0A4F4F9BD490A749D5437F821CF06DF1
Decree of the Minister of Health on Clinical Trials of Investigative Medicinal Products for Human Use and on the Application of Good Clinical Practice
http://www.mkvt.hu/PDF/decree35.pdf
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| 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 affiliation
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p.000001: c) the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol
p.000001: but falls within current practice and the prescription of the medicine is clearly separated from the decision
p.000001: to include the patient in the study; and
p.000001: d) no additional diagnostic or monitoring procedure is used on the patient beyond the usual clinical practice, and
p.000001: e) only epidemiological methods will be used for the analysis of the collected data.
p.000001: § 2 (1) In term of this Decree:
p.000001: a) clinical trial: any investigation in human subjects carried out in either one site or multiple sites intended to
p.000001: aa) discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more
p.000001: investigational medicinal product(s),
p.000001: ab) and/or to identify any adverse reactions to one or more investigational medicinal product(s)
p.000001: ac) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal
p.000001: product(s) with the objective of ascertaining its (their) safety and/or efficacy and/or risk- benefit ratio not
p.000001: including non-interventional trials;
p.000001: b) multi-centre clinical trial: clinical trials conducted in line with the same protocol at more than one
p.000001: investigational sites by more than one investigator, where investigational sites may be situated within the European
p.000001: Economic Area (hereinafter referred to as the EEA), or, pursuant to an international treaty concluded with the European
p.000001: Community or the EEA, in a state with a legal status identical to that of EEA states (hereinafter referred to as a
p.000001: state party to the EEA- treaty) and in third countries;
p.000001: c) investigational medicinal product: a pharmaceutical form of an active substance or placebo being tested or used as
p.000001: a reference (comparator) in a clinical trial, including products already with a marketing authorisation but used or
p.000001: assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised
p.000001: indication, or when used to gain further information about the authorised form;
p.000001: d)sponsor: a natural or legal entity, a company without a legal personality which takes responsibility
p.000001: for the initiation, management and/or financing of a clinical trial. The investigator and the
p.000001: sponsor may be the same entity;
p.000001: e) investigator: a person qualified as a physician or a dentist who is responsible for the conduction of
p.000001: the clinical trial at the investigational site;
p.000001: f) principal investigator: the leader responsible for the team if a trial is conducted by a team of individuals at the
p.000001: investigational site;
p.000001: g) investigator’s brochure: a compilation of the clinical and non-clinical data on the
p.000001: investigational medicinal product or products which are relevant to the study of the
p.000001: investigational product or products enabling the physician or the trial supervisor to objectively assess the
p.000001: risk-benefit ratio of the clinical trial. The sponsor must update the brochure at least once a year;
p.000001:
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p.000006: and are continuously monitored;
p.000006: h) the ETT-KFEB supports the protocol from special-ethical aspects in the possession of an expert opinion given
p.000006: in accordance with the disease in question and with the patient group concerned;
p.000006: i) it is reasonably expected that the application of the investigational medicinal product has beneficial
p.000006: effects in excess of the adverse effects for the patient, or does not constitute a risk at all.
p.000006: § 10 Persons enlisted in § 9 may not be involved in clinical trials as healthy volunteers.
p.000006: § 11 If a subject becomes mentally competent as a result of a judicial decision or of the change of his/her state
p.000006: during the clinical trial, he/she must be informed of the clinical trial as soon as possible, and his/her acceptance
p.000006: of its continuation must be acquired with the observance of the contents of § 6. Otherwise the clinical trial may not
p.000006: be continued on the persons involved.
p.000006:
p.000006: Prerequisites of applying for an official authorisation
p.000006:
p.000006: § 12 (1) If another natural or legal entity, or a company without a legal personality is assigned by the sponsor to
p.000006: discharge some or all of its responsibilities related to the trial, the sponsor remains liable for
p.000006: compliance with the provisions of this Decree and with the provisions of a separate law on clinical trials.
p.000006: If the sponsor is not established in one of the states which are party to the EEA-treaty, then its legal representative
p.000006: must be established in a state which is party to the EEA-agreement.
p.000006: (2) – (5)
p.000006:
p.000006: (6) The contract between the health service provider and the sponsor relating to the clinical trial of the
p.000006: investigational medicinal product may be signed also before the licensing procedure; however its validity is
p.000006: subject to the official licensing of the clinical trial.
p.000006: (7) Phase I clinical trials may only be conducted at investigational sites qualified by NIP as clinical
p.000006: pharmacological sites. The qualification process must be conducted upon the request of the head of the health care
p.000006: provider. In the course of the qualification process, NIP will conduct an on-site inspection. The qualification process
p.000006: must be repeated every three years.
p.000006:
p.000006: Official authorisation of the clinical trial
p.000006:
p.000006: § 13 (1)
p.000006: (2) Use of an investigational medicinal product on humans may be authorised if the personal terms of the principal
p.000006: investigator and the material terms of the investigational site(s) comply with terms
p.000006: specified in Annex 2 to this decree.
p.000006: (3) – (4)
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p.000007: § 14 (1) Sponsor notifies the head of the health care provider conducting the clinical trial and the principal
p.000007: investigator about NIP’s decision regarding the approval, and prior to the commencement of the trial submits
p.000007: NIP’s decision and the protocol synopsis in Hungarian to the competent institutional ethics committee (hereinafter
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p.000007: and business and other relationship with the inspected parties. This statement must be taken into consideration when
p.000007: assigning the inspector to the inspection in question.
p.000007: (9) Upon request, the sponsor must provide NIP with sample from the required lot of the investigational medicinal
p.000007: product in an amount sufficient for quality testing within 1 working day.
p.000007: 20. §
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p.000008: Report on adverse events
p.000008:
p.000008: § 21 (1) The investigator shall immediately notifiy the sponsor and the IKEB of any serious adverse events, with the
p.000008: exception of those defined as not to be reported immediately in the protocol or the investigator’s brochure.
p.000008: Following immediate notification, the investigator provides the sponsor and IKEB with a detailed written report of
p.000008: the event. In the notification and the written report, the subject may only be identified by his or her unique code.
p.000008: (2)The investigator reports to the sponsor all adverse events and abnormal laboratory results regarded to be of
p.000008: particular importance in respect of the safety assessment of the trial in line with the specifications of and within
p.000008: the timeframe provided in the protocol.
p.000008: (3)In case of reported death of the subject the investigator provides all additionally required information
p.000008: to the sponsor and to the IKEB.
p.000008: (4)The sponsor shall keep regular records of each adverse event reported by the investigator. Upon request, this
p.000008: record will be made available to the countries party to the EEA-treaty and whose territory the clinical
p.000008: trials are conducted in.
p.000008:
p.000008: Report on serious adverse reactions
p.000008:
p.000008: § 22 (1) The sponsor ensures that all suspected serious unexpected adverse reactions that are fatal or
p.000008: life-threatening and all related relevant information are reported to the EMEA EudraVigilance database
p.000008: immediately but no later than seven days from obtaining knowledge of such. The sponsor ensures that all suspected
p.000008: serious unexpected adverse reactions occurring at Hungarian investigational sites that are fatal or
p.000008: life-threatening and all related relevant information are reported electronically to NIP, the ETT-KFEB and the
p.000008: competent authority of countries which are party to the EEA-treaty immediately but no later than seven days
p.000008: from obtaining knowledge of such. Within an additional eight days, the sponsor will also report all significant
p.000008: information obtained during the follow-up of the adverse event in question.
p.000008: (2) The sponsor ensures that all other suspected serious unexpected adverse reactions are reported to the
p.000008: EMEA EudraVigilance database immediately but no later than fifteen days from obtaining knowledge of such. The sponsor
p.000008: will report all other suspected serious unexpected adverse reactions occurring at Hungarian investigational sites
p.000008: electronically to NIP, the ETT- KFEB and the competent authority of countries which are party to the EEA-treaty
p.000008: immediately but no later than seven days from obtaining knowledge of such.
p.000008: (3) Periodically, but at least every six months, the sponsor shall provide NIP, ETT-KFEB and all other
p.000008: investigators participating in the clinical trial with a cumulative list in electronic format containing all SUSAR
p.000008: associated with a given investigational medicinal product.
p.000008: (4) Once a year, the sponsor provides NIP, the ETT-KFEB and the competent authority of countries which are party to the
p.000008: EEA-treaty with an electronic report containing all suspected serious adverse reactions occurring over this
p.000008: period and associated with the investigational medicinal product, as well as information on the subjects' safety.
p.000008: (5) NIP keeps a record of all SUSARs reported in connection with a given investigational medicinal product. In the
p.000008: case of non-commercial trials the NIP, and for all other trials the sponsor, will report all received
p.000008: SUSARs in connection with the investigational medicinal product to the EMEA immediately but no later than the
p.000008: deadline specified in Paragraphs (1) and (2).
p.000008: (6) In addition to the provisions in Sections 21 and this Section, the sponsor and the investigator must
p.000008: take all urgent safety measures to protect the subjects against any immediate threat after any new information or
p.000008: event jeopardising subject safety or concerning the continuation of the trial or the development of the
p.000008: investigational medicinal product become known to them. The sponsor shall immediately but no later than 24 hours
p.000008: notify NIP ETT-KFEB of such events and measures taken.
p.000008:
p.000008: Report on the completion of the trial
p.000008:
p.000008: § 23 (1) The sponsor notifies the NIP of the completion of the trial, of the number of patients involved, and of
p.000008: significant events on a data-sheet downloadable from the webpage of the EMEA within ninety days from the completion of
p.000008: the trial. The NIP informs the ETT-KFEB within eight days from the notification.
