Circular No. 08/2014/TT-BYT on activities supporting clinical trial research in Vietnam

CIRCULAR

Regulations on activities supporting clinical trial research in Vstrict N |||at s

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Pursuant to Decree No. 63/2012/NĐ-CP dated October 23, 2012 of the Government stipulating functions, tasks, powers, and organizational structure1 August year of the Ministry of Health in issuing Circulars regulating activities organization specialized agency under the People's Committee of the province/city.Deputy ministers of ministerial-level agencies,the Ministry of Health;

a) Implementing activities to prevent and control infectious diseases, HIV/AIDS: monitoring, early detection, vaccination, preventive treatment, implementing epidemic control measures, and mitigating the consequences of epidemics; preventing and controlling risk factors for the emergence and spread of epidemics and diseases;policies of clinical trial research in Vietnam. hỗ trợ This Circular stipulates conditions, registration, scope of activities, rights and responsibilities of organizations engaged in supporting clinical trial research in Vietnam (hereinafter referred to as research support organizations).

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Activities supporting clinical trial research

Article 2. Interpretation of Terms

1. include monitoring, inspection, statistical analysis, and data management, testing, and administrative support in clinical trial research. Clinical Research Associate (CRA)

2. is a person with a relevant academic degree and experience suitable for the field of clinical trial research support, familiar with the research dossier, the United Nations International Conference on Harmonisation Good Clinical Practice Guidelines (ICH GCP), and other related legal regulations. Clinical Research Coordinator (CRC)

3. is a person from a research support organization for clinical trial research, tasked with assisting the principal investigator during the clinical trial research process; managing documents, files, and data related to the research; supporting the clinical trial drug recipient organization when working with sponsors, monitors, and inspectors. CONDITIONS FOR ACTIVITIES SUPPORTING CLINICAL TRIAL RESEARCH IN VIETNAM

Chapter II

Article 3. General Conditions for Research Support Organizations
1. Organizational Conditions:

It must be an entity with legal personality operating in the field of clinical trial research, established by a decision of the competent state agency for state organizations or a business registration certificate or a license issued by a competent state agency in Vietnam for private organizations, non-governmental organizations.

a) The head of the specialized department must have a college degree or higher in a relevant health science field corresponding to the organization's registered professional activities, with at least three years of experience in at least one field related to clinical trial research support activities.

b) Must have sufficient staff meeting the conditions stipulated in this Circular corresponding to the organization's registered professional activities.

2. Human resource conditions:

3. Infrastructure Conditions: Must have a headquarters, infrastructure, and equipment ensuring the implementation of clinical trial research support activities consistent with the organization's registered professional activities according to Model No. 01 attached to this Circular.

4. Quality Assurance Conditions:

a) Must have standard operating procedures (SOPs) for clinical trial registration activities.

b) Must have a document storage system capable of providing evidence that activities are carried out in accordance with the SOPs.

c) Must have a quality assurance system in accordance with ISO standards or equivalent standards.

5. In addition to the general conditions stipulated in this Article, research support organizations registering one or more clinical trial research support activities such as research monitoring, research inspection, statistical analysis and data management, research testing, and research administrative support must meet the corresponding conditions stipulated in Articles 4, 5, 6, 7, and 8 of this Circular.

c) Have a quality assurance system in accordance with ISO standards or equivalent standards.

5. In addition to the general conditions prescribed in this Article, an organization supporting research that registers one or more research support activities such as study monitoring, testing, statistical analysis, and research data management, research testing, administrative support for research must meet the corresponding conditions stipulated in Articles 4, 5, 6, 7, and 8 of this Circular.

Article 4. Conditions for organizations supporting research that have registered to conduct clinical trial monitoring activities

1. Meeting the conditions stipulated in Article 3 of this Circular.

2. Having at least one clinical trial monitor who meets the following conditions:

a) Legally employed by the research support organization. For foreign individuals, they must have a work permit issued by the competent authority of Vietnam.

b) Holding a bachelor's degree or higher in a relevant field corresponding to research support activities.

c) Possessing a certificate or certification of initial training in clinical trial monitoring and good clinical practice issued by the Ministry of Health or an organization recognized by the Ministry of Health.

d) Holding a certificate or certification of theoretical and practical annual refresher training on clinical trial monitoring.

Article 5. Conditions for organizations supporting research that have registered to conduct clinical trial inspection activities

1. Meeting the conditions stipulated in Article 3 of this Circular.

2. Having at least one clinical trial inspector who meets the following conditions:

a) Legally employed by the research support organization. For foreign individuals, they must have a work permit issued by the competent authority of Vietnam.

b) Holding a bachelor's degree or higher in a related field corresponding to clinical trial inspection activities.

c) Possessing a certificate or certification of initial theoretical training, practical inspection, and regular refresher training on clinical trials.

