0A4F4F9BD490A749D5437F821CF06DF1
Resolution of the Government of Armenia of January 24, 2002: Procedure for Clinical Trials of New Mediations of Armenia
https://www.arlis.am/DocumentView.aspx?docID=9154
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This file was generated: 2020-07-14 06:16:15
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
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p.(None): Signatory body Prime Minister of the Republic of Armenia Date of signature 24.01.2002
p.(None): Ratifying body The President of the Republic of Armenia Ratification Date 24.01.2002
p.(None): Effective Date 24.01.2002 Effective Date 30.03.2019
p.(None): Modifiers and incorporations
p.(None): RA GOVERNMENT'S DECISION ON CLINICAL RESEARCH OF NEW MEDICINES IN RA
p.(None): ON APPROVING THE ORDER
p.(None): "I ratify"
p.(None): Republic of Armenia
p.(None): President Kocharyan
p.(None): January 24, 2002
p.(None): GOVERNMENT OF THE REPUBLIC OF ARMENIA
p.(None): WHAT AND M?
p.(None): N 63 of January 24, 2002
p.(None): mouse. Yerevan:
p.(None): CLINICAL PARTICULARS OF NEW DRUGS IN THE REPUBLIC OF ARMENIA
p.(None): ON APPROVING THE ORDER
p.(None): Republic of Armenia “On medical care and services for the population”
p.(None): In accordance with Article 21 of the Law, the Government of the Republic of Armenia
p.(None): decides.
p.(None): 1. Approve new clinical drugs in the Republic of Armenia
p.(None): procedure for conducting surveys (attached).
p.(None): 2. This Decision shall enter into force on 24 January 2002.
p.(None): Republic of Armenia
p.(None): Prime Minister Margaryan
p.(None): Is approved
p.(None): The Government of the Republic of Armenia 2002
p.(None): by decision N 63 of January 24
p.(None): ORDER:
p.(None): CLINICAL PARTICULARS OF NEW DRUGS IN THE REPUBLIC OF ARMENIA
p.(None): HOLDING:
p.(None): I. GENERAL PROVISIONS
p.(None): 1. This Order of the Republic of Armenia on Medical Care and Services of the Population
p.(None): In accordance with Article 21 of the Law of the Republic, defines Armenia
p.(None): Clinical trials of new drugs in the Republic (hereinafter referred to as clinical)
p.(None): procedures).
p.(None): 2. Clinical trials are conducted on drug safety and safety
p.(None): about establishing efficacy as well as potential side effects
p.(None): to get data.
p.(None): 3. Permission to conduct clinical trials is granted by Armenia
p.(None): Ministry of Health of the Republic (hereinafter Ministry).
p.(None): 4. Clinical trials shall be conducted in a medical setting selected for this purpose
p.(None): on the basis of institutions. Conduct clinical trials
p.(None): The list of eligible medical institutions is approved by the Ministry
p.(None): by taking into account:
p.(None): a) Experience in conducting scientific research in a given medical institution;
p.(None): (b) the equipment of the medical establishment concerned;
p.(None): c) the level of professional and scientific training of medical personnel.
p.(None): II. BASIC CONCEPTS USED IN THIS ORDER
p.(None): 5. The basic terms used in this Procedure are:
p.(None): clinical trial (testing) on the safety of a human-tested drug;
p.(None): an efficacy study aimed at the drug being studied
p.(None): detection of clinical, pharmacological, pharmacodynamic properties or
p.(None): confirmation and / or detection of side effects, absorption into the body,
p.(None): Distribution, bioremediation and (or) organism study;
p.(None): Effectiveness of the drug - positive effect of the drug on the course of the disease
p.(None): Characteristics:
p.(None): drug safety - the danger to the effectiveness of the drug and to the body
p.(None): Characteristics of comparative evaluation of evaluation.
p.(None): Adverse effects: prevention, diagnosis, treatment or treatment of the disease
p.(None): therapeutic doses of drugs used to regulate physiological functions
p.(None): negative or unpredictable effects caused by imports;
p.(None): side effect - any undesirable effects on the body of the person being examined
p.(None): a phenomenon that may be unrelated to drug use:
p.(None): Pre-clinical examination - an unrelated biomedical examination
p.(None): with human experiments;
p.(None): Clinical Trials Program - Research Tasks
p.(None): describing the methodology, procedure, statistics, and organization
p.(None): document:
p.(None): Researcher responsible for conducting clinical research
p.(None): physical person.
