quantity and volume of basic works
fulfilled according to the clinical trial contract (between the entity in possession
of the medical device and the organizer of the test)
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4
b
Research method (sampling, sizing, techniques,
experimental authenticity, representativeness of tests, figures, etc.)
Remark:
4
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Completeness of science reports (statement,
summary report, document, data, clinical trial record, preclinical trial
record, other papers, duration, progress and expenditure)
Remark:
4
5.2
Fulfillment of research contents
12
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Attainment of goals of the clinical trial
+ Result of the test method planned with clinical
reality
+ Does result of the clinical trial indicate full
evaluation and anticipation of risks and adverse effects of the device and
solutions?
Remark:
4
b
Evaluation of latent risks and recommendation of
safety measures for patients, medical personnel and individuals concerned
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4
c
Ethical assessment
+ Health condition of performers of the clinical trial
after their use of the device
+ Expertise and experience of performers of the
clinical trial
Remark:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
5.3
Scientific value of the result of the clinical
trial
8
a
Scientific value, originality and creativity of
the research
Remark:
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
b
Announcement of research findings (on newspaper
and publications)
Remark:
4
5.4
Applicability of the result of the clinical trial
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
a
Practical applicability of research findings
Remark:
4
b
Economic - social effects of the research
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4
5.5
Assessment of management, training and other
contributions
10
a
Assessment of research organization and
management
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
4
b
Result of training
Remark:
4
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
Other contributions
Remark:
2
Total point
50
6. General remark on the result of the research
...
...
...
Please sign up or sign in to your
TVPL Pro Membership to see English documents.
(this part only applies when the research is
"Failed")
8. Opinions of members of the Council on
unsolved issues and their recommendations
COUNCIL MEMBER
(Sign and write
full name)
Đã cập nhật Luật Đất đai 2024 mới nhất