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Health / Drug Usage
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p.000001: Decree 35/2005 (VIII. 26.) of the Minister of Health
p.000001:
p.000001: on the clinical trial of investigational medicinal products to be used on humans and on the application of the Good
p.000001: Clinical Practice
p.000001:
p.000001: Based on the authorisation granted in subsection o) of Section (2), § 247 of Act CLIV of 1997 on Health Care
p.000001: (hereinafter referred to as “Health Care Act”) and in subsection d) of Section (2) § 24 of Act XXV of 1998 on
p.000001: Pharmaceuticals for Human Use (hereinafter referred to as “Drug Law”) and in compliance with the provisions of
p.000001: the Oviedo Convention of the European Council on the protection of the human rights and dignity of human beings in
p.000001: respect of the application of biology and medical science announced in Act VI of 2002 as well as of the Additional
p.000001: Protocol on the Prohibition of Cloning Human Beings I hereby order the followings:
p.000001: § 1 The provisions of this Decree are applicable to medical research conducted with investigational
p.000001: products intended for human use (Section 157 of the Health Care Act; hereinafter referred to as “clinical trial”).
p.000001: Non-interventional trials are not considered as clinical trials in case:
p.000001: a) the medicine is not prescribed for the purpose of the trial, and
p.000001: b)the product is prescribed in the usual manner in accordance with the terms of the marketing authorisation; and
p.000001: c) the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol
p.000001: but falls within current practice and the prescription of the medicine is clearly separated from the decision
p.000001: to include the patient in the study; and
p.000001: d) no additional diagnostic or monitoring procedure is used on the patient beyond the usual clinical practice, and
p.000001: e) only epidemiological methods will be used for the analysis of the collected data.
p.000001: § 2 (1) In term of this Decree:
p.000001: a) clinical trial: any investigation in human subjects carried out in either one site or multiple sites intended to
p.000001: aa) discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more
p.000001: investigational medicinal product(s),
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p.000001: or summary of product characteristics for an authorised product);
p.000001: p) equivalence study: the comparative analysis of the bioequivalence, pharmacodynamic or therapeutic equivalence of the
p.000001: investigational medicinal product with another medicine (based on pharmacokinetic results);
p.000001: q)
p.000001: r) SUSAR: Suspected Unexpected Serious Adverse Reaction;
p.000001: s) Phase I study: the investigation of the tolerability, safety, pharmacokinetics, pharmacodynamic
p.000001: effects of an investigational medicinal product in healthy volunteers or special patient populations. Phase I
p.000001: studies can also be conducted to establish the therapeutic dose range;
p.000001: t) Phase II study: a study of the investigational medicinal product for an indication selected on the basis of its
p.000001: pharmacological effect to establish its efficacy, the relationship between dose and effect, the optimal
p.000001: therapeutic dose as well as safety and tolerability.
p.000001: u) Phase III study: a randomized, controlled, comparative study involving a larger patient population to demonstrate
p.000001: the efficacy, safety and tolerability of the investigational medicinal product;
p.000001: v) Phase IV study: a study to further investigate the risk-benefit ratio, the safety and tolerability of
p.000001: the investigational medicinal product with a marketing authorization when used according to the summary of product
p.000001: characteristics.
p.000001: (2) With regard to matters not regulated in Section (1), for the purposes of this Decree, the definitions of terms in
p.000001: the Health Care Act, the Drug Law, the act on the approval procedure for medical research in humans, the clinical
p.000001: trial of investigational medicinal products for human use and clinical trial of medical devices intended
p.000001: for human use, the act on the marketing of medicines for human use, and the act on the personal and material
p.000001: conditions of the production of medicines for human use will be taken into account.
p.000001: (3) With regard to investigational medicinal products, the provisions of the legislation on the qualification
p.000001: criteria for the quality assurance pharmacist will also be applied mutatis mutandis.
p.000001: 3. § (1) Each clinical trial, including bioavailability and bioequivalence studies, must be planned,
p.000001: conducted and reported in line with the principles of Good Clinical Practice (hereinafter referred to as
p.000001: “GCP”) and the Helsinki Declaration on the ethical principles of medical research. The text of the GCP as
p.000001: amended will be published by the NIP in Hungarian language. An announcement regarding the publication and its place be
p.000001: made by the NIP in the Health Care Journal (Egészségügyi Közlöny).
p.000001: (2) At all times, clinical trials must be planned and conducted in accordance with the professional
p.000001: standards, in particular the detailed guides published by the European Commission on clinical trials
p.000001: as amended, which will be published by the NIP in Hungarian
p.000001:
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p.000002: translation.
p.000002: (3) A set of methodology guidelines on significant professional and ethical issues, in particular the
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p.000003: e) a description of reasonably expected benefits, or in the event participation in the clinical trial involves no
p.000003: benefit for the subject, communication of this fact;
p.000003: f) information on treatment, compensation and indemnification to be offered in case of occurrence of damages
p.000003: arising out of the clinical trial [Section (1) § 21 of the Health Care Act], and on the method of their use, as well as
p.000003: the name and availability of person and organisation in Hungary whom or which the subject may contact in case of
p.000003: occurrence of the damage;
p.000003: g) compensation of the subject for costs if any;
p.000003: h) notification of the fact that the consent is voluntary and uninfluenced, and may be revoked at any time either
p.000003: verbally or in writing without justification and any disadvantages to the subject;
p.000003: i) rules relating to the handling of the data of the subject and to their accessibility;
p.000003: j) detailed information on the essence of the application of the placebo if a placebo is used, and on the likelihood of
p.000003: the subject's getting into the placebo group;
p.000003: k) brief description of the effects of the investigational medicinal product;
p.000003: l) the future healthcare of the subject after completion of the trial, if required;
p.000003: m)
p.000003: n) the name of the insurance company stated in the liability insurance prescribed by Section (5)
p.000003: § 3 of Act XCV of 2005 on drugs to be used on humans and on the modification of other laws regulating the drug market.
p.000003: (5)
p.000003: (6)The subject's informed consent must contain at least the followings:
p.000003: a)identification data of the clinical trial;
p.000003: b)designation of the health service provider where the clinical trial will be conducted;
p.000003:
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p.000004: c)name, position, designation of the scope of the leader of the clinical trial and of the person giving information;
p.000004: d) identifiers of the subject (name, date and place of birth), and, in case of subjects with limited or no capacity to
p.000004: act, also the identifiers of the person authorized to give consent as defined in Section 16 § of the Health Care
p.000004: Act (hereinafter referred to as “the person authorized to give consent”);
p.000004: e) declaration by the subject, or, in the case of subjects with limited or no capacity to act, the person authorized to
p.000004: give consent, that his/her consent to participation in the clinical trial was given after receiving information
p.000004: according to Paragraph (1), voluntarily and freely, in awareness that it may be revoked any time, either
p.000004: verbally or in writing, without justification;
p.000004: f) date of the signature of the informed consent form;
p.000004: g) the signature of the principal investigator or of the person giving information;
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Searching for indicator substance:
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p.000001: to include the patient in the study; and
p.000001: d) no additional diagnostic or monitoring procedure is used on the patient beyond the usual clinical practice, and
p.000001: e) only epidemiological methods will be used for the analysis of the collected data.
p.000001: § 2 (1) In term of this Decree:
p.000001: a) clinical trial: any investigation in human subjects carried out in either one site or multiple sites intended to
p.000001: aa) discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more
p.000001: investigational medicinal product(s),
p.000001: ab) and/or to identify any adverse reactions to one or more investigational medicinal product(s)
p.000001: ac) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal
p.000001: product(s) with the objective of ascertaining its (their) safety and/or efficacy and/or risk- benefit ratio not
p.000001: including non-interventional trials;
p.000001: b) multi-centre clinical trial: clinical trials conducted in line with the same protocol at more than one
p.000001: investigational sites by more than one investigator, where investigational sites may be situated within the European
p.000001: Economic Area (hereinafter referred to as the EEA), or, pursuant to an international treaty concluded with the European
p.000001: Community or the EEA, in a state with a legal status identical to that of EEA states (hereinafter referred to as a
p.000001: state party to the EEA- treaty) and in third countries;
p.000001: c) investigational medicinal product: a pharmaceutical form of an active substance or placebo being tested or used as
p.000001: a reference (comparator) in a clinical trial, including products already with a marketing authorisation but used or
p.000001: assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised
p.000001: indication, or when used to gain further information about the authorised form;
p.000001: d)sponsor: a natural or legal entity, a company without a legal personality which takes responsibility
p.000001: for the initiation, management and/or financing of a clinical trial. The investigator and the
p.000001: sponsor may be the same entity;
p.000001: e) investigator: a person qualified as a physician or a dentist who is responsible for the conduction of
p.000001: the clinical trial at the investigational site;
p.000001: f) principal investigator: the leader responsible for the team if a trial is conducted by a team of individuals at the
p.000001: investigational site;
p.000001: g) investigator’s brochure: a compilation of the clinical and non-clinical data on the
p.000001: investigational medicinal product or products which are relevant to the study of the
p.000001: investigational product or products enabling the physician or the trial supervisor to objectively assess the
p.000001: risk-benefit ratio of the clinical trial. The sponsor must update the brochure at least once a year;
p.000001:
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p.000001: h) protocol: a document that describes the objective(s), design, methodology, statistical considerations and
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Health / Healthy People
Searching for indicator healthy volunteers:
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p.000006: withdraw from the trial at any time:
p.000006: d) except for the compensation as per Section 5 (11), no incentives, financial inducements, benefits or fees may be
p.000006: given to a subject;
p.000006: e) the research in question is essential to validate data obtained in clinical trials on persons with capacity to act
p.000006: or by other research methods and relates directly to a life-threatening or debilitating clinical condition
p.000006: from which the incapacitated adult concerned suffers;
p.000006: f) the clinical trial has been designed and will be conducted to minimise pain, anxiety, fear and any other
p.000006: foreseeable risk in relation to the current condition and developmental stage of the subject;
p.000006: g) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually specified,
p.000006: and are continuously monitored;
p.000006: h) the ETT-KFEB supports the protocol from special-ethical aspects in the possession of an expert opinion given
p.000006: in accordance with the disease in question and with the patient group concerned;
p.000006: i) it is reasonably expected that the application of the investigational medicinal product has beneficial
p.000006: effects in excess of the adverse effects for the patient, or does not constitute a risk at all.
p.000006: § 10 Persons enlisted in § 9 may not be involved in clinical trials as healthy volunteers.
p.000006: § 11 If a subject becomes mentally competent as a result of a judicial decision or of the change of his/her state
p.000006: during the clinical trial, he/she must be informed of the clinical trial as soon as possible, and his/her acceptance
p.000006: of its continuation must be acquired with the observance of the contents of § 6. Otherwise the clinical trial may not
p.000006: be continued on the persons involved.
p.000006:
p.000006: Prerequisites of applying for an official authorisation
p.000006:
p.000006: § 12 (1) If another natural or legal entity, or a company without a legal personality is assigned by the sponsor to
p.000006: discharge some or all of its responsibilities related to the trial, the sponsor remains liable for
p.000006: compliance with the provisions of this Decree and with the provisions of a separate law on clinical trials.
p.000006: If the sponsor is not established in one of the states which are party to the EEA-treaty, then its legal representative
p.000006: must be established in a state which is party to the EEA-agreement.
p.000006: (2) – (5)
p.000006:
p.000006: (6) The contract between the health service provider and the sponsor relating to the clinical trial of the
p.000006: investigational medicinal product may be signed also before the licensing procedure; however its validity is
p.000006: subject to the official licensing of the clinical trial.
