PROVIDING FOR ACTIVITIES SUPPORTING CLINICAL TRIAL RESEARCH IN VIETNAM

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).

1.Activities of supporting clinical trial research include supervision, inspection, statistical analysis and data management, conduct tests and provide administrative supports in clinical trial research.

2.Clinical Research Associate – CRA means 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 - CRC means 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.

1. Organizational conditions:

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 activities of supporting 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 activities of supporting clinical trial research in line with scope of professional activities as registered of the research supporting organizations according to Form No. 01 promulgated together 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 activities of supporting 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.

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.

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.

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.

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.

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.

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.

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.

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

1. A registration for activities of supporting clinical trial research in Vietnam according to Form No. 01 promulgated together 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 promulgated together 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.

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.

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 activities of supporting 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.

1. Registration order of activities of supporting 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 promulgated together 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 activities of supporting clinical trial research made according to Form No. 05 promulgated together 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 promulgated together 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.

1. Professional supporting 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, paraclinical 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.

1. To be entitled to conduct activities of supporting 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 activities of supporting 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 activities of supporting clinical trial research.

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

2. To be responsible before law for activities of supporting 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 activities of supporting clinical trial research in Vietnam made according to Form No. 07 promulgated together 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 activities of supporting clinical trial research in Vietnam.

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

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 activities of supporting clinical trial research in Vietnam according to Form No. 08 promulgated together with this Circular.

b) The organization registered activities of supporting 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 activities of supporting clinical trial research in Vietnam.

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

This Circular takes effect on May 01, 2014.

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

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./.

 

 

 

Name of the registration organization:

The legal representative:

Position:

Office address:

Telephone No.:

Fax:

Email:

To register for our activities of supporting clinical trial research in Vietnam with specific activities as below:

1.

2.

3.

4.

5.

6.

7.

Other papers enclosed with this registration in accordance with provisions of the Ministry of Health include:

1.

2.

3.

We commit to conduct our activities registered with the Ministry of Health in full compliance with the legal provisions of Vietnam, guidelines and prevailing regulations related to the current clinical trial research in Vietnam, subject to inspection and examination by the competent management state agencies of Vietnam.

 

 

 

Name of the registration organization:

Personnel registered for activities of supporting clinical trial research include (with curriculum vitae, professional qualifications, training certificates enclosed)

 

 

 

Name of organization:

The legal representative:

Position:

Office address:

Telephone No:

Fax:

Email:

To notify on changes, supplementation of personnel/ information involving activities of supporting clinical trial research in Vietnam, specifically as follows:

1.1 Old information

1.2 New information

 

 

 

Subject: The receipt of the registration dossier of activities of supporting clinical trial research

The Department of Science, Technology and Training under the Ministry of Health is pleased to notify your organization that we have received your registration for activities No.………..date……………and enclosed documents.

Comparing with the current regulations on registration of activities supporting clinical research in Vietnam, we are pleased to notify your organization that:

□ The registration is complete in accordance with the prevailing provisions.

□ The registration is incomplete and needed to be supplemented with documents as follows:

1.

2.

3.

 

 

 

The Department of Science, Technology and Training has received the registration dossier of activities of supporting clinical trial research of the organization.

After considering the dossier, the Department of Science, Technology and Training accepted in term of a policy to permit the organization to conduct activities of supporting clinical trial research in Vietnam.

We suggest the organization to conduct activities of supporting clinical trial research in compliance with the registration of the organization with the Ministry of Health; fully comply with the legal provisions of Vietnam, guidelines and prevailing regulations related to the current clinical trial research in Vietnam, subject to inspection and examination by the competent management state agencies of Vietnam.

Pleased to notify your organization for information and implementation./.

 

 

 

The Department of Science, Technology and Training has received the registration dossier of activities of supporting clinical trial research of the organization.

After considering the dossier, the Department of Science, Technology and Training does not accept for organization to implement activities of supporting clinical trial research in Vietnam due to reasons as below:

1.

2.

……

Pleased to notify your organization for information and implementation./.

 

 

 

 

Name of organization:

The legal representative:

Position:

Office address:

Telephone No:

Fax:               Email:

Pleased to report on activities of supporting clinical research of our organization during last time as below:

1. To describe activities of supporting clinical research conducted in comparison with the registered contents.

2. To describe the supported researches (with specific contents: name of the research, stages of research, basis for research, scope of research, situation of selecting patients, summarize safe and effective data (if any), summarize cases of violating and misleading the draft, reasons for terminating the research early (if any). 

3. Results of inspection, examination (if any) (enclosed with minutes, conclusion of inspection or examination).

 

 

 

The Department of Science, Technology and Training together with the Standing Committee for assessment of ethical issues in biological research, Ministry of Health has a plan to check the activities of supporting clinical trial research in your organization with the following contents:

1. Contents:

2. Time:

3. Members:

Pleased to notify your organization for information and implementation./.