p.(None): research person (tested) - a patient or participant in a clinical trial
p.(None): a healthy volunteer undergoing a trial or comparative drug trial;
p.(None): clinical activity - planning, conducting clinical research,
p.(None): to conduct, observe, conduct independent evaluation, with documentation
p.(None): the principle of formulating and presenting its results;
p.(None): Ethics Committee - an independent body responsible for testing
p.(None): health, safety, human rights and population
p.(None): to provide appropriate guarantees.
p.(None): III. EXAMINATION OF CLINICAL RESEARCH MATERIALS
p.(None): 6. The researcher has permission to conduct clinical trials
p.(None): submits an application to the Ministry, which is attached to the clinic
p.(None): The package of documents required for research by the Ministry
p.(None): according to the approved list.
p.(None): 7. The documents submitted by the researcher should contain the following:
p.(None): data:
p.(None): a) Pre-clinical study of drug safety and efficacy
p.(None): results:
p.(None): (b) Persuasive data on the positive effect of drug use in excess of the drug
p.(None): the danger to the individual;
p.(None): c) positive opinion of the Ethics Committee.
p.(None): 8. The Ethics Committee provides clinical trials of drugs
p.(None): volunteering, security of participants and rights
p.(None): protection, giving the danger and effectiveness of clinical research
p.(None): assessment of the ratio, as well as compliance with ethics. Ethics:
p.(None): The Committee on Issues operates on a public basis and is not remunerated. Ethics:
p.(None): The composition and the Charter of the Committee on Issues shall be approved by the Ministry.
p.(None): 9. The documents submitted by the researcher are kept in the Ministry
p.(None): 2 stages of expertise
p.(None): a) In the first stage a preliminary examination is carried out which clarifies
p.(None): Compliance of submitted documents with approved requirements
p.(None): in terms of design accuracy and completeness;
p.(None): b) The second phase is the implementation of a clinical research program
p.(None): examination to confirm it. The examination period is 60 days.
p.(None): 10. Clinical evaluation of medicines during examination of submitted documents
p.(None): if necessary or provided additional data related to the study
p.(None): If the Ministry has any comments on the materials
p.(None): The customer may require additional documents or disclosures
p.(None): defect elimination. Additional Documentation and Defects
p.(None): the time spent on elimination does not fall within the prescribed forensic examination
p.(None): in due time.
...
p.(None): the nature, significance, methods and potential hazards of the study, as well as
p.(None): is informed of its right to refuse it at any stage of the trial;
p.(None): after which he gives his written consent to participate.
p.(None): 17. It is forbidden to conduct clinical trials:
p.(None): a) Pregnant women, except where necessary information is available
p.(None): only when pregnant women are tested and when pregnant or pregnant
p.(None): for a minimum.
p.(None): b) military servicemen;
p.(None): (c) persons in places of detention as well as in detention facilities
p.(None): on.
p.(None): 18. Clinical trials are underway in the Ministry and Ethics
p.(None): under the constant supervision of the Commission. Research observations
p.(None): are held every 3 months or as needed. Verification:
p.(None): in the event of detection of non-compliant phenomena
p.(None): a protocol is drawn up which is submitted to the researcher and / or client:
p.(None): to get acquainted:
p.(None): 19. The researcher and / or the client are obliged to cancel within 30 days
p.(None): deficiencies and shortcomings found during clinical trial examination
p.(None): to inform the Ministry.
p.(None): 20. The Ministry is not in the position to detect violations of the approved plan
p.(None): confirm the results of the clinical trial of the drug. Ministry accepted
p.(None): notifies the researcher in writing within three days of the decision and / or
p.(None): to the customer.
p.(None): 21. Violations of Ethics and Clinical Research Program data
p.(None): falsification, unpredictable side effects and phenomena, the person being examined
p.(None): the ministry suspends in the event of a threat to life or health
p.(None): test procedure.
p.(None): 22. The researcher obtained as a result of a clinical trial
p.(None): based on data submitted to the Ministry.
p.(None): 23. The Ministry shall submit the report submitted within one month
p.(None): confirmation in case of professional expertise and positive conclusion.
p.(None): The Ministry shall inform in writing within three days of the decision
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): 12. The Ministry makes a decision based on the results of the examination
p.(None): about clinical trial authorization and within three days in writing
p.(None): informs the customer.
