C661DEC5EFCA0F83910449083B33AEF8
Decree 35/2005 (VIII.26.) of the Minister of Health on the Clinical Trials of Investigational Medicinal Products for Human Use and on the Application of Good Clinical Practice
https://leaux.net/URLS/General/Hungary_2005_Decree_352005_VIII.26._of_the_Minister_of_Health_on_the_Clinical_Trials_of_Investigational_Medicinal_Products_for_Human_Use_and_on_the_Application_of_Good_Clinical_Practice.pdf
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Examining the file media/Synopses/19E878C2E0B8810DED674716E2F2BCC0.html:
This file was generated: 2020-04-14 02:07:05
| 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
Political / Political
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p.(None): (g) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): (h) the EGTC KFEB is an expert opinion appropriate to the disease in question and the group of patients concerned
p.(None): professionally and ethically supports the study plan in its possession;
p.(None): (i) there are reasonable grounds for believing that the use of the investigational medicinal product outweighs the adverse effects
p.(None): effects on the patient or no risk at all.
p.(None): § 10 The persons listed in § 9 shall not be included in a clinical trial as healthy volunteers
p.(None): can be involved.
p.(None): § 11 If the subject during the clinical trial is due to either a court decision or a change in his or her condition
p.(None): becomes effective, the clinical trial shall be informed as soon as possible and the
p.(None): With the proper application of the provisions of §, your consent must be obtained to continue it.
p.(None): Otherwise, the clinical trial may not be continued in the person concerned.
p.(None): Preconditions for applying for an official permit
p.(None): § 12. (1) *
p.(None): If principal is some or all, related to the investigation
p.(None): entrusts another natural or legal person with the performance of his duties, in which case the principal shall also be liable
p.(None): the provisions on clinical trials contained in this Regulation and in specific legislation
p.(None): compliance. If the principal is not established in a State party to the EEA Agreement, the legal
p.(None): must be established in a State party to the EEA Agreement.
p.(None): (2) - (5) *
p.(None): (6) For the clinical trial of the investigational medicinal product between the healthcare provider and the sponsor
p.(None): contract may be concluded before the authorization procedure, but
p.(None): conditional official authorization of the clinical trial.
p.(None): (7) *
p.(None): Official authorization of a clinical trial
p.(None): § 13. (1) *
p.(None): (2) The use of an investigational medicinal product in humans may be authorized if the clinical trial
p.(None): the personal and material conditions of the test site (s) comply with the requirements of Article 2 of this Regulation
p.(None): the conditions set out in Annex I.
p.(None): (3) - (4) *
p.(None): § 14. * (1) *
p.(None): (2) With regard to clinical trials, IKEB is responsible for the rights and safety of subjects
p.(None): protection. IKEB may not issue professional-ethical opinions on clinical trials.
p.(None): (3) *
p.(None): § 15. *
p.(None): Procedure of the EGTC KFEB
p.(None): § 16 (1) *
p.(None): prevail.
p.(None): For the composition of the EGTC KFEB, the Eütv. Section 159 (6)
p.(None): 2. The sponsor may request an opinion from the EGTC KFEB in relation to clinical trials on any professional-ethical
p.(None): to which the EGTC KFEB will reply within sixty days.
p.(None): Section 17 (1) - (7) *
p.(None): (8) The EGTC KFEB shall keep the inspection master file and, by archiving, the investigators
p.(None): documents relating to the professional qualifications and inspection procedures of the inspection
p.(None): for three years after its completion.
p.(None): § 18 *
p.(None): 18 / A. § *
p.(None): Clinical trial control
p.(None): § 19. (1) *
p.(None): The inspector of OGYÉI is a pharmacist or a medical university
...
p.(None): may send it to the EGTC KFEB, which shall, if justified, initiate an inspection at OGYÉI.
p.(None): (6) - (7) *
p.(None): (8) *
p.(None): The inspector referred to in paragraph 1 shall declare in writing that:
p.(None): what are the interests, business and other relationships with the parties under control. This
p.(None): this statement shall be taken into account when appointing the inspector for an ad hoc inspection.
p.(None): (9) *
p.(None): At the request of OGYÉI, the client is obliged to carry out the inspection within 1 working day
p.(None): a quantity of the appropriate batch of the preparation suitable for quality control
p.(None): made.
p.(None): § 20 *
p.(None): Reporting of adverse events
p.(None): § 21. (1) *
p.(None): The investigator is all severe at the test site
p.(None): immediately notify the sponsor and IKEB of any adverse event, except for those
p.(None): according to the study plan or the prospectus prepared for the investigators
p.(None): reporting. The investigator shall provide a detailed written report of the incident upon immediate notification
p.(None): also sends to the client and IKEB. In the notification and the written report, the subject is exclusively unique
p.(None): identifiable by its code.
p.(None): (2) In the study plan, it was identified as being of high importance for the safety assessment of the study
p.(None): adverse events or laboratory abnormalities as specified by the investigator in the study plan,
p.(None): report to the principal within the time specified therein.
p.(None): (3) In the event of a reported death of a subject, the investigator shall request any additional information
p.(None): provides for the principal and IKEB.
p.(None): (4) The sponsor shall keep detailed records of all adverse events reported by the investigator. This
p.(None): available to the States party to the EEA Agreement upon request
p.(None): in which the clinical trial is conducted.
p.(None): Reporting of serious side effects
p.(None): § 22 *
p.(None): (1) *
p.(None): The principal is required to take care of any death or life
p.(None): endangering SUSAR and all relevant information
p.(None): but no later than seven days after becoming aware of it, the EMEA EudraVigilance
p.(None): database. The sponsor will take care of all fatalities occurring at all test sites in Hungary
p.(None): life-threatening SUSAR and all relevant information is prompt - but no later than
p.(None): within seven days of becoming aware of its electronic report to OGYÉI,
p.(None): to the competent authority of the EEA EGCC and of the State concerned which is a party to the EEA Agreement. To the principal
p.(None): within a further eight days, any significant data obtained during the follow-up of the adverse reaction in question
p.(None): must report.
p.(None): (2) *
p.(None): The principal must take care of all other SUSARs promptly - but
p.(None): within fifteen days of becoming aware of the report to the EMEA EudraVigilance
p.(None): database. The Client shall provide all other SUSARs occurring at the Hungarian test site
p.(None): immediately, but no later than fifteen days after becoming aware of it, send it electronically to OGYÉI,
p.(None): the competent authority of the EEA EGCC and the States party to the EEA Agreement.
p.(None): (3) *
p.(None): The sponsor is responsible for each specific test preparation
p.(None): periodically, in the form of a summary list of SUSAR occurring in the clinical trial
p.(None): participating all investigators.
p.(None): (4) *
p.(None): The sponsor of the clinical trial for the entire duration of the trial
p.(None): all serious suspected adverse reactions to the product,
p.(None): and an electronic report on the safety of the subjects once a year
p.(None): shall be sent to OGYÉI, the EGTC KFEB and the competent authority of the State concerned which is a party to the EEA Agreement.
p.(None): (5) *
p.(None): OGYÉI keeps records of each test preparation
p.(None): SUSAR. In the case of non-commercial tests, OGYÉI is all of that test
p.(None): SUSAR which has come to its notice in connection with the preparation without delay, but no later than
p.(None): The EMEA shall report to the EudraVigilance database within the deadline set out in paragraph 2.
p.(None): (6) *
p.(None): In addition to the provisions of Section 21 and this Section, the investigation
p.(None): endangering the safety of subjects by continuing the study or the study preparation
p.(None): after the occurrence of new information or event related to the development of the
p.(None): investigator should take appropriate urgent safety measures in order to conduct the test
p.(None): the girls
p.(None): protect against all imminent dangers. The principal shall be informed of such events and of what has been done
p.(None): immediately, but no later than within 24 hours, inform OGYÉI and ETT KFEB in writing.
p.(None): Report on the completion of the investigation
p.(None): § 23 *
p.(None): Within ninety days of the completion of the investigation, the sponsor shall:
p.(None): It will notify OGYÉI of the completion of the study in a form that can be downloaded from the EMEA website. OGYÉI a
p.(None): inform the EGTC KFEB within eight days of the notification.
p.(None): Retention of test documentation
p.(None): § 24. (1) The inspection master file shall contain the basic documents
p.(None): which allow both the conduct of the clinical trial and the quality of the data
p.(None): be evaluable. The documents must indicate whether the investigators and the sponsor have complied
p.(None): the principles of GCP. The test master file shall be based on an inspection carried out by an independent auditor or a
p.(None): for official control.
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Health / Drug Usage
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p.(None): 4. The written prospectus shall contain, in particular, the following, as appropriate:
p.(None): (a) the identity of the clinical trial;
p.(None): b) an indication of the research nature of the clinical trial, the purpose of the clinical trial, the expected duration,
p.(None): the number of persons to be involved, the course of the clinical trial, the nature of the planned interventions,
p.(None): frequency;
p.(None): (c) other accepted treatment options available to the subject,
p.(None): and information that the clinical trial is discontinuing treatment that has already begun
p.(None): can mean and the treatment started
p.(None): the consequences for the subject of its interruption;
p.(None): (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
p.(None): an indication that adverse events that did not occur in advance may occur during the clinical trial
p.(None): visible;
p.(None): (e) a description of the reasonably foreseeable benefits or if the subject benefits from the clinical trial
p.(None): not expected, disclosure of this fact;
p.(None): f) *
p.(None): harm to the subject related to the clinical trial
p.(None): treatment to be provided in the event of the occurrence or violation of the right to privacy, compensation for damage, or
p.(None): for the payment of damages and compensation [GyT. Section 21 (1)] and the manner of their use
p.(None): information, as well as the name and contact details in Hungary of the person and organization to whom you are
p.(None): to which the subject may turn in the event of damage;
p.(None): (g) the reimbursement of costs to the subject, if any;
p.(None): (h) a warning that the consent is voluntary and free from influence,
p.(None): it may be withdrawn at any time, either orally or in writing, without giving reasons, without this being examined
p.(None): subject would be at a disadvantage;
p.(None): (i) rules on the handling of, and access to, subject data;
p.(None): (j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
p.(None): the likelihood of the subject being placed in the placebo group;
p.(None): (k) a brief pharmacological description of the test preparation;
p.(None): (l) the nature of the test subject, if any, after completion of the study
p.(None): receive additional health care;
p.(None): m) *
p.(None): n) *
p.(None): and GyT. It is included in the liability insurance pursuant to Section 3 (5)
p.(None): the name of the insurer.
p.(None): (5) *
p.(None): 6. The subject's informed consent shall include at least the following:
p.(None): (a) the identity of the clinical trial;
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted;
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): designation;
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
p.(None): (hereinafter referred to as the person entitled to make a declaration) identifier
p.(None): data;
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a statement - for participation in a clinical trial
p.(None): after giving the information provided for in paragraph 1, give its consent voluntarily, without influence
p.(None): Aware that it may be revoked at any time, orally or in writing, without giving any reason;
p.(None): (f) the date of signature of the statement of consent;
p.(None): (g) the signature of the clinical trial director or information provider;
p.(None): (h) the signature of the person giving his consent.
p.(None): (7) *
p.(None): The person providing the information and the subject - and to a limited extent
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the person entitled to make the statement
p.(None): He shall also sign the written information referred to in paragraph 4.
p.(None): 8. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 4.
p.(None): received and informed of the statement of consent referred to in paragraph 6
p.(None): he verbally agreed.
p.(None): (9) *
p.(None): 6 / A. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): the subject shall be informed separately. For information out
p.(None): it should also cover the right of the subject to be sampled separately
p.(None): refuse, in which case the genetic data relating to him will remain anonymous
...
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): Name,
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.(None): hereinafter referred to as "the person entitled to make the declaration"),
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a declaration - in a genetic test for pharmacological purposes
p.(None): consent to participate in accordance with Article 6 / A. § or waiver thereof
p.(None): voluntarily, without influence, knowing that at any time, orally or in writing, without giving reasons,
p.(None): revocable,
p.(None): (f) consent to the taking of a sample of the quantity and quality indicated in the prospectus and to the subject
p.(None): to use your data,
p.(None): (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.(None): biobank and the method of disposal, so it is possible to place the sample in 6 / A. §
p.(None): Storage and disposal in accordance with paragraph 2 (g),
p.(None): (h) the subject's statement on further sampling of the sample placed in the biobank
p.(None): participation; in this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): ie it contributes to its use for diagnostic and research purposes,
p.(None): (i) the manner in which the result is to be communicated, even if the subject does not have access to it,
p.(None): j) consent to or exclusion from any future request,
p.(None): k) the date of signature of the statement of consent,
p.(None): l) the signature of the head of the clinical trial or the person providing the information,
p.(None): (m) the signature of the person giving his consent.
p.(None): Clinical trials in minors
p.(None): § 7 Clinical examination of minors according to Eütv. Section 159 (4) and Section 4
p.(None): Even in the case of the correct application of the provisions of § 6, it can only be performed if all of the following conditions are met:
...
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p.(None): lén✖y human rights and dignity in the application of biology and medicine
p.(None): on the protection of the population of Oviedo (zhmtétnpy :, //vlaalnamdiinntg.wazolte
p.(None): Supplement to the Convention on the Prohibition of the Cloning of Human Beings
p.(None): In accordance with the provisions of its Protocol, I hereby order:
p.(None): Jogtár demo?
p.(None): § 1 The requirements of this Decree with test preparations for human use
p.(None): medical research (Eütv. 1u5t7m. §_, saotouvrácbeb = iankebtajno: gta
p.(None): clinical trial). Does not qualify as a clinical trial a
p.(None): a non-interventional trial in which:
p.(None): (a) the medicinal product is not prescribed for the purpose of testing, and
p.(None): (b) a medicinal product in the usual manner in clinical practice, in accordance with the terms of the marketing authorization
p.(None): are ordered, and
p.(None): (c) the involvement of the patient in a particular treatment strategy is not determined in advance by a study
p.(None): plan, but the medicine is prescribed in accordance with current clinical practice and is prescribed
p.(None): clearly separated from the decision to include the patient in the study, and
p.(None): (d) in addition to normal clinical practice, the patient has additional diagnostic or
p.(None): no monitoring procedure is used, and
p.(None): (e) only epidemiological methods are used to analyze the data collected.
p.(None): § 2. (1) For the purposes of this Decree
p.(None): (a) clinical trial: a medical trial performed on any human
p.(None): research carried out at one or more test sites for the purpose of one or more test sites
p.(None): preparation
p.(None): (aa) the exploration of its clinical, pharmacological or pharmacodynamic effects; and
p.(None): (b) the identification of the adverse drug reaction caused by it; or
p.(None): (ac) study of absorption, distribution, metabolism and excretion,
p.(None): to demonstrate the safety, efficacy, benefit / risk balance of the product
p.(None): excluding non-interventional studies;
p.(None): (b) multicenter clinical trial: according to the same study design, but
p.(None): a clinical trial performed at more than one study site by more than one investigator,
p.(None): where the test sites are located in the European Economic Area (hereinafter referred to as the EEA) and in the European Economic Area
p.(None): Community or the
p.(None): Under an international agreement concluded with the EEA in a State with the same status as an EEA Member State (a
p.(None): hereinafter referred to as "EEA States") and in third countries;
p.(None): (c) investigational medicinal product: active substance or placebo,
p.(None): in a pharmaceutical form that is being tested in a clinical trial or as a reference (comparative)
p.(None): used as a preparation, including preparations already on the market
p.(None): but different from the agreed SPC or different
p.(None): used in the presentation or packaging or from the indication in the approved summary of product characteristics
p.(None): used in a different indication or with a medicinal product already authorized
p.(None): used to collect additional data on
p.(None): d) *
p.(None): sponsor: any natural or legal person who you are
p.(None): which initiates, conducts, and funds the clinical trial. It can be the investigator and the principal
p.(None): the same person;
...
Searching for indicator substance:
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p.(None): clearly separated from the decision to include the patient in the study, and
p.(None): (d) in addition to normal clinical practice, the patient has additional diagnostic or
p.(None): no monitoring procedure is used, and
p.(None): (e) only epidemiological methods are used to analyze the data collected.
p.(None): § 2. (1) For the purposes of this Decree
p.(None): (a) clinical trial: a medical trial performed on any human
p.(None): research carried out at one or more test sites for the purpose of one or more test sites
p.(None): preparation
p.(None): (aa) the exploration of its clinical, pharmacological or pharmacodynamic effects; and
p.(None): (b) the identification of the adverse drug reaction caused by it; or
p.(None): (ac) study of absorption, distribution, metabolism and excretion,
p.(None): to demonstrate the safety, efficacy, benefit / risk balance of the product
p.(None): excluding non-interventional studies;
p.(None): (b) multicenter clinical trial: according to the same study design, but
p.(None): a clinical trial performed at more than one study site by more than one investigator,
p.(None): where the test sites are located in the European Economic Area (hereinafter referred to as the EEA) and in the European Economic Area
p.(None): Community or the
p.(None): Under an international agreement concluded with the EEA in a State with the same status as an EEA Member State (a
p.(None): hereinafter referred to as "EEA States") and in third countries;
p.(None): (c) investigational medicinal product: active substance or placebo,
p.(None): in a pharmaceutical form that is being tested in a clinical trial or as a reference (comparative)
p.(None): used as a preparation, including preparations already on the market
p.(None): but different from the agreed SPC or different
p.(None): used in the presentation or packaging or from the indication in the approved summary of product characteristics
p.(None): used in a different indication or with a medicinal product already authorized
p.(None): used to collect additional data on
p.(None): d) *
p.(None): sponsor: any natural or legal person who you are
p.(None): which initiates, conducts, and funds the clinical trial. It can be the investigator and the principal
p.(None): the same person;
p.(None): (e) investigator: a person qualified in medicine or dentistry whose task is to:
p.(None): conducting a clinical trial at the study site;
p.(None): (f) principal investigator: the responsible leader of the team at a particular investigation site if the
p.(None): a clinical trial is conducted by a group of several investigators;
p.(None): (g) investigator’s brochure: the investigator’s brochure or
p.(None): a summary of the relevant clinical and non-clinical data on the product
p.(None): for the study of the investigational medicinal product or products
p.(None): benefit / risk associated with the clinical trial for the physician and the investigator
p.(None): objective assessment. The prospectus must be updated by the sponsor at least annually;
p.(None): h) study plan (protocol): study purpose, layout, methodology, statistical
p.(None): deliberations and organization of a document containing the subjects
p.(None): inclusion and exclusion criteria, monitoring and publication principles, including the study design
p.(None): any successive versions and any amendments thereto;
...