p.000006: (7) Phase I clinical trials may only be conducted at investigational sites qualified by NIP as clinical
p.000006: pharmacological sites. The qualification process must be conducted upon the request of the head of the health care
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Searching for indicator volunteers:
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p.000001: investigational product or products enabling the physician or the trial supervisor to objectively assess the
p.000001: risk-benefit ratio of the clinical trial. The sponsor must update the brochure at least once a year;
p.000001:
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p.000001: h) protocol: a document that describes the objective(s), design, methodology, statistical considerations and
p.000001: organisation of a trial, also specifying the inclusion and exclusion criteria for trial subjects as well as
p.000001: monitoring and publication principles, including, successive versions of the protocol and protocol amendments;
p.000001: i) subject: an individual who participates in a clinical trial as either a recipient of the
p.000001: investigational medicinal product or a control;
p.000001: j) informed consent: the consent of an individual with capacity invited to participate in the trial obtained in
p.000001: accordance with Section 159 (1) e) of the Health Care Act, or with Section 159 (4) d) of the Health Care Act in case
p.000001: of persons with limited or no capacity to act;
p.000001: k) recruitment: public announcement by the health care provider conducting the clinical trial as authorised by the
p.000001: Országos Gyógyszerészeti Intézet (National Institute of Pharmacy, hereinafter referred to as “NIP”) for the
p.000001: inclusion of volunteers into a specific clinical trial as subjects in addition to the patients treated by the health
p.000001: care provider;
p.000001: l) adverse event: any untoward medical occurrence in a patient or clinical trial subject administered a
p.000001: medicinal product and which does not necessarily have a causal relationship with the treatment applied;
p.000001: m) adverse reaction: all untoward and unintended responses to an investigational medicinal product related to any dose
p.000001: administered;
p.000001: n) serious adverse reaction or serious adverse event: any untoward medical occurrence or effect that at any dose
p.000001: results in death, is life-threatening, requires hospitalisation or prolongation of existing
p.000001: hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly
p.000001: or birth defect;
p.000001: o) unexpected adverse reaction: an adverse reaction, the nature or severity of which is not consistent with the
p.000001: applicable product information (e.g. investigator's brochure for an unauthorised investigational product
p.000001: or summary of product characteristics for an authorised product);
p.000001: p) equivalence study: the comparative analysis of the bioequivalence, pharmacodynamic or therapeutic equivalence of the
p.000001: investigational medicinal product with another medicine (based on pharmacokinetic results);
p.000001: q)
p.000001: r) SUSAR: Suspected Unexpected Serious Adverse Reaction;
p.000001: s) Phase I study: the investigation of the tolerability, safety, pharmacokinetics, pharmacodynamic
p.000001: effects of an investigational medicinal product in healthy volunteers or special patient populations. Phase I
p.000001: studies can also be conducted to establish the therapeutic dose range;
p.000001: t) Phase II study: a study of the investigational medicinal product for an indication selected on the basis of its
p.000001: pharmacological effect to establish its efficacy, the relationship between dose and effect, the optimal
p.000001: therapeutic dose as well as safety and tolerability.
p.000001: u) Phase III study: a randomized, controlled, comparative study involving a larger patient population to demonstrate
p.000001: the efficacy, safety and tolerability of the investigational medicinal product;
p.000001: v) Phase IV study: a study to further investigate the risk-benefit ratio, the safety and tolerability of
p.000001: the investigational medicinal product with a marketing authorization when used according to the summary of product
p.000001: characteristics.
p.000001: (2) With regard to matters not regulated in Section (1), for the purposes of this Decree, the definitions of terms in
p.000001: the Health Care Act, the Drug Law, the act on the approval procedure for medical research in humans, the clinical
p.000001: trial of investigational medicinal products for human use and clinical trial of medical devices intended
p.000001: for human use, the act on the marketing of medicines for human use, and the act on the personal and material
p.000001: conditions of the production of medicines for human use will be taken into account.
p.000001: (3) With regard to investigational medicinal products, the provisions of the legislation on the qualification
p.000001: criteria for the quality assurance pharmacist will also be applied mutatis mutandis.
...
p.000002: accepted therapy.
p.000002: (5) The clinical trial must be planned and conducted in a way which minimises any possible injury, pain, fear
p.000002: or anxiety of the subject. During planning and control of the clinical trial all foreseeable risks relating to
p.000002: the age and health state of the subject must be taken into consideration.
p.000002: (6) The health state of the subject must be carefully controlled and documented before the commencement of
p.000002: the clinical trial, continuously during the clinical trial, and after the trial.
p.000002: (7) If the clinical trial involves the inclusion of persons of reproductive age, during the planning and
p.000002: approval of the clinical trial and the provision of information to subjects, particular attention must
p.000002: be paid to the impact of trial participation on the subject’s reproductive ability and pre-existing
p.000002: or subsequent pregnancy, as well as the health of the embryo or the foetus.
p.000002: (8)Act LXIII of 1992 on the protection of personal data and on the disclosure of data of public interest, and Act
p.000002: XLVII of 1997 on the handling and protection of health care data and of the relating personal data, as well as
p.000002: regulations relating to data handling covered by separate legal rules must be followed during the clinical trials.
p.000002: (9) With the exception of healthy volunteers, primarily patients receiving medical care from the health care
p.000002: provider conducting the clinical trial must be enrolled in clinical trials.
p.000002:
p.000003: 3
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p.000003:
p.000003: (10) The health care provider conducting the clinical trial may only recruit subjects with capacity to act
p.000003: through an announcement published in the printed press or on its own web site, as well as the website of
p.000003: professional and patient organisations or the sponsor. Such an announcement may not be published for
p.000003: advertising purposes, and may not specify the name and manufacturer of the investigational medicinal product, or the
p.000003: name of the entity authorised to market it. The recruitment announcement published must refer to the
p.000003: existence of the official authorisation.
p.000003: (11) Subjects may receive a compensation for their loss of income and actual and confirmed costs incurred in
p.000003: connection with their participation in the clinical trial, in particular travelling costs. No other remuneration
p.000003: or fee may be payable to subjects with the exception of non- therapeutic pharmacokinetic or interaction,
p.000003: Phase I or bio equivalence studies.
p.000003: (12)Investigational medicinal products and any tools used for their administration must be made available by the
p.000003: sponsor free.
p.000003:
p.000003: Subject information, informed consent to the clinical trial
p.000003: § 6 (1) The principal investigator or the investigator informs the mentally competent person to be involved in the
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.000002: Gazette (Hivatalos Értesítõ) published as a supplement of the Hungarian Official Journal.
p.000002: (4) This decree will be applied in line with Regulation (EC) No 1901/2006/EC of the European Parliament
p.000002: and of the Council on medicinal products for paediatric use amending Regulation (EEC) No 1768/92, Directive
p.000002: 2001/20/EC, Directive2001/83/EC and Regulation (EC) No 726/2004 as well as EC/1394/2007 of the European Parliament
p.000002: and of the Council of
p.000002: 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and
p.000002: Regulation (EC) No 726/2004.
p.000002:
p.000002:
p.000002:
p.000002: Protection of trial subjects
p.000002:
p.000002: § 4 The rights, safety and welfare of the subject have a priority over the interests of the science and society,
p.000002: therefore the exposure of the subjects to risks must be limited to the minimum extent.
p.000002: §5(1) Clinical trials may be conducted, and investigational medicinal products may be used on humans only in the
p.000002: possession of the NIP's authorisation. Clinical trials may be conducted only according to terms specified in the NIP's
p.000002: approval resolution, and to the requirements given in the approved protocol. Terms specified in the approval
p.000002: resolution of the clinical trial, and the requirements given in the authorized protocol, as well
p.000002: as requirements relating to the commencement and control of clinical trials are qualified as occupational
p.000002: rules.
p.000002: (2) Mentally competent persons may be involved in clinical trials only if terms specified in Sections (1)
p.000002: to (3) of § 159 of the Health Care Act and requirements given in this regulation are met.
p.000002: (3) The clinical trial may not replace studies and medical treatments necessary on the basis of the state of the
p.000002: subject.
p.000002: (4) In the event the use of placebo is planned, the research documentation attached to the application
p.000002: for official authorisation must contain a case-specific justification of the necessity for the use of a control
p.000002: group in the trial. The use of placebo may not pose substantial additional risks to the subject or the threat
p.000002: of irreversible health injury. Placebo may only be used for the shortest time required, the subject’s condition
p.000002: must be continuously monitored throughout the trial, and in case of any symptoms indicating substantial
p.000002: deterioration in the subject’s condition, the subject must immediately receive the best available scientifically
p.000002: accepted therapy.
p.000002: (5) The clinical trial must be planned and conducted in a way which minimises any possible injury, pain, fear
p.000002: or anxiety of the subject. During planning and control of the clinical trial all foreseeable risks relating to
p.000002: the age and health state of the subject must be taken into consideration.
p.000002: (6) The health state of the subject must be carefully controlled and documented before the commencement of
...
p.000002: provider conducting the clinical trial must be enrolled in clinical trials.
p.000002:
p.000003: 3
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p.000003:
p.000003: (10) The health care provider conducting the clinical trial may only recruit subjects with capacity to act
p.000003: through an announcement published in the printed press or on its own web site, as well as the website of
p.000003: professional and patient organisations or the sponsor. Such an announcement may not be published for
p.000003: advertising purposes, and may not specify the name and manufacturer of the investigational medicinal product, or the
p.000003: name of the entity authorised to market it. The recruitment announcement published must refer to the
p.000003: existence of the official authorisation.
p.000003: (11) Subjects may receive a compensation for their loss of income and actual and confirmed costs incurred in
p.000003: connection with their participation in the clinical trial, in particular travelling costs. No other remuneration
p.000003: or fee may be payable to subjects with the exception of non- therapeutic pharmacokinetic or interaction,
p.000003: Phase I or bio equivalence studies.
p.000003: (12)Investigational medicinal products and any tools used for their administration must be made available by the
p.000003: sponsor free.
p.000003:
p.000003: Subject information, informed consent to the clinical trial
p.000003: § 6 (1) The principal investigator or the investigator informs the mentally competent person to be involved in the
p.000003: clinical trial orally and in writing in Hungarian - or in the mother tongue of the person or in any other language
p.000003: designated by the person as known to him/her - in a way interpretable even for the laic on the contents of
p.000003: Sections (3) and (4) of § 159 of the Health Care Act.
p.000003: (2)Person giving information must take a special care to establish if the person to be involved in the study is
p.000003: mentally competent or not. Establishments made in relation to it are recorded by the person giving information in the
p.000003: research and health documentation.