p.(None): 13. In the clinical research program approved by the Ministry
p.(None): If the customer needs to make any changes, he or she shall apply
p.(None): submits to the Ministry, where the materials are presented in the prescribed manner
p.(None): are reviewed and a decision is made to adopt these changes.
p.(None): IV. PROCEDURE OF CLINICAL RESEARCH
p.(None): 14. Accuracy and accuracy of data obtained from clinical trial
p.(None): the researcher is responsible for reliability.
p.(None): 15. The researcher must:
p.(None): a) immediately inform the Ministry, Ethics Committee
p.(None): changes to the clinical trial plan, as well as:
p.(None): and unpredictable side effects during research
p.(None): about phenomena:
p.(None): b) immediately terminate the clinical trial of the person being examined
p.(None): in case of danger to life or health;
p.(None): c) ensure the confidentiality of the data concerning the person under investigation;
p.(None): d) record, process and record data obtained as a result of a clinical trial
p.(None): maintain it in such a way that their accuracy and reliability can be monitored.
p.(None): 16. Clinical trial person (s) involved
p.(None): The doctor conducting the study is informed in advance
p.(None): the nature, significance, methods and potential hazards of the study, as well as
p.(None): is informed of its right to refuse it at any stage of the trial;
p.(None): after which he gives his written consent to participate.
p.(None): 17. It is forbidden to conduct clinical trials:
p.(None): a) Pregnant women, except where necessary information is available
p.(None): only when pregnant women are tested and when pregnant or pregnant
p.(None): for a minimum.
p.(None): b) military servicemen;
p.(None): (c) persons in places of detention as well as in detention facilities
p.(None): on.
p.(None): 18. Clinical trials are underway in the Ministry and Ethics
p.(None): under the constant supervision of the Commission. Research observations
p.(None): are held every 3 months or as needed. Verification:
p.(None): in the event of detection of non-compliant phenomena
p.(None): a protocol is drawn up which is submitted to the researcher and / or client:
p.(None): to get acquainted:
p.(None): 19. The researcher and / or the client are obliged to cancel within 30 days
p.(None): deficiencies and shortcomings found during clinical trial examination
p.(None): to inform the Ministry.
p.(None): 20. The Ministry is not in the position to detect violations of the approved plan
p.(None): confirm the results of the clinical trial of the drug. Ministry accepted
p.(None): notifies the researcher in writing within three days of the decision and / or
p.(None): to the customer.
p.(None): 21. Violations of Ethics and Clinical Research Program data
p.(None): falsification, unpredictable side effects and phenomena, the person being examined
p.(None): the ministry suspends in the event of a threat to life or health
p.(None): test procedure.
p.(None): 22. The researcher obtained as a result of a clinical trial
p.(None): based on data submitted to the Ministry.
p.(None): 23. The Ministry shall submit the report submitted within one month
p.(None): confirmation in case of professional expertise and positive conclusion.
...
Social / Soldier
Searching for indicator military:
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p.(None): IV. PROCEDURE OF CLINICAL RESEARCH
p.(None): 14. Accuracy and accuracy of data obtained from clinical trial
p.(None): the researcher is responsible for reliability.
p.(None): 15. The researcher must:
p.(None): a) immediately inform the Ministry, Ethics Committee
p.(None): changes to the clinical trial plan, as well as:
p.(None): and unpredictable side effects during research
p.(None): about phenomena:
p.(None): b) immediately terminate the clinical trial of the person being examined
p.(None): in case of danger to life or health;
p.(None): c) ensure the confidentiality of the data concerning the person under investigation;
p.(None): d) record, process and record data obtained as a result of a clinical trial
p.(None): maintain it in such a way that their accuracy and reliability can be monitored.
p.(None): 16. Clinical trial person (s) involved
p.(None): The doctor conducting the study is informed in advance
p.(None): the nature, significance, methods and potential hazards of the study, as well as
p.(None): is informed of its right to refuse it at any stage of the trial;
p.(None): after which he gives his written consent to participate.
p.(None): 17. It is forbidden to conduct clinical trials:
p.(None): a) Pregnant women, except where necessary information is available
p.(None): only when pregnant women are tested and when pregnant or pregnant
p.(None): for a minimum.
p.(None): b) military servicemen;
p.(None): (c) persons in places of detention as well as in detention facilities
p.(None): on.