Health / Health
Searching for indicator health:
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p.(None): Status of the legislation in force today (14/04/2020). THE ! "signs past and future changes in paragraphs
p.(None): represent.
p.(None): This document contains website 1 of the legislation. To print the entire legislation, select it in the header
p.(None): found print icon!
p.(None): 35/2005. (VIII. 26.) EüM decree
p.(None): on clinical trials of investigational medicinal products for human use and good clinical practice
p.(None): application
p.(None): CLIV of 1997 on health. § (hereinafter: Eütv.)
p.(None): (2) (o) and Regulation (EC) No 1907/2006 on medicinal products for human use.
p.(None): évi XXV. Authorization received in Section 24 (2) (d) of the Act (hereinafter: Gytv.)
p.(None): in accordance with Annex VI to promulgated by law, the Council of Europe emIbnegriy
p.(None): lén✖y human rights and dignity in the application of biology and medicine
p.(None): on the protection of the population of Oviedo (zhmtétnpy :, //vlaalnamdiinntg.wazolte
p.(None): Supplement to the Convention on the Prohibition of the Cloning of Human Beings
p.(None): In accordance with the provisions of its Protocol, I hereby order:
p.(None): Jogtár demo?
p.(None): § 1 The requirements of this Decree with test preparations for human use
p.(None): medical research (Eütv. 1u5t7m. §_, saotouvrácbeb = iankebtajno: gta
p.(None): clinical trial). Does not qualify as a clinical trial a
p.(None): a non-interventional trial in which:
p.(None): (a) the medicinal product is not prescribed for the purpose of testing, and
p.(None): (b) a medicinal product in the usual manner in clinical practice, in accordance with the terms of the marketing authorization
p.(None): are ordered, and
p.(None): (c) the involvement of the patient in a particular treatment strategy is not determined in advance by a study
p.(None): plan, but the medicine is prescribed in accordance with current clinical practice and is prescribed
p.(None): clearly separated from the decision to include the patient in the study, and
p.(None): (d) in addition to normal clinical practice, the patient has additional diagnostic or
p.(None): no monitoring procedure is used, and
p.(None): (e) only epidemiological methods are used to analyze the data collected.
p.(None): § 2. (1) For the purposes of this Decree
p.(None): (a) clinical trial: a medical trial performed on any human
...
p.(None): the same person;
p.(None): (e) investigator: a person qualified in medicine or dentistry whose task is to:
p.(None): conducting a clinical trial at the study site;
p.(None): (f) principal investigator: the responsible leader of the team at a particular investigation site if the
p.(None): a clinical trial is conducted by a group of several investigators;
p.(None): (g) investigator’s brochure: the investigator’s brochure or
p.(None): a summary of the relevant clinical and non-clinical data on the product
p.(None): for the study of the investigational medicinal product or products
p.(None): benefit / risk associated with the clinical trial for the physician and the investigator
p.(None): objective assessment. The prospectus must be updated by the sponsor at least annually;
p.(None): h) study plan (protocol): study purpose, layout, methodology, statistical
p.(None): deliberations and organization of a document containing the subjects
p.(None): inclusion and exclusion criteria, monitoring and publication principles, including the study design
p.(None): any successive versions and any amendments thereto;
p.(None): (i) subject: a person in a clinical trial who is the subject of a clinical trial
p.(None): who is participating in the study as a control;
p.(None): j) *
p.(None): informed consent: to participate in the study
p.(None): requested person with legal capacity under the Eütv. A statement pursuant to Section 159 (1) (e),
p.(None): or a minor with limited legal capacity and capacity to act with health care
p.(None): In the case of a person who is partially restricted or incapacitated with regard to the exercise of related rights, the Eütv.
p.(None): A statement pursuant to Section 159 (4) (d);
p.(None): k) *
p.(None): recruitment: the health of the person conducting the clinical trial
p.(None): by the National Institute of Pharmacy and Food Health (hereinafter: OGYÉI)
p.(None): authorized public call for the purpose of being a volunteer other than the patients he or she cares for
p.(None): include individuals as subjects in a specific clinical trial;
p.(None): (l) adverse event: a patient or subject treated with a study preparation
p.(None): an adverse change in his state of health which is not necessarily causally related
p.(None): with the treatment applied;
p.(None): (m) adverse reaction: occurring at any dose of the test preparation
p.(None): any adverse and undesirable reactions associated with the test preparation;
p.(None): (n) serious adverse reaction or serious adverse event:
p.(None): side effect or adverse event is severe if any dose of the study product is administered
p.(None): subject’s death, life-threatening, hospitalization, ongoing hospitalization.
p.(None): prolongation of care, permanent or significant damage to health, disability
p.(None): followed by or congenital anomaly, birth defect occurs;
p.(None): (o) unexpected adverse reaction: an adverse reaction of a nature or severity
p.(None): differs from the adverse reaction in the corresponding product information, such as the study preparation
p.(None): the package leaflet prepared for the investigator or, in the case of a medicinal product, the summary of product characteristics;
p.(None): (p) equivalence study: the study preparation is with another medicinal product
p.(None): bioequivalence (based on pharmacokinetic results), pharmacodynamic or therapeutic equivalence
p.(None): comparative study;
p.(None): q) *
p.(None): r) *
p.(None): SUSAR (Suspected Unexpected Serious Adverse Reaction): assumed
p.(None): unexpected serious side effect;
p.(None): s) *
p.(None): Phase I study: the tolerability of the test preparation,
p.(None): safety, pharmacokinetics and pharmacodynamic effects are healthy
p.(None): volunteers or special patient groups. A further goal of the Phase I study may be the therapeutic dose
p.(None): range determination;
p.(None): t) *
p.(None): II. phase I study: the pharmacological effect of the test preparation
p.(None): in an indication selected on the basis of the efficacy of the investigational medicinal product
p.(None): confirmation of the dose-response relationship, the optimal therapeutic dose
p.(None): safety and tolerability testing;
p.(None): u) *
p.(None): III. Phase I study: the efficacy of the study product,
p.(None): safety and tolerability in a larger number of patients in a controlled, randomized, placebo-controlled
p.(None): a test in a comparative test set-up;
p.(None): v) *
p.(None): ARC. Phase I study: the marketing authorization holder
p.(None): a study using the test preparation in accordance with the SPC, which
p.(None): aims to further investigate the benefit / risk balance, safety and tolerability.
p.(None): (2) *
p.(None): With regard to matters not covered by paragraph 1, this Regulation
p.(None): in the Eütv., on medicinal products for human use and other, the pharmaceutical market
p.(None): Act XCV of 2005 on the Amendment of Regulatory Acts. (hereinafter: GyT.), on man
p.(None): medical research, clinical trials of human investigational medicinal products
p.(None): and medical devices intended for human clinical use
p.(None): in the legislation on the rules of the authorization procedure for clinical trials, human
p.(None): legislation on the placing on the market of medicinal products for human use and for human use
p.(None): contained in the legislation on the personal and material conditions of the manufacture of
p.(None): definitions should be taken into account.
p.(None): (3) In the case of investigational medicinal products, it is authorized to ensure the quality of medicinal products
p.(None): the relevant provisions of the legislation on the conditions of qualification of a person shall also apply mutatis mutandis.
p.(None): § 3 (1) *
p.(None): All clinical trials - bioavailability and bioequivalence
p.(None): principles of good clinical practice (GCP)
p.(None): in accordance with the Helsinki Declaration on Ethical Principles in Medical Research
p.(None): be planned, carried out and reported. The current text of the GCP in the Hungarian language of OGYÉI
p.(None): It publishes. OGYÉI will publish a notice about the publication and its place in the Health Bulletin.
p.(None): (2) *
p.(None): The design and conduct of clinical trials is professional
p.(None): rules, in particular those published by the European Commission on clinical trials
p.(None): In accordance with the version of the detailed instructions in force at any time, which are published by OGYÉI in Hungarian
p.(None): publish in translation.
p.(None): (3) *
p.(None): The OGYÉI and the independent ethics committee according to the separate legislation, the
p.(None): Clinical Pharmacology Ethics Committee of the Health Science Council (hereinafter: ETT KFEB)
p.(None): issues methodological guidance on significant professional and ethical issues, in particular for each clinical trial
p.(None): phases, the use of placebo in clinical trials.
p.(None): On the publication of the guide and its place, the OGYÉI and the ETT KFEB as an appendix to the Hungarian Gazette
p.(None): will publish a notice in the Official Journal of the European Union.
p.(None): (4) *
p.(None): This Regulation is intended for pediatric use
p.(None): Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
p.(None): Council Regulation on Advanced Therapy Medicinal Products and Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 amending Regulation (EC) No 726/2004
p.(None): shall apply subject to Council Regulation.
p.(None): Protection of test subjects
p.(None): § 4 The rights, safety and well-being of the subject shall be given priority over science and
p.(None): against the interests of society, therefore the risk to the research subject should be kept to a minimum
p.(None): restricted.
p.(None): § 5 (1) *
p.(None): To perform a clinical trial, a study preparation in humans
p.(None): may only be used with the permission of OGYÉI. Clinical examination is only authorized by OGYÉI
p.(None): the conditions laid down in Decision
p.(None): may be continued according to the requirements of an approved test plan.
p.(None): (2) A person with legal capacity may be involved in a clinical trial if the Eütv. 159th
p.(None): § (1) - (3) and the requirements provided for in this Decree.
p.(None): (3) A clinical trial shall not be a substitute for a subject appropriate to its condition
p.(None): examinations and treatments.
p.(None): (4) *
p.(None): For the intended use of placebo, for official authorization
p.(None): the research dossier submitted with the application must include the placebo to be used in the study
p.(None): specific justification for the need for a control group. The use of placebo should not be reported to the subject
p.(None): significant additional risk to it or cause irreversible damage to health
p.(None): hazard. Placebo should only be used for the shortest time required by the test subject
p.(None): should be monitored continuously during the study, immediately in the event of signs of significant deterioration
p.(None): it must be provided with the best scientifically accepted therapy available.
p.(None): (5) The clinical trial shall be designed and conducted in a manner that minimizes the subject
p.(None): possible damage, pain, fear and anxiety. Age of the subject, health
p.(None): All foreseeable risks associated with the condition should be considered in the clinical trial
p.(None): planning and control.
p.(None): (6) The health status of the subject prior to the commencement of the clinical trial during the clinical trial
p.(None): must be carefully monitored and documented continuously and after the test.
p.(None): (7) If persons of reproductive age are to be included in a clinical trial, the design of the clinical trial,
p.(None): authorization, special attention shall be paid to the study subjects when informing the subjects
p.(None): subject with respect to clinical
p.(None): fertility, fertility, pregnancy or fertility at the time of the clinical trial.
p.(None): pregnancy, embryonal / fetal health.
p.(None): (8) *
p.(None): In clinical trials, the right to information self - determination and the
p.(None): CXII of 2011 on freedom of information. law, health and related
p.(None): XLVII of 1997 on the processing and protection of personal data law as well as in separate legislation
p.(None): The provisions on data processing set out in
p.(None): (9) As a subject to a clinical trial, with the exception of healthy volunteers, the clinical trial
p.(None): Patients cared for by a healthcare provider should be primarily involved.
p.(None): (10) *
p.(None): The healthcare provider conducting the clinical trial is the print media,
p.(None): or by means of a call published on its website, as well as professional and patient organizations,
p.(None): and may recruit competent subjects on the sponsor's website. The recruitment
p.(None): the call must not be for advertising purposes or contain the trade name of the investigational medicinal product,
p.(None): manufacturer and
p.(None): the designation of the person authorized to place it on the market.
p.(None): ! (10a) *
p.(None): In the case of a clinical trial pursuant to Section 7, the healthcare provider shall be
p.(None): to comply with the requirements of paragraph 10
p.(None): you can make the description of the planned clinical trials public on your own website as well as on the websites of professional and patient organizations.
p.(None): (11) *
p.(None): For the subject by participating in the clinical trial
p.(None): loss of income and costs, in particular in connection with travel
p.(None): Reimbursement may be made for costs incurred and justified. Other benefit to the subject
p.(None): or fee - non-therapeutic pharmacokinetic or interaction, phase I, and
p.(None): except for bioequivalence testing.
p.(None): (12) Test preparations and any devices used for their administration to the sponsor
p.(None): must be made available free of charge.
...
p.(None): visible;
p.(None): (e) a description of the reasonably foreseeable benefits or if the subject benefits from the clinical trial
p.(None): not expected, disclosure of this fact;
p.(None): f) *
p.(None): harm to the subject related to the clinical trial
p.(None): treatment to be provided in the event of the occurrence or violation of the right to privacy, compensation for damage, or
p.(None): for the payment of damages and compensation [GyT. Section 21 (1)] and the manner of their use
p.(None): information, as well as the name and contact details in Hungary of the person and organization to whom you are
p.(None): to which the subject may turn in the event of damage;
p.(None): (g) the reimbursement of costs to the subject, if any;
p.(None): (h) a warning that the consent is voluntary and free from influence,
p.(None): it may be withdrawn at any time, either orally or in writing, without giving reasons, without this being examined
p.(None): subject would be at a disadvantage;
p.(None): (i) rules on the handling of, and access to, subject data;
p.(None): (j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
p.(None): the likelihood of the subject being placed in the placebo group;
p.(None): (k) a brief pharmacological description of the test preparation;
p.(None): (l) the nature of the test subject, if any, after completion of the study
p.(None): receive additional health care;
p.(None): m) *
p.(None): n) *
p.(None): and GyT. It is included in the liability insurance pursuant to Section 3 (5)
p.(None): the name of the insurer.
p.(None): (5) *
p.(None): 6. The subject's informed consent shall include at least the following:
p.(None): (a) the identity of the clinical trial;
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted;
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): designation;
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
p.(None): (hereinafter referred to as the person entitled to make a declaration) identifier
p.(None): data;
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a statement - for participation in a clinical trial
p.(None): after giving the information provided for in paragraph 1, give its consent voluntarily, without influence
p.(None): Aware that it may be revoked at any time, orally or in writing, without giving any reason;
p.(None): (f) the date of signature of the statement of consent;
p.(None): (g) the signature of the clinical trial director or information provider;
p.(None): (h) the signature of the person giving his consent.
p.(None): (7) *
p.(None): The person providing the information and the subject - and to a limited extent
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the person entitled to make the statement
p.(None): He shall also sign the written information referred to in paragraph 4.
p.(None): 8. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 4.
p.(None): received and informed of the statement of consent referred to in paragraph 6
p.(None): he verbally agreed.
p.(None): (9) *
p.(None): 6 / A. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): the subject shall be informed separately. For information out
p.(None): it should also cover the right of the subject to be sampled separately
p.(None): refuse, in which case the genetic data relating to him will remain anonymous
p.(None): cannot be used in any way. Refusal of sampling does not constitute participation of the subject
p.(None): obstacle in the remainder of the clinical trial. Information on and consent to sampling
p.(None): should be included in a separate document.
p.(None): (2) Prior to sampling for the purpose of human genetic testing, the subject is subject to genetic counseling
p.(None): shall be informed within the framework of:
p.(None): (a) the purpose, quantitative and qualitative details of the sampling,
p.(None): (b) the benefits and risks of performing or not performing the study,
p.(None): (c) any possible outcome for the data subject and his or her close relatives
p.(None): consequences,
...
p.(None): (g) whether it may decide to place the sample it provides in a biobank;
p.(None): placement method so that a sample is possible
p.(None): (ga) storage of personal data,
p.(None): gb) in encrypted form,
p.(None): gc) pseudonymised, ie in a form in which the
p.(None): the replacement code has been made available to the subject exclusively,
p.(None): (gd) anonymised, ie in a form where all the data relating to the subject are available
p.(None): personally identifiable information has been rendered inoperable.
p.(None): (3) The test subject shall also be informed that the sample placed in the biobank may decide to continue
p.(None): participation in research. In this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): that is, it contributes to its use for diagnostic and research purposes.
p.(None): 6 / B. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): shall be sampled, a separate statement of consent shall be drawn up.
p.(None): 2. The subject's informed consent shall include at least the following:
p.(None): a) the identification data of the clinical trial,
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted,
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): Name,
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.(None): hereinafter referred to as "the person entitled to make the declaration"),
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a declaration - in a genetic test for pharmacological purposes
p.(None): consent to participate in accordance with Article 6 / A. § or waiver thereof
p.(None): voluntarily, without influence, knowing that at any time, orally or in writing, without giving reasons,
p.(None): revocable,
p.(None): (f) consent to the taking of a sample of the quantity and quality indicated in the prospectus and to the subject
p.(None): to use your data,
p.(None): (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.(None): biobank and the method of disposal, so it is possible to place the sample in 6 / A. §
p.(None): Storage and disposal in accordance with paragraph 2 (g),
p.(None): (h) the subject's statement on further sampling of the sample placed in the biobank
p.(None): participation; in this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): ie it contributes to its use for diagnostic and research purposes,
p.(None): (i) the manner in which the result is to be communicated, even if the subject does not have access to it,
p.(None): j) consent to or exclusion from any future request,
...
