Chương V Thông tư 32/2023/TT-BYT: Thực hành tốt thử kỹ thuật mới, phương pháp mới hoặc thử thiết bị y tế trên lâm sàng

Chapter V

GOOD CLINICAL PRACTICE (GCP)

Section 1. Regulations on GCP

Article 17. GCP rules and standards

Promulgate GCP rules and standards in Appendix XXI of this Circular based on reference to guidance from ICH and WHO.

Article 18. GCP evaluations and compliance assessment

1. Initial evaluation: Conducted when the clinical testing body conducts clinical trials of new techniques, new methods or medical equipment (hereinafter referred to as the testing body).

2. Scheduled evaluation: Conducted to maintain compliance with GCP, scheduled assessment is carried out every 3 years from the date of issuance of GCP compliance certificate (excluding unscheduled assessments and inspections).

3. Unscheduled evaluation of GCP compliance is carried out in accordance with Article 27 of this Circular.

4. Assessment of GCP compliance: The Ministry of Health and Department of Health, based on state management requirements, shall assess GCP compliance or integrate GCP compliance assessment into the annual inspection schedule for other professional activities or during unscheduled assessments of the testing body’s compliance with GCP.

Article 19. GCP compliance levels

1. Level 1: The testing body is in full compliance with GCP, with no findings requiring corrective action.

2. Level 2: The testing body may have issues that need to be remedied to meet GCP, provided that such issues do not affect the accuracy and integrity of research data, and the safety and health of clinical trial participants.

3. Level 3: The testing body does not meet GCP in the following cases:

a) There is a matter that does not comply with GCP standards and may compromise the accuracy and integrity of research data and/or the health and safety of clinical trial participants;

b) Commit fraud, falsification, alteration of figures, data and documents.

Section 2. INITIAL EVALUATION OF GCP COMPLIANCE

Article 20. Application for initial evaluation of GCP compliance

1. Application form for initial evaluation of GCP compliance is provided in Form No. 01 in Appendix XXII of this Circular.

2. Declaration of general information about the testing body; facilities, list of medical devices; list of personnel who are eligible for GCP compliance assessment; standard operating procedures (SOPs), the quality control system for clinical trials and documents to prove and confirm those declarations. Documentation details follow the instructions in Appendix No. XXII of this Circular.

3. Copy of the operating license if the testing body is a healthcare facility; copy of the establishment decision or a copy of the business registration certificate accompanied by a copy of the certificate of scientific and technological activities if the testing body is a scientific and technological organization.

Article 21. Procedures for receiving applications for and evaluation of GCP compliance

1. The testing body submits one set of application as prescribed in Article 20 of this Circular to the Ministry of Health (Department of Science, Technology and Training).

2. Within 10 working days of receiving the application, the Department of Science, Technology and Training checks the completeness and validity of the application. In case the application is complete and valid, the Department of Science, Technology and Training organizes an evaluation team according to Article 28 of this Circular to undertake an on-site evaluation at the testing body within 15 working days.

In case the application is not complete and valid, the Department of Science, Technology and Training shall notify the testing body in writing.

3. The evaluation team undertakes an on-site evaluation of the testing body’s compliance with the GCP standards specified in Appendix No. XXI of this Circular.

4. Based on the on-site evaluation results at the testing body, the evaluation team discusses with the testing body about the evaluation matters to meet GCP and prepares an evaluation report Form No. 02, Appendix No. XXIII of this Circular, which determines the level of GCP compliance of the testing body according to Article 19 of this Circular.

Article 22. Process for evaluating GCP compliance

1. The evaluation team announces the Decision to establish the evaluation team; purposes, evaluation matters and plan at the testing body.

2. The testing body presents a summary of the organization, personnel, activities, application of GCP or other issues according to the evaluation matters.

3. The evaluation team undertakes an on-site evaluation of the implementation of GCP application at the testing body according to each specific evaluation matter.

4. The evaluation team meets with the testing body to notify the testing body's level of compliance with GCP according to Article 19 of this Circular, non-compliant issues that need to be remedied, found during the evaluation process (if any); discuss with the clinical testing body if they have a different opinion on any non-compliant matter with the team's evaluation.