p.(None): 18. Clinical trials are underway in the Ministry and Ethics
p.(None): under the constant supervision of the Commission. Research observations
p.(None): are held every 3 months or as needed. Verification:
p.(None): in the event of detection of non-compliant phenomena
p.(None): a protocol is drawn up which is submitted to the researcher and / or client:
p.(None): to get acquainted:
p.(None): 19. The researcher and / or the client are obliged to cancel within 30 days
p.(None): deficiencies and shortcomings found during clinical trial examination
p.(None): to inform the Ministry.
p.(None): 20. The Ministry is not in the position to detect violations of the approved plan
p.(None): confirm the results of the clinical trial of the drug. Ministry accepted
p.(None): notifies the researcher in writing within three days of the decision and / or
p.(None): to the customer.
p.(None): 21. Violations of Ethics and Clinical Research Program data
p.(None): falsification, unpredictable side effects and phenomena, the person being examined
p.(None): the ministry suspends in the event of a threat to life or health
p.(None): test procedure.
p.(None): 22. The researcher obtained as a result of a clinical trial
p.(None): based on data submitted to the Ministry.
p.(None): 23. The Ministry shall submit the report submitted within one month
p.(None): confirmation in case of professional expertise and positive conclusion.
p.(None): The Ministry shall inform in writing within three days of the decision
...
Social / Threat of Stigma
Searching for indicator threat:
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p.(None): only when pregnant women are tested and when pregnant or pregnant
p.(None): for a minimum.
p.(None): b) military servicemen;
p.(None): (c) persons in places of detention as well as in detention facilities
p.(None): on.
p.(None): 18. Clinical trials are underway in the Ministry and Ethics
p.(None): under the constant supervision of the Commission. Research observations
p.(None): are held every 3 months or as needed. Verification:
p.(None): in the event of detection of non-compliant phenomena
p.(None): a protocol is drawn up which is submitted to the researcher and / or client:
p.(None): to get acquainted:
p.(None): 19. The researcher and / or the client are obliged to cancel within 30 days
p.(None): deficiencies and shortcomings found during clinical trial examination
p.(None): to inform the Ministry.
p.(None): 20. The Ministry is not in the position to detect violations of the approved plan
p.(None): confirm the results of the clinical trial of the drug. Ministry accepted
p.(None): notifies the researcher in writing within three days of the decision and / or
p.(None): to the customer.
p.(None): 21. Violations of Ethics and Clinical Research Program data
p.(None): falsification, unpredictable side effects and phenomena, the person being examined
p.(None): the ministry suspends in the event of a threat to life or health
p.(None): test procedure.
p.(None): 22. The researcher obtained as a result of a clinical trial
p.(None): based on data submitted to the Ministry.
p.(None): 23. The Ministry shall submit the report submitted within one month
p.(None): confirmation in case of professional expertise and positive conclusion.
p.(None): The Ministry shall inform in writing within three days of the decision
...
Social / Women
Searching for indicator women:
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p.(None): about clinical trial authorization and within three days in writing
p.(None): informs the customer.
p.(None): 13. In the clinical research program approved by the Ministry
p.(None): If the customer needs to make any changes, he or she shall apply
p.(None): submits to the Ministry, where the materials are presented in the prescribed manner
p.(None): are reviewed and a decision is made to adopt these changes.
p.(None): IV. PROCEDURE OF CLINICAL RESEARCH
p.(None): 14. Accuracy and accuracy of data obtained from clinical trial
p.(None): the researcher is responsible for reliability.
p.(None): 15. The researcher must:
p.(None): a) immediately inform the Ministry, Ethics Committee
p.(None): changes to the clinical trial plan, as well as:
p.(None): and unpredictable side effects during research
p.(None): about phenomena:
p.(None): b) immediately terminate the clinical trial of the person being examined
p.(None): in case of danger to life or health;
p.(None): c) ensure the confidentiality of the data concerning the person under investigation;
p.(None): d) record, process and record data obtained as a result of a clinical trial
p.(None): maintain it in such a way that their accuracy and reliability can be monitored.
p.(None): 16. Clinical trial person (s) involved
p.(None): The doctor conducting the study is informed in advance
p.(None): the nature, significance, methods and potential hazards of the study, as well as
p.(None): is informed of its right to refuse it at any stage of the trial;
p.(None): after which he gives his written consent to participate.