p.(None): no financial incentive is applied, no other benefit or fee may be granted to the minor subject;
p.(None): (g) the authorization of medicinal products for human or veterinary use; and
p.(None): laying down Community procedures for the supervision of
p.(None): Establishing a European Medicines Agency
p.(None): European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.(None): hereinafter referred to as the EMEA);
p.(None): (h) a clinical examination for pain, anxiety, fear and any other condition associated with illness and
p.(None): designed and maintained to minimize the foreseeable risk associated with its state of development;
p.(None): (i) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): j) in the possession of the opinion of the pediatric specialist of the EGTC KFEB, professionally and ethically
p.(None): test plan.
p.(None): Involvement of incapacitated adults in a clinical trial
p.(None): § 8 A person who has previously had legal capacity may not be involved in any clinical trial
p.(None): expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
p.(None): who has previously refused to give his consent to the
p.(None): testing.
p.(None): § 9 *
p.(None): Rights related to health care in its capacity to act
p.(None): partially or completely limited in its capacity to act, and
p.(None): Act V of 2013 on the Civil Code 2: 9. In the case of adults who are incapable of acting in accordance with
p.(None): for research carried out in urgent need, the Eütv. Except in the case pursuant to Section 160 of the Eütv. § 159
p.(None): Paragraph 4 and paragraphs 4 to 6. and § 8 only in that case
p.(None): a clinical trial may be performed if all of the following conditions are met:
p.(None): (a) the statement of consent of the person entitled to make the statement shall be the presumed will of the subject
p.(None): and may be revoked at any time without prejudice to the subject;
p.(None): (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.(None): adverse effects;
p.(None): (c) the investigator and the study director take full account of the opinion
p.(None): and a subject capable of assessing the situation explicitly precludes access to the clinical trial
p.(None): participation or wish to withdraw from the investigation at any time;
p.(None): d) inducement or financial means of any kind, except for the compensation pursuant to Section 5 (11)
p.(None): no incentive is applied, no other benefit or charge shall be granted to the subject;
p.(None): (e) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or other research methods and is directly related to a
p.(None): a clinical condition that is life-threatening or significantly detrimental to mental health and in which the person concerned suffers;
p.(None): (f) the clinical examination for pain, anxiety, fear and any other illness and disease.
p.(None): designed and maintained to minimize the foreseeable risk associated with the current condition of the subject;
p.(None): (g) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): (h) the EGTC KFEB is an expert opinion appropriate to the disease in question and the group of patients concerned
p.(None): professionally and ethically supports the study plan in its possession;
p.(None): (i) there are reasonable grounds for believing that the use of the investigational medicinal product outweighs the adverse effects
p.(None): effects on the patient or no risk at all.
p.(None): § 10 The persons listed in § 9 shall not be included in a clinical trial as healthy volunteers
p.(None): can be involved.
p.(None): § 11 If the subject during the clinical trial is due to either a court decision or a change in his or her condition
p.(None): becomes effective, the clinical trial shall be informed as soon as possible and the
p.(None): With the proper application of the provisions of §, your consent must be obtained to continue it.
p.(None): Otherwise, the clinical trial may not be continued in the person concerned.
p.(None): Preconditions for applying for an official permit
p.(None): § 12. (1) *
p.(None): If principal is some or all, related to the investigation
...
p.(None): II. Clinical trial site II. phase test
p.(None): III. Other clinical trial site
p.(None): I. Clinical pharmacology site for phase I study
p.(None): A) Material conditions:
p.(None): The clinical pharmacology research site is a university clinic or a hospital department at the institution
p.(None): a unit with an intensive care unit background, separate from active patient care, for which
p.(None): laboratory equipment and facilities for the Phase I study are available.
p.(None): A clinical pharmacology test site shall be provided locally in a separate piece of legislation, a
p.(None): the minimum conditions for on-call time for machinery and other equipment
p.(None): equipment, with the exception of the maternity unit package and the car.
p.(None): The number of beds for a clinical trial shall be specified in the decision to classify the trial site.
p.(None): B) Personal conditions:
p.(None): 1. The head of the clinical pharmacology site must have:
p.(None): a) a specialist in a clinical profession,
p.(None): (b) a clinical pharmacological examination.
p.(None): 2. The examiner must have
p.(None): a) a specialist in a clinical profession,
p.(None): (b) by a clinical pharmacological examination or not more than five years before the start of the clinical trial.
p.(None): with proof of successful completion of an older university-organized GCP course.
p.(None): 3. *
p.(None): The study director must have clinical pharmacology
p.(None): specialist examination.
p.(None): II. Clinical trial site II. phase test
p.(None): THE) *
p.(None): Material conditions:
p.(None): Inpatient department or outpatient clinic in a university clinic or hospital,
p.(None): or other specialist practice that has appropriate diagnostic units and that complies
p.(None): the minimum personal and material conditions of the health care provider specified in a separate legal regulation, and a
p.(None): it also has the means and equipment necessary to perform the planned test.
p.(None): B) Personal conditions:
p.(None): The study director should have the intended use of the study preparation
p.(None): with a specialist examination in an appropriate clinical field and a clinical pharmacology examination, or for five years
p.(None): with no older certificate of completion of a GCP course organized by a university. If
p.(None): there are minors to be included in the study, and a pediatrician to be included in the study
p.(None): must also be.
p.(None): III. *
p.(None): Clinical trial site for other clinical trials
p.(None): 1. Other clinical investigations may be performed in accordance with Annex II. Material as defined in point A)
p.(None): conditions, and in a general practitioner’s or home pediatrician’s office. *
p.(None): 2. The study director must have a certificate not older than five years
p.(None): that he has completed a GCP course organized by a university. *
p.(None): Annex 3 to Decree 35/2005 (VIII. 26.) EüM *
p.(None): Modified: 16/2014. (III. 12.) of the EMMI Decree § 12 a). Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a).
p.(None): Modified: 3/2014. (I. 16.) EMMI Decree § 17 a), 23/2015. (IV. 28.) of the EMMI Decree § 72 a).
p.(None): Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a).
p.(None): Repealed: 21 X 2009.
p.(None): Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
p.(None): In the case of pending applications for examination, the provisions of this Regulation shall apply.
p.(None): Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
p.(None): In the case of pending applications for examination, the provisions of this Regulation shall apply.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.(None): European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.(None): hereinafter referred to as the EMEA);
p.(None): (h) a clinical examination for pain, anxiety, fear and any other condition associated with illness and
p.(None): designed and maintained to minimize the foreseeable risk associated with its state of development;
p.(None): (i) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): j) in the possession of the opinion of the pediatric specialist of the EGTC KFEB, professionally and ethically
p.(None): test plan.
p.(None): Involvement of incapacitated adults in a clinical trial
p.(None): § 8 A person who has previously had legal capacity may not be involved in any clinical trial
p.(None): expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
p.(None): who has previously refused to give his consent to the
p.(None): testing.
p.(None): § 9 *
p.(None): Rights related to health care in its capacity to act
p.(None): partially or completely limited in its capacity to act, and
p.(None): Act V of 2013 on the Civil Code 2: 9. In the case of adults who are incapable of acting in accordance with
p.(None): for research carried out in urgent need, the Eütv. Except in the case pursuant to Section 160 of the Eütv. § 159
p.(None): Paragraph 4 and paragraphs 4 to 6. and § 8 only in that case
p.(None): a clinical trial may be performed if all of the following conditions are met:
p.(None): (a) the statement of consent of the person entitled to make the statement shall be the presumed will of the subject
p.(None): and may be revoked at any time without prejudice to the subject;
p.(None): (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.(None): adverse effects;
p.(None): (c) the investigator and the study director take full account of the opinion
p.(None): and a subject capable of assessing the situation explicitly precludes access to the clinical trial
p.(None): participation or wish to withdraw from the investigation at any time;
p.(None): d) inducement or financial means of any kind, except for the compensation pursuant to Section 5 (11)
p.(None): no incentive is applied, no other benefit or charge shall be granted to the subject;
p.(None): (e) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or other research methods and is directly related to a
p.(None): a clinical condition that is life-threatening or significantly detrimental to mental health and in which the person concerned suffers;
p.(None): (f) the clinical examination for pain, anxiety, fear and any other illness and disease.
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None): (c) the consent of the person entitled to make the statement to the opinion; and
p.(None): contains the probable will of a minor capable of assessing the situation, and this statement at any time
p.(None): can be revoked without the minor suffering any disadvantage;
p.(None): (d) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.(None): properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.(None): (e) the investigator or study director shall take into account the views of a minor who is able to form an opinion and assess the situation;
p.(None): expressly discourages participation in the clinical trial or the exclusion of any person from the trial at any time.
p.(None): step;
p.(None): f) persuasion by any material means, except for the compensation pursuant to Section 5 (11), or
p.(None): no financial incentive is applied, no other benefit or fee may be granted to the minor subject;
p.(None): (g) the authorization of medicinal products for human or veterinary use; and
p.(None): laying down Community procedures for the supervision of
p.(None): Establishing a European Medicines Agency
p.(None): European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.(None): hereinafter referred to as the EMEA);
p.(None): (h) a clinical examination for pain, anxiety, fear and any other condition associated with illness and
p.(None): designed and maintained to minimize the foreseeable risk associated with its state of development;
p.(None): (i) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): j) in the possession of the opinion of the pediatric specialist of the EGTC KFEB, professionally and ethically
p.(None): test plan.
p.(None): Involvement of incapacitated adults in a clinical trial
p.(None): § 8 A person who has previously had legal capacity may not be involved in any clinical trial
p.(None): expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
p.(None): who has previously refused to give his consent to the
p.(None): testing.
p.(None): § 9 *
p.(None): Rights related to health care in its capacity to act
p.(None): partially or completely limited in its capacity to act, and
p.(None): Act V of 2013 on the Civil Code 2: 9. In the case of adults who are incapable of acting in accordance with
p.(None): for research carried out in urgent need, the Eütv. Except in the case pursuant to Section 160 of the Eütv. § 159
p.(None): Paragraph 4 and paragraphs 4 to 6. and § 8 only in that case
p.(None): a clinical trial may be performed if all of the following conditions are met:
p.(None): (a) the statement of consent of the person entitled to make the statement shall be the presumed will of the subject
p.(None): and may be revoked at any time without prejudice to the subject;
p.(None): (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.(None): adverse effects;
p.(None): (c) the investigator and the study director take full account of the opinion
p.(None): and a subject capable of assessing the situation explicitly precludes access to the clinical trial
p.(None): participation or wish to withdraw from the investigation at any time;
p.(None): d) inducement or financial means of any kind, except for the compensation pursuant to Section 5 (11)
p.(None): no incentive is applied, no other benefit or charge shall be granted to the subject;
p.(None): (e) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or other research methods and is directly related to a
p.(None): a clinical condition that is life-threatening or significantly detrimental to mental health and in which the person concerned suffers;
p.(None): (f) the clinical examination for pain, anxiety, fear and any other illness and disease.
p.(None): designed and maintained to minimize the foreseeable risk associated with the current condition of the subject;
p.(None): (g) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): (h) the EGTC KFEB is an expert opinion appropriate to the disease in question and the group of patients concerned
p.(None): professionally and ethically supports the study plan in its possession;
p.(None): (i) there are reasonable grounds for believing that the use of the investigational medicinal product outweighs the adverse effects
p.(None): effects on the patient or no risk at all.
p.(None): § 10 The persons listed in § 9 shall not be included in a clinical trial as healthy volunteers
p.(None): can be involved.
p.(None): § 11 If the subject during the clinical trial is due to either a court decision or a change in his or her condition
p.(None): becomes effective, the clinical trial shall be informed as soon as possible and the
p.(None): With the proper application of the provisions of §, your consent must be obtained to continue it.
p.(None): Otherwise, the clinical trial may not be continued in the person concerned.
p.(None): Preconditions for applying for an official permit
p.(None): § 12. (1) *
p.(None): If principal is some or all, related to the investigation
p.(None): entrusts another natural or legal person with the performance of his duties, in which case the principal shall also be liable
...
Health / healthy volunteers
Searching for indicator healthy volunteers:
(return to top)
p.(None): it must be provided with the best scientifically accepted therapy available.
p.(None): (5) The clinical trial shall be designed and conducted in a manner that minimizes the subject
p.(None): possible damage, pain, fear and anxiety. Age of the subject, health
p.(None): All foreseeable risks associated with the condition should be considered in the clinical trial
p.(None): planning and control.
p.(None): (6) The health status of the subject prior to the commencement of the clinical trial during the clinical trial
p.(None): must be carefully monitored and documented continuously and after the test.
p.(None): (7) If persons of reproductive age are to be included in a clinical trial, the design of the clinical trial,
p.(None): authorization, special attention shall be paid to the study subjects when informing the subjects
p.(None): subject with respect to clinical
p.(None): fertility, fertility, pregnancy or fertility at the time of the clinical trial.
p.(None): pregnancy, embryonal / fetal health.
p.(None): (8) *
p.(None): In clinical trials, the right to information self - determination and the
p.(None): CXII of 2011 on freedom of information. law, health and related
p.(None): XLVII of 1997 on the processing and protection of personal data law as well as in separate legislation
p.(None): The provisions on data processing set out in
p.(None): (9) As a subject to a clinical trial, with the exception of healthy volunteers, the clinical trial
p.(None): Patients cared for by a healthcare provider should be primarily involved.
p.(None): (10) *
p.(None): The healthcare provider conducting the clinical trial is the print media,
p.(None): or by means of a call published on its website, as well as professional and patient organizations,
p.(None): and may recruit competent subjects on the sponsor's website. The recruitment
p.(None): the call must not be for advertising purposes or contain the trade name of the investigational medicinal product,
p.(None): manufacturer and
p.(None): the designation of the person authorized to place it on the market.
p.(None): ! (10a) *
p.(None): In the case of a clinical trial pursuant to Section 7, the healthcare provider shall be
p.(None): to comply with the requirements of paragraph 10
p.(None): you can make the description of the planned clinical trials public on your own website as well as on the websites of professional and patient organizations.
p.(None): (11) *
p.(None): For the subject by participating in the clinical trial
p.(None): loss of income and costs, in particular in connection with travel
p.(None): Reimbursement may be made for costs incurred and justified. Other benefit to the subject
p.(None): or fee - non-therapeutic pharmacokinetic or interaction, phase I, and
p.(None): except for bioequivalence testing.
p.(None): (12) Test preparations and any devices used for their administration to the sponsor
p.(None): must be made available free of charge.
p.(None): Informing the subject, consent to the clinical trial
p.(None): § 6. (1) The person with legal capacity to be involved in a clinical trial shall be the head of the clinical trial or
...
p.(None): participation or wish to withdraw from the investigation at any time;
p.(None): d) inducement or financial means of any kind, except for the compensation pursuant to Section 5 (11)
p.(None): no incentive is applied, no other benefit or charge shall be granted to the subject;
p.(None): (e) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or other research methods and is directly related to a
p.(None): a clinical condition that is life-threatening or significantly detrimental to mental health and in which the person concerned suffers;
p.(None): (f) the clinical examination for pain, anxiety, fear and any other illness and disease.
p.(None): designed and maintained to minimize the foreseeable risk associated with the current condition of the subject;
p.(None): (g) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): (h) the EGTC KFEB is an expert opinion appropriate to the disease in question and the group of patients concerned
p.(None): professionally and ethically supports the study plan in its possession;
p.(None): (i) there are reasonable grounds for believing that the use of the investigational medicinal product outweighs the adverse effects
p.(None): effects on the patient or no risk at all.
p.(None): § 10 The persons listed in § 9 shall not be included in a clinical trial as healthy volunteers
p.(None): can be involved.
p.(None): § 11 If the subject during the clinical trial is due to either a court decision or a change in his or her condition
p.(None): becomes effective, the clinical trial shall be informed as soon as possible and the
p.(None): With the proper application of the provisions of §, your consent must be obtained to continue it.
p.(None): Otherwise, the clinical trial may not be continued in the person concerned.
p.(None): Preconditions for applying for an official permit
p.(None): § 12. (1) *
p.(None): If principal is some or all, related to the investigation
p.(None): entrusts another natural or legal person with the performance of his duties, in which case the principal shall also be liable
p.(None): the provisions on clinical trials contained in this Regulation and in specific legislation
p.(None): compliance. If the principal is not established in a State party to the EEA Agreement, the legal
p.(None): must be established in a State party to the EEA Agreement.
p.(None): (2) - (5) *
p.(None): (6) For the clinical trial of the investigational medicinal product between the healthcare provider and the sponsor
p.(None): contract may be concluded before the authorization procedure, but
p.(None): conditional official authorization of the clinical trial.
p.(None): (7) *
p.(None): Official authorization of a clinical trial
p.(None): § 13. (1) *
p.(None): (2) The use of an investigational medicinal product in humans may be authorized if the clinical trial
p.(None): the personal and material conditions of the test site (s) comply with the requirements of Article 2 of this Regulation
p.(None): the conditions set out in Annex I.