p.000003: (3)The information and the informed consent must be recorded on a separate sheet in writing. One original of the
p.000003: informed consent and of the written information must be retained in the research documentation, and one
p.000003: original must be handed over to the subject.
p.000003: (4)The written information must contain, in particular, the followings:
p.000003:
p.000003: a) identification data of the clinical trial;
p.000003: b) reference to the research nature of the clinical trial, the purpose of the clinical trial, its
p.000003: expected duration, the number of persons to be involved, the process of the clinical trial, the nature and
p.000003: frequency of the proposed interventions
p.000003: c) all other accepted treatment options available to the subject, information regarding the possibility that
p.000003: the clinical trial may interrupt the treatment already in progress, and the potential consequences of suspension of the
p.000003: treatment already in progress for the subject;
p.000003: d) detailed description of the possible and expected consequences, risks and discomforts, as well as reference if
p.000003: adverse events may occur during the clinical trial which are unforeseeable;
p.000003: e) a description of reasonably expected benefits, or in the event participation in the clinical trial involves no
p.000003: benefit for the subject, communication of this fact;
p.000003: f) information on treatment, compensation and indemnification to be offered in case of occurrence of damages
...
p.000005: in the required manner, including storage in accordance with Section 6/A (2) g).
p.000005: h) the statement of the subject regarding the inclusion of the sample deposited in the biobank for further
p.000005: investigations; in this case, the subject must make a statement regarding whether he or she consents to the use of the
p.000005: sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes, depending on
p.000005: the primary purpose of the sampling,
p.000005: i) disclosure of the results even in the event the subject has no access to them,
p.000005: j) consent to or rejection of the possibility of being contacted in the future
p.000005: k) date of signature on the informed consent;
p.000005: l) signatures of the principal investigator or the person providing the information;
p.000005: m) signature of the person giving the informed consent.
p.000005:
p.000005: Clinical trials made on persons of minor age
p.000005:
p.000005: § 7 Clinical trial may be conducted on persons of minor age, even if the contents of Section (4) § 159 and of § 4 to §
p.000005: 6 of Health Care Act are adequately followed, if all the following terms are met:
p.000005: a) the research in question is indispensable for the validation of data acquired with clinical trials made on mentally
p.000005: competent persons or with other research methods;
p.000005: b) the research is directly related to the clinical aspect from which the person of minor age suffers,
p.000005: or is of a nature which may be conducted only on persons of minor age;
p.000005: c) the informed consent given by the person entitled to make a declaration contains the presumable will
p.000005: of the person of minor age capable of having an opinion and evaluating the situation, and this declaration
p.000005: may be withdrawn at any time without causing any disadvantage to the person of minor age;
p.000005: d) the investigator having an experience in connection with persons of minor age adequately informed the
p.000005: person of minor age on the investigation, its adverse and beneficial effects in a way understandable to him/her -
p.000005: depending on his/her intellectual level;
...
p.000005: investigator or the principal investigator;
p.000005: f except for the compensation as per Section 5 § (11), no incentives, financial inducements, benefits or
p.000005: fees may be given to a minor subject;
p.000005: g) the relevant scientific guides of the European Medicines Agency established by the European Parliament's and the
p.000005: Council's Regulation 726/2004/EC on the specification of community procedures relating to the licensing and
p.000005: supervision of drugs destined for human or veterinary treatment purposes, and on the establishment of the
p.000005: European Medicines Agency (hereinafter: EMEA) are observed;
p.000005: h) the clinical trial was planned and is conducted with the minimisation of pain, anxiety, fear and of any other
p.000005: risk foreseeable in connection with the disease and with the state of advancement of the person of minor age;
p.000005: i) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually
p.000005: specified, and are continuously monitored;
p.000005: j) the ECCP OF MRC supports the protocol from special-ethical aspects in the possession of the expert opinion of a
p.000005: paediatrician.
p.000005: Clinical trials on adults with no capacity to act
p.000005:
p.000005: § 8 Persons, who definitely refused to take part in such trials previously when they were mentally
p.000005: competent, may not be involved in any clinical trials. Persons, who refused to accept the given trial previously
p.000005: when they were mentally competent, may not be involved in the given
p.000006: 6
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p.000006:
p.000006: clinical trial either.
p.000006: § 9 With the exception of emergency research as defined in Section 160 of the Health Care Act, even if the provisions
p.000006: of Section 159 (4), Sections 4 through 6 and Section 8 of the Health Care Act are applied, clinical trials may
p.000006: only be conducted on majors placed under guardianship excluding or limiting their capacity if all of the
p.000006: following conditions are met:
p.000006: a) the informed consent of person authorized to give consent must represent the presumed will of a subject and it may
p.000006: be revoked at any time without detriment to the subject;
p.000006: b) the subject was informed of the trial, of its beneficial and adverse effects in a comprehensible manner;
p.000006: c) the investigator and the principal investigator fully takes it into consideration, if the subject capable of having
p.000006: an opinion and evaluating the situation definitely refuses to take part in the clinical trial or wants to
p.000006: withdraw from the trial at any time:
p.000006: d) except for the compensation as per Section 5 (11), no incentives, financial inducements, benefits or fees may be
p.000006: given to a subject;
p.000006: e) the research in question is essential to validate data obtained in clinical trials on persons with capacity to act
p.000006: or by other research methods and relates directly to a life-threatening or debilitating clinical condition
p.000006: from which the incapacitated adult concerned suffers;
p.000006: f) the clinical trial has been designed and will be conducted to minimise pain, anxiety, fear and any other
p.000006: foreseeable risk in relation to the current condition and developmental stage of the subject;
p.000006: g) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually specified,
p.000006: and are continuously monitored;
p.000006: h) the ETT-KFEB supports the protocol from special-ethical aspects in the possession of an expert opinion given
p.000006: in accordance with the disease in question and with the patient group concerned;
p.000006: i) it is reasonably expected that the application of the investigational medicinal product has beneficial
p.000006: effects in excess of the adverse effects for the patient, or does not constitute a risk at all.
p.000006: § 10 Persons enlisted in § 9 may not be involved in clinical trials as healthy volunteers.
p.000006: § 11 If a subject becomes mentally competent as a result of a judicial decision or of the change of his/her state
p.000006: during the clinical trial, he/she must be informed of the clinical trial as soon as possible, and his/her acceptance
p.000006: of its continuation must be acquired with the observance of the contents of § 6. Otherwise the clinical trial may not
p.000006: be continued on the persons involved.
p.000006:
p.000006: Prerequisites of applying for an official authorisation
p.000006:
p.000006: § 12 (1) If another natural or legal entity, or a company without a legal personality is assigned by the sponsor to
p.000006: discharge some or all of its responsibilities related to the trial, the sponsor remains liable for
p.000006: compliance with the provisions of this Decree and with the provisions of a separate law on clinical trials.
p.000006: If the sponsor is not established in one of the states which are party to the EEA-treaty, then its legal representative
p.000006: must be established in a state which is party to the EEA-agreement.
p.000006: (2) – (5)
p.000006:
p.000006: (6) The contract between the health service provider and the sponsor relating to the clinical trial of the
p.000006: investigational medicinal product may be signed also before the licensing procedure; however its validity is
p.000006: subject to the official licensing of the clinical trial.
p.000006: (7) Phase I clinical trials may only be conducted at investigational sites qualified by NIP as clinical
p.000006: pharmacological sites. The qualification process must be conducted upon the request of the head of the health care
p.000006: provider. In the course of the qualification process, NIP will conduct an on-site inspection. The qualification process
...
Searching for indicator disability:
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p.000001: i) subject: an individual who participates in a clinical trial as either a recipient of the
p.000001: investigational medicinal product or a control;
p.000001: j) informed consent: the consent of an individual with capacity invited to participate in the trial obtained in
p.000001: accordance with Section 159 (1) e) of the Health Care Act, or with Section 159 (4) d) of the Health Care Act in case
p.000001: of persons with limited or no capacity to act;
p.000001: k) recruitment: public announcement by the health care provider conducting the clinical trial as authorised by the
p.000001: Országos Gyógyszerészeti Intézet (National Institute of Pharmacy, hereinafter referred to as “NIP”) for the
p.000001: inclusion of volunteers into a specific clinical trial as subjects in addition to the patients treated by the health
p.000001: care provider;
p.000001: l) adverse event: any untoward medical occurrence in a patient or clinical trial subject administered a
p.000001: medicinal product and which does not necessarily have a causal relationship with the treatment applied;
p.000001: m) adverse reaction: all untoward and unintended responses to an investigational medicinal product related to any dose
p.000001: administered;
p.000001: n) serious adverse reaction or serious adverse event: any untoward medical occurrence or effect that at any dose
p.000001: results in death, is life-threatening, requires hospitalisation or prolongation of existing
p.000001: hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly
p.000001: or birth defect;
p.000001: o) unexpected adverse reaction: an adverse reaction, the nature or severity of which is not consistent with the
p.000001: applicable product information (e.g. investigator's brochure for an unauthorised investigational product
p.000001: or summary of product characteristics for an authorised product);
p.000001: p) equivalence study: the comparative analysis of the bioequivalence, pharmacodynamic or therapeutic equivalence of the
p.000001: investigational medicinal product with another medicine (based on pharmacokinetic results);
p.000001: q)
p.000001: r) SUSAR: Suspected Unexpected Serious Adverse Reaction;
p.000001: s) Phase I study: the investigation of the tolerability, safety, pharmacokinetics, pharmacodynamic
p.000001: effects of an investigational medicinal product in healthy volunteers or special patient populations. Phase I
p.000001: studies can also be conducted to establish the therapeutic dose range;
p.000001: t) Phase II study: a study of the investigational medicinal product for an indication selected on the basis of its
p.000001: pharmacological effect to establish its efficacy, the relationship between dose and effect, the optimal
p.000001: therapeutic dose as well as safety and tolerability.
p.000001: u) Phase III study: a randomized, controlled, comparative study involving a larger patient population to demonstrate
p.000001: the efficacy, safety and tolerability of the investigational medicinal product;
p.000001: v) Phase IV study: a study to further investigate the risk-benefit ratio, the safety and tolerability of
...
