Circular No. 55/2015/TT-BYT on recognizing clinical trials of new techniques and methods in medical examination and treatment

CIRCULAR

REGULATIONS ON THE RECOGNITION OF CLINICAL TRIALS OF NEW TECHNOLOGIES AND METHODS IN DIAGNOSIS AND TREATMENT

PURSUANTPursuant to the Law on Diagnosis and Treatment dated November 23, 2009;

Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;The Director of the Department of Science, Technology and Training - Ministry of Health,

3. Supplement Appendix 35 Guidelines for diagnosing and assessing occupational COVID-19 disease attached hereto.hereby promulgates this Circular on the recognition of clinical trials of new technologies and methods in diagnosis and treatment.

This Circular regulates the conditions, authority, dossier, and procedures for recognizing clinical trials of new technologies and methods in diagnosis and treatment in Vietnam, including: a) Technologies and methods researched for the first time in Vietnam; b) Technologies and methods researched for the first time abroad, which have not completed research or have completed research and acceptance but have not been applied either abroad or in Vietnam.New technologies and methods in diagnosis and treatment are medical technologies and methods that are newly invented and researched in Vietnam and/or worldwide with the purpose of diagnosing, preventing, treating, restoring function, intervening, replacing, or adjusting physiological functions of humans.1. Ensuring the quality of diagnosis and treatment and safety for patients.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

The principal researcher is the person primarily responsible for the entire process of clinical trials of new technologies and methods in diagnosis and treatment at the trial site.

Article 3. Classification of new technologies and methods in diagnosis and treatment

1. New technologies and methods in diagnosis and treatment are divided into three groups based on the level of risk affecting the health and life of patients, including:

Article 2. Interpretation of Terms

a) Group I (low risk): non-invasive or minimally invasive technologies and methods with little risk of affecting the health of patients.

b) Group II (moderate risk): invasive technologies and methods with some risk of affecting the health of patients.

c) Group III (high risk): invasive technologies and high-risk technologies with potential to affect the life and/or pose a high risk of affecting the health of patients.

2. The Ministry of Health will consider and decide on the classification of new technologies and methods into one of the groups specified in Clause 1 of this Article for each specific dossier based on the advisory report of the Bioethics Evaluation Board - Ministry of Health (hereinafter referred to as the Bioethics Evaluation Board).

3. The Ministry of Health shall issue professional criteria to determine the classification of new technologies and methods in diagnosis and treatment applicable to clinical trials as stipulated in Clause 1 of this Article.

Article 4. Rights and responsibilities of organizations and individuals in clinical trials of new technologies and methods in diagnosis and treatment

1. Rights of organizations and individuals with new technologies and methods:

a) To select and propose organizations meeting requirements to conduct clinical trials of new technologies and methods.

b) To own all results of clinical trials of new technologies and methods according to the laws on intellectual property.

c) To terminate the research if the organization conducting the trial seriously violates the approved research protocol.

2. Responsibilities of organizations and individuals with new technologies and methods:

a) To provide accurate, complete, and truthful information to participants in clinical trials of new technologies and methods.

b) To compensate and indemnify participants in clinical trials of new technologies and methods if risks occur due to clinical trials according to current laws.

c) To be liable under the law for the effectiveness and safety of new technologies and methods provided by them.

d) To comply with the laws on clinical trials of new technologies and methods in diagnosis and treatment.

3. Rights of organizations conducting clinical trials of new technologies and methods:

a) To receive funding from organizations and individuals with new technologies and methods for conducting clinical trials according to the law.

b) To use the results of clinical trials of new technologies and methods according to agreements with organizations and individuals with new technologies and methods for clinical trials.

4. Responsibilities of organizations conducting clinical trials of new technologies and methods:

a) To comply with Good Clinical Practice (GCP) principles for new technologies and methods in diagnosis and treatment as prescribed by the Ministry of Health.

b) To monitor the health and illness of participants in clinical trials according to agreements in contracts or research protocols.