p.(None): (3) - (4) *
p.(None): § 14. * (1) *
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): the number of persons to be involved, the course of the clinical trial, the nature of the planned interventions,
p.(None): frequency;
p.(None): (c) other accepted treatment options available to the subject,
p.(None): and information that the clinical trial is discontinuing treatment that has already begun
p.(None): can mean and the treatment started
p.(None): the consequences for the subject of its interruption;
p.(None): (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
p.(None): an indication that adverse events that did not occur in advance may occur during the clinical trial
p.(None): visible;
p.(None): (e) a description of the reasonably foreseeable benefits or if the subject benefits from the clinical trial
p.(None): not expected, disclosure of this fact;
p.(None): f) *
p.(None): harm to the subject related to the clinical trial
p.(None): treatment to be provided in the event of the occurrence or violation of the right to privacy, compensation for damage, or
p.(None): for the payment of damages and compensation [GyT. Section 21 (1)] and the manner of their use
p.(None): information, as well as the name and contact details in Hungary of the person and organization to whom you are
p.(None): to which the subject may turn in the event of damage;
p.(None): (g) the reimbursement of costs to the subject, if any;
p.(None): (h) a warning that the consent is voluntary and free from influence,
p.(None): it may be withdrawn at any time, either orally or in writing, without giving reasons, without this being examined
p.(None): subject would be at a disadvantage;
p.(None): (i) rules on the handling of, and access to, subject data;
p.(None): (j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
p.(None): the likelihood of the subject being placed in the placebo group;
p.(None): (k) a brief pharmacological description of the test preparation;
p.(None): (l) the nature of the test subject, if any, after completion of the study
p.(None): receive additional health care;
p.(None): m) *
p.(None): n) *
p.(None): and GyT. It is included in the liability insurance pursuant to Section 3 (5)
p.(None): the name of the insurer.
p.(None): (5) *
p.(None): 6. The subject's informed consent shall include at least the following:
p.(None): (a) the identity of the clinical trial;
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted;
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): designation;
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
...
p.(None): 8. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 4.
p.(None): received and informed of the statement of consent referred to in paragraph 6
p.(None): he verbally agreed.
p.(None): (9) *
p.(None): 6 / A. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): the subject shall be informed separately. For information out
p.(None): it should also cover the right of the subject to be sampled separately
p.(None): refuse, in which case the genetic data relating to him will remain anonymous
p.(None): cannot be used in any way. Refusal of sampling does not constitute participation of the subject
p.(None): obstacle in the remainder of the clinical trial. Information on and consent to sampling
p.(None): should be included in a separate document.
p.(None): (2) Prior to sampling for the purpose of human genetic testing, the subject is subject to genetic counseling
p.(None): shall be informed within the framework of:
p.(None): (a) the purpose, quantitative and qualitative details of the sampling,
p.(None): (b) the benefits and risks of performing or not performing the study,
p.(None): (c) any possible outcome for the data subject and his or her close relatives
p.(None): consequences,
p.(None): (d) the methods and duration of storage of the genetic sample and data, the genetic data stored in different forms
p.(None): samples and the possibilities for identifying data,
p.(None): (e) unless otherwise stated by the subject, the genetic sample is in an archived collection
p.(None): the possible transfer of stored genetic samples,
p.(None): (f) that he or she is entitled to have access to the genetic data generated by the human genetic test; and
p.(None): (g) whether it may decide to place the sample it provides in a biobank;
p.(None): placement method so that a sample is possible
p.(None): (ga) storage of personal data,
p.(None): gb) in encrypted form,
p.(None): gc) pseudonymised, ie in a form in which the
p.(None): the replacement code has been made available to the subject exclusively,
p.(None): (gd) anonymised, ie in a form where all the data relating to the subject are available
p.(None): personally identifiable information has been rendered inoperable.
p.(None): (3) The test subject shall also be informed that the sample placed in the biobank may decide to continue
p.(None): participation in research. In this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): that is, it contributes to its use for diagnostic and research purposes.
p.(None): 6 / B. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): shall be sampled, a separate statement of consent shall be drawn up.
p.(None): 2. The subject's informed consent shall include at least the following:
p.(None): a) the identification data of the clinical trial,
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted,
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): Name,
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
...
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a declaration - in a genetic test for pharmacological purposes
p.(None): consent to participate in accordance with Article 6 / A. § or waiver thereof
p.(None): voluntarily, without influence, knowing that at any time, orally or in writing, without giving reasons,
p.(None): revocable,
p.(None): (f) consent to the taking of a sample of the quantity and quality indicated in the prospectus and to the subject
p.(None): to use your data,
p.(None): (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.(None): biobank and the method of disposal, so it is possible to place the sample in 6 / A. §
p.(None): Storage and disposal in accordance with paragraph 2 (g),
p.(None): (h) the subject's statement on further sampling of the sample placed in the biobank
p.(None): participation; in this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): ie it contributes to its use for diagnostic and research purposes,
p.(None): (i) the manner in which the result is to be communicated, even if the subject does not have access to it,
p.(None): j) consent to or exclusion from any future request,
p.(None): k) the date of signature of the statement of consent,
p.(None): l) the signature of the head of the clinical trial or the person providing the information,
p.(None): (m) the signature of the person giving his consent.
p.(None): Clinical trials in minors
p.(None): § 7 Clinical examination of minors according to Eütv. Section 159 (4) and Section 4
p.(None): Even in the case of the correct application of the provisions of § 6, it can only be performed if all of the following conditions are met:
p.(None): (a) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or to validate data obtained through other research methods;
p.(None): (b) the research is directly related to the clinical condition in which the minor suffers or is of a nature
p.(None): which can only be performed on minors;
p.(None): (c) the consent of the person entitled to make the statement to the opinion; and
p.(None): contains the probable will of a minor capable of assessing the situation, and this statement at any time
p.(None): can be revoked without the minor suffering any disadvantage;
p.(None): (d) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.(None): properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
...
p.(None): § 8 A person who has previously had legal capacity may not be involved in any clinical trial
p.(None): expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
p.(None): who has previously refused to give his consent to the
p.(None): testing.
p.(None): § 9 *
p.(None): Rights related to health care in its capacity to act
p.(None): partially or completely limited in its capacity to act, and
p.(None): Act V of 2013 on the Civil Code 2: 9. In the case of adults who are incapable of acting in accordance with
p.(None): for research carried out in urgent need, the Eütv. Except in the case pursuant to Section 160 of the Eütv. § 159
p.(None): Paragraph 4 and paragraphs 4 to 6. and § 8 only in that case
p.(None): a clinical trial may be performed if all of the following conditions are met:
p.(None): (a) the statement of consent of the person entitled to make the statement shall be the presumed will of the subject
p.(None): and may be revoked at any time without prejudice to the subject;
p.(None): (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.(None): adverse effects;
p.(None): (c) the investigator and the study director take full account of the opinion
p.(None): and a subject capable of assessing the situation explicitly precludes access to the clinical trial
p.(None): participation or wish to withdraw from the investigation at any time;
p.(None): d) inducement or financial means of any kind, except for the compensation pursuant to Section 5 (11)
p.(None): no incentive is applied, no other benefit or charge shall be granted to the subject;
p.(None): (e) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or other research methods and is directly related to a
p.(None): a clinical condition that is life-threatening or significantly detrimental to mental health and in which the person concerned suffers;
p.(None): (f) the clinical examination for pain, anxiety, fear and any other illness and disease.
p.(None): designed and maintained to minimize the foreseeable risk associated with the current condition of the subject;
p.(None): (g) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): (h) the EGTC KFEB is an expert opinion appropriate to the disease in question and the group of patients concerned
p.(None): professionally and ethically supports the study plan in its possession;
p.(None): (i) there are reasonable grounds for believing that the use of the investigational medicinal product outweighs the adverse effects
p.(None): effects on the patient or no risk at all.
p.(None): § 10 The persons listed in § 9 shall not be included in a clinical trial as healthy volunteers
...
p.(None): (6) *
p.(None): In addition to the provisions of Section 21 and this Section, the investigation
p.(None): endangering the safety of subjects by continuing the study or the study preparation
p.(None): after the occurrence of new information or event related to the development of the
p.(None): investigator should take appropriate urgent safety measures in order to conduct the test
p.(None): the girls
p.(None): protect against all imminent dangers. The principal shall be informed of such events and of what has been done
p.(None): immediately, but no later than within 24 hours, inform OGYÉI and ETT KFEB in writing.
p.(None): Report on the completion of the investigation
p.(None): § 23 *
p.(None): Within ninety days of the completion of the investigation, the sponsor shall:
p.(None): It will notify OGYÉI of the completion of the study in a form that can be downloaded from the EMEA website. OGYÉI a
p.(None): inform the EGTC KFEB within eight days of the notification.
p.(None): Retention of test documentation
p.(None): § 24. (1) The inspection master file shall contain the basic documents
p.(None): which allow both the conduct of the clinical trial and the quality of the data
p.(None): be evaluable. The documents must indicate whether the investigators and the sponsor have complied
p.(None): the principles of GCP. The test master file shall be based on an inspection carried out by an independent auditor or a
p.(None): for official control.
p.(None): (2) The sponsor and the investigator shall post-investigate the clinical trial
p.(None): for at least five years after the completion of the investigation
p.(None): keep it and archive it in a way that makes it easy to find. The principal must be out
p.(None): designate those who are responsible for archiving at the client and have access to the archives solely for that purpose
p.(None): should be limited to those entitled to
p.(None): (3) Any ownership of the processed data and test documentation
p.(None): change must be documented. Written to the new owner
p.(None): a statement on data management and archiving
p.(None): compliance with the provisions of
p.(None): (4) The media used for archiving must be such that the documents are complete and legible.
p.(None): remain.
p.(None): Miscellaneous and transitional provisions
p.(None): § 25. (1) This Decree - with the exception of paragraph (2) - shall enter into force on 15 September 2005 by:
p.(None): shall apply to proceedings instituted after its entry into force.
p.(None): (2) The provision contained in subsection (9), section 6 (4) (n) and a
p.(None): Section 17 (2) (m) shall enter into force on 1 November 2005, with the derogation provided for in Section (4)
p.(None): into force.
p.(None): (3) *
p.(None): (4) *
p.(None): (5) - (6) *
p.(None): (7) *
p.(None): The principal shall be responsible for the procedures provided for in this Regulation
p.(None): is obliged to pay an administrative service fee of the amount specified by law. The
p.(None): administrative service fee does not include VAT. Non - commercial investigation
p.(None): There is no administrative service fee for authorization procedures.
p.(None): (8) *
p.(None): (9) *
p.(None): (10) *
p.(None): (11) This Regulation complies with the following Union acts:
p.(None): (a) Directive 2001/20 / EC of the European Parliament and of the Council of 4 April 2001 on human consumption
p.(None): good clinical practice to be used in clinical trials with
p.(None): approximation of the laws, regulations and administrative provisions of the Member States
p.(None): (b) European Commission Directive 2005/28 / EC of 8 April 2005 on the principles and principles of good clinical practice
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): may only be used with the permission of OGYÉI. Clinical examination is only authorized by OGYÉI
p.(None): the conditions laid down in Decision
p.(None): may be continued according to the requirements of an approved test plan.
p.(None): (2) A person with legal capacity may be involved in a clinical trial if the Eütv. 159th
p.(None): § (1) - (3) and the requirements provided for in this Decree.
p.(None): (3) A clinical trial shall not be a substitute for a subject appropriate to its condition
p.(None): examinations and treatments.
p.(None): (4) *
p.(None): For the intended use of placebo, for official authorization
p.(None): the research dossier submitted with the application must include the placebo to be used in the study
p.(None): specific justification for the need for a control group. The use of placebo should not be reported to the subject
p.(None): significant additional risk to it or cause irreversible damage to health
p.(None): hazard. Placebo should only be used for the shortest time required by the test subject
p.(None): should be monitored continuously during the study, immediately in the event of signs of significant deterioration
p.(None): it must be provided with the best scientifically accepted therapy available.
p.(None): (5) The clinical trial shall be designed and conducted in a manner that minimizes the subject
p.(None): possible damage, pain, fear and anxiety. Age of the subject, health
p.(None): All foreseeable risks associated with the condition should be considered in the clinical trial
p.(None): planning and control.
p.(None): (6) The health status of the subject prior to the commencement of the clinical trial during the clinical trial
p.(None): must be carefully monitored and documented continuously and after the test.
p.(None): (7) If persons of reproductive age are to be included in a clinical trial, the design of the clinical trial,
p.(None): authorization, special attention shall be paid to the study subjects when informing the subjects
p.(None): subject with respect to clinical
p.(None): fertility, fertility, pregnancy or fertility at the time of the clinical trial.
p.(None): pregnancy, embryonal / fetal health.
p.(None): (8) *
p.(None): In clinical trials, the right to information self - determination and the
p.(None): CXII of 2011 on freedom of information. law, health and related
p.(None): XLVII of 1997 on the processing and protection of personal data law as well as in separate legislation
p.(None): The provisions on data processing set out in
p.(None): (9) As a subject to a clinical trial, with the exception of healthy volunteers, the clinical trial
p.(None): Patients cared for by a healthcare provider should be primarily involved.
p.(None): (10) *
p.(None): The healthcare provider conducting the clinical trial is the print media,
p.(None): or by means of a call published on its website, as well as professional and patient organizations,
p.(None): and may recruit competent subjects on the sponsor's website. The recruitment
p.(None): the call must not be for advertising purposes or contain the trade name of the investigational medicinal product,
p.(None): manufacturer and
p.(None): the designation of the person authorized to place it on the market.
p.(None): ! (10a) *
p.(None): In the case of a clinical trial pursuant to Section 7, the healthcare provider shall be
p.(None): to comply with the requirements of paragraph 10
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.(None): conducting a clinical trial at the study site;
p.(None): (f) principal investigator: the responsible leader of the team at a particular investigation site if the
p.(None): a clinical trial is conducted by a group of several investigators;
p.(None): (g) investigator’s brochure: the investigator’s brochure or
p.(None): a summary of the relevant clinical and non-clinical data on the product
p.(None): for the study of the investigational medicinal product or products
p.(None): benefit / risk associated with the clinical trial for the physician and the investigator
p.(None): objective assessment. The prospectus must be updated by the sponsor at least annually;
p.(None): h) study plan (protocol): study purpose, layout, methodology, statistical
p.(None): deliberations and organization of a document containing the subjects
p.(None): inclusion and exclusion criteria, monitoring and publication principles, including the study design
p.(None): any successive versions and any amendments thereto;
p.(None): (i) subject: a person in a clinical trial who is the subject of a clinical trial
p.(None): who is participating in the study as a control;
p.(None): j) *
p.(None): informed consent: to participate in the study
p.(None): requested person with legal capacity under the Eütv. A statement pursuant to Section 159 (1) (e),
p.(None): or a minor with limited legal capacity and capacity to act with health care
p.(None): In the case of a person who is partially restricted or incapacitated with regard to the exercise of related rights, the Eütv.
p.(None): A statement pursuant to Section 159 (4) (d);
p.(None): k) *
p.(None): recruitment: the health of the person conducting the clinical trial
p.(None): by the National Institute of Pharmacy and Food Health (hereinafter: OGYÉI)
p.(None): authorized public call for the purpose of being a volunteer other than the patients he or she cares for
p.(None): include individuals as subjects in a specific clinical trial;
p.(None): (l) adverse event: a patient or subject treated with a study preparation
p.(None): an adverse change in his state of health which is not necessarily causally related
p.(None): with the treatment applied;
p.(None): (m) adverse reaction: occurring at any dose of the test preparation
p.(None): any adverse and undesirable reactions associated with the test preparation;
p.(None): (n) serious adverse reaction or serious adverse event:
p.(None): side effect or adverse event is severe if any dose of the study product is administered
p.(None): subject’s death, life-threatening, hospitalization, ongoing hospitalization.
p.(None): prolongation of care, permanent or significant damage to health, disability
p.(None): followed by or congenital anomaly, birth defect occurs;
p.(None): (o) unexpected adverse reaction: an adverse reaction of a nature or severity
p.(None): differs from the adverse reaction in the corresponding product information, such as the study preparation
...
p.(None): (3) *
p.(None): The OGYÉI and the independent ethics committee according to the separate legislation, the
p.(None): Clinical Pharmacology Ethics Committee of the Health Science Council (hereinafter: ETT KFEB)
p.(None): issues methodological guidance on significant professional and ethical issues, in particular for each clinical trial
p.(None): phases, the use of placebo in clinical trials.
p.(None): On the publication of the guide and its place, the OGYÉI and the ETT KFEB as an appendix to the Hungarian Gazette
p.(None): will publish a notice in the Official Journal of the European Union.
p.(None): (4) *
p.(None): This Regulation is intended for pediatric use
p.(None): Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
p.(None): Council Regulation on Advanced Therapy Medicinal Products and Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 amending Regulation (EC) No 726/2004
p.(None): shall apply subject to Council Regulation.
p.(None): Protection of test subjects
p.(None): § 4 The rights, safety and well-being of the subject shall be given priority over science and
p.(None): against the interests of society, therefore the risk to the research subject should be kept to a minimum
p.(None): restricted.
p.(None): § 5 (1) *
p.(None): To perform a clinical trial, a study preparation in humans
p.(None): may only be used with the permission of OGYÉI. Clinical examination is only authorized by OGYÉI
p.(None): the conditions laid down in Decision
p.(None): may be continued according to the requirements of an approved test plan.
p.(None): (2) A person with legal capacity may be involved in a clinical trial if the Eütv. 159th
p.(None): § (1) - (3) and the requirements provided for in this Decree.
p.(None): (3) A clinical trial shall not be a substitute for a subject appropriate to its condition
p.(None): examinations and treatments.
p.(None): (4) *
p.(None): For the intended use of placebo, for official authorization
p.(None): the research dossier submitted with the application must include the placebo to be used in the study
p.(None): specific justification for the need for a control group. The use of placebo should not be reported to the subject
p.(None): significant additional risk to it or cause irreversible damage to health
p.(None): hazard. Placebo should only be used for the shortest time required by the test subject
p.(None): should be monitored continuously during the study, immediately in the event of signs of significant deterioration
p.(None): it must be provided with the best scientifically accepted therapy available.
p.(None): (5) The clinical trial shall be designed and conducted in a manner that minimizes the subject
...