p.(None): 17. It is forbidden to conduct clinical trials:
p.(None): a) Pregnant women, except where necessary information is available
p.(None): only when pregnant women are tested and when pregnant or pregnant
p.(None): for a minimum.
p.(None): b) military servicemen;
p.(None): (c) persons in places of detention as well as in detention facilities
p.(None): on.
p.(None): 18. Clinical trials are underway in the Ministry and Ethics
p.(None): under the constant supervision of the Commission. Research observations
p.(None): are held every 3 months or as needed. Verification:
p.(None): in the event of detection of non-compliant phenomena
p.(None): a protocol is drawn up which is submitted to the researcher and / or client:
p.(None): to get acquainted:
p.(None): 19. The researcher and / or the client are obliged to cancel within 30 days
p.(None): deficiencies and shortcomings found during clinical trial examination
p.(None): to inform the Ministry.
p.(None): 20. The Ministry is not in the position to detect violations of the approved plan
p.(None): confirm the results of the clinical trial of the drug. Ministry accepted
p.(None): notifies the researcher in writing within three days of the decision and / or
p.(None): to the customer.
p.(None): 21. Violations of Ethics and Clinical Research Program data
p.(None): falsification, unpredictable side effects and phenomena, the person being examined
p.(None): the ministry suspends in the event of a threat to life or health
p.(None): test procedure.
p.(None): 22. The researcher obtained as a result of a clinical trial
p.(None): based on data submitted to the Ministry.
p.(None): 23. The Ministry shall submit the report submitted within one month
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): with human experiments;
p.(None): Clinical Trials Program - Research Tasks
p.(None): describing the methodology, procedure, statistics, and organization
p.(None): document:
p.(None): Researcher responsible for conducting clinical research
p.(None): physical person.
p.(None): research person (tested) - a patient or participant in a clinical trial
p.(None): a healthy volunteer undergoing a trial or comparative drug trial;
p.(None): clinical activity - planning, conducting clinical research,
p.(None): to conduct, observe, conduct independent evaluation, with documentation
p.(None): the principle of formulating and presenting its results;
p.(None): Ethics Committee - an independent body responsible for testing
p.(None): health, safety, human rights and population
p.(None): to provide appropriate guarantees.
p.(None): III. EXAMINATION OF CLINICAL RESEARCH MATERIALS
p.(None): 6. The researcher has permission to conduct clinical trials
p.(None): submits an application to the Ministry, which is attached to the clinic
p.(None): The package of documents required for research by the Ministry
p.(None): according to the approved list.
p.(None): 7. The documents submitted by the researcher should contain the following:
p.(None): data:
p.(None): a) Pre-clinical study of drug safety and efficacy
p.(None): results:
p.(None): (b) Persuasive data on the positive effect of drug use in excess of the drug
p.(None): the danger to the individual;
p.(None): c) positive opinion of the Ethics Committee.
p.(None): 8. The Ethics Committee provides clinical trials of drugs
p.(None): volunteering, security of participants and rights
p.(None): protection, giving the danger and effectiveness of clinical research
p.(None): assessment of the ratio, as well as compliance with ethics. Ethics:
p.(None): The Committee on Issues operates on a public basis and is not remunerated. Ethics:
p.(None): The composition and the Charter of the Committee on Issues shall be approved by the Ministry.
p.(None): 9. The documents submitted by the researcher are kept in the Ministry
p.(None): 2 stages of expertise
p.(None): a) In the first stage a preliminary examination is carried out which clarifies
p.(None): Compliance of submitted documents with approved requirements
p.(None): in terms of design accuracy and completeness;
p.(None): b) The second phase is the implementation of a clinical research program
p.(None): examination to confirm it. The examination period is 60 days.
p.(None): 10. Clinical evaluation of medicines during examination of submitted documents
p.(None): if necessary or provided additional data related to the study
p.(None): If the Ministry has any comments on the materials
p.(None): The customer may require additional documents or disclosures
p.(None): defect elimination. Additional Documentation and Defects
p.(None): the time spent on elimination does not fall within the prescribed forensic examination
p.(None): in due time.
p.(None): 11. If the customer does not correct the defects discovered within 60 days, he / she will not
p.(None): provide any additional information required or justification for delay;
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
| military | Soldier |
| opinion | philosophical differences/differences of opinion |
| pregnant | Pregnant |
| threat | Threat of Stigma |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input