5. Rights of participants in clinical trials of new technologies and methods:

a) To be provided with accurate, complete, and truthful information before clinical trials about the trial process and possible risks.

b) To be compensated for damages by organizations and individuals with new technologies and methods for clinical trials if caused by clinical trials.

c) To keep personal information confidential.

d) To receive healthcare throughout the trial period according to the approved research protocol, to be examined and treated for adverse events encountered due to clinical trials.

đ) To be compensated for damages arising from clinical trials according to current laws.

e) To have the right to withdraw from the clinical trial at any time without bearing any responsibility and still enjoy the following benefits:

- Continued healthcare according to currently applied standard treatment methods.

- Compensation paid up to the withdrawal date.

đ) Be entitled to receive allowances and compensation for damages arising from clinical trial risks in accordance with current laws.

e) Have the right to withdraw from the clinical trial at any time without incurring any liability and still enjoy the following benefits:

- Continued health care in accordance with currently applied standard treatment methods.

- Receipt of allowances up to the withdrawal date.

Chapter II

Article CONDITIONS FOR RECOGNITION OF CLINICAL TRIALS OF NEW TECHNOLOGIES AND METHODS IN DIAGNOSIS AND TREATMENT

Article 5. Conditions for recognition of clinical trials of new technologies and methods in diagnosis and treatment

1. Clinical trials of new technologies and methods in diagnosis and treatment must be conducted in accordance with the provisions set forth in Articles 6, 7, 8, and 9 of this Circular.

2. The results of clinical trials of new technologies and methods in diagnosis and treatment must be submitted to the Ethics Review Board for permission to apply.

3. Clinical trials of new technologies and methods must comply with the regulations on file requirements and procedures for approval of research plans and recognition of clinical trials of new technologies and methods in diagnosis and treatment as stipulated in Articles 11, 12, and 13 of this Circular.

Article 6. Conditions for new technologies and methods to be clinically tested

1. They must have been studied in preclinical stages, with documentation proving their safety to proceed with subsequent phases of testing.

2. There must be results from previous phase clinical trials if requesting to conduct clinical trials of new technologies and methods in subsequent phases.

Article 7. Conditions for organizations receiving clinical trials of new technologies and methods in diagnosis and treatment

1. They must be healthcare facilities that have been granted operating licenses in accordance with laws on diagnosis and treatment; their scope of professional activities must be appropriate for the new technologies and methods being clinically tested.

2. They must have an Institutional Ethics Committee (hereinafter referred to as the Ethics Committee) established by the head of the healthcare facility. The Ethics Committee must consist of at least five members including the Chairperson, Vice-Chairperson, Committee Members, and Secretary.

3. They must have researchers participating in clinical trials who meet the conditions specified in Article 8 of this Circular.

Article 8. Conditions for researchers participating in clinical trials of new technologies and methods in diagnosis and treatment

1. They must hold a medical practice certificate with a scope of professional practice suitable for the new technologies and methods being clinically tested.

2. They must have participated in training and continuing education on Good Clinical Practice (GCP) in research.

Article 9. Conditions for implementing clinical trials of new technologies and methods in diagnosis and treatment

1. Fully adhere to the following clinical trial research phases:

a) Phase 1 (the first human trial phase):

- Objective: to evaluate safety and provide preliminary assessment of efficacy of new technologies and methods.

- Sample size: selected appropriately from 10 study subjects or more, sufficient to make judgments about safety and preliminary efficacy of the new technologies and methods being clinically tested.

b) Phase 2:

- Objective: to confirm efficacy and safety of new technologies and methods to obtain recognition and permission to apply research results.

- Sample size: studied on a larger number of patients than in Phase 1; sample size needs to be calculated based on ensuring statistical significance, providing sufficient information to confirm efficacy and safety of the new technologies and methods being clinically tested and related issues.

c) Phase 3 (implemented after new technologies and methods have been permitted for application in Vietnam):

- Objective: to collect additional evidence on safety and efficacy of new technologies and methods during application when there is a need to assess and improve new technologies and methods or upon request by state management agencies due to safety and efficacy issues of new technologies and methods in diagnosis and treatment.