p.(None): subject would be at a disadvantage;
p.(None): (i) rules on the handling of, and access to, subject data;
p.(None): (j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
p.(None): the likelihood of the subject being placed in the placebo group;
p.(None): (k) a brief pharmacological description of the test preparation;
p.(None): (l) the nature of the test subject, if any, after completion of the study
p.(None): receive additional health care;
p.(None): m) *
p.(None): n) *
p.(None): and GyT. It is included in the liability insurance pursuant to Section 3 (5)
p.(None): the name of the insurer.
p.(None): (5) *
p.(None): 6. The subject's informed consent shall include at least the following:
p.(None): (a) the identity of the clinical trial;
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted;
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): designation;
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
p.(None): (hereinafter referred to as the person entitled to make a declaration) identifier
p.(None): data;
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a statement - for participation in a clinical trial
p.(None): after giving the information provided for in paragraph 1, give its consent voluntarily, without influence
p.(None): Aware that it may be revoked at any time, orally or in writing, without giving any reason;
p.(None): (f) the date of signature of the statement of consent;
p.(None): (g) the signature of the clinical trial director or information provider;
p.(None): (h) the signature of the person giving his consent.
p.(None): (7) *
p.(None): The person providing the information and the subject - and to a limited extent
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the person entitled to make the statement
p.(None): He shall also sign the written information referred to in paragraph 4.
p.(None): 8. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 4.
p.(None): received and informed of the statement of consent referred to in paragraph 6
p.(None): he verbally agreed.
p.(None): (9) *
p.(None): 6 / A. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): the subject shall be informed separately. For information out
p.(None): it should also cover the right of the subject to be sampled separately
p.(None): refuse, in which case the genetic data relating to him will remain anonymous
p.(None): cannot be used in any way. Refusal of sampling does not constitute participation of the subject
p.(None): obstacle in the remainder of the clinical trial. Information on and consent to sampling
p.(None): should be included in a separate document.
p.(None): (2) Prior to sampling for the purpose of human genetic testing, the subject is subject to genetic counseling
p.(None): shall be informed within the framework of:
p.(None): (a) the purpose, quantitative and qualitative details of the sampling,
p.(None): (b) the benefits and risks of performing or not performing the study,
p.(None): (c) any possible outcome for the data subject and his or her close relatives
p.(None): consequences,
p.(None): (d) the methods and duration of storage of the genetic sample and data, the genetic data stored in different forms
p.(None): samples and the possibilities for identifying data,
...
p.(None): (ga) storage of personal data,
p.(None): gb) in encrypted form,
p.(None): gc) pseudonymised, ie in a form in which the
p.(None): the replacement code has been made available to the subject exclusively,
p.(None): (gd) anonymised, ie in a form where all the data relating to the subject are available
p.(None): personally identifiable information has been rendered inoperable.
p.(None): (3) The test subject shall also be informed that the sample placed in the biobank may decide to continue
p.(None): participation in research. In this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): that is, it contributes to its use for diagnostic and research purposes.
p.(None): 6 / B. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): shall be sampled, a separate statement of consent shall be drawn up.
p.(None): 2. The subject's informed consent shall include at least the following:
p.(None): a) the identification data of the clinical trial,
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted,
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): Name,
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.(None): hereinafter referred to as "the person entitled to make the declaration"),
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a declaration - in a genetic test for pharmacological purposes
p.(None): consent to participate in accordance with Article 6 / A. § or waiver thereof
p.(None): voluntarily, without influence, knowing that at any time, orally or in writing, without giving reasons,
p.(None): revocable,
p.(None): (f) consent to the taking of a sample of the quantity and quality indicated in the prospectus and to the subject
p.(None): to use your data,
p.(None): (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.(None): biobank and the method of disposal, so it is possible to place the sample in 6 / A. §
p.(None): Storage and disposal in accordance with paragraph 2 (g),
p.(None): (h) the subject's statement on further sampling of the sample placed in the biobank
p.(None): participation; in this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): ie it contributes to its use for diagnostic and research purposes,
p.(None): (i) the manner in which the result is to be communicated, even if the subject does not have access to it,
p.(None): j) consent to or exclusion from any future request,
p.(None): k) the date of signature of the statement of consent,
p.(None): l) the signature of the head of the clinical trial or the person providing the information,
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): a test in a comparative test set-up;
p.(None): v) *
p.(None): ARC. Phase I study: the marketing authorization holder
p.(None): a study using the test preparation in accordance with the SPC, which
p.(None): aims to further investigate the benefit / risk balance, safety and tolerability.
p.(None): (2) *
p.(None): With regard to matters not covered by paragraph 1, this Regulation
p.(None): in the Eütv., on medicinal products for human use and other, the pharmaceutical market
p.(None): Act XCV of 2005 on the Amendment of Regulatory Acts. (hereinafter: GyT.), on man
p.(None): medical research, clinical trials of human investigational medicinal products
p.(None): and medical devices intended for human clinical use
p.(None): in the legislation on the rules of the authorization procedure for clinical trials, human
p.(None): legislation on the placing on the market of medicinal products for human use and for human use
p.(None): contained in the legislation on the personal and material conditions of the manufacture of
p.(None): definitions should be taken into account.
p.(None): (3) In the case of investigational medicinal products, it is authorized to ensure the quality of medicinal products
p.(None): the relevant provisions of the legislation on the conditions of qualification of a person shall also apply mutatis mutandis.
p.(None): § 3 (1) *
p.(None): All clinical trials - bioavailability and bioequivalence
p.(None): principles of good clinical practice (GCP)
p.(None): in accordance with the Helsinki Declaration on Ethical Principles in Medical Research
p.(None): be planned, carried out and reported. The current text of the GCP in the Hungarian language of OGYÉI
p.(None): It publishes. OGYÉI will publish a notice about the publication and its place in the Health Bulletin.
p.(None): (2) *
p.(None): The design and conduct of clinical trials is professional
p.(None): rules, in particular those published by the European Commission on clinical trials
p.(None): In accordance with the version of the detailed instructions in force at any time, which are published by OGYÉI in Hungarian
p.(None): publish in translation.
p.(None): (3) *
p.(None): The OGYÉI and the independent ethics committee according to the separate legislation, the
p.(None): Clinical Pharmacology Ethics Committee of the Health Science Council (hereinafter: ETT KFEB)
p.(None): issues methodological guidance on significant professional and ethical issues, in particular for each clinical trial
p.(None): phases, the use of placebo in clinical trials.
p.(None): On the publication of the guide and its place, the OGYÉI and the ETT KFEB as an appendix to the Hungarian Gazette
p.(None): will publish a notice in the Official Journal of the European Union.
p.(None): (4) *
p.(None): This Regulation is intended for pediatric use
p.(None): Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
p.(None): Council Regulation on Advanced Therapy Medicinal Products and Directive 2001/83 / EC
...
p.(None): (10) *
p.(None): The healthcare provider conducting the clinical trial is the print media,
p.(None): or by means of a call published on its website, as well as professional and patient organizations,
p.(None): and may recruit competent subjects on the sponsor's website. The recruitment
p.(None): the call must not be for advertising purposes or contain the trade name of the investigational medicinal product,
p.(None): manufacturer and
p.(None): the designation of the person authorized to place it on the market.
p.(None): ! (10a) *
p.(None): In the case of a clinical trial pursuant to Section 7, the healthcare provider shall be
p.(None): to comply with the requirements of paragraph 10
p.(None): you can make the description of the planned clinical trials public on your own website as well as on the websites of professional and patient organizations.
p.(None): (11) *
p.(None): For the subject by participating in the clinical trial
p.(None): loss of income and costs, in particular in connection with travel
p.(None): Reimbursement may be made for costs incurred and justified. Other benefit to the subject
p.(None): or fee - non-therapeutic pharmacokinetic or interaction, phase I, and
p.(None): except for bioequivalence testing.
p.(None): (12) Test preparations and any devices used for their administration to the sponsor
p.(None): must be made available free of charge.
p.(None): Informing the subject, consent to the clinical trial
p.(None): § 6. (1) The person with legal capacity to be involved in a clinical trial shall be the head of the clinical trial or
p.(None): the examiner orally and in writing, in Hungarian, - or in the person's mother tongue, or by the person
p.(None): in another language indicated as known - informs the Eütv.
p.(None): 159 (3) and (4).
p.(None): (2) The person providing the information shall pay particular attention to examining whether the involvement is involved
p.(None): the desired person is not incapacitated. The findings in this regard are provided by the information provider
p.(None): person shall be recorded in the research and medical records.
p.(None): 3. The information and consent shall be recorded in a separate sheet. The consent form
p.(None): and one original copy of each written information shall be retained in the research dossier,
p.(None): and one original shall be handed over to the subject.
p.(None): 4. The written prospectus shall contain, in particular, the following, as appropriate:
p.(None): (a) the identity of the clinical trial;
p.(None): b) an indication of the research nature of the clinical trial, the purpose of the clinical trial, the expected duration,
p.(None): the number of persons to be involved, the course of the clinical trial, the nature of the planned interventions,
p.(None): frequency;
p.(None): (c) other accepted treatment options available to the subject,
p.(None): and information that the clinical trial is discontinuing treatment that has already begun
p.(None): can mean and the treatment started
p.(None): the consequences for the subject of its interruption;
p.(None): (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
p.(None): an indication that adverse events that did not occur in advance may occur during the clinical trial
p.(None): visible;
p.(None): (e) a description of the reasonably foreseeable benefits or if the subject benefits from the clinical trial
p.(None): not expected, disclosure of this fact;
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): the relevant provisions of the legislation on the conditions of qualification of a person shall also apply mutatis mutandis.
p.(None): § 3 (1) *
p.(None): All clinical trials - bioavailability and bioequivalence
p.(None): principles of good clinical practice (GCP)
p.(None): in accordance with the Helsinki Declaration on Ethical Principles in Medical Research
p.(None): be planned, carried out and reported. The current text of the GCP in the Hungarian language of OGYÉI
p.(None): It publishes. OGYÉI will publish a notice about the publication and its place in the Health Bulletin.
p.(None): (2) *
p.(None): The design and conduct of clinical trials is professional
p.(None): rules, in particular those published by the European Commission on clinical trials
p.(None): In accordance with the version of the detailed instructions in force at any time, which are published by OGYÉI in Hungarian
p.(None): publish in translation.
p.(None): (3) *
p.(None): The OGYÉI and the independent ethics committee according to the separate legislation, the
p.(None): Clinical Pharmacology Ethics Committee of the Health Science Council (hereinafter: ETT KFEB)
p.(None): issues methodological guidance on significant professional and ethical issues, in particular for each clinical trial
p.(None): phases, the use of placebo in clinical trials.
p.(None): On the publication of the guide and its place, the OGYÉI and the ETT KFEB as an appendix to the Hungarian Gazette
p.(None): will publish a notice in the Official Journal of the European Union.
p.(None): (4) *
p.(None): This Regulation is intended for pediatric use
p.(None): Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
p.(None): Council Regulation on Advanced Therapy Medicinal Products and Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 amending Regulation (EC) No 726/2004
p.(None): shall apply subject to Council Regulation.
p.(None): Protection of test subjects
p.(None): § 4 The rights, safety and well-being of the subject shall be given priority over science and
p.(None): against the interests of society, therefore the risk to the research subject should be kept to a minimum
p.(None): restricted.
p.(None): § 5 (1) *
p.(None): To perform a clinical trial, a study preparation in humans
p.(None): may only be used with the permission of OGYÉI. Clinical examination is only authorized by OGYÉI
p.(None): the conditions laid down in Decision
p.(None): may be continued according to the requirements of an approved test plan.
p.(None): (2) A person with legal capacity may be involved in a clinical trial if the Eütv. 159th
p.(None): § (1) - (3) and the requirements provided for in this Decree.
p.(None): (3) A clinical trial shall not be a substitute for a subject appropriate to its condition
p.(None): examinations and treatments.
p.(None): (4) *
p.(None): For the intended use of placebo, for official authorization
...
p.(None): (2) The sponsor and the investigator shall post-investigate the clinical trial
p.(None): for at least five years after the completion of the investigation
p.(None): keep it and archive it in a way that makes it easy to find. The principal must be out
p.(None): designate those who are responsible for archiving at the client and have access to the archives solely for that purpose
p.(None): should be limited to those entitled to
p.(None): (3) Any ownership of the processed data and test documentation
p.(None): change must be documented. Written to the new owner
p.(None): a statement on data management and archiving
p.(None): compliance with the provisions of
p.(None): (4) The media used for archiving must be such that the documents are complete and legible.
p.(None): remain.
p.(None): Miscellaneous and transitional provisions
p.(None): § 25. (1) This Decree - with the exception of paragraph (2) - shall enter into force on 15 September 2005 by:
p.(None): shall apply to proceedings instituted after its entry into force.
p.(None): (2) The provision contained in subsection (9), section 6 (4) (n) and a
p.(None): Section 17 (2) (m) shall enter into force on 1 November 2005, with the derogation provided for in Section (4)
p.(None): into force.
p.(None): (3) *
p.(None): (4) *
p.(None): (5) - (6) *
p.(None): (7) *
p.(None): The principal shall be responsible for the procedures provided for in this Regulation
p.(None): is obliged to pay an administrative service fee of the amount specified by law. The
p.(None): administrative service fee does not include VAT. Non - commercial investigation
p.(None): There is no administrative service fee for authorization procedures.
p.(None): (8) *
p.(None): (9) *
p.(None): (10) *
p.(None): (11) This Regulation complies with the following Union acts:
p.(None): (a) Directive 2001/20 / EC of the European Parliament and of the Council of 4 April 2001 on human consumption
p.(None): good clinical practice to be used in clinical trials with
p.(None): approximation of the laws, regulations and administrative provisions of the Member States
p.(None): (b) European Commission Directive 2005/28 / EC of 8 April 2005 on the principles and principles of good clinical practice
p.(None): laying down detailed guidelines for the use of investigational medicinal products for human use,
p.(None): and the authorization to manufacture or import such products;
p.(None): c) *
p.(None): (12) *
p.(None): This Regulation is intended for pediatric use
p.(None): Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
p.(None): lays down the provisions necessary for the implementation of this Council Regulation.
p.(None): (13) *
p.(None): This Regulation shall apply to advanced therapy medicinal products and to
p.(None): Of 13 November 2007 amending Directive 2001/83 / EC and Regulation (EC) No 726/2004
p.(None): Provisions necessary for the implementation of Regulation (EC) No 1394/2007 of the European Parliament and of the Council
p.(None): states.
p.(None): Annex 1 to Decree 35/2005 (VIII. 26.) EüM *
p.(None): Annex 2 to Decree 35/2005 (VIII. 26.) EüM
p.(None): Personal and material conditions for conducting clinical trials
p.(None): In terms of their scope, the following types of test sites can be distinguished:
p.(None): I. Clinical pharmacology site for phase I study
p.(None): II. Clinical trial site II. phase test
p.(None): III. Other clinical trial site
p.(None): I. Clinical pharmacology site for phase I study
p.(None): A) Material conditions:
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): used to collect additional data on
p.(None): d) *
p.(None): sponsor: any natural or legal person who you are
p.(None): which initiates, conducts, and funds the clinical trial. It can be the investigator and the principal
p.(None): the same person;
p.(None): (e) investigator: a person qualified in medicine or dentistry whose task is to:
p.(None): conducting a clinical trial at the study site;
p.(None): (f) principal investigator: the responsible leader of the team at a particular investigation site if the
p.(None): a clinical trial is conducted by a group of several investigators;
p.(None): (g) investigator’s brochure: the investigator’s brochure or
p.(None): a summary of the relevant clinical and non-clinical data on the product
p.(None): for the study of the investigational medicinal product or products
p.(None): benefit / risk associated with the clinical trial for the physician and the investigator
p.(None): objective assessment. The prospectus must be updated by the sponsor at least annually;
p.(None): h) study plan (protocol): study purpose, layout, methodology, statistical
p.(None): deliberations and organization of a document containing the subjects
p.(None): inclusion and exclusion criteria, monitoring and publication principles, including the study design
p.(None): any successive versions and any amendments thereto;
p.(None): (i) subject: a person in a clinical trial who is the subject of a clinical trial
p.(None): who is participating in the study as a control;
p.(None): j) *
p.(None): informed consent: to participate in the study
p.(None): requested person with legal capacity under the Eütv. A statement pursuant to Section 159 (1) (e),
p.(None): or a minor with limited legal capacity and capacity to act with health care
p.(None): In the case of a person who is partially restricted or incapacitated with regard to the exercise of related rights, the Eütv.
p.(None): A statement pursuant to Section 159 (4) (d);
p.(None): k) *
p.(None): recruitment: the health of the person conducting the clinical trial
p.(None): by the National Institute of Pharmacy and Food Health (hereinafter: OGYÉI)
p.(None): authorized public call for the purpose of being a volunteer other than the patients he or she cares for
p.(None): include individuals as subjects in a specific clinical trial;
p.(None): (l) adverse event: a patient or subject treated with a study preparation
p.(None): an adverse change in his state of health which is not necessarily causally related
p.(None): with the treatment applied;
p.(None): (m) adverse reaction: occurring at any dose of the test preparation
p.(None): any adverse and undesirable reactions associated with the test preparation;
p.(None): (n) serious adverse reaction or serious adverse event:
p.(None): side effect or adverse event is severe if any dose of the study product is administered
p.(None): subject’s death, life-threatening, hospitalization, ongoing hospitalization.
p.(None): prolongation of care, permanent or significant damage to health, disability
...
p.(None): (g) the reimbursement of costs to the subject, if any;
p.(None): (h) a warning that the consent is voluntary and free from influence,
p.(None): it may be withdrawn at any time, either orally or in writing, without giving reasons, without this being examined
p.(None): subject would be at a disadvantage;
p.(None): (i) rules on the handling of, and access to, subject data;
p.(None): (j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
p.(None): the likelihood of the subject being placed in the placebo group;
p.(None): (k) a brief pharmacological description of the test preparation;
p.(None): (l) the nature of the test subject, if any, after completion of the study
p.(None): receive additional health care;
p.(None): m) *
p.(None): n) *
p.(None): and GyT. It is included in the liability insurance pursuant to Section 3 (5)
p.(None): the name of the insurer.