5. Prepare and sign an evaluation report: The evaluation report is signed by the leader of the clinical testing body and the head of the evaluation team; the report must show the composition of the evaluation team, location, time, scope of evaluation, and list and specifically analyze non-compliant issues that the testing body needs to remedy (if any) compared with the corresponding provisions of this Circular, evaluate the level of compliance with GCP of the testing body according to Article 19 of this Circular, differences of opinion between the evaluation team and the testing body on GCP compliance issues (if any). The report is made into 2 copies: 1 copy is kept at the testing body, 1 copy is kept at the application receiving agency.

Article 23. Handling of GCP evaluation results

1. In case the GCP compliance evaluation report concludes that the testing body meets GCP as prescribed in Clause 1, Article 19 of this Circular, then within 10 working days of signing the evaluation report, the Minister of Health assigns the Department of Science, Technology and Training to issue a Certificate of GCP compliance according to Form No. 03 specified in Appendix No. XXIII of this Circular.

2. In case the GCP compliance evaluation report concludes that the testing body needs to address their non-compliance as prescribed in Clause 2, Article 19 of this Circular:

a) Within 5 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science Technology and Training sends a GCP compliance evaluation report with a written notification of non-compliant issues that need to be remedied to the testing body;

b) After resolving the mentioned non-compliant issues, the testing body must have a written report with evidence (documents, photos, videos, certificates) proving that they have been completed that;

c) Within 20 days of receiving the remediation report from the testing body, the Department of Science, Technology and Training shall review that report and conclude on the GCP compliance status of the testing body:

- In case the remediation is satisfactory: the Department of Science, Technology and Training shall comply with Clause 1 of this Article.

- In case the remediation is unsatisfactory: the Department of Science, Technology and Training shall issue a written request for further remediation.

d) Within 6 months from the date the Department of Science, Technology and Training issues a written request for further remediation, if the testing body fails to submit such a report as requested, their submitted application will be considered invalid and the evaluation of GCP compliance must be done again from the beginning.

3. In case the GCP compliance evaluation report concludes that the testing body does not meet GCP as prescribed in Clause 3, Article 19 of this Circular: Within 5 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science Technology and Training sends a notice of GCP non-compliance together with a GCP compliance evaluation report to the testing body and refuses to issue a certificate of GCP compliance.

4. Within 5 working days of issuing the certificate of GCP compliance, the Department of Science, Technology and Training shall publish on the Ministry of Health's website and the Department of Science, Technology and Training’s website the following information:

a) Name and address of the testing body that meets GCP;

b) Full name of the person in charge, practice certificate number (if the testing body is a healthcare facility);

c) Number of certificate of GCP compliance (if any);

d) Expiry date of GCP compliance evaluation and next periodic evaluation date;

dd) Scope of operation of the testing body.

Section 3. EVALUATION OF GCP COMPLIANCE MAINTENANCE

Article 24. Scheduled evaluation of GCP compliance maintenance

1. Every December, the Department of Science, Technology and Training publishes on their website a list of testing bodies subject to evaluation of GCP compliance maintenance in the following year.

2. Based on the list published by the Department of Science, Technology and Training, each testing body must submit an application for evaluation of GCP compliance maintenance as prescribed in Clause 6 of this Article to the Department of Science, Technology and Training withing 60 days, before the expiration date of the issued certificate of GCP compliance.

3. In case the testing body fails to submit such an application for scheduled evaluation within the time limit specified in Clause 2 of this Article, within 15 working days from the deadline, the Department of Science, Technology and Training shall issue a document requesting the testing body to submit the application according to regulations.

4. Within 45 days from the date the Department of Science, Technology and Training issues a written request, the testing body must submit a report on their GCP compliance maintenance together with an explanation for late submission. If the testing body fails to submit a report after this deadline, the Department of Science, Technology and Training shall undertake an unscheduled evaluation to check if the testing body maintains their GCP compliance according to Article 27 of this Circular.

5. After submitting the application for scheduled evaluation of GCP compliance maintenance within the prescribed time, the testing body may continue to conduct their clinical trials of new techniques, new methods or medical devices according to the scope specified in the issued certificate of GCP compliance until there are results from the mentioned scheduled evaluation and must ensure maintenance of meeting GCP principles and standards.

6. Application for scheduled evaluation of GCP compliance maintenance includes:

a) Application form for scheduled evaluation of GCP compliance maintenance laid down in Form No. 04 specified in Appendix XXIII of this Circular;

b) Summary report on clinical trials of new techniques, new methods or medical devices of the testing body during the last 3 years from the previous evaluation (excluding unscheduled evaluations, inspections and examinations by the Ministry of Health, Department of Health) to the date of application for the scheduled evaluation;

c) Updated documentation on the testing body's facilities, technical capabilities, and personnel (if changed).