Article 6. Conditions for organizations supporting research that have registered to conduct statistical analysis and data management activities for clinical trial research

1. Meeting the conditions stipulated in Article 3 of this Circular.

2. Having at least one statistician who meets the following conditions:

a) Legally employed by the research support organization. For foreign individuals, they must have a work permit issued by the competent authority of Vietnam.

b) Holding a certificate of biostatistics training from a qualified training institution in Vietnam or abroad.

c) Receiving regular annual training in the field of statistics.

3. Having at least one data manager with a certificate or certification of training in data management and the use of software or systems for data management meeting the requirements of Good Clinical Practice (GCP).

4. Having equipment and information technology systems ensuring data security for statistical analysis and data management activities. The software used for data management and statistical analysis must have a quality control method appropriate to its use.

Article 7. Conditions for organizations supporting research that have registered to conduct clinical trial research testing activities

1. Meeting the conditions stipulated in Article 3 of this Circular.

2. Having a laboratory that meets the following conditions:

a) Meeting the ISO 15189 standard or an equivalent or higher standard suitable for the type of testing conducted in research. If the research support organization sends samples to a laboratory abroad, it must have a certification of the laboratory's standards.

b) Having adequate physical facilities, equipment, and personnel suitable for the scope of expertise and having been granted an operating license or a certification of biosafety standards for laboratories according to the law.

Article 8. Conditions for organizations supporting research that have registered to conduct administrative support activities for clinical trial research

1. Meeting the conditions stipulated in Article 3 of this Circular.

2. Having at least one clinical research coordinator who meets the following conditions:

a) Legally employed by the research support organization. For foreign individuals, they must have a work permit issued by the competent authority of Vietnam.

b) Holding a college degree or higher in a relevant field corresponding to the research support activities being performed.

c) Possessing a certificate of good clinical practice training issued by the Ministry of Health or organizations recognized by the Ministry of Health.

d) Holding a certificate or certification of training on clinical trial protocol and clinical trial procedures before performing research support activities.

Chapter III

REGISTRATION FOR RESEARCH SUPPORT ACTIVITIES
CLINICAL TRIALS

Article 9. Authority to Receive Registration for Clinical Trial Support Activities in Vietnam

Prior to conducting clinical trial support activities, the research support organization shall be responsible for registering or notifying such activities in accordance with the forms prescribed in Article 10 of this Circular at the Department of Science, Technology and Training under the Ministry of Health.

Article 10. Forms of Registration and Notification for Clinical Trial Support Activities in Vietnam

1. Registration of clinical trial support activities.

2. Notification of changes or additions to the legal representative, specialist in charge, name, address of the headquarters, or administrative contact information of the research support organization.

Article 11. Registration Documents

The organization applying for registration of clinical trial support activities shall submit the following registration documents:

1. A registration application form for clinical trial support activities in Vietnam according to Form No. 01 issued together with this Circular.

2. A certified copy of one of the following documents: Decision on Establishment, Operating Permit, Investment Permit, or Business Registration Certificate of the organization.

3. A personnel declaration form according to Form No. 02 issued together with this Circular.

4. Requirements for registration documents related to clinical trial monitoring activities:

a) A certified copy of a bachelor's degree or higher in a relevant field corresponding to the clinical trial support activities.

b) A certified copy of a certificate or training completion certificate for clinical trial monitoring and good clinical practice issued by the Ministry of Health or recognized organizations.

c) A certified copy of a certificate or training completion certificate for annual theoretical and practical training in clinical trial monitoring.

5. Requirements for registration documents related to clinical trial inspection activities:

a) A certified copy of a bachelor's degree or higher in a relevant field related to clinical trial inspection.

b) A certified copy of a certificate or training completion certificate for initial theoretical training, practical inspection training, and annual refresher training in clinical trials.

6. Requirements for registration documents related to statistical analysis and data management activities for clinical trials:

a) A certified copy of a certificate in biostatistics training issued by authorized training institutions in Vietnam or abroad for statistical analysts.

b) A certified copy of a certificate for annual refresher training in statistics for statistical analysts.

c) A certified copy of a certificate or training completion certificate for training in data management and software or system management meeting Good Clinical Practice (GCP) standards for data managers.

d) A list of equipment, statistical software, and secure information technology systems suitable for each type of research for data collection, processing, analysis, and management.

7. Requirements for registration documents related to clinical trial testing activities:

a) A certified copy of documentation proving that the laboratory has an internal quality control system or participates in external quality control or inter-laboratory comparison testing with laboratories meeting ISO 15189 standards.

b) A certified copy of the operating permit or safety standard certification for the laboratory.