Health / Motherhood/Family
Searching for indicator family:
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p.000004: the subject received the information as defined in Paragraph (4), was advised of the content of the informed consent as
p.000004: defined in Paragraph (6), and consented to it verbally.
p.000004: (9) If any new substantial information becomes available in connection with the clinical trial that would affect the
p.000004: contents of the written information, an amendment of the authorisation must be initiated in accordance with the
p.000004: provisions of Section 18. The subject must be informed again in conformity with the amended written information, and
p.000004: his or her consent must be requested for the continuation of the clinical trial.
p.000004: 6/A. § (1) If a sample is collected during the clinical trial for human genetic testing, the subject must
p.000004: be informed separately about the procedure. Information must also cover the subject’s right to refuse to
p.000004: give a sample, in which case the genetic data of the subject may not be used even anonymously. Refusal to give a
p.000004: sample will not constitute an obstacle to the subject’s participation in the rest of the clinical
p.000004: trial. Information on and consent to the sampling will be included in a separate document.
p.000004: (2) Before collection of a sample for human genetic testing, as part of a genetic consultation, the subject must be
p.000004: advised of
p.000004: a) the purpose and quantitative and qualitative details of the sampling,
p.000004: b) the risks and benefits of the testing and lack of testing,
p.000004: c) the potential consequences of the findings for the subject and his or her family,
p.000004: d) the manner and duration of the storage of the genetic sample and data and the various options regarding the
p.000004: identification of the genetic samples and data stored in different forms,
p.000004: e) if not specified otherwise in a statement by the subject, the potential transfer of the genetic
p.000004: sample into an archived collection,
p.000004: f) the subject’s right to learn about the genetic data generated during the human genetics testing,
p.000004: g) the option to decide about depositing the sample in a biobank and about the manner of deposition, including
p.000004: (ga) storage with personal identification information, (gb) storage with data encryption,
p.000004: (gc) storage with pseudonymised data, meaning the code that replaces personal identification
p.000004: information will be known only to the subject,
p.000004: (gd) storage with anonymised data, meaning all personal identification information of the subject has been made
p.000004: unsuitable for identification.
p.000004: (3) The subject must be informed of the option to include the sample deposited in the biobank for
p.000004: further investigations. In this case, the subject must make a statement regarding whether he or she consents to
p.000004: the use of the sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes,
p.000004: depending on the primary purpose of the sampling.
p.000004: 6/B. § (1) If a sample is collected during the trial for human genetic testing, a separate informed
p.000004: consent will be prepared.
p.000004: (2) The subject’s informed consent will include the following as a minimum:
p.000004: a) identifiers of the clinical trial;
...
Social / Access to Social Goods
Searching for indicator access:
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p.000005: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000005:
p.000005: defined in Section 16 of the Health Care Act (hereinafter referred to as “person authorized to give consent”);
p.000005: e) declaration by the subject, or, in the case of subjects with limited or no capacity to act, the person authorized
p.000005: to give consent, that his/her consent to participation in genetic testing for pharmacology purpose was given
p.000005: after accepting or declining the provision of information as specified in Section 6/A, voluntarily and freely, in
p.000005: awareness that it may be revoked any time, either verbally or in writing, without justification;
p.000005: f) consent to the collection of sample in the quantity and quality specified in the information and to the use of the
p.000005: data of the subject,
p.000005: g) the statement on the storage of samples, with the option to deposit the sample provided by him or her in a biobank
p.000005: in the required manner, including storage in accordance with Section 6/A (2) g).
p.000005: h) the statement of the subject regarding the inclusion of the sample deposited in the biobank for further
p.000005: investigations; in this case, the subject must make a statement regarding whether he or she consents to the use of the
p.000005: sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes, depending on
p.000005: the primary purpose of the sampling,
p.000005: i) disclosure of the results even in the event the subject has no access to them,
p.000005: j) consent to or rejection of the possibility of being contacted in the future
p.000005: k) date of signature on the informed consent;
p.000005: l) signatures of the principal investigator or the person providing the information;
p.000005: m) signature of the person giving the informed consent.
p.000005:
p.000005: Clinical trials made on persons of minor age
p.000005:
p.000005: § 7 Clinical trial may be conducted on persons of minor age, even if the contents of Section (4) § 159 and of § 4 to §
p.000005: 6 of Health Care Act are adequately followed, if all the following terms are met:
p.000005: a) the research in question is indispensable for the validation of data acquired with clinical trials made on mentally
p.000005: competent persons or with other research methods;
p.000005: b) the research is directly related to the clinical aspect from which the person of minor age suffers,
p.000005: or is of a nature which may be conducted only on persons of minor age;
p.000005: c) the informed consent given by the person entitled to make a declaration contains the presumable will
...
p.000008: event jeopardising subject safety or concerning the continuation of the trial or the development of the
p.000008: investigational medicinal product become known to them. The sponsor shall immediately but no later than 24 hours
p.000008: notify NIP ETT-KFEB of such events and measures taken.
p.000008:
p.000008: Report on the completion of the trial
p.000008:
p.000008: § 23 (1) The sponsor notifies the NIP of the completion of the trial, of the number of patients involved, and of
p.000008: significant events on a data-sheet downloadable from the webpage of the EMEA within ninety days from the completion of
p.000008: the trial. The NIP informs the ETT-KFEB within eight days from the notification.
p.000008:
p.000009: 9
p.000009:
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p.000009:
p.000009: Retaining of trial documentation
p.000009:
p.000009: § 24 (1) The trial master file must contain all basic documents which make it possible to evaluate
p.000009: both the conduction of the clinical trial and the quality of the data. Documents must evidence if the
p.000009: investigators and the sponsor met the principles of GCP. The trial master file serves as a basis for
p.000009: inspections made by inspectors independent from the sponsor or by authorities.
p.000009: (2) The sponsor and the investigator must retain basic documents relating to the clinical trial, necessary
p.000009: for the post-control of the clinical trial at least for five years after the completion of the trial, and must archive
p.000009: them in a way which enables easy retrieval. The sponsor must designate persons who are responsible for the archiving at
p.000009: the sponsor, and access to the archives must be limited exclusively to persons authorised to have an access.
p.000009: (3) Any change in the processed data and in the ownership of the documentation of the trial must be
p.000009: documented. The new owner must undertake to observe regulations relating to data- handling and archiving in
p.000009: a written declaration.
p.000009: (4) Data-carriers used for archiving must provide for complete and legible documents.
p.000009:
p.000009: Miscellaneous and transitional provisions
p.000009:
p.000009: § 25 (1) This decree comes into force on 15lh September, 2005 - except for the contents of Section (2)
p.000009: -, and its regulations must be applied in procedures launched after its coming into effect.
p.000009: (2) The provisions in Section (9), subsection n) of Section (4) § 6, and subsection m) of Section
p.000009: (2) § 17 - with the deviation given in Section (4) - come into force on 1st November, 2005. (3)
p.000009: (4)
p.000009: (5) – (6)
p.000009: (7) The sponsor is required to pay an administrative service fee for the proceedings regulated in this Decree in the
p.000009: amount as defined in a separate law. The administrative service fee is exclusive of value added tax. No administrative
p.000009: service fee is charged for the approval procedure of non- commercial trials.
p.000009: (8)
p.000009: (9)
p.000009:
p.000009: (10)
p.000009: (11)The purpose of this Decree is to ensure compliance with the following Union acts:
p.000009:
p.000009: a) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.000009: laws, regulations and administrative provisions of the Member States relating to the implementation of
p.000009: good clinical practice in the conduct of clinical trials on medicinal products for human use;
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Social / Age
Searching for indicator age:
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p.000002: as requirements relating to the commencement and control of clinical trials are qualified as occupational
p.000002: rules.
p.000002: (2) Mentally competent persons may be involved in clinical trials only if terms specified in Sections (1)
p.000002: to (3) of § 159 of the Health Care Act and requirements given in this regulation are met.
p.000002: (3) The clinical trial may not replace studies and medical treatments necessary on the basis of the state of the
p.000002: subject.
p.000002: (4) In the event the use of placebo is planned, the research documentation attached to the application
p.000002: for official authorisation must contain a case-specific justification of the necessity for the use of a control
p.000002: group in the trial. The use of placebo may not pose substantial additional risks to the subject or the threat
p.000002: of irreversible health injury. Placebo may only be used for the shortest time required, the subject’s condition
p.000002: must be continuously monitored throughout the trial, and in case of any symptoms indicating substantial
p.000002: deterioration in the subject’s condition, the subject must immediately receive the best available scientifically
p.000002: accepted therapy.
p.000002: (5) The clinical trial must be planned and conducted in a way which minimises any possible injury, pain, fear
p.000002: or anxiety of the subject. During planning and control of the clinical trial all foreseeable risks relating to
p.000002: the age and health state of the subject must be taken into consideration.
p.000002: (6) The health state of the subject must be carefully controlled and documented before the commencement of
p.000002: the clinical trial, continuously during the clinical trial, and after the trial.
p.000002: (7) If the clinical trial involves the inclusion of persons of reproductive age, during the planning and
p.000002: approval of the clinical trial and the provision of information to subjects, particular attention must
p.000002: be paid to the impact of trial participation on the subject’s reproductive ability and pre-existing
p.000002: or subsequent pregnancy, as well as the health of the embryo or the foetus.
p.000002: (8)Act LXIII of 1992 on the protection of personal data and on the disclosure of data of public interest, and Act
p.000002: XLVII of 1997 on the handling and protection of health care data and of the relating personal data, as well as
p.000002: regulations relating to data handling covered by separate legal rules must be followed during the clinical trials.
p.000002: (9) With the exception of healthy volunteers, primarily patients receiving medical care from the health care
p.000002: provider conducting the clinical trial must be enrolled in clinical trials.
p.000002:
p.000003: 3
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p.000003:
p.000003: (10) The health care provider conducting the clinical trial may only recruit subjects with capacity to act
p.000003: through an announcement published in the printed press or on its own web site, as well as the website of
p.000003: professional and patient organisations or the sponsor. Such an announcement may not be published for
...
p.000005: after accepting or declining the provision of information as specified in Section 6/A, voluntarily and freely, in
p.000005: awareness that it may be revoked any time, either verbally or in writing, without justification;
p.000005: f) consent to the collection of sample in the quantity and quality specified in the information and to the use of the
p.000005: data of the subject,
p.000005: g) the statement on the storage of samples, with the option to deposit the sample provided by him or her in a biobank
p.000005: in the required manner, including storage in accordance with Section 6/A (2) g).
p.000005: h) the statement of the subject regarding the inclusion of the sample deposited in the biobank for further
p.000005: investigations; in this case, the subject must make a statement regarding whether he or she consents to the use of the
p.000005: sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes, depending on
p.000005: the primary purpose of the sampling,
p.000005: i) disclosure of the results even in the event the subject has no access to them,
p.000005: j) consent to or rejection of the possibility of being contacted in the future
p.000005: k) date of signature on the informed consent;
p.000005: l) signatures of the principal investigator or the person providing the information;
p.000005: m) signature of the person giving the informed consent.