p.(None): (5) *
p.(None): 6. The subject's informed consent shall include at least the following:
p.(None): (a) the identity of the clinical trial;
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted;
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): designation;
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
p.(None): (hereinafter referred to as the person entitled to make a declaration) identifier
p.(None): data;
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a statement - for participation in a clinical trial
p.(None): after giving the information provided for in paragraph 1, give its consent voluntarily, without influence
p.(None): Aware that it may be revoked at any time, orally or in writing, without giving any reason;
p.(None): (f) the date of signature of the statement of consent;
p.(None): (g) the signature of the clinical trial director or information provider;
p.(None): (h) the signature of the person giving his consent.
p.(None): (7) *
p.(None): The person providing the information and the subject - and to a limited extent
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the person entitled to make the statement
p.(None): He shall also sign the written information referred to in paragraph 4.
p.(None): 8. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 4.
p.(None): received and informed of the statement of consent referred to in paragraph 6
p.(None): he verbally agreed.
p.(None): (9) *
p.(None): 6 / A. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): the subject shall be informed separately. For information out
p.(None): it should also cover the right of the subject to be sampled separately
p.(None): refuse, in which case the genetic data relating to him will remain anonymous
p.(None): cannot be used in any way. Refusal of sampling does not constitute participation of the subject
p.(None): obstacle in the remainder of the clinical trial. Information on and consent to sampling
p.(None): should be included in a separate document.
p.(None): (2) Prior to sampling for the purpose of human genetic testing, the subject is subject to genetic counseling
p.(None): shall be informed within the framework of:
p.(None): (a) the purpose, quantitative and qualitative details of the sampling,
p.(None): (b) the benefits and risks of performing or not performing the study,
...
p.(None): (f) that he or she is entitled to have access to the genetic data generated by the human genetic test; and
p.(None): (g) whether it may decide to place the sample it provides in a biobank;
p.(None): placement method so that a sample is possible
p.(None): (ga) storage of personal data,
p.(None): gb) in encrypted form,
p.(None): gc) pseudonymised, ie in a form in which the
p.(None): the replacement code has been made available to the subject exclusively,
p.(None): (gd) anonymised, ie in a form where all the data relating to the subject are available
p.(None): personally identifiable information has been rendered inoperable.
p.(None): (3) The test subject shall also be informed that the sample placed in the biobank may decide to continue
p.(None): participation in research. In this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): that is, it contributes to its use for diagnostic and research purposes.
p.(None): 6 / B. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): shall be sampled, a separate statement of consent shall be drawn up.
p.(None): 2. The subject's informed consent shall include at least the following:
p.(None): a) the identification data of the clinical trial,
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted,
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): Name,
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.(None): hereinafter referred to as "the person entitled to make the declaration"),
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a declaration - in a genetic test for pharmacological purposes
p.(None): consent to participate in accordance with Article 6 / A. § or waiver thereof
p.(None): voluntarily, without influence, knowing that at any time, orally or in writing, without giving reasons,
p.(None): revocable,
p.(None): (f) consent to the taking of a sample of the quantity and quality indicated in the prospectus and to the subject
p.(None): to use your data,
p.(None): (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.(None): biobank and the method of disposal, so it is possible to place the sample in 6 / A. §
p.(None): Storage and disposal in accordance with paragraph 2 (g),
p.(None): (h) the subject's statement on further sampling of the sample placed in the biobank
p.(None): participation; in this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): ie it contributes to its use for diagnostic and research purposes,
p.(None): (i) the manner in which the result is to be communicated, even if the subject does not have access to it,
p.(None): j) consent to or exclusion from any future request,
p.(None): k) the date of signature of the statement of consent,
p.(None): l) the signature of the head of the clinical trial or the person providing the information,
p.(None): (m) the signature of the person giving his consent.
p.(None): Clinical trials in minors
p.(None): § 7 Clinical examination of minors according to Eütv. Section 159 (4) and Section 4
p.(None): Even in the case of the correct application of the provisions of § 6, it can only be performed if all of the following conditions are met:
p.(None): (a) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or to validate data obtained through other research methods;
p.(None): (b) the research is directly related to the clinical condition in which the minor suffers or is of a nature
p.(None): which can only be performed on minors;
p.(None): (c) the consent of the person entitled to make the statement to the opinion; and
p.(None): contains the probable will of a minor capable of assessing the situation, and this statement at any time
p.(None): can be revoked without the minor suffering any disadvantage;
p.(None): (d) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.(None): properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.(None): (e) the investigator or study director shall take into account the views of a minor who is able to form an opinion and assess the situation;
p.(None): expressly discourages participation in the clinical trial or the exclusion of any person from the trial at any time.
p.(None): step;
p.(None): f) persuasion by any material means, except for the compensation pursuant to Section 5 (11), or
p.(None): no financial incentive is applied, no other benefit or fee may be granted to the minor subject;
p.(None): (g) the authorization of medicinal products for human or veterinary use; and
p.(None): laying down Community procedures for the supervision of
p.(None): Establishing a European Medicines Agency
p.(None): European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.(None): hereinafter referred to as the EMEA);
p.(None): (h) a clinical examination for pain, anxiety, fear and any other condition associated with illness and
p.(None): designed and maintained to minimize the foreseeable risk associated with its state of development;
p.(None): (i) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): j) in the possession of the opinion of the pediatric specialist of the EGTC KFEB, professionally and ethically
p.(None): test plan.
p.(None): Involvement of incapacitated adults in a clinical trial
p.(None): § 8 A person who has previously had legal capacity may not be involved in any clinical trial
p.(None): expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
p.(None): who has previously refused to give his consent to the
p.(None): testing.
p.(None): § 9 *
p.(None): Rights related to health care in its capacity to act
...
Social / home
Searching for indicator home:
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p.(None): 1. The head of the clinical pharmacology site must have:
p.(None): a) a specialist in a clinical profession,
p.(None): (b) a clinical pharmacological examination.
p.(None): 2. The examiner must have
p.(None): a) a specialist in a clinical profession,
p.(None): (b) by a clinical pharmacological examination or not more than five years before the start of the clinical trial.
p.(None): with proof of successful completion of an older university-organized GCP course.
p.(None): 3. *
p.(None): The study director must have clinical pharmacology
p.(None): specialist examination.
p.(None): II. Clinical trial site II. phase test
p.(None): THE) *
p.(None): Material conditions:
p.(None): Inpatient department or outpatient clinic in a university clinic or hospital,
p.(None): or other specialist practice that has appropriate diagnostic units and that complies
p.(None): the minimum personal and material conditions of the health care provider specified in a separate legal regulation, and a
p.(None): it also has the means and equipment necessary to perform the planned test.
p.(None): B) Personal conditions:
p.(None): The study director should have the intended use of the study preparation
p.(None): with a specialist examination in an appropriate clinical field and a clinical pharmacology examination, or for five years
p.(None): with no older certificate of completion of a GCP course organized by a university. If
p.(None): there are minors to be included in the study, and a pediatrician to be included in the study
p.(None): must also be.
p.(None): III. *
p.(None): Clinical trial site for other clinical trials
p.(None): 1. Other clinical investigations may be performed in accordance with Annex II. Material as defined in point A)
p.(None): conditions, and in a general practitioner’s or home pediatrician’s office. *
p.(None): 2. The study director must have a certificate not older than five years
p.(None): that he has completed a GCP course organized by a university. *
p.(None): Annex 3 to Decree 35/2005 (VIII. 26.) EüM *
p.(None): Modified: 16/2014. (III. 12.) of the EMMI Decree § 12 a). Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a).
p.(None): Modified: 3/2014. (I. 16.) EMMI Decree § 17 a), 23/2015. (IV. 28.) of the EMMI Decree § 72 a).
p.(None): Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a).
p.(None): Repealed: 21 X 2009.
p.(None): Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
p.(None): In the case of pending applications for examination, the provisions of this Regulation shall apply.
p.(None): Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
p.(None): In the case of pending applications for examination, the provisions of this Regulation shall apply.
p.(None): Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
p.(None): In the case of pending applications for examination, the provisions of this Regulation shall apply.
p.(None): Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
p.(None): In the case of pending applications for examination, the provisions of this Regulation shall apply.
p.(None): Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
p.(None): In the case of pending applications for examination, the provisions of this Regulation shall apply.
p.(None): Found: 32/2009 (X. 20.) EüM Decree § 1 (2). Modified: 16/2014. (III. 12.) EMMI Decree § 11 b).
p.(None): Modified: 3/2014. (I. 16.) EMMI Decree § 17 b), 23/2015. (IV. 28.) EMMI Decree § 72 b).
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): (h) the subject's statement on further sampling of the sample placed in the biobank
p.(None): participation; in this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): ie it contributes to its use for diagnostic and research purposes,
p.(None): (i) the manner in which the result is to be communicated, even if the subject does not have access to it,
p.(None): j) consent to or exclusion from any future request,
p.(None): k) the date of signature of the statement of consent,
p.(None): l) the signature of the head of the clinical trial or the person providing the information,
p.(None): (m) the signature of the person giving his consent.
p.(None): Clinical trials in minors
p.(None): § 7 Clinical examination of minors according to Eütv. Section 159 (4) and Section 4
p.(None): Even in the case of the correct application of the provisions of § 6, it can only be performed if all of the following conditions are met:
p.(None): (a) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or to validate data obtained through other research methods;
p.(None): (b) the research is directly related to the clinical condition in which the minor suffers or is of a nature
p.(None): which can only be performed on minors;
p.(None): (c) the consent of the person entitled to make the statement to the opinion; and
p.(None): contains the probable will of a minor capable of assessing the situation, and this statement at any time
p.(None): can be revoked without the minor suffering any disadvantage;
p.(None): (d) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.(None): properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.(None): (e) the investigator or study director shall take into account the views of a minor who is able to form an opinion and assess the situation;
p.(None): expressly discourages participation in the clinical trial or the exclusion of any person from the trial at any time.
p.(None): step;
p.(None): f) persuasion by any material means, except for the compensation pursuant to Section 5 (11), or
p.(None): no financial incentive is applied, no other benefit or fee may be granted to the minor subject;
p.(None): (g) the authorization of medicinal products for human or veterinary use; and
p.(None): laying down Community procedures for the supervision of
p.(None): Establishing a European Medicines Agency
p.(None): European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.(None): hereinafter referred to as the EMEA);
p.(None): (h) a clinical examination for pain, anxiety, fear and any other condition associated with illness and
p.(None): designed and maintained to minimize the foreseeable risk associated with its state of development;
p.(None): (i) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): j) in the possession of the opinion of the pediatric specialist of the EGTC KFEB, professionally and ethically
p.(None): test plan.
p.(None): Involvement of incapacitated adults in a clinical trial
p.(None): § 8 A person who has previously had legal capacity may not be involved in any clinical trial
p.(None): expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
p.(None): who has previously refused to give his consent to the
p.(None): testing.
p.(None): § 9 *
p.(None): Rights related to health care in its capacity to act
p.(None): partially or completely limited in its capacity to act, and
p.(None): Act V of 2013 on the Civil Code 2: 9. In the case of adults who are incapable of acting in accordance with
p.(None): for research carried out in urgent need, the Eütv. Except in the case pursuant to Section 160 of the Eütv. § 159
p.(None): Paragraph 4 and paragraphs 4 to 6. and § 8 only in that case
p.(None): a clinical trial may be performed if all of the following conditions are met:
p.(None): (a) the statement of consent of the person entitled to make the statement shall be the presumed will of the subject
p.(None): and may be revoked at any time without prejudice to the subject;
p.(None): (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.(None): adverse effects;
p.(None): (c) the investigator and the study director take full account of the opinion
p.(None): and a subject capable of assessing the situation explicitly precludes access to the clinical trial
p.(None): participation or wish to withdraw from the investigation at any time;
p.(None): d) inducement or financial means of any kind, except for the compensation pursuant to Section 5 (11)
p.(None): no incentive is applied, no other benefit or charge shall be granted to the subject;
p.(None): (e) the research in question is essential for clinical trials on persons with legal capacity
p.(None): or other research methods and is directly related to a
p.(None): a clinical condition that is life-threatening or significantly detrimental to mental health and in which the person concerned suffers;
p.(None): (f) the clinical examination for pain, anxiety, fear and any other illness and disease.
p.(None): designed and maintained to minimize the foreseeable risk associated with the current condition of the subject;
p.(None): (g) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): (h) the EGTC KFEB is an expert opinion appropriate to the disease in question and the group of patients concerned
p.(None): professionally and ethically supports the study plan in its possession;
p.(None): (i) there are reasonable grounds for believing that the use of the investigational medicinal product outweighs the adverse effects
p.(None): effects on the patient or no risk at all.
p.(None): § 10 The persons listed in § 9 shall not be included in a clinical trial as healthy volunteers
p.(None): can be involved.
p.(None): § 11 If the subject during the clinical trial is due to either a court decision or a change in his or her condition
p.(None): becomes effective, the clinical trial shall be informed as soon as possible and the
p.(None): With the proper application of the provisions of §, your consent must be obtained to continue it.
p.(None): Otherwise, the clinical trial may not be continued in the person concerned.
p.(None): Preconditions for applying for an official permit
p.(None): § 12. (1) *
p.(None): If principal is some or all, related to the investigation
p.(None): entrusts another natural or legal person with the performance of his duties, in which case the principal shall also be liable
p.(None): the provisions on clinical trials contained in this Regulation and in specific legislation
p.(None): compliance. If the principal is not established in a State party to the EEA Agreement, the legal
p.(None): must be established in a State party to the EEA Agreement.
p.(None): (2) - (5) *
p.(None): (6) For the clinical trial of the investigational medicinal product between the healthcare provider and the sponsor
p.(None): contract may be concluded before the authorization procedure, but
p.(None): conditional official authorization of the clinical trial.
p.(None): (7) *
p.(None): Official authorization of a clinical trial
p.(None): § 13. (1) *
p.(None): (2) The use of an investigational medicinal product in humans may be authorized if the clinical trial
p.(None): the personal and material conditions of the test site (s) comply with the requirements of Article 2 of this Regulation
p.(None): the conditions set out in Annex I.
p.(None): (3) - (4) *
p.(None): § 14. * (1) *
p.(None): (2) With regard to clinical trials, IKEB is responsible for the rights and safety of subjects
p.(None): protection. IKEB may not issue professional-ethical opinions on clinical trials.
p.(None): (3) *
p.(None): § 15. *
p.(None): Procedure of the EGTC KFEB
p.(None): § 16 (1) *
p.(None): prevail.
p.(None): For the composition of the EGTC KFEB, the Eütv. Section 159 (6)
p.(None): 2. The sponsor may request an opinion from the EGTC KFEB in relation to clinical trials on any professional-ethical
p.(None): to which the EGTC KFEB will reply within sixty days.
p.(None): Section 17 (1) - (7) *
p.(None): (8) The EGTC KFEB shall keep the inspection master file and, by archiving, the investigators
p.(None): documents relating to the professional qualifications and inspection procedures of the inspection
p.(None): for three years after its completion.
p.(None): § 18 *
p.(None): 18 / A. § *
p.(None): Clinical trial control
p.(None): § 19. (1) *
p.(None): The inspector of OGYÉI is a pharmacist or a medical university
p.(None): a diploma or equivalent recognized by the university and not more than five years old, awarded by a university
p.(None): may be a person with a certificate of successful completion of an organized GCP course. OGYÉI is
p.(None): keep a register of inspectors. Before starting the inspection, the inspector is inspected by OGYÉI
p.(None): presents the certificate of inspection issued.
p.(None): (2) - (4) *
p.(None): (5) *
p.(None): During an approved clinical trial, subjects and
p.(None): persons entitled to make a statement, investigators, the EGTC KFEB, the head of the service provider conducting the investigation, and
p.(None): IKEB may file a complaint with OGYÉI if, in their opinion, the clinical trial is
p.(None): different from those specified in the authorization or the test plan. The approved clinical trial
p.(None): IKEB may also communicate its comments to the study director and the service provider's manager, as well as
p.(None): may send it to the EGTC KFEB, which shall, if justified, initiate an inspection at OGYÉI.
p.(None): (6) - (7) *
p.(None): (8) *
p.(None): The inspector referred to in paragraph 1 shall declare in writing that:
p.(None): what are the interests, business and other relationships with the parties under control. This
p.(None): this statement shall be taken into account when appointing the inspector for an ad hoc inspection.
p.(None): (9) *
p.(None): At the request of OGYÉI, the client is obliged to carry out the inspection within 1 working day
p.(None): a quantity of the appropriate batch of the preparation suitable for quality control
p.(None): made.
p.(None): § 20 *
p.(None): Reporting of adverse events
p.(None): § 21. (1) *
p.(None): The investigator is all severe at the test site
p.(None): immediately notify the sponsor and IKEB of any adverse event, except for those
p.(None): according to the study plan or the prospectus prepared for the investigators
p.(None): reporting. The investigator shall provide a detailed written report of the incident upon immediate notification
p.(None): also sends to the client and IKEB. In the notification and the written report, the subject is exclusively unique
p.(None): identifiable by its code.
p.(None): (2) In the study plan, it was identified as being of high importance for the safety assessment of the study
p.(None): adverse events or laboratory abnormalities as specified by the investigator in the study plan,
p.(None): report to the principal within the time specified therein.
p.(None): (3) In the event of a reported death of a subject, the investigator shall request any additional information
...