8. Requirements for registration documents related to administrative support activities for clinical trials:

a) A certified copy of a college degree or higher in a relevant field corresponding to the administrative support activities being performed.

b) A certified copy of a certificate for good clinical practice training issued by the Ministry of Health or recognized organizations.

c) A certified copy of a certificate or training completion certificate for comprehensive training on clinical trial protocols and procedures before performing clinical trial support work.

Article 12. Documents for Notifying Changes or Additions to Legal Representatives, Specialized Managers; Name, Address of Head Office or Administrative Contact Information of Research Support Organizations

Research support organizations shall submit the following documents for notification:

1. Notification of changes or additions according to Model No. 03 issued together with this Circular.

2. Certified copies of relevant certificates and diplomas related to the scope of specialized activities of the legal representative or the specialized manager.

Article 13. General Conditions Regarding Language, Form, and Legal Validity of Documents

1. Language in the documents:

The registration documents of research support organizations must be in Vietnamese. Foreign language technical materials must be translated into Vietnamese.

2. Forms of documents:

Registration documents for clinical trial research support activities in Vietnam must be prepared on A4 paper size, securely bound, with a table of contents, materials arranged in accordance with the table of contents, separated and indicated by sections, and each section must be numbered for easy reference.

3. Legal validity of documents:

The application form and contents of registration documents must be signed and stamped by the legal representative or the legally authorized representative of the registering organization according to regulations. Legal documents from foreign sources must be authenticated by the competent authority and legalized by consular certification according to regulations.

Article 14. Procedures for Registration and Notifying Changes or Additions to Clinical Trial Research Support Activities

1. Procedure for registering clinical trial research support activities:

a) The research support organization shall submit one original set and one copy of the registration directly to the Ministry of Health.

b) The Department of Science, Technology and Training of the Ministry of Health is responsible for receiving registration documents from research support organizations, using the Receipt Form No. 04 issued together with this Circular; guiding supplementary documents that are not compliant.

c) Within twenty working days from the date of receipt of complete and valid documents, the Department of Science, Technology and Training of the Ministry of Health shall examine and issue a written approval for clinical trial research support activities according to Model No. 05 issued together with this Circular. In case of non-approval, the Department of Science, Technology and Training of the Ministry of Health must issue a written notice according to Model No. 06 issued together with this Circular, clearly stating the reasons.

2. Procedure for notifying changes or additions:

a) The research support organization shall submit one set of change or addition notification documents directly to the Ministry of Health within seven working days from the date of change or addition.

b) The Department of Science, Technology and Training of the Ministry of Health is responsible for receiving change or addition notification documents from research support organizations.

Chapter IV

SCOPE, RIGHTS AND RESPONSIBILITIES OF RESEARCH SUPPORT ORGANIZATIONS FOR CLINICAL TRIAL RESEARCH
CLINICAL TRIAL RESEARCH

Article 15. Scope of Clinical Trial Research Support Activities

1. Professional support activities in clinical trial research include:

a) Developing and enhancing research proposals and research materials.

b) Labeling research products according to current standards and regulations.

c) Evaluating and selecting qualified research facilities and researchers.

d) Preparing documents and materials for submission to competent authorities for research review.

đ) Selecting qualified staff to monitor research.

e) Implementing and maintaining quality systems.

g) Surveying and evaluating research facilities before starting research, monitoring start-up research, periodic monitoring according to schedule, and end-of-study monitoring.

h) Providing and updating appropriate information for researchers.

i) Monitoring research product management at research facilities.

k) Participating fully in inspection, audit, and monitoring rounds.

l) Assessing safety and reporting adverse events.

m) Analyzing data, managing data, and storing research records.

n) Reporting progress and results of research.

o) Performing financial tasks.

p) Other sponsor tasks in clinical trial research in compliance with Good Clinical Practice (GCP) guidelines.

2. Administrative support activities in clinical trial research include:

a) Supporting the establishment and operation of clinical trial offices.

b) Supporting the drafting of Standard Operating Procedures (SOPs).

c) Supporting research product management.

d) Supporting patient screening and selection.

đ) Supporting the process of obtaining informed consent forms for participation in research.

e) Supporting data entry into Case Report Forms (CRFs) and Electronic Case Report Forms (eCRFs).

g) Supporting the storage and management of source documents, essential documents, and related files.

h) Supporting the implementation of research according to the research protocol, SOPs, and GCP guidelines (monitoring and guiding procedures to ensure compliance).

i) Supporting the review and update of required documents.

k) Supporting patient follow-up.

l) Supporting the reporting of adverse events/severe adverse events.

m) Supporting log-in, activation, and updates to online research systems if applicable.

Supporting preparatory work for sponsor inspections and audits.

o) Supporting preparatory work for regulatory authority inspections.

p) Supporting other requirements from the principal investigator.