p.000005:
p.000005: Clinical trials made on persons of minor age
p.000005:
p.000005: § 7 Clinical trial may be conducted on persons of minor age, even if the contents of Section (4) § 159 and of § 4 to §
p.000005: 6 of Health Care Act are adequately followed, if all the following terms are met:
p.000005: a) the research in question is indispensable for the validation of data acquired with clinical trials made on mentally
p.000005: competent persons or with other research methods;
p.000005: b) the research is directly related to the clinical aspect from which the person of minor age suffers,
p.000005: or is of a nature which may be conducted only on persons of minor age;
p.000005: c) the informed consent given by the person entitled to make a declaration contains the presumable will
p.000005: of the person of minor age capable of having an opinion and evaluating the situation, and this declaration
p.000005: may be withdrawn at any time without causing any disadvantage to the person of minor age;
p.000005: d) the investigator having an experience in connection with persons of minor age adequately informed the
p.000005: person of minor age on the investigation, its adverse and beneficial effects in a way understandable to him/her -
p.000005: depending on his/her intellectual level;
p.000005: e) the explicit wish of a minor who is capable of forming an opinion and assessing this information to
p.000005: refuse participation or to be withdrawn from the clinical trial at any time is taken into consideration by the
p.000005: investigator or the principal investigator;
p.000005: f except for the compensation as per Section 5 § (11), no incentives, financial inducements, benefits or
p.000005: fees may be given to a minor subject;
p.000005: g) the relevant scientific guides of the European Medicines Agency established by the European Parliament's and the
p.000005: Council's Regulation 726/2004/EC on the specification of community procedures relating to the licensing and
p.000005: supervision of drugs destined for human or veterinary treatment purposes, and on the establishment of the
p.000005: European Medicines Agency (hereinafter: EMEA) are observed;
p.000005: h) the clinical trial was planned and is conducted with the minimisation of pain, anxiety, fear and of any other
p.000005: risk foreseeable in connection with the disease and with the state of advancement of the person of minor age;
p.000005: i) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually
p.000005: specified, and are continuously monitored;
p.000005: j) the ECCP OF MRC supports the protocol from special-ethical aspects in the possession of the expert opinion of a
p.000005: paediatrician.
p.000005: Clinical trials on adults with no capacity to act
p.000005:
p.000005: § 8 Persons, who definitely refused to take part in such trials previously when they were mentally
p.000005: competent, may not be involved in any clinical trials. Persons, who refused to accept the given trial previously
p.000005: when they were mentally competent, may not be involved in the given
p.000006: 6
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p.000006:
p.000006: clinical trial either.
p.000006: § 9 With the exception of emergency research as defined in Section 160 of the Health Care Act, even if the provisions
p.000006: of Section 159 (4), Sections 4 through 6 and Section 8 of the Health Care Act are applied, clinical trials may
p.000006: only be conducted on majors placed under guardianship excluding or limiting their capacity if all of the
p.000006: following conditions are met:
...
p.000010: 2. The investigator must have
p.000010: a) a specialist's qualification in any clinical field,
p.000010: b) a certification exam on clinical pharmacology or a certification of a successful examination at a GCP course
p.000010: organised by a university, and not older than five years before the commencement of the clinical trial.
p.000010:
p.000010: 3. The principal investigator must have completed a certification exam on clinical pharmacology.
p.000010:
p.000010: //. Clinical investigational site for trial in phase II
p.000010:
p.000010: A) Material terms:
p.000010:
p.000010: In-patient ward or a special out-patient clinic at a university clinic or hospital, or other specialist's
p.000010: surgery which has an intensive therapeutic division background within the institute, as well as adequate diagnostic
p.000010: units the facilities and personnel, and which meets the personal and material minimum terms relating to the health
p.000010: institution and specified in a separate legal rule, and is provided with tools and facilities necessary for the
p.000010: conduction of the proposed trial.
p.000010:
p.000010: B) Personal terms:
p.000010:
p.000010: The principal investigator must have a specialist’s qualification in a clinical field corresponding with the intended
p.000010: use of the investigational medicinal product, with a certification exam on
p.000011: 11
p.000011:
p.000011: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000011:
p.000011: clinical pharmacology, or a certificate confirming successful completion of a GCP training course organised by a
p.000011: university not more than five years ago. In case persons of minor age are also included in the trial, a
p.000011: paediatrician must be also involved as an investigator.
p.000011:
p.000011:
p.000011: ///. Clinical investigational site for other clinical trials
p.000011: 1. Other clinical trials may be conducted if material terms specified in article II. A) are met, as well as in a
p.000011: physician's or paediatrician's surgery.
p.000011: 2. The principal investigator must have a certificate confirming successful completion of a GCP training
p.000011: course organised by a university not more than five years ago.
p.000011:
p.000011: Annex 3 to Decree 35/2005 (VIII. 26.) of the Minister of Health
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
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p.000011:
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p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
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p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
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p.000011:
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p.000011:
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p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000002: of irreversible health injury. Placebo may only be used for the shortest time required, the subject’s condition
p.000002: must be continuously monitored throughout the trial, and in case of any symptoms indicating substantial
p.000002: deterioration in the subject’s condition, the subject must immediately receive the best available scientifically
p.000002: accepted therapy.
p.000002: (5) The clinical trial must be planned and conducted in a way which minimises any possible injury, pain, fear
p.000002: or anxiety of the subject. During planning and control of the clinical trial all foreseeable risks relating to
p.000002: the age and health state of the subject must be taken into consideration.
p.000002: (6) The health state of the subject must be carefully controlled and documented before the commencement of
p.000002: the clinical trial, continuously during the clinical trial, and after the trial.
p.000002: (7) If the clinical trial involves the inclusion of persons of reproductive age, during the planning and
p.000002: approval of the clinical trial and the provision of information to subjects, particular attention must
p.000002: be paid to the impact of trial participation on the subject’s reproductive ability and pre-existing
p.000002: or subsequent pregnancy, as well as the health of the embryo or the foetus.
p.000002: (8)Act LXIII of 1992 on the protection of personal data and on the disclosure of data of public interest, and Act
p.000002: XLVII of 1997 on the handling and protection of health care data and of the relating personal data, as well as
p.000002: regulations relating to data handling covered by separate legal rules must be followed during the clinical trials.
p.000002: (9) With the exception of healthy volunteers, primarily patients receiving medical care from the health care
p.000002: provider conducting the clinical trial must be enrolled in clinical trials.
p.000002:
p.000003: 3
p.000003: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000003:
p.000003: (10) The health care provider conducting the clinical trial may only recruit subjects with capacity to act
p.000003: through an announcement published in the printed press or on its own web site, as well as the website of
p.000003: professional and patient organisations or the sponsor. Such an announcement may not be published for
p.000003: advertising purposes, and may not specify the name and manufacturer of the investigational medicinal product, or the
p.000003: name of the entity authorised to market it. The recruitment announcement published must refer to the
p.000003: existence of the official authorisation.
p.000003: (11) Subjects may receive a compensation for their loss of income and actual and confirmed costs incurred in
p.000003: connection with their participation in the clinical trial, in particular travelling costs. No other remuneration
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000001: u) Phase III study: a randomized, controlled, comparative study involving a larger patient population to demonstrate
p.000001: the efficacy, safety and tolerability of the investigational medicinal product;
p.000001: v) Phase IV study: a study to further investigate the risk-benefit ratio, the safety and tolerability of
p.000001: the investigational medicinal product with a marketing authorization when used according to the summary of product
p.000001: characteristics.
p.000001: (2) With regard to matters not regulated in Section (1), for the purposes of this Decree, the definitions of terms in
p.000001: the Health Care Act, the Drug Law, the act on the approval procedure for medical research in humans, the clinical
p.000001: trial of investigational medicinal products for human use and clinical trial of medical devices intended
p.000001: for human use, the act on the marketing of medicines for human use, and the act on the personal and material
p.000001: conditions of the production of medicines for human use will be taken into account.
p.000001: (3) With regard to investigational medicinal products, the provisions of the legislation on the qualification
p.000001: criteria for the quality assurance pharmacist will also be applied mutatis mutandis.
p.000001: 3. § (1) Each clinical trial, including bioavailability and bioequivalence studies, must be planned,
p.000001: conducted and reported in line with the principles of Good Clinical Practice (hereinafter referred to as
p.000001: “GCP”) and the Helsinki Declaration on the ethical principles of medical research. The text of the GCP as
p.000001: amended will be published by the NIP in Hungarian language. An announcement regarding the publication and its place be
p.000001: made by the NIP in the Health Care Journal (Egészségügyi Közlöny).
p.000001: (2) At all times, clinical trials must be planned and conducted in accordance with the professional
p.000001: standards, in particular the detailed guides published by the European Commission on clinical trials
p.000001: as amended, which will be published by the NIP in Hungarian
p.000001:
p.000002: 2
p.000002: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000002:
p.000002: translation.
p.000002: (3) A set of methodology guidelines on significant professional and ethical issues, in particular the
p.000002: definition of and distinction between clinical study phases and the use of placebo in clinical trials will be published
p.000002: by NIP and the Ethics Committee for Clinical Pharmacology of the Medical Research Council (hereinafter referred to as
p.000002: ETT-KFEB), an independent ethics committee as defined in a separate law. An announcement regarding the
p.000002: publication of the guidelines and its place will be placed by the NIP and ETT-KFEB in the Official
p.000002: Gazette (Hivatalos Értesítõ) published as a supplement of the Hungarian Official Journal.
p.000002: (4) This decree will be applied in line with Regulation (EC) No 1901/2006/EC of the European Parliament
p.000002: and of the Council on medicinal products for paediatric use amending Regulation (EEC) No 1768/92, Directive
p.000002: 2001/20/EC, Directive2001/83/EC and Regulation (EC) No 726/2004 as well as EC/1394/2007 of the European Parliament
p.000002: and of the Council of
...
p.000003: 3
p.000003: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000003:
p.000003: (10) The health care provider conducting the clinical trial may only recruit subjects with capacity to act
p.000003: through an announcement published in the printed press or on its own web site, as well as the website of
p.000003: professional and patient organisations or the sponsor. Such an announcement may not be published for
p.000003: advertising purposes, and may not specify the name and manufacturer of the investigational medicinal product, or the
p.000003: name of the entity authorised to market it. The recruitment announcement published must refer to the
p.000003: existence of the official authorisation.
p.000003: (11) Subjects may receive a compensation for their loss of income and actual and confirmed costs incurred in
p.000003: connection with their participation in the clinical trial, in particular travelling costs. No other remuneration
p.000003: or fee may be payable to subjects with the exception of non- therapeutic pharmacokinetic or interaction,
p.000003: Phase I or bio equivalence studies.
