Thông tư 08/2014/TT-BYT hỗ trợ nghiên cứu thử nghiệm lâm sàng tại Việt Nam

THE MINISTRY OF HEALTH

Circular No.08/2014/TT-BYT dated February 26, 2014 of the Ministry of Health February 26, 2014 providing for the support activities of clinical trial research in Vietnam

Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012, defining functions, tasks, powers and organizational structure of the Ministry of Health;

The Minister of Health promulgates Circular providing for activities supporting clinical trial research in Vietnam.

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope of regulation, subjects of application

This Circular promulgates conditions, registration, scope of activities, rights and duties of organizations operating in support for clinical trial research in Vietnam (below collectively referred to as the research supporting organizations).

Article 2. Interpretation of terms

1.Support activities for clinical trial researchinclude supervision, inspection, statistical analysis and data management, conduct tests and provide administrative supports in clinical trial research.

2.Clinical Research Associate – CRAmeans a person who have professional qualifications and experiences which are consistent with field of supporting clinical trials which are required to conduct supervision, understand well research profiles and regulation of the International Conference on Harmonization of registration dossier of pharmaceuticals – guideline for Goods Clinical Practice (ICH GCP) and other relevant legal provisions.

3.Clinical Research Coordinator - CRCmeans a person working for an organization supporting clinical trial research, having task to support the main researcher during the process of the clinical trial research; managing documents, files and databases relating to the research; supporting for the organization receiving clinical drug trial upon working with donors, supervisors and inspectors.

Chapter 2.

CONDITIONS FOR SUPPORT ACTIVITIES FOR CLINICAL TRIAL RESEARCH IN VIETNAM

Article 3. General conditions of support organizations for clinical trial research

1. Organizationalconditions:

Being organizations which have legal person status, operate in the field of clinical trial research, established according to decisions of competent state agencies for state-run organizations or certificates of business registration or operation licenses issued by competent state agencies in Vietnam for private organizations and non-governmental organizations.

2.Conditions on human force:

a) Persons who are in charge of profession must have college degrees or higher of health science sector in line with scope of professional activities of organizations supporting clinical trial research, and have 03 years of experience or more in at least one sector pertaining to support activities for clinical trial research.

b) Have sufficient staff satisfying conditions as prescribed in this Circular and consistent with scope of professional activities as registered of the research supporting organizations.

3.Conditions on material facilities:

Have head offices, material facilities and equipment that ensure deployment of support activities for clinical trial research in line with scope of professional activities as registered of the research supporting organizations according to Form No. 01 issued with this Circular.

4.Conditions on quality assurance:

a) Have standard operating procedure (SOP) for activities of clinical trial registration.

b) Have a system of document storage which is capable of providing evidence that activities have been conducted in accordance with SOP.

c) Have a system of quality assurance according to ISO standard or equivalent standards.

5.Beside general conditions as prescribed in this Article, a research supporting organization that registers one or many support activities for clinical trial research such as research supervision, research inspection, statistical analysis and management of research data, research tests, research administrative supports is required to satisfy respective conditions specified in Articles 4, 5, 6, 7 and 8 of this Circular.

Article 4. Conditions for supporting research organization registered the activities for supervising clinical trial research

1.Have sufficient conditions as prescribed in Article 3 of this Circular.

2.Have at least 01 clinical research supervisor who satisfies the following conditions:

a) Being legally recruited by the research supporting organization. For foreigners, it is required to have work permits issued by competent state agencies of Vietnam.

b) Have a university degree or higher in sector that is suitable with research supporting activities.

c) Have a diploma or a certificate for preliminary training on clinical research supervision and good clinical practice issued by the Ministry of Health or an organization accredited by the Ministry of Health.

d) Have a diploma or a certificate for being trained on theory and practice of annual supervision on clinical trial research.

Article 5. Conditions for supporting research organization registered the activities for inspecting clinical trial research

1.Have sufficient conditions as prescribed in Article 3 of this Circular.

2.Have at least 01 employee in charge of clinical trial research examination who satisfies the following conditions:

a) Being legally recruited by the research supporting organization. For foreigners, it is required to have work permits issued by competent state agencies of Vietnam.

b) Have a university degree or more in sector pertaining to activities of clinical trial research examination.

c) Have a diploma or a certificate for being trained on preliminary theory and examination practice and periodic training on clinical trial research.

Article 6. Conditions for research supporting organizations that register activities of statistical analysis and management of clinical trial research data

1.To have sufficient conditions as prescribed in Article 3 of this Circular.