3. Research monitoring activities in clinical trial research.

a) Monitors appointed to conduct research monitoring according to approved schedules to track the progress of clinical trials and ensure that the research is conducted, recorded, and reported in accordance with the research protocol, standard operating procedures (SOPs), good clinical practice (GCP) principles, and other relevant legal provisions.

b) Monitoring activities are carried out throughout the research process including pre-study monitoring, periodic monitoring during the study according to the approved schedule, and unscheduled monitoring as required by the research support organization/sponsor and regulatory authorities, and end-of-study monitoring.

c) Research monitoring at research sites includes: Recruitment locations, relevant clinical laboratories involved in the research.

d) Research monitoring activities must be reported in writing to the research implementing unit before and after the monitoring is conducted. The specific activities of the monitor include:

- Verifying the professional qualifications, proficiency of the researchers, and the readiness of resources before and throughout the research.

- Checking the availability and completeness of storage facilities for research products at the research site.

- Ensuring the provision of research products to subjects with the prescribed dosage, time schedule, and appropriate usage instructions.

- Ensuring the proper recording, clarity, and completeness of essential documentation.

- Ensuring that researchers are adequately trained.

- Monitoring the compliance of researchers with the research protocol and reporting deviations to the sponsor.

- Observing and reporting subject selection rates to the sponsor.

- Ensuring that research case records are properly recorded, clearly, and fully.

- Submitting written reports to the sponsor after each monitoring visit at the research site.

- Supervising and documenting the storage, handling, distribution, and recovery of research products according to the protocol and standard operating procedures.

Article 16. Rights of Research Support Organizations

1. To carry out research support activities for clinical trials in Vietnam within the scope registered for operation in Vietnam in accordance with the law.

2. Negotiating and signing contracts to implement research support activities for clinical trials with organizations having test drugs or organizations conducting clinical drug trials in accordance with the law.

3. Acting on behalf of organizations having test drugs or organizations conducting clinical drug trials to work with research subjects, the Ministry of Health's Bioethics Issues Review Board, or relevant state management agencies related to clinical trials in accordance with the terms of the contracts signed by all parties.

4. Other rights agreed upon in the contracts signed for research support activities for clinical trials.

Article 17. Responsibilities of Research Support Organizations

1. Adhering to legal regulations on research support activities for clinical trials, complying with Good Clinical Practice (GCP) and ethical standards in biomedical research.

2. Being responsible under the law for direct research support activities for clinical trials carried out in Vietnam.

3. Developing plans and organizing continuous training for staff.

4. Reporting annually to the Department of Science, Technology and Training, Ministry of Health on research support activities for clinical trials in Vietnam according to Form No. 07 issued together with this Circular and submitting ad hoc reports when requested by the Ministry of Health.

5. Reporting to the Department of Science, Technology and Training, Ministry of Health and performing procedures as prescribed when there is a change in any of the following circumstances:

a) Ceasing research support activities for clinical trials in Vietnam.

b) Merging, splitting, dissolving research support organizations in Vietnam.

Chapter V

IMPLEMENTING PROVISIONS

Article 18. Inspection of Research Support Organization Activities

1. The Ministry of Health organizes regular or ad hoc inspections of the activities of research support organizations in Vietnam.

2. Procedures for inspecting the activities of research support organizations:

a) The Ministry of Health sends a notification 10 working days prior to conducting inspections at organizations registered to carry out research support activities for clinical trials in Vietnam according to Form No. 08 issued together with this Circular.

b) Organizations registered to carry out research support activities for clinical trials in Vietnam are responsible for preparing personnel and work contents according to the Ministry of Health's notification.

c) Within 20 working days from the date of inspection, the Ministry of Health sends a written notification of the inspection results to organizations registered to carry out research support activities for clinical trials in Vietnam.

3. Research support organizations are responsible for implementing the Ministry of Health's inspection conclusions.

Article 19. Effective Date

This Circular takes effect from May 1, 2014.

Article 20. Transitional Provisions

Organizations that have carried out research support activities for clinical trials before the effective date of this Circular must complete registration procedures in accordance with this Circular by November 1, 2014.

Article 21. Responsibility for Implementation

1. The Ministry of Health assigns the Department of Science and Technology and Training to lead the implementation of this Circular.

2. Heads of relevant agencies, organizations, and units have the responsibility to organize the dissemination, promotion, and implementation of this Circular so that the relevant entities are aware and comply. During the implementation process, if there are difficulties, agencies, organizations, and individuals are advised to promptly report to the Department of Science and Technology and Training, Ministry of Health for consideration and resolution.

During the implementation process, if there are difficulties, agencies, organizations, and individuals are advised to promptly report to the Department of Science and Technology and Training, Ministry of Health for consideration and resolution./.