p.000003: (12)Investigational medicinal products and any tools used for their administration must be made available by the
p.000003: sponsor free.
p.000003:
p.000003: Subject information, informed consent to the clinical trial
p.000003: § 6 (1) The principal investigator or the investigator informs the mentally competent person to be involved in the
p.000003: clinical trial orally and in writing in Hungarian - or in the mother tongue of the person or in any other language
p.000003: designated by the person as known to him/her - in a way interpretable even for the laic on the contents of
p.000003: Sections (3) and (4) of § 159 of the Health Care Act.
p.000003: (2)Person giving information must take a special care to establish if the person to be involved in the study is
p.000003: mentally competent or not. Establishments made in relation to it are recorded by the person giving information in the
p.000003: research and health documentation.
p.000003: (3)The information and the informed consent must be recorded on a separate sheet in writing. One original of the
p.000003: informed consent and of the written information must be retained in the research documentation, and one
p.000003: original must be handed over to the subject.
p.000003: (4)The written information must contain, in particular, the followings:
p.000003:
p.000003: a) identification data of the clinical trial;
p.000003: b) reference to the research nature of the clinical trial, the purpose of the clinical trial, its
p.000003: expected duration, the number of persons to be involved, the process of the clinical trial, the nature and
p.000003: frequency of the proposed interventions
p.000003: c) all other accepted treatment options available to the subject, information regarding the possibility that
p.000003: the clinical trial may interrupt the treatment already in progress, and the potential consequences of suspension of the
p.000003: treatment already in progress for the subject;
p.000003: d) detailed description of the possible and expected consequences, risks and discomforts, as well as reference if
p.000003: adverse events may occur during the clinical trial which are unforeseeable;
...
Social / Threat of Stigma
Searching for indicator threat:
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p.000002:
p.000002: § 4 The rights, safety and welfare of the subject have a priority over the interests of the science and society,
p.000002: therefore the exposure of the subjects to risks must be limited to the minimum extent.
p.000002: §5(1) Clinical trials may be conducted, and investigational medicinal products may be used on humans only in the
p.000002: possession of the NIP's authorisation. Clinical trials may be conducted only according to terms specified in the NIP's
p.000002: approval resolution, and to the requirements given in the approved protocol. Terms specified in the approval
p.000002: resolution of the clinical trial, and the requirements given in the authorized protocol, as well
p.000002: as requirements relating to the commencement and control of clinical trials are qualified as occupational
p.000002: rules.
p.000002: (2) Mentally competent persons may be involved in clinical trials only if terms specified in Sections (1)
p.000002: to (3) of § 159 of the Health Care Act and requirements given in this regulation are met.
p.000002: (3) The clinical trial may not replace studies and medical treatments necessary on the basis of the state of the
p.000002: subject.
p.000002: (4) In the event the use of placebo is planned, the research documentation attached to the application
p.000002: for official authorisation must contain a case-specific justification of the necessity for the use of a control
p.000002: group in the trial. The use of placebo may not pose substantial additional risks to the subject or the threat
p.000002: of irreversible health injury. Placebo may only be used for the shortest time required, the subject’s condition
p.000002: must be continuously monitored throughout the trial, and in case of any symptoms indicating substantial
p.000002: deterioration in the subject’s condition, the subject must immediately receive the best available scientifically
p.000002: accepted therapy.
p.000002: (5) The clinical trial must be planned and conducted in a way which minimises any possible injury, pain, fear
p.000002: or anxiety of the subject. During planning and control of the clinical trial all foreseeable risks relating to
p.000002: the age and health state of the subject must be taken into consideration.
p.000002: (6) The health state of the subject must be carefully controlled and documented before the commencement of
p.000002: the clinical trial, continuously during the clinical trial, and after the trial.
p.000002: (7) If the clinical trial involves the inclusion of persons of reproductive age, during the planning and
p.000002: approval of the clinical trial and the provision of information to subjects, particular attention must
p.000002: be paid to the impact of trial participation on the subject’s reproductive ability and pre-existing
p.000002: or subsequent pregnancy, as well as the health of the embryo or the foetus.
p.000002: (8)Act LXIII of 1992 on the protection of personal data and on the disclosure of data of public interest, and Act
...
p.000008: electronically to NIP, the ETT- KFEB and the competent authority of countries which are party to the EEA-treaty
p.000008: immediately but no later than seven days from obtaining knowledge of such.
p.000008: (3) Periodically, but at least every six months, the sponsor shall provide NIP, ETT-KFEB and all other
p.000008: investigators participating in the clinical trial with a cumulative list in electronic format containing all SUSAR
p.000008: associated with a given investigational medicinal product.
p.000008: (4) Once a year, the sponsor provides NIP, the ETT-KFEB and the competent authority of countries which are party to the
p.000008: EEA-treaty with an electronic report containing all suspected serious adverse reactions occurring over this
p.000008: period and associated with the investigational medicinal product, as well as information on the subjects' safety.
p.000008: (5) NIP keeps a record of all SUSARs reported in connection with a given investigational medicinal product. In the
p.000008: case of non-commercial trials the NIP, and for all other trials the sponsor, will report all received
p.000008: SUSARs in connection with the investigational medicinal product to the EMEA immediately but no later than the
p.000008: deadline specified in Paragraphs (1) and (2).
p.000008: (6) In addition to the provisions in Sections 21 and this Section, the sponsor and the investigator must
p.000008: take all urgent safety measures to protect the subjects against any immediate threat after any new information or
p.000008: event jeopardising subject safety or concerning the continuation of the trial or the development of the
p.000008: investigational medicinal product become known to them. The sponsor shall immediately but no later than 24 hours
p.000008: notify NIP ETT-KFEB of such events and measures taken.
p.000008:
p.000008: Report on the completion of the trial
p.000008:
p.000008: § 23 (1) The sponsor notifies the NIP of the completion of the trial, of the number of patients involved, and of
p.000008: significant events on a data-sheet downloadable from the webpage of the EMEA within ninety days from the completion of
p.000008: the trial. The NIP informs the ETT-KFEB within eight days from the notification.
p.000008:
p.000009: 9
p.000009:
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p.000009:
p.000009: Retaining of trial documentation
p.000009:
p.000009: § 24 (1) The trial master file must contain all basic documents which make it possible to evaluate
p.000009: both the conduction of the clinical trial and the quality of the data. Documents must evidence if the
p.000009: investigators and the sponsor met the principles of GCP. The trial master file serves as a basis for
p.000009: inspections made by inspectors independent from the sponsor or by authorities.
p.000009: (2) The sponsor and the investigator must retain basic documents relating to the clinical trial, necessary
p.000009: for the post-control of the clinical trial at least for five years after the completion of the trial, and must archive
p.000009: them in a way which enables easy retrieval. The sponsor must designate persons who are responsible for the archiving at
...
Social / Trade Union Membership
Searching for indicator union:
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p.000009: them in a way which enables easy retrieval. The sponsor must designate persons who are responsible for the archiving at
p.000009: the sponsor, and access to the archives must be limited exclusively to persons authorised to have an access.
p.000009: (3) Any change in the processed data and in the ownership of the documentation of the trial must be
p.000009: documented. The new owner must undertake to observe regulations relating to data- handling and archiving in
p.000009: a written declaration.
p.000009: (4) Data-carriers used for archiving must provide for complete and legible documents.
p.000009:
p.000009: Miscellaneous and transitional provisions
p.000009:
p.000009: § 25 (1) This decree comes into force on 15lh September, 2005 - except for the contents of Section (2)
p.000009: -, and its regulations must be applied in procedures launched after its coming into effect.
p.000009: (2) The provisions in Section (9), subsection n) of Section (4) § 6, and subsection m) of Section
p.000009: (2) § 17 - with the deviation given in Section (4) - come into force on 1st November, 2005. (3)
p.000009: (4)
p.000009: (5) – (6)
p.000009: (7) The sponsor is required to pay an administrative service fee for the proceedings regulated in this Decree in the
p.000009: amount as defined in a separate law. The administrative service fee is exclusive of value added tax. No administrative
p.000009: service fee is charged for the approval procedure of non- commercial trials.
p.000009: (8)
p.000009: (9)
p.000009:
p.000009: (10)
p.000009: (11)The purpose of this Decree is to ensure compliance with the following Union acts:
p.000009:
p.000009: a) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.000009: laws, regulations and administrative provisions of the Member States relating to the implementation of
p.000009: good clinical practice in the conduct of clinical trials on medicinal products for human use;
p.000009: b) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good
p.000009: clinical practice as regards investigational medicinal products for human use, as well as the requirements for
p.000009: authorisation of the manufacturing or importation of such products.
p.000009: (12) This decree defines the provision required for the implementation of Regulation (EC) No 1901/2006/EC of
p.000009: the European Parliament and of the Council on medicinal products for paediatric use amending Regulation (EEC)
p.000009: No 1768/92, Directive 2001/20/EC, Directive2001/83/EC and Regulation (EC) No 726/2004.
p.000009: (13) This decree defines the provision required for the implementation of EC/1394/2007 of the European
p.000009: Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive
p.000009: 2001/83/EC and Regulation (EC) No 726/2004.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000010:
p.000010:
p.000010: Annex 1 to Decree 35/2005 (VIII. 26.) of the Minister of Health
p.000010:
p.000010:
p.000010:
p.000010: Annex 2 to Decree 35/2005 (VIII. 26.) of the Minister of Health Personal and material terms of the completion of the
p.000010: clinical trials
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000005: after accepting or declining the provision of information as specified in Section 6/A, voluntarily and freely, in
p.000005: awareness that it may be revoked any time, either verbally or in writing, without justification;
p.000005: f) consent to the collection of sample in the quantity and quality specified in the information and to the use of the
p.000005: data of the subject,
p.000005: g) the statement on the storage of samples, with the option to deposit the sample provided by him or her in a biobank
p.000005: in the required manner, including storage in accordance with Section 6/A (2) g).
p.000005: h) the statement of the subject regarding the inclusion of the sample deposited in the biobank for further
p.000005: investigations; in this case, the subject must make a statement regarding whether he or she consents to the use of the
p.000005: sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes, depending on
p.000005: the primary purpose of the sampling,
p.000005: i) disclosure of the results even in the event the subject has no access to them,
p.000005: j) consent to or rejection of the possibility of being contacted in the future
p.000005: k) date of signature on the informed consent;
p.000005: l) signatures of the principal investigator or the person providing the information;
p.000005: m) signature of the person giving the informed consent.