Economic / Economic/Poverty
Searching for indicator income:
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p.(None): fertility, fertility, pregnancy or fertility at the time of the clinical trial.
p.(None): pregnancy, embryonal / fetal health.
p.(None): (8) *
p.(None): In clinical trials, the right to information self - determination and the
p.(None): CXII of 2011 on freedom of information. law, health and related
p.(None): XLVII of 1997 on the processing and protection of personal data law as well as in separate legislation
p.(None): The provisions on data processing set out in
p.(None): (9) As a subject to a clinical trial, with the exception of healthy volunteers, the clinical trial
p.(None): Patients cared for by a healthcare provider should be primarily involved.
p.(None): (10) *
p.(None): The healthcare provider conducting the clinical trial is the print media,
p.(None): or by means of a call published on its website, as well as professional and patient organizations,
p.(None): and may recruit competent subjects on the sponsor's website. The recruitment
p.(None): the call must not be for advertising purposes or contain the trade name of the investigational medicinal product,
p.(None): manufacturer and
p.(None): the designation of the person authorized to place it on the market.
p.(None): ! (10a) *
p.(None): In the case of a clinical trial pursuant to Section 7, the healthcare provider shall be
p.(None): to comply with the requirements of paragraph 10
p.(None): you can make the description of the planned clinical trials public on your own website as well as on the websites of professional and patient organizations.
p.(None): (11) *
p.(None): For the subject by participating in the clinical trial
p.(None): loss of income and costs, in particular in connection with travel
p.(None): Reimbursement may be made for costs incurred and justified. Other benefit to the subject
p.(None): or fee - non-therapeutic pharmacokinetic or interaction, phase I, and
p.(None): except for bioequivalence testing.
p.(None): (12) Test preparations and any devices used for their administration to the sponsor
p.(None): must be made available free of charge.
p.(None): Informing the subject, consent to the clinical trial
p.(None): § 6. (1) The person with legal capacity to be involved in a clinical trial shall be the head of the clinical trial or
p.(None): the examiner orally and in writing, in Hungarian, - or in the person's mother tongue, or by the person
p.(None): in another language indicated as known - informs the Eütv.
p.(None): 159 (3) and (4).
p.(None): (2) The person providing the information shall pay particular attention to examining whether the involvement is involved
p.(None): the desired person is not incapacitated. The findings in this regard are provided by the information provider
p.(None): person shall be recorded in the research and medical records.
p.(None): 3. The information and consent shall be recorded in a separate sheet. The consent form
p.(None): and one original copy of each written information shall be retained in the research dossier,
p.(None): and one original shall be handed over to the subject.
p.(None): 4. The written prospectus shall contain, in particular, the following, as appropriate:
p.(None): (a) the identity of the clinical trial;
...
Searching for indicator economic:
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p.(None): clinical trial). Does not qualify as a clinical trial a
p.(None): a non-interventional trial in which:
p.(None): (a) the medicinal product is not prescribed for the purpose of testing, and
p.(None): (b) a medicinal product in the usual manner in clinical practice, in accordance with the terms of the marketing authorization
p.(None): are ordered, and
p.(None): (c) the involvement of the patient in a particular treatment strategy is not determined in advance by a study
p.(None): plan, but the medicine is prescribed in accordance with current clinical practice and is prescribed
p.(None): clearly separated from the decision to include the patient in the study, and
p.(None): (d) in addition to normal clinical practice, the patient has additional diagnostic or
p.(None): no monitoring procedure is used, and
p.(None): (e) only epidemiological methods are used to analyze the data collected.
p.(None): § 2. (1) For the purposes of this Decree
p.(None): (a) clinical trial: a medical trial performed on any human
p.(None): research carried out at one or more test sites for the purpose of one or more test sites
p.(None): preparation
p.(None): (aa) the exploration of its clinical, pharmacological or pharmacodynamic effects; and
p.(None): (b) the identification of the adverse drug reaction caused by it; or
p.(None): (ac) study of absorption, distribution, metabolism and excretion,
p.(None): to demonstrate the safety, efficacy, benefit / risk balance of the product
p.(None): excluding non-interventional studies;
p.(None): (b) multicenter clinical trial: according to the same study design, but
p.(None): a clinical trial performed at more than one study site by more than one investigator,
p.(None): where the test sites are located in the European Economic Area (hereinafter referred to as the EEA) and in the European Economic Area
p.(None): Community or the
p.(None): Under an international agreement concluded with the EEA in a State with the same status as an EEA Member State (a
p.(None): hereinafter referred to as "EEA States") and in third countries;
p.(None): (c) investigational medicinal product: active substance or placebo,
p.(None): in a pharmaceutical form that is being tested in a clinical trial or as a reference (comparative)
p.(None): used as a preparation, including preparations already on the market
p.(None): but different from the agreed SPC or different
p.(None): used in the presentation or packaging or from the indication in the approved summary of product characteristics
p.(None): used in a different indication or with a medicinal product already authorized
p.(None): used to collect additional data on
p.(None): d) *
p.(None): sponsor: any natural or legal person who you are
p.(None): which initiates, conducts, and funds the clinical trial. It can be the investigator and the principal
p.(None): the same person;
p.(None): (e) investigator: a person qualified in medicine or dentistry whose task is to:
p.(None): conducting a clinical trial at the study site;
p.(None): (f) principal investigator: the responsible leader of the team at a particular investigation site if the
p.(None): a clinical trial is conducted by a group of several investigators;
p.(None): (g) investigator’s brochure: the investigator’s brochure or
p.(None): a summary of the relevant clinical and non-clinical data on the product
p.(None): for the study of the investigational medicinal product or products
p.(None): benefit / risk associated with the clinical trial for the physician and the investigator
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.(None): (f) principal investigator: the responsible leader of the team at a particular investigation site if the
p.(None): a clinical trial is conducted by a group of several investigators;
p.(None): (g) investigator’s brochure: the investigator’s brochure or
p.(None): a summary of the relevant clinical and non-clinical data on the product
p.(None): for the study of the investigational medicinal product or products
p.(None): benefit / risk associated with the clinical trial for the physician and the investigator
p.(None): objective assessment. The prospectus must be updated by the sponsor at least annually;
p.(None): h) study plan (protocol): study purpose, layout, methodology, statistical
p.(None): deliberations and organization of a document containing the subjects
p.(None): inclusion and exclusion criteria, monitoring and publication principles, including the study design
p.(None): any successive versions and any amendments thereto;
p.(None): (i) subject: a person in a clinical trial who is the subject of a clinical trial
p.(None): who is participating in the study as a control;
p.(None): j) *
p.(None): informed consent: to participate in the study
p.(None): requested person with legal capacity under the Eütv. A statement pursuant to Section 159 (1) (e),
p.(None): or a minor with limited legal capacity and capacity to act with health care
p.(None): In the case of a person who is partially restricted or incapacitated with regard to the exercise of related rights, the Eütv.
p.(None): A statement pursuant to Section 159 (4) (d);
p.(None): k) *
p.(None): recruitment: the health of the person conducting the clinical trial
p.(None): by the National Institute of Pharmacy and Food Health (hereinafter: OGYÉI)
p.(None): authorized public call for the purpose of being a volunteer other than the patients he or she cares for
p.(None): include individuals as subjects in a specific clinical trial;
p.(None): (l) adverse event: a patient or subject treated with a study preparation
p.(None): an adverse change in his state of health which is not necessarily causally related
p.(None): with the treatment applied;
p.(None): (m) adverse reaction: occurring at any dose of the test preparation
p.(None): any adverse and undesirable reactions associated with the test preparation;
p.(None): (n) serious adverse reaction or serious adverse event:
p.(None): side effect or adverse event is severe if any dose of the study product is administered
p.(None): subject’s death, life-threatening, hospitalization, ongoing hospitalization.
p.(None): prolongation of care, permanent or significant damage to health, disability
p.(None): followed by or congenital anomaly, birth defect occurs;
p.(None): (o) unexpected adverse reaction: an adverse reaction of a nature or severity
p.(None): differs from the adverse reaction in the corresponding product information, such as the study preparation
p.(None): the package leaflet prepared for the investigator or, in the case of a medicinal product, the summary of product characteristics;
...
p.(None): the call must not be for advertising purposes or contain the trade name of the investigational medicinal product,
p.(None): manufacturer and
p.(None): the designation of the person authorized to place it on the market.
p.(None): ! (10a) *
p.(None): In the case of a clinical trial pursuant to Section 7, the healthcare provider shall be
p.(None): to comply with the requirements of paragraph 10
p.(None): you can make the description of the planned clinical trials public on your own website as well as on the websites of professional and patient organizations.
p.(None): (11) *
p.(None): For the subject by participating in the clinical trial
p.(None): loss of income and costs, in particular in connection with travel
p.(None): Reimbursement may be made for costs incurred and justified. Other benefit to the subject
p.(None): or fee - non-therapeutic pharmacokinetic or interaction, phase I, and
p.(None): except for bioequivalence testing.
p.(None): (12) Test preparations and any devices used for their administration to the sponsor
p.(None): must be made available free of charge.
p.(None): Informing the subject, consent to the clinical trial
p.(None): § 6. (1) The person with legal capacity to be involved in a clinical trial shall be the head of the clinical trial or
p.(None): the examiner orally and in writing, in Hungarian, - or in the person's mother tongue, or by the person
p.(None): in another language indicated as known - informs the Eütv.
p.(None): 159 (3) and (4).
p.(None): (2) The person providing the information shall pay particular attention to examining whether the involvement is involved
p.(None): the desired person is not incapacitated. The findings in this regard are provided by the information provider
p.(None): person shall be recorded in the research and medical records.
p.(None): 3. The information and consent shall be recorded in a separate sheet. The consent form
p.(None): and one original copy of each written information shall be retained in the research dossier,
p.(None): and one original shall be handed over to the subject.
p.(None): 4. The written prospectus shall contain, in particular, the following, as appropriate:
p.(None): (a) the identity of the clinical trial;
p.(None): b) an indication of the research nature of the clinical trial, the purpose of the clinical trial, the expected duration,
p.(None): the number of persons to be involved, the course of the clinical trial, the nature of the planned interventions,
p.(None): frequency;
p.(None): (c) other accepted treatment options available to the subject,
p.(None): and information that the clinical trial is discontinuing treatment that has already begun
p.(None): can mean and the treatment started
p.(None): the consequences for the subject of its interruption;
p.(None): (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
p.(None): an indication that adverse events that did not occur in advance may occur during the clinical trial
p.(None): visible;
p.(None): (e) a description of the reasonably foreseeable benefits or if the subject benefits from the clinical trial
p.(None): not expected, disclosure of this fact;
p.(None): f) *
p.(None): harm to the subject related to the clinical trial
p.(None): treatment to be provided in the event of the occurrence or violation of the right to privacy, compensation for damage, or
...
p.(None): (i) rules on the handling of, and access to, subject data;
p.(None): (j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
p.(None): the likelihood of the subject being placed in the placebo group;
p.(None): (k) a brief pharmacological description of the test preparation;
p.(None): (l) the nature of the test subject, if any, after completion of the study
p.(None): receive additional health care;
p.(None): m) *
p.(None): n) *
p.(None): and GyT. It is included in the liability insurance pursuant to Section 3 (5)
p.(None): the name of the insurer.
p.(None): (5) *
p.(None): 6. The subject's informed consent shall include at least the following:
p.(None): (a) the identity of the clinical trial;
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted;
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): designation;
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
p.(None): (hereinafter referred to as the person entitled to make a declaration) identifier
p.(None): data;
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a statement - for participation in a clinical trial
p.(None): after giving the information provided for in paragraph 1, give its consent voluntarily, without influence
p.(None): Aware that it may be revoked at any time, orally or in writing, without giving any reason;
p.(None): (f) the date of signature of the statement of consent;
p.(None): (g) the signature of the clinical trial director or information provider;
p.(None): (h) the signature of the person giving his consent.
p.(None): (7) *
p.(None): The person providing the information and the subject - and to a limited extent
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the person entitled to make the statement
p.(None): He shall also sign the written information referred to in paragraph 4.
p.(None): 8. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 4.
p.(None): received and informed of the statement of consent referred to in paragraph 6
p.(None): he verbally agreed.
p.(None): (9) *
p.(None): 6 / A. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): the subject shall be informed separately. For information out
p.(None): it should also cover the right of the subject to be sampled separately
p.(None): refuse, in which case the genetic data relating to him will remain anonymous
p.(None): cannot be used in any way. Refusal of sampling does not constitute participation of the subject
p.(None): obstacle in the remainder of the clinical trial. Information on and consent to sampling
p.(None): should be included in a separate document.
p.(None): (2) Prior to sampling for the purpose of human genetic testing, the subject is subject to genetic counseling
p.(None): shall be informed within the framework of:
p.(None): (a) the purpose, quantitative and qualitative details of the sampling,
p.(None): (b) the benefits and risks of performing or not performing the study,
p.(None): (c) any possible outcome for the data subject and his or her close relatives
p.(None): consequences,
p.(None): (d) the methods and duration of storage of the genetic sample and data, the genetic data stored in different forms
p.(None): samples and the possibilities for identifying data,
p.(None): (e) unless otherwise stated by the subject, the genetic sample is in an archived collection
...
p.(None): the replacement code has been made available to the subject exclusively,
p.(None): (gd) anonymised, ie in a form where all the data relating to the subject are available
p.(None): personally identifiable information has been rendered inoperable.
p.(None): (3) The test subject shall also be informed that the sample placed in the biobank may decide to continue
p.(None): participation in research. In this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): that is, it contributes to its use for diagnostic and research purposes.
p.(None): 6 / B. § *
p.(None): (1) If a human genetic study is performed during a clinical trial
p.(None): shall be sampled, a separate statement of consent shall be drawn up.
p.(None): 2. The subject's informed consent shall include at least the following:
p.(None): a) the identification data of the clinical trial,
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted,
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): Name,
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): partially restricted or
p.(None): in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.(None): hereinafter referred to as "the person entitled to make the declaration"),
p.(None): e) *
p.(None): a statement that the subject - limited
p.(None): a minor with legal capacity and rights related to health care in his or her capacity for action
p.(None): in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
p.(None): person entitled to make a declaration - in a genetic test for pharmacological purposes
p.(None): consent to participate in accordance with Article 6 / A. § or waiver thereof
p.(None): voluntarily, without influence, knowing that at any time, orally or in writing, without giving reasons,
p.(None): revocable,
p.(None): (f) consent to the taking of a sample of the quantity and quality indicated in the prospectus and to the subject
p.(None): to use your data,
p.(None): (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.(None): biobank and the method of disposal, so it is possible to place the sample in 6 / A. §
p.(None): Storage and disposal in accordance with paragraph 2 (g),
p.(None): (h) the subject's statement on further sampling of the sample placed in the biobank
p.(None): participation; in this case, the subject must declare that:
p.(None): according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
p.(None): ie it contributes to its use for diagnostic and research purposes,
p.(None): (i) the manner in which the result is to be communicated, even if the subject does not have access to it,
p.(None): j) consent to or exclusion from any future request,
p.(None): k) the date of signature of the statement of consent,
p.(None): l) the signature of the head of the clinical trial or the person providing the information,
p.(None): (m) the signature of the person giving his consent.
...
p.(None): (e) the investigator or study director shall take into account the views of a minor who is able to form an opinion and assess the situation;
p.(None): expressly discourages participation in the clinical trial or the exclusion of any person from the trial at any time.
p.(None): step;
p.(None): f) persuasion by any material means, except for the compensation pursuant to Section 5 (11), or
p.(None): no financial incentive is applied, no other benefit or fee may be granted to the minor subject;
p.(None): (g) the authorization of medicinal products for human or veterinary use; and
p.(None): laying down Community procedures for the supervision of
p.(None): Establishing a European Medicines Agency
p.(None): European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.(None): hereinafter referred to as the EMEA);
p.(None): (h) a clinical examination for pain, anxiety, fear and any other condition associated with illness and
p.(None): designed and maintained to minimize the foreseeable risk associated with its state of development;
p.(None): (i) the study is performed in such a way that both the risk threshold and the degree of pain are
p.(None): defined and continuously monitored;
p.(None): j) in the possession of the opinion of the pediatric specialist of the EGTC KFEB, professionally and ethically
p.(None): test plan.
p.(None): Involvement of incapacitated adults in a clinical trial
p.(None): § 8 A person who has previously had legal capacity may not be involved in any clinical trial
p.(None): expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
p.(None): who has previously refused to give his consent to the
p.(None): testing.
p.(None): § 9 *
p.(None): Rights related to health care in its capacity to act
p.(None): partially or completely limited in its capacity to act, and
p.(None): Act V of 2013 on the Civil Code 2: 9. In the case of adults who are incapable of acting in accordance with
p.(None): for research carried out in urgent need, the Eütv. Except in the case pursuant to Section 160 of the Eütv. § 159
p.(None): Paragraph 4 and paragraphs 4 to 6. and § 8 only in that case
p.(None): a clinical trial may be performed if all of the following conditions are met:
p.(None): (a) the statement of consent of the person entitled to make the statement shall be the presumed will of the subject
p.(None): and may be revoked at any time without prejudice to the subject;
p.(None): (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.(None): adverse effects;
p.(None): (c) the investigator and the study director take full account of the opinion
p.(None): and a subject capable of assessing the situation explicitly precludes access to the clinical trial
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): The investigator is all severe at the test site
p.(None): immediately notify the sponsor and IKEB of any adverse event, except for those
p.(None): according to the study plan or the prospectus prepared for the investigators
p.(None): reporting. The investigator shall provide a detailed written report of the incident upon immediate notification
p.(None): also sends to the client and IKEB. In the notification and the written report, the subject is exclusively unique
p.(None): identifiable by its code.
p.(None): (2) In the study plan, it was identified as being of high importance for the safety assessment of the study
p.(None): adverse events or laboratory abnormalities as specified by the investigator in the study plan,
p.(None): report to the principal within the time specified therein.
p.(None): (3) In the event of a reported death of a subject, the investigator shall request any additional information
p.(None): provides for the principal and IKEB.