- Sample size: calculated appropriately to provide additional evidence on safety and efficacy of the new technologies and methods.

2. Specific sample sizes in clinical trials of new technologies and methods as stipulated in Clause 1 of this Article shall be reviewed and decided by the Ethics Review Board for each research dossier.

3. Clinical trials and exemption from some clinical trial phases for new technologies and methods:

a) New technologies and methods researched for the first time in Vietnam:

- Technologies and methods in Group III must undergo full preclinical and Phase 1 and 2 clinical trials.

- Technologies and methods in Group II are exempted from preclinical trials.

- Technologies and methods in Group I are exempted from preclinical and Phase 1 clinical trials.

b) New technologies and methods researched for the first time abroad:

- New technologies and methods that have completed and reported research results from previous phases abroad, and continue to implement subsequent phases of research in that country may be considered for simultaneous implementation of research in Vietnam.

- New technologies and methods that have completed research and acceptance but not yet applied abroad and in Vietnam:

+ Technologies and methods in Group III are exempted from preclinical trials.

+ Technologies and methods in Group II are exempted from preclinical trials and Phase 1 clinical trials.

+ Technologies and methods in Group I are exempted from preclinical and Phase 1 and 2 clinical trials.

4. Handling adverse events during clinical trials:

a) The principal investigator of the organization conducting the clinical trial is responsible for monitoring, detecting, and managing adverse events occurring on study subjects at their research facility.

b) In case a complication occurs that poses danger to the life of a participant in clinical trials for new techniques or methods, the principal investigator and the organization conducting the clinical trial must immediately stop the trial on that participant, provide the best available care and treatment at the research facility, and simultaneously report the situation urgently to the Ethics Committee, the Ethical Review Board, and the Science and Technology Training Department of the Ministry of Health in accordance with current regulations.

c) Based on the advisory opinion of the Ethical Review Board, the Ministry of Health shall consider and decide whether to continue, temporarily suspend, or terminate the research to ensure safety for the research subject.

5. Collection of information and data:

a) Information recorded during the clinical trial of new techniques or methods must be documented in the research medical record (Case Report Form - CRF) in paper form. Regular monitoring must be conducted to ensure that the data in the research medical record are consistent with the source documents.

b) Relevant documents necessary for clinical evaluation (laboratory test forms, diagnostic imaging results, prescriptions, and other documents) must be photocopied from the original, clearly indicating the name of the person who verified them, specifying their origin, and must be managed and stored according to regulations.

6. Data processing:

a) Research data from clinical trials of new techniques or methods must be processed using appropriate biostatistical methods and must be handled by an agency or organization with the function and expertise to process data independently from the agency or organization receiving the trial to ensure objectivity, truthfulness, and reliability.

b) Statistical analysis results must be presented clearly to enable discernment of differences in clinical outcomes. The effectiveness of treatment must be evaluated based on the level of confidence and results obtained from statistical analysis. The final report of the clinical trial must be consistent with the statistical analysis results.

7. Document storage:

a) Source documents, electronic databases, and essential documents related to clinical trials of new techniques or methods must be fully preserved and stored for at least ten years at the research facility, starting from the end date of the study.

b) The principal investigator is responsible for the entire process of preserving and storing research documents and has the responsibility to present them upon request by inspection teams, supervisory bodies, and competent state management agencies.

8. Reporting research results:

a) The reporting of clinical trial results for new techniques or methods is carried out in accordance with Appendix No. 06 issued together with this Circular.

b) The principal investigator is responsible for the scientific accuracy, truthfulness of the data, conclusions, assessments, and other contents of the report.

Chapter III

AUTHORITY, FILES, AND PROCEDURES FOR RECOGNITION OF CLINICAL TRIALS OF NEW TECHNIQUES AND METHODS IN DIAGNOSIS AND TREATMENT

Article 10. Authority for recognizing clinical trials of new techniques and methods in diagnosis and treatment.

1. The Minister of Health approves the research outline for clinical trials of new techniques and methods in diagnosis and treatment.