7. The process and handling of results from evaluation of GCP compliance maintenance shall comply with Article 22 and Article 23 of this Circular.

Article 25. Handling of results from scheduled evaluation of GCP compliance maintenance

1. In case the GCP compliance evaluation report concludes that the testing body meets GCP as prescribed in Clause 1, Article 19 of this Circular:

Within 10 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science, Technology and Training shall issue a certificate of GCP compliance according to Form No. 03 in Appendix XXIII of this Circular.

2. In case the GCP compliance evaluation report concludes that the testing body needs to remedy the non-compliance as prescribed in Clause 2, Article 19 of this Circular:

a) Within 5 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science, Technology and Training shall send a written request to the testing body to remedy the non-compliance, send a remediation report to the Department of Science, Technology and Training;

b) Within 45 days from the date the Department of Science, Technology and Training issues a written request, the testing body must complete the remediation and submit a written report with evidence (documents, images, videos, certificates) to prove they have completed the remediation of existing issues stated in the evaluation report;

c) Within 20 days of receiving the remediation report accompanied by evidence (documents, photos, videos, certificates), the Department of Science, Technology and Training to evaluate the results from remediation by the testing body and conclude on the testing body’s GCP compliance status as follows:

- If the remediation is satisfactory: The Department of Science, Technology and Training shall issue a certificate of GCP compliance according to Form No. 03 in Appendix XXIII of this Circular.

- If the remediation is unsatisfactory: the Department of Science, Technology and Training shall issue a written request for further remediation of remaining non-compliant issues. The extension period for remediation and report is 45 days from the date of the written request.

d) Within 90 days of completing the on-site evaluation, if the testing body fails to submit a remediation report or the remediation done as prescribed in Point c of this Clause is still unsatisfactory, the Department of Science, Technology and Training shall issue a notice of GCP non-compliance, and the Department of Science, Technology and Training shall then, depending on the nature and extent of the violation, take one or more measures according to Points a and b, Clause 3 of this Article.

3. In case the GCP compliance evaluation report concludes that the testing body does not meet GCP as prescribed in Clause 3, Article 19 of this Circular: Within 5 working days of completing the on-site evaluation at the testing body and signing an evaluation report, based on the evaluation of the detected existing risks to the quality of research, health and safety of participants of new techniques, new methods, and medical devices , the Department of Science, Technology and Training shall issue a notice of GCP non-compliance, and the Department of Science, Technology and Training shall then, depending on the nature and extent of the violation, take one or more of the following measures:

a) Propose competent authorities to impose administrative penalties on the testing body in accordance with law on penalties for administrative violations;

b) Revoke the certificate of GCP compliance issued to the testing body.

4. Within 5 working days from the date of conclusion that a testing body is evaluated as GCP compliant or from the date of issuance of the decision on revocation of the certificate of GCP compliance, the Department of Science, Technology and Training shall update corresponding information on their website as prescribed in Clause 4, Article 23 of this Circular.

Article 26. Change control

1. At intervals between scheduled evaluations, the testing body must apply for evaluation of GCP compliance or report changes using Form No. 05 specified in Appendix No. XXIII issued herewith if they falls under one of the following cases:

a) Change the scope of the certificate of GCP compliance;

b) Change the location of clinical trials of new techniques, new methods or medical devices; change the location of one of the technical rooms serving clinical trials of new techniques, new methods or medical devices (examination rooms, treatment rooms, emergency rooms, laboratories) at a new location;

c) Change or add one of the technical rooms to serve clinical trials of new techniques, new methods or medical devices (examination rooms, treatment rooms, emergency rooms, laboratories) at the same location of clinical trials;

d) Change information about the name and address of the testing body, update information related to the testing body, change the names of departments and divisions of the testing body related to the clinical trials of new techniques, new methods or medical devices.

2. If a testing body makes any changes as prescribed in Points a and b, Clause 1 of this Article, they must send an application for evaluation of GCP compliance as prescribed in Article 20 of this Circular. The procedures of evaluating GCP compliance, classifying results and handling results from evaluating GCP compliance are carried out according to Articles 22 and 23 of this Circular.

3. In case the testing body makes any changes specified in Points c and d, Clause 1 of this Article, the testing body shall send a written report on such change along with documentation corresponding to the change to the Department of Science, Technology and Training.