2.To have at least 01 statistical staff who satisfies following conditions:

a) Being legally recruited by the research supporting organization. For foreigners, it is required to have work permits issued by competent state agencies of Vietnam.

b) Having a training certificate of biomedical statistics issued by a competent training establishment in Vietnam or a foreign country.

c) Being trained and improved periodically and yearly on statistical sector.

3.Having at least 01 data-managing staff that has a diploma or a certificate of being trained on management and use of software or a data management system which satisfies standards under requirements of GCP.

4.Having equipment and information technology system to ensure the safety of data for activities of statistical analysis and data management. The software used for activities of data management and statistical analysis must have suitable methods to check the software quality.

Article 7. Conditions for research supporting organizations which register testing activities in clinical trial research

1.Have sufficient conditions as prescribed in Article 3 of this Circular.

2.Having testing labs which satisfy following conditions:

a) ISO 15189 Standard or equivalent or higher standard in line with types of tests to be conduct in research. The research supporting organizations transferring samples to testing labs in foreign countries shall be required to have standard certificates of those testing labs.

b) Have full conditions on material facilities, equipment, human resources in line with professional scope and have been granted operational licenses or certificates of satisfaction of biological safety standards for a testing lab in accordance with legal provisions.

Article 8. Conditions for supporting research organization registered the activities for administrative support for clinical trial research

1.Having sufficient conditions as prescribed in Article 3 of this Circular.

2.Having at least 01 clinical research coordinator who satisfies the following conditions:

a) Being legally recruited by the research supporting organization. For foreigners, it is required to have work permits issued by competent state agencies of Vietnam.

b) Having a college degree or higher in sector consistent with research support activities which are conducted.

c) Have a training certificate on good clinical practice issued by the Ministry of Health or organizations accredited by the Ministry of Health.

d) Having a diploma or a certificate of being trained on draft on clinical trial research and procedure of clinical trial research before conducting work of supporting clinical trial research.

Chapter 3.

REGISTRATION OF SUPPORT ACTIVITIES FOR CLINICAL TRIAL RESEARCH

Article 9. State agencies receiving registration of support activities for clinical trial research in Vietnam

Before conducting activities supporting clinical trial research, research supporting organizations are responsible for conducting the registration or notifying in forms as prescribed in Article 10 of this Circular at the Department of Science, Technology and Training, the Ministry of Health.

Article 10. Forms for registration, notifying involving support activities for clinical trial research in Vietnam

1.Registration of activities supporting clinical trial research.

2.Notification on change, supplementation of the legal representative, person in charge of professional operation; name, address of the head quarter or the administrative contact information of the research supporting organization.

Article 11. Registration dossier

The organization which registers support activities for clinical trial research shall send a registration dossier comprising of:

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

2.A certified copy of one of following documents: The establishment decision, the operational license, the investment license or the certificate of enterprise registration of an organization.

3.A list of personnel made according to Form No. 02 issued with this Circular.

4.Requirements on a dossier for activities of supervising clinical trial research:

a) Having a certified copy of the university degree or higher in sector consistent with activities of research support.

b) Have a certified copy of a diploma or a certificate of being trained on clinical research supervision and good clinical practice issued by the Ministry of Health or an organization accredited by the Ministry of Health.

c) Have a certified copy of a diploma or a certificate of being trained on theory and practice of annual supervision on clinical trial research.

5.Requirements on a dossier for activities of clinical trial research examination:

a) A certified copy of a university degree or higher in a sector which is relevant to sectors of clinical trial research examination.

b) A certified copy of diploma or certificate of being trained on preliminary theory, examination practice and periodic training on clinical trial research.

6.Requirements on a dossier for activities of statistical analysis and data management of clinical trial research:

a) A certified copy of a certificate of being trained on biomedical statistics issued by a competent training establishment in Vietnam or a foreign country for a statistical analysis staff.

b) A certified copy of a certificate of being trained and improved annually on statistical field for a statistical analysis staff.

c) A certified copy of a diploma or a certificate of being trained on management and use of software or a data management system which satisfies standards under requirements of GCP for a data management staff.

d) List of equipment, statistical software and secured information technology system which are compatible with each form of research in serve of the collection, processing, analysis and management of data.

7.Requirements on a dossier for testing activities in clinical trial research:

a) A certified copy of papers proving that the testing lab has a system ensuring internal inspection quality or has participated in ensuring external inspection quality or has participated in comparison inter-lab testing quality with testing labs which have met ISO 15189 Standard.

b) A certified copy of the operational license or the certificate of satisfying biological safety standards for testing labs.