2. Based on the approved research outline by the Minister of Health, research results, and the minutes of the ethical review board's recommendation to allow application, the Director of the Science and Technology Training Department of the Ministry of Health decides to recognize clinical trials of new techniques and methods in diagnosis and treatment.

Article 11. Documents for requesting approval of research outline and recognition of clinical trial of new techniques and methods in diagnosis and treatment

1. The documents for requesting approval of the research outline for clinical trials of new techniques and methods include:

a) The application form for approval of the research outline for clinical trials of new techniques and methods submitted by the organization conducting the trial according to Appendix No. 01 issued together with this Circular.

b) The cooperation agreement on research between the agency, organization, or individual having the new technique or method and the organization conducting the clinical trial according to Appendix No. 02 issued together with this Circular.

c) The cooperation agreement between the organization or individual having the new technique or method and the organization supporting the clinical trial research (if any) according to Appendix No. 03 issued together with this Circular.

d) The detailed research outline according to Appendix No. 04 issued together with this Circular.

đ) The data collection form for research/Clinical research case report form (CRF).

e) The scientific curriculum vitae of the principal researcher.

g) The information provision document about the research and the consent form for voluntary participation in the research.

h) The minutes of the scientific and ethical evaluation meeting of the Ethics Committee (the organization conducting the clinical trial of new techniques and methods).

i) Professional documents on the new techniques and methods being clinically tested, including:

- Preclinical research documents of the new techniques and methods being clinically tested: reports on safety, efficacy, and usage recommendations.

- Clinical trial research documents of previous stages (if requesting a subsequent stage clinical trial).

2. The documents for requesting recognition of the clinical trial of new techniques and methods include:

a) The application form for recognition of the clinical trial of new techniques and methods submitted by the organization conducting the clinical trial according to Appendix No. 05 issued together with this Circular.

b) A copy of the Decision approving the research outline that has been approved.

c) The Decision establishing the Institutional Review Board.

d) The minutes of the Institutional Review Board meeting.

đ) The clinical trial research result report of new techniques and methods according to regulations and may supplement other relevant information as necessary according to Appendix No. 06 issued together with this Circular.

Article 12. Procedures for requesting approval of the research outline for clinical trials of new techniques and methods in diagnosis and treatment

1. The organization conducting the clinical trial of new techniques and methods submits one set of documents for requesting approval of the research outline for clinical trials of new techniques and methods in diagnosis and treatment in Vietnamese to the Science, Technology and Training Department of the Ministry of Health.

2. The Science, Technology and Training Department checks the validity of the documents within five working days. In cases where the documents are not valid, a specific notification and guidance must be provided to the institution to supplement the documents.

3. Within twenty-five working days from the date of receiving all required documents as stipulated in Article 11 of this Circular, the Ministry of Health convenes a meeting of the Ethical Evaluation Board and prepares minutes for evaluating the research outline for clinical trials of new techniques and methods in diagnosis and treatment.

4. Within five working days from the date of the Ethical Evaluation Board's evaluation minutes, the Science, Technology and Training Department compiles and completes the documents and submits them to the Minister of Health for a decision to approve the research outline for clinical trials of new techniques and methods in diagnosis and treatment if the research outline meets the requirements. If the research outline is not approved or requires revision, the Science, Technology and Training Department issues a notification to the institution detailing the reasons.

5. In cases where the research outline needs revision, the institution is responsible for cooperating with the Science, Technology and Training Department to complete the documents within a maximum period of sixty days from the date of receipt of the notification. Beyond this period, the approval procedure for the research outline must be restarted from the beginning.

6. Within five working days from the date of receiving the completed research outline and documents according to the notification, the Science, Technology and Training Department compiles and completes the documents and submits them to the Minister of Health for a decision to approve the research outline for clinical trials of new techniques and methods in diagnosis and treatment.

Article 13. Procedures for Recognizing Clinical Trials of New Techniques and Methods in Diagnosis and Treatment

1. Organizations conducting clinical trials of new techniques and methods shall submit a dossier in Vietnamese requesting recognition of research on clinical trials of new techniques and methods in diagnosis and treatment to the Science, Technology and Training Department of the Ministry of Health.