Article 27. Unscheduled evaluation of GCP compliance

1. Unscheduled evaluation of GCP compliance at the testing body is undertaken in one of the following cases:

a) The testing body fails to submit a report on evaluation of GCP compliance maintenance as prescribed in Article 24 of this Circular;

b) The testing body has made changes or additions as prescribed in Point c, Clause 1, Article 26 of this Circular, and those changes and additions pose a risk of affecting the accuracy and integrity of research data on clinical trials or affect the safety and rights of clinical trial participants;

c) The testing body has been found in serious violation of GCP principles and standards, based on inspection findings of competent authorities;

d) The testing body has been reported to seriously violate GCP principles and standards.

2. Documentation of and procedures for unscheduled evaluation at the testing body are set out in Clauses 6 and 7, Article 24 of this Circular.

Section 4. EVALUATION TEAM OF GCP COMPLIANCE

Article 28. Composition and qualifications of evaluation team members

1. The Minister of Health establishes an evaluation team of GCP compliance composed of:

a) Representative of the Leadership of the Department of Science, Technology and Training as the team leader;

b) Representative of the Leadership of the Legal Department as the deputy team leader;

c) Representative of the Leadership of the Department of Infrastructure and Medical Devices as the deputy team leader (evaluation of GCP compliance by a testing body of medical device);

d) Representatives from units affiliated to the Ministry of Health as members, including: Department of Science, Technology and Training; Department of Medical Examination and Treatment Management; Legal Department; Department of Infrastructure and Medical Devices; Department of Traditional Medicine and Pharmacy Administration;

dd) Representative of the Department of Health of province where the testing body is headquartered as member;

e) Experts in the field of expertise related to the scope of evaluation as members. Members of relevant agencies and units where necessary;

g) Expert from the Department of Science, Technology and Training as the team secretary.

2. Standing evaluation team of GCP compliance specified in Clause 1 of this Article is located at the Department of Science, Technology and Training affiliated to Ministry of Health. The evaluation team leader invites appropriate members for each specific evaluation case.

3. Evaluation team members who are experts in specialized fields related to the scope of evaluation must have the following qualifications:

a) Obtain at least a bachelor’s degree;

b) Have been trained on GCP and GCP evaluation;

c) Be honest, objective ,and strictly comply with regulations and legal regulations during the evaluation process, have no conflicts of interest with the testing body being evaluated according to Clause 4 of this Article.

4. Principles for assessing conflicts of interest: Members of the evaluation team are considered to have conflicts of interest with the testing body being evaluated if they fall into one of the following cases:

a) Have worked within the last 5 years for the evaluated testing body;

b) Have engaged in consulting services within the last 5 years for the evaluated testing body;

c) Have a financial interest in the evaluated testing body;

d) Have a spouse, child, parent, sibling, parent's sibling, or spouse, or child working for the evaluated testing body.

Article 29. Responsibilities and powers of the evaluation team and responsibilities of the testing body

1. Responsibilities of the evaluation team:

a) Evaluate all activities of the testing body according to the corresponding GCP principles and standards specified in Article 17 of this Circular and relevant technical regulations; specifically record the evaluation matters, non-compliant issues, disagreement between the evaluation team and the testing body (if any); prepare evaluation reports;

b) Keep all relevant information about the evaluation and testing body confidential; except in cases with the consent of the testing body or at the request of a competent authority to serve inspection and investigation.

2. Powers of the evaluation team:

a) Inspect the entire area related to clinical trials of new techniques, new methods or medical devices of the testing body;

b) Request to provide documents related to clinical trials of new techniques, new methods or medical devices of the testing body;

c) Collect documents and evidence (copy documents, take photos, record videos) to prove the non-compliant issues found during the evaluation process;

d) Make a report and request the testing body to suspend clinical trials of new techniques, new methods or medical devices if during the evaluation process the team has found that the testing body has violated the regulations that seriously affect the accuracy and integrity of research data and/or the safety and health of participants in clinical trials, and then report it to competent persons as per regulations.

3. Responsibilities of the testing body:

a) Implement this Circular in line with the circumstances of the testing body;

b) Maintain compliance with GCP principles and standards throughout the testing body’s operation;

c) Carry out clinical trials of new techniques, new methods or medical devices in accordance with the licensed scope on the basis of compliance with legal regulations;

d) Comply with regulations on deadlines, applications, and procedures for evaluating GCP compliance in accordance with this Circular;

dd) Submit to unscheduled inspection and evaluation of GCP compliance maintenance conducted by competent authorities as per the law.