8.Requirements on a dossier for activities of administrative support in clinical trial research:

a) A certified copy of the college degree or higher in the field consistent with research supporting activities which are conducted.

b) A certified copy of a certificate of being trained on good clinical practice issued by the Ministry of Health or an organization accredited by the Ministry of Health.

c) A certified copy of a diploma or a certificate of being fully trained on draft clinical trial research and procedure of clinical trial research before conducting work involving support for clinical trial research.

Article 12. A dossier for  change, supplementation of the legal representative, person in charge or professional operation, name, address of the head office or the administrative contact information of the research supporting organization.

The research supporting organization shall send a dossier of notification which includes:

1.Notifications on change or supplementation made according to Form No. 03 of this Circular.

2.A certified copy of a diploma, a certificate which is related to scope of professional activities of the legal representative or the person in charge or professional operation.

Article 13. General conditions on language, forms and legality of a dossier

1.The language used in the dossier:

The language in the registration dossier of a research supporting organization must be Vietnamese. Professional documents in foreign languages must be translated into Vietnamese.

2.Form of a dossier:

A registration dossier for support activities for clinical trial research in Vietnam must be prepared in A4 paper size, firmly bound, have an table of content, documents are arranged according to order of table of content, have separation and guideline between sections, separated parts must be numbered according to order for easy reference.

3.The legality of a dossier:

The application of registration and contents in the registration dossier must be signed by the legal representative or the legally-authorized person of the registering organization and sealed as prescribed. The legal documents originated in foreign countries must be verified the signature by competent state agencies and consular legalized in accordance with regulations.

Article 14. Registration order and notification on change, supplementation of support activities for clinical trial research

1.Registration order of support activities for clinical trial research:

a) The research supporting organization shall send 01 set of original dossier and 01 set of duplicate dossier directly to the Ministry of Health.

b) Department of Science, Technology and Training, Ministry of Health is the one-stop office to receive registration dossiers of research supporting organizations, issuing the receipt made according to Form No. 04 issued with this Circular; guiding the supplementation of invalid dossiers.

c) Within 20 working days, since the date of receiving a full and valid dossier, the Department of Science, Technology and Training, Ministry of Health shall be responsible for considering and having a written consent on support activities for clinical trial research made according to Form No. 05 issued with this Circular. In case of refusal, the Department of Science, Technology and Training, Ministry of Health must have a written notification made according to Form No. 06 issued with this Circular, in which reasons are clearly stated.

2.Order in notifying change or supplementation:

a) The research supporting organization shall send 01 set of notification dossier directly to the Ministry of Health within 07 working days, since the day of having changes or supplementation.

b) The Department of Science, Technology and Training, Ministry of Health is the one-stop office to receive notification dossiers from the research supporting organizations.

Chapter 4.

SCOPE, RIGHTS AND OBLIGATIONS OF ORGANIZATIONS SUPPORTING CLINICAL TRIAL RESEARCH

Article 15. Scope of support activities for clinical trial research

1. Professional ssupporting activities in clinical trial research shall include:

a) To build, develop research drafts and research documents.

b) To label researched products in compliance with prevailing standards and provisions.

c) To assess, select the researching establishments and eligible researchers.

d) To prepare dossiers, documents to submit to state agencies competent to the research appraisal.

dd) To select eligible cadres to supervise the research.

e) To deploy and maintain quality systems.

g) To survey and assess basically before starting to research, supervise the start of the research, supervise periodically under schedule and supervise the end of the research.

h) To provide, update suitable information for researchers.

i) To supervise the management of researched products at the researching establishments.

k) To participate fully in courses of inspection, check, supervision of research.

l) To assess the safety and report disadvantage incidents.

m) To analyze data, manage data and store the research documents.

n) To report the research progresses and results.

o) To perform financial tasks.

p) Other tasks of donors in clinical trial research which comply with GCP.

2.Administrative support activities in clinical trial research shall comprise of:

a) To support the setting up and operation of clinical trial office.

b) To support for composing a standard operating process (SOP).

c) To support the management of the researched products.

d) To support for screening and selecting patients.

dd) To support the professional operation in collecting notes of voluntary participation in research.

e) To support for putting data in Case Report Form (CRF) and electronic Case Report Form (eCRF)

g) To support for storing, managing the source documents, essential documents and relevant profiles.

h) To support for conducting the research in line with the draft, SOP and GCP (monitoring, guiding processes to ensure for the right implementation).

i) To support for checking and updating the requirement dossiers.

k) To support for monitoring patients.

l) To support for reporting incidents / serious incidents.

m) To support for logging, activating, updating into online research systems (if any).

n) The professional operations to support for preparation work in serve of supervisions and inspections by donors.

o) The professional operations to support for preparation work in serve of inspections by competent state agencies.

p) The professional operations to support for other requirements from main researchers.