2. The Science, Technology and Training Department checks the validity of the documents within five working days. In cases where the documents are not valid, a specific notification and guidance must be provided to the institution to supplement the documents.

3. Within twenty-five working days from the date of receipt of complete files as stipulated in Article 11 of this Circular, the Ministry of Health shall convene the Ethics Review Board to issue a record of acceptance of research on clinical trials of new techniques and methods in diagnosis and treatment, including conclusions recommending approval, approval after revision, or disapproval.

4. Within five working days from the date of issuance of the record of the Ethics Review Board's recommendation for approval of new techniques and methods, the Director of the Science, Technology and Training Department shall decide to recognize research on clinical trials of new techniques and methods in diagnosis and treatment according to Appendix No. 07 issued together with this Circular. In cases where the record recommends approval after revision or disapproval, the Science, Technology and Training Department shall notify the organization and specify the reasons.

5. In cases where the record recommends approval after revision, the organization shall be responsible for cooperating with the Science, Technology and Training Department to complete the dossier within a maximum period of sixty days from the date of receipt of the notification. Beyond this deadline, the recognition procedure must be restarted from the beginning.

6. Within five working days from the date of receipt of the completed dossier in accordance with the notification, the Director of the Science, Technology and Training Department shall decide to recognize research on clinical trials of new techniques and methods in diagnosis and treatment.

Chapter IV

IMPLEMENTING PROVISIONS

Article 14. Inspection of the Research Process of Clinical Trials of New Techniques and Methods in Diagnosis and Treatment

1. The Science, Technology and Training Department of the Ministry of Health shall establish inspection teams periodically or at random for specific cases to inspect the process of research on clinical trials of new techniques and methods in diagnosis and treatment. State management agencies with authority, organizations, individuals with new techniques and methods undergoing clinical trials, and research support organizations approved in writing by the Ministry of Health may propose to send personnel to systematically inspect the research process.

2. Content of Inspection:

a) Ensuring the rights, interests, and health of participants in clinical trials of new techniques and methods in diagnosis and treatment.

b) Ensuring that all data recorded during the research are complete, accurate, timely, and comply with the approved research protocol, Good Clinical Practice (GCP) guidelines, and current relevant regulations.

3. Procedure for Conducting Inspections:

a) The Science, Technology and Training Department of the Ministry of Health shall notify the organization conducting clinical trials of new techniques and methods ten working days in advance of the inspection.

b) The organization conducting clinical trials of new techniques and methods shall be responsible for preparing personnel and work contents according to the notification of the Science, Technology and Training Department of the Ministry of Health.

c) Within five working days from the end of the inspection, the inspection team shall complete the inspection record; report and propose recommendations based on the inspection record to the competent state management agency as a basis for consideration and handling in accordance with the law.

d) Within twenty working days from the date of conducting the inspection, the Science, Technology and Training Department of the Ministry of Health shall notify the results of the inspection in writing to the organization conducting clinical trials of new techniques and methods.

đ) The organization conducting clinical trials of new techniques and methods shall be responsible for implementing the conclusions of the inspection by the Science, Technology and Training Department of the Ministry of Health.

Article 15. Effective Date

This Circular takes effect from February 16, 2016.

Article 16. Responsibility for Implementation

1. The Director of the Science, Technology and Training Department of the Ministry of Health shall be responsible for organizing and implementing the provisions of this Circular.

2. Directors of Provincial Health Departments under central cities, heads of health departments of ministries and sectors shall be responsible for disseminating and directing the implementation of this Circular for medical facilities under their jurisdiction.

3. The Director of the Science, Technology and Training Department, the Head of the Ministry’s Office, the Head of the Ministry’s Inspectorate, Heads of Departments, Directors of Bureaus, General Directors of General Bureaus under the Ministry of Health, medical facilities nationwide, and related organizations and individuals shall be responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to promptly reflect them to the Science, Technology and Training Department of the Ministry of Health for examination and resolution./.