p.(None): (4) The sponsor shall keep detailed records of all adverse events reported by the investigator. This
p.(None): available to the States party to the EEA Agreement upon request
p.(None): in which the clinical trial is conducted.
p.(None): Reporting of serious side effects
p.(None): § 22 *
p.(None): (1) *
p.(None): The principal is required to take care of any death or life
p.(None): endangering SUSAR and all relevant information
p.(None): but no later than seven days after becoming aware of it, the EMEA EudraVigilance
p.(None): database. The sponsor will take care of all fatalities occurring at all test sites in Hungary
p.(None): life-threatening SUSAR and all relevant information is prompt - but no later than
p.(None): within seven days of becoming aware of its electronic report to OGYÉI,
p.(None): to the competent authority of the EEA EGCC and of the State concerned which is a party to the EEA Agreement. To the principal
p.(None): within a further eight days, any significant data obtained during the follow-up of the adverse reaction in question
p.(None): must report.
p.(None): (2) *
p.(None): The principal must take care of all other SUSARs promptly - but
p.(None): within fifteen days of becoming aware of the report to the EMEA EudraVigilance
p.(None): database. The Client shall provide all other SUSARs occurring at the Hungarian test site
p.(None): immediately, but no later than fifteen days after becoming aware of it, send it electronically to OGYÉI,
p.(None): the competent authority of the EEA EGCC and the States party to the EEA Agreement.
p.(None): (3) *
p.(None): The sponsor is responsible for each specific test preparation
p.(None): periodically, in the form of a summary list of SUSAR occurring in the clinical trial
p.(None): participating all investigators.
p.(None): (4) *
p.(None): The sponsor of the clinical trial for the entire duration of the trial
p.(None): all serious suspected adverse reactions to the product,
p.(None): and an electronic report on the safety of the subjects once a year
p.(None): shall be sent to OGYÉI, the EGTC KFEB and the competent authority of the State concerned which is a party to the EEA Agreement.
p.(None): (5) *
p.(None): OGYÉI keeps records of each test preparation
p.(None): SUSAR. In the case of non-commercial tests, OGYÉI is all of that test
p.(None): SUSAR which has come to its notice in connection with the preparation without delay, but no later than
p.(None): The EMEA shall report to the EudraVigilance database within the deadline set out in paragraph 2.
p.(None): (6) *
p.(None): In addition to the provisions of Section 21 and this Section, the investigation
p.(None): endangering the safety of subjects by continuing the study or the study preparation
p.(None): after the occurrence of new information or event related to the development of the
p.(None): investigator should take appropriate urgent safety measures in order to conduct the test
p.(None): the girls
p.(None): protect against all imminent dangers. The principal shall be informed of such events and of what has been done
p.(None): immediately, but no later than within 24 hours, inform OGYÉI and ETT KFEB in writing.
p.(None): Report on the completion of the investigation
p.(None): § 23 *
p.(None): Within ninety days of the completion of the investigation, the sponsor shall:
p.(None): It will notify OGYÉI of the completion of the study in a form that can be downloaded from the EMEA website. OGYÉI a
p.(None): inform the EGTC KFEB within eight days of the notification.
p.(None): Retention of test documentation
p.(None): § 24. (1) The inspection master file shall contain the basic documents
p.(None): which allow both the conduct of the clinical trial and the quality of the data
p.(None): be evaluable. The documents must indicate whether the investigators and the sponsor have complied
p.(None): the principles of GCP. The test master file shall be based on an inspection carried out by an independent auditor or a
...
General/Other / participants in a control group
Searching for indicator control group:
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p.(None): and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 amending Regulation (EC) No 726/2004
p.(None): shall apply subject to Council Regulation.
p.(None): Protection of test subjects
p.(None): § 4 The rights, safety and well-being of the subject shall be given priority over science and
p.(None): against the interests of society, therefore the risk to the research subject should be kept to a minimum
p.(None): restricted.
p.(None): § 5 (1) *
p.(None): To perform a clinical trial, a study preparation in humans
p.(None): may only be used with the permission of OGYÉI. Clinical examination is only authorized by OGYÉI
p.(None): the conditions laid down in Decision
p.(None): may be continued according to the requirements of an approved test plan.
p.(None): (2) A person with legal capacity may be involved in a clinical trial if the Eütv. 159th
p.(None): § (1) - (3) and the requirements provided for in this Decree.
p.(None): (3) A clinical trial shall not be a substitute for a subject appropriate to its condition
p.(None): examinations and treatments.
p.(None): (4) *
p.(None): For the intended use of placebo, for official authorization
p.(None): the research dossier submitted with the application must include the placebo to be used in the study
p.(None): specific justification for the need for a control group. The use of placebo should not be reported to the subject
p.(None): significant additional risk to it or cause irreversible damage to health
p.(None): hazard. Placebo should only be used for the shortest time required by the test subject
p.(None): should be monitored continuously during the study, immediately in the event of signs of significant deterioration
p.(None): it must be provided with the best scientifically accepted therapy available.
p.(None): (5) The clinical trial shall be designed and conducted in a manner that minimizes the subject
p.(None): possible damage, pain, fear and anxiety. Age of the subject, health
p.(None): All foreseeable risks associated with the condition should be considered in the clinical trial
p.(None): planning and control.
p.(None): (6) The health status of the subject prior to the commencement of the clinical trial during the clinical trial
p.(None): must be carefully monitored and documented continuously and after the test.
p.(None): (7) If persons of reproductive age are to be included in a clinical trial, the design of the clinical trial,
p.(None): authorization, special attention shall be paid to the study subjects when informing the subjects
p.(None): subject with respect to clinical
p.(None): fertility, fertility, pregnancy or fertility at the time of the clinical trial.
...
Searching for indicator placebo:
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p.(None): clearly separated from the decision to include the patient in the study, and
p.(None): (d) in addition to normal clinical practice, the patient has additional diagnostic or
p.(None): no monitoring procedure is used, and
p.(None): (e) only epidemiological methods are used to analyze the data collected.
p.(None): § 2. (1) For the purposes of this Decree
p.(None): (a) clinical trial: a medical trial performed on any human
p.(None): research carried out at one or more test sites for the purpose of one or more test sites
p.(None): preparation
p.(None): (aa) the exploration of its clinical, pharmacological or pharmacodynamic effects; and
p.(None): (b) the identification of the adverse drug reaction caused by it; or
p.(None): (ac) study of absorption, distribution, metabolism and excretion,
p.(None): to demonstrate the safety, efficacy, benefit / risk balance of the product
p.(None): excluding non-interventional studies;
p.(None): (b) multicenter clinical trial: according to the same study design, but
p.(None): a clinical trial performed at more than one study site by more than one investigator,
p.(None): where the test sites are located in the European Economic Area (hereinafter referred to as the EEA) and in the European Economic Area
p.(None): Community or the
p.(None): Under an international agreement concluded with the EEA in a State with the same status as an EEA Member State (a
p.(None): hereinafter referred to as "EEA States") and in third countries;
p.(None): (c) investigational medicinal product: active substance or placebo,
p.(None): in a pharmaceutical form that is being tested in a clinical trial or as a reference (comparative)
p.(None): used as a preparation, including preparations already on the market
p.(None): but different from the agreed SPC or different
p.(None): used in the presentation or packaging or from the indication in the approved summary of product characteristics
p.(None): used in a different indication or with a medicinal product already authorized
p.(None): used to collect additional data on
p.(None): d) *
p.(None): sponsor: any natural or legal person who you are
p.(None): which initiates, conducts, and funds the clinical trial. It can be the investigator and the principal
p.(None): the same person;
p.(None): (e) investigator: a person qualified in medicine or dentistry whose task is to:
p.(None): conducting a clinical trial at the study site;
p.(None): (f) principal investigator: the responsible leader of the team at a particular investigation site if the
p.(None): a clinical trial is conducted by a group of several investigators;
p.(None): (g) investigator’s brochure: the investigator’s brochure or
p.(None): a summary of the relevant clinical and non-clinical data on the product
p.(None): for the study of the investigational medicinal product or products
p.(None): benefit / risk associated with the clinical trial for the physician and the investigator
p.(None): objective assessment. The prospectus must be updated by the sponsor at least annually;
p.(None): h) study plan (protocol): study purpose, layout, methodology, statistical
p.(None): deliberations and organization of a document containing the subjects
p.(None): inclusion and exclusion criteria, monitoring and publication principles, including the study design
p.(None): any successive versions and any amendments thereto;
...
p.(None): subject’s death, life-threatening, hospitalization, ongoing hospitalization.
p.(None): prolongation of care, permanent or significant damage to health, disability
p.(None): followed by or congenital anomaly, birth defect occurs;
p.(None): (o) unexpected adverse reaction: an adverse reaction of a nature or severity
p.(None): differs from the adverse reaction in the corresponding product information, such as the study preparation
p.(None): the package leaflet prepared for the investigator or, in the case of a medicinal product, the summary of product characteristics;
p.(None): (p) equivalence study: the study preparation is with another medicinal product
p.(None): bioequivalence (based on pharmacokinetic results), pharmacodynamic or therapeutic equivalence
p.(None): comparative study;
p.(None): q) *
p.(None): r) *
p.(None): SUSAR (Suspected Unexpected Serious Adverse Reaction): assumed
p.(None): unexpected serious side effect;
p.(None): s) *
p.(None): Phase I study: the tolerability of the test preparation,
p.(None): safety, pharmacokinetics and pharmacodynamic effects are healthy
p.(None): volunteers or special patient groups. A further goal of the Phase I study may be the therapeutic dose
p.(None): range determination;
p.(None): t) *
p.(None): II. phase I study: the pharmacological effect of the test preparation
p.(None): in an indication selected on the basis of the efficacy of the investigational medicinal product
p.(None): confirmation of the dose-response relationship, the optimal therapeutic dose
p.(None): safety and tolerability testing;
p.(None): u) *
p.(None): III. Phase I study: the efficacy of the study product,
p.(None): safety and tolerability in a larger number of patients in a controlled, randomized, placebo-controlled
p.(None): a test in a comparative test set-up;
p.(None): v) *
p.(None): ARC. Phase I study: the marketing authorization holder
p.(None): a study using the test preparation in accordance with the SPC, which
p.(None): aims to further investigate the benefit / risk balance, safety and tolerability.
p.(None): (2) *
p.(None): With regard to matters not covered by paragraph 1, this Regulation
p.(None): in the Eütv., on medicinal products for human use and other, the pharmaceutical market
p.(None): Act XCV of 2005 on the Amendment of Regulatory Acts. (hereinafter: GyT.), on man
p.(None): medical research, clinical trials of human investigational medicinal products
p.(None): and medical devices intended for human clinical use
p.(None): in the legislation on the rules of the authorization procedure for clinical trials, human
p.(None): legislation on the placing on the market of medicinal products for human use and for human use
p.(None): contained in the legislation on the personal and material conditions of the manufacture of
p.(None): definitions should be taken into account.
p.(None): (3) In the case of investigational medicinal products, it is authorized to ensure the quality of medicinal products
p.(None): the relevant provisions of the legislation on the conditions of qualification of a person shall also apply mutatis mutandis.
p.(None): § 3 (1) *
p.(None): All clinical trials - bioavailability and bioequivalence
p.(None): principles of good clinical practice (GCP)
p.(None): in accordance with the Helsinki Declaration on Ethical Principles in Medical Research
p.(None): be planned, carried out and reported. The current text of the GCP in the Hungarian language of OGYÉI
p.(None): It publishes. OGYÉI will publish a notice about the publication and its place in the Health Bulletin.
p.(None): (2) *
p.(None): The design and conduct of clinical trials is professional
p.(None): rules, in particular those published by the European Commission on clinical trials
p.(None): In accordance with the version of the detailed instructions in force at any time, which are published by OGYÉI in Hungarian
p.(None): publish in translation.
p.(None): (3) *
p.(None): The OGYÉI and the independent ethics committee according to the separate legislation, the
p.(None): Clinical Pharmacology Ethics Committee of the Health Science Council (hereinafter: ETT KFEB)
p.(None): issues methodological guidance on significant professional and ethical issues, in particular for each clinical trial
p.(None): phases, the use of placebo in clinical trials.
p.(None): On the publication of the guide and its place, the OGYÉI and the ETT KFEB as an appendix to the Hungarian Gazette
p.(None): will publish a notice in the Official Journal of the European Union.
p.(None): (4) *
p.(None): This Regulation is intended for pediatric use
p.(None): Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
p.(None): Council Regulation on Advanced Therapy Medicinal Products and Directive 2001/83 / EC
p.(None): and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 amending Regulation (EC) No 726/2004
p.(None): shall apply subject to Council Regulation.
p.(None): Protection of test subjects
p.(None): § 4 The rights, safety and well-being of the subject shall be given priority over science and
p.(None): against the interests of society, therefore the risk to the research subject should be kept to a minimum
p.(None): restricted.
p.(None): § 5 (1) *
p.(None): To perform a clinical trial, a study preparation in humans
p.(None): may only be used with the permission of OGYÉI. Clinical examination is only authorized by OGYÉI
p.(None): the conditions laid down in Decision
p.(None): may be continued according to the requirements of an approved test plan.
p.(None): (2) A person with legal capacity may be involved in a clinical trial if the Eütv. 159th
p.(None): § (1) - (3) and the requirements provided for in this Decree.
p.(None): (3) A clinical trial shall not be a substitute for a subject appropriate to its condition
p.(None): examinations and treatments.
p.(None): (4) *
p.(None): For the intended use of placebo, for official authorization
p.(None): the research dossier submitted with the application must include the placebo to be used in the study
p.(None): specific justification for the need for a control group. The use of placebo should not be reported to the subject
p.(None): significant additional risk to it or cause irreversible damage to health
p.(None): hazard. Placebo should only be used for the shortest time required by the test subject
p.(None): should be monitored continuously during the study, immediately in the event of signs of significant deterioration
p.(None): it must be provided with the best scientifically accepted therapy available.
p.(None): (5) The clinical trial shall be designed and conducted in a manner that minimizes the subject
p.(None): possible damage, pain, fear and anxiety. Age of the subject, health
p.(None): All foreseeable risks associated with the condition should be considered in the clinical trial
p.(None): planning and control.
p.(None): (6) The health status of the subject prior to the commencement of the clinical trial during the clinical trial
p.(None): must be carefully monitored and documented continuously and after the test.
p.(None): (7) If persons of reproductive age are to be included in a clinical trial, the design of the clinical trial,
p.(None): authorization, special attention shall be paid to the study subjects when informing the subjects
p.(None): subject with respect to clinical
p.(None): fertility, fertility, pregnancy or fertility at the time of the clinical trial.
p.(None): pregnancy, embryonal / fetal health.
p.(None): (8) *
p.(None): In clinical trials, the right to information self - determination and the
p.(None): CXII of 2011 on freedom of information. law, health and related
p.(None): XLVII of 1997 on the processing and protection of personal data law as well as in separate legislation
...
p.(None): frequency;
p.(None): (c) other accepted treatment options available to the subject,
p.(None): and information that the clinical trial is discontinuing treatment that has already begun
p.(None): can mean and the treatment started
p.(None): the consequences for the subject of its interruption;
p.(None): (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
p.(None): an indication that adverse events that did not occur in advance may occur during the clinical trial
p.(None): visible;
p.(None): (e) a description of the reasonably foreseeable benefits or if the subject benefits from the clinical trial
p.(None): not expected, disclosure of this fact;
p.(None): f) *
p.(None): harm to the subject related to the clinical trial
p.(None): treatment to be provided in the event of the occurrence or violation of the right to privacy, compensation for damage, or
p.(None): for the payment of damages and compensation [GyT. Section 21 (1)] and the manner of their use
p.(None): information, as well as the name and contact details in Hungary of the person and organization to whom you are
p.(None): to which the subject may turn in the event of damage;
p.(None): (g) the reimbursement of costs to the subject, if any;
p.(None): (h) a warning that the consent is voluntary and free from influence,
p.(None): it may be withdrawn at any time, either orally or in writing, without giving reasons, without this being examined
p.(None): subject would be at a disadvantage;
p.(None): (i) rules on the handling of, and access to, subject data;
p.(None): (j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
p.(None): the likelihood of the subject being placed in the placebo group;
p.(None): (k) a brief pharmacological description of the test preparation;
p.(None): (l) the nature of the test subject, if any, after completion of the study
p.(None): receive additional health care;
p.(None): m) *
p.(None): n) *
p.(None): and GyT. It is included in the liability insurance pursuant to Section 3 (5)
p.(None): the name of the insurer.
p.(None): (5) *
p.(None): 6. The subject's informed consent shall include at least the following:
p.(None): (a) the identity of the clinical trial;
p.(None): (b) the name of the healthcare provider where the clinical trial is to be conducted;
p.(None): c) the name, position and position of the head of the clinical trial or the person providing the information
p.(None): designation;
p.(None): d) *
p.(None): the identity of the subject (name, place and date of birth),
p.(None): a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.(None): In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
p.(None): (hereinafter referred to as the person entitled to make a declaration) identifier
p.(None): data;
p.(None): e) *
p.(None): a statement that the subject - limited
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| control group | participants in a control group |
| drug | Drug Usage |
| economic | Economic/Poverty |
| health | Health |
| healthy volunteers | healthy volunteers |
| home | home |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| income | Economic/Poverty |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| party | Political |
| placebo | participants in a control group |
| restricted | Incarcerated |
| substance | Drug Usage |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| control group | ['placebo'] |
| drug | ['influence', 'substance'] |
| economic | ['income'] |
| income | ['economic'] |
| influence | ['drug', 'substance'] |
| placebo | ['controlXgroup'] |
| substance | ['influence', 'drug'] |
Trigger Words
capacity
consent
ethics
harm
protection
risk
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input