3. Activities of supervising clinical trial research.

a) Supervisors are assigned to conduct activities of research supervision under the approved schedules aiming to monitor developments of clinical trials and to ensure for the research to be conducted, recorded and reported in line with the research draft, standard operating procedures (SOPs), good clinical practice principals (GCP) and other relevant legal provisions.

b) Supervision activities shall be conducted during the research, including: supervision before the deployment of the research, supervision during the periodical research under the approved schedule and extraordinary supervision at the request of research supporting organizations or donors and competent agencies that manage or supervise the completion of the research.

c) Research supervision at a research establishment shall include: Places for selecting objects, preclinical units related to the research.

d) Activities of research supervision must be reported in writing to research conducting units before and after conducting the supervision. Specific activities of a supervisor shall include:

-To verify professional qualifications and skills of researchers and the availability of resources before and during the research.

-To check the availability and completion of means for storing researched products at the research establishment.

-To check the provision of researched products to objects in terms of appropriate dosage, prescribed period and the instruction manual.

-To ensure the hand-over, receipt and the storage of essential documents.

-To ensure researchers are completely trained.

-To supervise the compliance of the draft by researchers and to notify donors in cases of differences.

-To observe and report the selection percentage of objects for donors.

-To ensure the research clinical records are recorded properly, clearly and completely.

-To send reports in writing to donors after each supervision at the research location.

-To supervise and put in writing the storage, handling, distribution and withdrawal of researched products in line with the draft and standard operating procedures.

Article 16. Rights of the research supporting organizations

1.To be entitled to conduct support activities for clinical trial research in Vietnam in compliance with the scope of activities registered in Vietnam as prescribed by law.

2.To negotiate and enter into contracts for conducting support activities for clinical research with organizations that have testing medicines or with organizations that receive the clinical drug test according to legal provisions.

3.To act on behalf of organizations that have testing medicines or organizations that receive the clinical drug test to work with researched objects and the Council for assessment of ethical issues in biological research, the Ministry of Health or competent state agencies relating to clinical trial in compliance with terms in the contracts signed by parties.

4.Other rights according to agreements in the signed contracts regarding support activities for clinical trial research.

Article 17. Obligations of the research supporting organizations

1.To comply with legal provisions related to support activities for clinical trial research, provisions on GCP and ethics in biological research.

2.To be responsible before law for support activities for clinical trial research which are directly conducted in Vietnam.

3.To build plans and organize training or continuous training for staff.

4.To annually report to the Department of Science, Technology and Training under the Ministry of Health on support activities for clinical trial research in Vietnam made according to Form No. 07 issued with this Circular and to irregularly report at the request of the Ministry of Health.

5.To report to the Department of Science, Technology and Training under the Ministry of Health and conduct procedures as prescribed when there is a change in one of following cases:

a) To stop support activities for clinical trial research in Vietnam.

b) To merge, split, separate or dissolve the research supporting organization in Vietnam.

Chapter 5.

IMPLEMENTATION PROVISIONS

Article 18. Inspection over activities of the research supporting organizations

1.The Ministry of Health shall periodically or extraordinarily check activities of the research supporting organizations in Vietnam.

2.Order of conducting inspection over activities of the research supporting organizations:

a) The Ministry of Health shall send a notification 10 working days before conducting the inspection work at an organization registered its support activities for clinical trial research in Vietnam according to Form No. 08 issued with this Circular.

b) The organization registered support activities for clinical trial research in Vietnam is responsible for arranging personnel and working contents according to the notification of the Ministry of Health.

c) Within 20 working days, since the date of conducting the inspection work, the Ministry of Health shall send a written notification on results of the inspection to the organization registered support activities for clinical trial research in Vietnam.

3.The research supporting organization is responsible for performing the inspection conclusions of the Ministry of Health.

Article 19. Implementation effect

This Circular takes effect on May 01, 2014.

Article 20. Transitional provisions

Organizations conducted support activities for clinical research before the effective date of this Circular, must complete procedures for registration in accordance with the Circular before 01 November 2014.

Article 21. Implementation

1.The Ministry of Health assigns the Department of Science, Technology and Training to chair the organization of deploying the implementation of this Circular.

2.Heads of related agencies, organizations and units shall be responsible for organizing the propaganda, dissemination, deployment of the implementation of the Circular to objects for information an implementation.

Any difficulties and problems arising in the course of implementation should be reported in a timely manner to the Department of Science, Technology and Training under the Ministry of Health for consideration and settlement./.

For the Ministry of Health

Deputy Minister

Le Quang Cuong

* All appendices are not translated herein.