p.000005:
p.000005: Clinical trials made on persons of minor age
p.000005:
p.000005: § 7 Clinical trial may be conducted on persons of minor age, even if the contents of Section (4) § 159 and of § 4 to §
p.000005: 6 of Health Care Act are adequately followed, if all the following terms are met:
p.000005: a) the research in question is indispensable for the validation of data acquired with clinical trials made on mentally
p.000005: competent persons or with other research methods;
p.000005: b) the research is directly related to the clinical aspect from which the person of minor age suffers,
p.000005: or is of a nature which may be conducted only on persons of minor age;
p.000005: c) the informed consent given by the person entitled to make a declaration contains the presumable will
p.000005: of the person of minor age capable of having an opinion and evaluating the situation, and this declaration
p.000005: may be withdrawn at any time without causing any disadvantage to the person of minor age;
p.000005: d) the investigator having an experience in connection with persons of minor age adequately informed the
p.000005: person of minor age on the investigation, its adverse and beneficial effects in a way understandable to him/her -
p.000005: depending on his/her intellectual level;
p.000005: e) the explicit wish of a minor who is capable of forming an opinion and assessing this information to
p.000005: refuse participation or to be withdrawn from the clinical trial at any time is taken into consideration by the
p.000005: investigator or the principal investigator;
p.000005: f except for the compensation as per Section 5 § (11), no incentives, financial inducements, benefits or
p.000005: fees may be given to a minor subject;
p.000005: g) the relevant scientific guides of the European Medicines Agency established by the European Parliament's and the
p.000005: Council's Regulation 726/2004/EC on the specification of community procedures relating to the licensing and
p.000005: supervision of drugs destined for human or veterinary treatment purposes, and on the establishment of the
p.000005: European Medicines Agency (hereinafter: EMEA) are observed;
p.000005: h) the clinical trial was planned and is conducted with the minimisation of pain, anxiety, fear and of any other
p.000005: risk foreseeable in connection with the disease and with the state of advancement of the person of minor age;
p.000005: i) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually
p.000005: specified, and are continuously monitored;
p.000005: j) the ECCP OF MRC supports the protocol from special-ethical aspects in the possession of the expert opinion of a
p.000005: paediatrician.
p.000005: Clinical trials on adults with no capacity to act
p.000005:
p.000005: § 8 Persons, who definitely refused to take part in such trials previously when they were mentally
p.000005: competent, may not be involved in any clinical trials. Persons, who refused to accept the given trial previously
p.000005: when they were mentally competent, may not be involved in the given
p.000006: 6
p.000006: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000006:
p.000006: clinical trial either.
p.000006: § 9 With the exception of emergency research as defined in Section 160 of the Health Care Act, even if the provisions
p.000006: of Section 159 (4), Sections 4 through 6 and Section 8 of the Health Care Act are applied, clinical trials may
p.000006: only be conducted on majors placed under guardianship excluding or limiting their capacity if all of the
p.000006: following conditions are met:
...
p.000010: b) a certification exam on clinical pharmacology,
p.000010: 2. The investigator must have
p.000010: a) a specialist's qualification in any clinical field,
p.000010: b) a certification exam on clinical pharmacology or a certification of a successful examination at a GCP course
p.000010: organised by a university, and not older than five years before the commencement of the clinical trial.
p.000010:
p.000010: 3. The principal investigator must have completed a certification exam on clinical pharmacology.
p.000010:
p.000010: //. Clinical investigational site for trial in phase II
p.000010:
p.000010: A) Material terms:
p.000010:
p.000010: In-patient ward or a special out-patient clinic at a university clinic or hospital, or other specialist's
p.000010: surgery which has an intensive therapeutic division background within the institute, as well as adequate diagnostic
p.000010: units the facilities and personnel, and which meets the personal and material minimum terms relating to the health
p.000010: institution and specified in a separate legal rule, and is provided with tools and facilities necessary for the
p.000010: conduction of the proposed trial.
p.000010:
p.000010: B) Personal terms:
p.000010:
p.000010: The principal investigator must have a specialist’s qualification in a clinical field corresponding with the intended
p.000010: use of the investigational medicinal product, with a certification exam on
p.000011: 11
p.000011:
p.000011: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000011:
p.000011: clinical pharmacology, or a certificate confirming successful completion of a GCP training course organised by a
p.000011: university not more than five years ago. In case persons of minor age are also included in the trial, a
p.000011: paediatrician must be also involved as an investigator.
p.000011:
p.000011:
p.000011: ///. Clinical investigational site for other clinical trials
p.000011: 1. Other clinical trials may be conducted if material terms specified in article II. A) are met, as well as in a
p.000011: physician's or paediatrician's surgery.
p.000011: 2. The principal investigator must have a certificate confirming successful completion of a GCP training
p.000011: course organised by a university not more than five years ago.
p.000011:
p.000011: Annex 3 to Decree 35/2005 (VIII. 26.) of the Minister of Health
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000002: group in the trial. The use of placebo may not pose substantial additional risks to the subject or the threat
p.000002: of irreversible health injury. Placebo may only be used for the shortest time required, the subject’s condition
p.000002: must be continuously monitored throughout the trial, and in case of any symptoms indicating substantial
p.000002: deterioration in the subject’s condition, the subject must immediately receive the best available scientifically
p.000002: accepted therapy.
p.000002: (5) The clinical trial must be planned and conducted in a way which minimises any possible injury, pain, fear
p.000002: or anxiety of the subject. During planning and control of the clinical trial all foreseeable risks relating to
p.000002: the age and health state of the subject must be taken into consideration.
p.000002: (6) The health state of the subject must be carefully controlled and documented before the commencement of
p.000002: the clinical trial, continuously during the clinical trial, and after the trial.
p.000002: (7) If the clinical trial involves the inclusion of persons of reproductive age, during the planning and
p.000002: approval of the clinical trial and the provision of information to subjects, particular attention must
p.000002: be paid to the impact of trial participation on the subject’s reproductive ability and pre-existing
p.000002: or subsequent pregnancy, as well as the health of the embryo or the foetus.
p.000002: (8)Act LXIII of 1992 on the protection of personal data and on the disclosure of data of public interest, and Act
p.000002: XLVII of 1997 on the handling and protection of health care data and of the relating personal data, as well as
p.000002: regulations relating to data handling covered by separate legal rules must be followed during the clinical trials.
p.000002: (9) With the exception of healthy volunteers, primarily patients receiving medical care from the health care
p.000002: provider conducting the clinical trial must be enrolled in clinical trials.
p.000002:
p.000003: 3
p.000003: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000003:
p.000003: (10) The health care provider conducting the clinical trial may only recruit subjects with capacity to act
p.000003: through an announcement published in the printed press or on its own web site, as well as the website of
p.000003: professional and patient organisations or the sponsor. Such an announcement may not be published for
p.000003: advertising purposes, and may not specify the name and manufacturer of the investigational medicinal product, or the
p.000003: name of the entity authorised to market it. The recruitment announcement published must refer to the
p.000003: existence of the official authorisation.
p.000003: (11) Subjects may receive a compensation for their loss of income and actual and confirmed costs incurred in
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000005: l) signatures of the principal investigator or the person providing the information;
p.000005: m) signature of the person giving the informed consent.
p.000005:
p.000005: Clinical trials made on persons of minor age
p.000005:
p.000005: § 7 Clinical trial may be conducted on persons of minor age, even if the contents of Section (4) § 159 and of § 4 to §
p.000005: 6 of Health Care Act are adequately followed, if all the following terms are met:
p.000005: a) the research in question is indispensable for the validation of data acquired with clinical trials made on mentally
p.000005: competent persons or with other research methods;
p.000005: b) the research is directly related to the clinical aspect from which the person of minor age suffers,
p.000005: or is of a nature which may be conducted only on persons of minor age;
p.000005: c) the informed consent given by the person entitled to make a declaration contains the presumable will
p.000005: of the person of minor age capable of having an opinion and evaluating the situation, and this declaration
p.000005: may be withdrawn at any time without causing any disadvantage to the person of minor age;
p.000005: d) the investigator having an experience in connection with persons of minor age adequately informed the
p.000005: person of minor age on the investigation, its adverse and beneficial effects in a way understandable to him/her -
p.000005: depending on his/her intellectual level;
p.000005: e) the explicit wish of a minor who is capable of forming an opinion and assessing this information to
p.000005: refuse participation or to be withdrawn from the clinical trial at any time is taken into consideration by the
p.000005: investigator or the principal investigator;
p.000005: f except for the compensation as per Section 5 § (11), no incentives, financial inducements, benefits or
p.000005: fees may be given to a minor subject;
p.000005: g) the relevant scientific guides of the European Medicines Agency established by the European Parliament's and the
p.000005: Council's Regulation 726/2004/EC on the specification of community procedures relating to the licensing and
p.000005: supervision of drugs destined for human or veterinary treatment purposes, and on the establishment of the
p.000005: European Medicines Agency (hereinafter: EMEA) are observed;
p.000005: h) the clinical trial was planned and is conducted with the minimisation of pain, anxiety, fear and of any other
p.000005: risk foreseeable in connection with the disease and with the state of advancement of the person of minor age;
p.000005: i) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually
p.000005: specified, and are continuously monitored;
p.000005: j) the ECCP OF MRC supports the protocol from special-ethical aspects in the possession of the expert opinion of a
p.000005: paediatrician.
p.000005: Clinical trials on adults with no capacity to act
p.000005:
p.000005: § 8 Persons, who definitely refused to take part in such trials previously when they were mentally
p.000005: competent, may not be involved in any clinical trials. Persons, who refused to accept the given trial previously
p.000005: when they were mentally competent, may not be involved in the given
p.000006: 6
p.000006: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000006:
p.000006: clinical trial either.
p.000006: § 9 With the exception of emergency research as defined in Section 160 of the Health Care Act, even if the provisions
p.000006: of Section 159 (4), Sections 4 through 6 and Section 8 of the Health Care Act are applied, clinical trials may
p.000006: only be conducted on majors placed under guardianship excluding or limiting their capacity if all of the
p.000006: following conditions are met:
p.000006: a) the informed consent of person authorized to give consent must represent the presumed will of a subject and it may
p.000006: be revoked at any time without detriment to the subject;
p.000006: b) the subject was informed of the trial, of its beneficial and adverse effects in a comprehensible manner;
p.000006: c) the investigator and the principal investigator fully takes it into consideration, if the subject capable of having
p.000006: an opinion and evaluating the situation definitely refuses to take part in the clinical trial or wants to
p.000006: withdraw from the trial at any time:
p.000006: d) except for the compensation as per Section 5 (11), no incentives, financial inducements, benefits or fees may be
p.000006: given to a subject;
p.000006: e) the research in question is essential to validate data obtained in clinical trials on persons with capacity to act
p.000006: or by other research methods and relates directly to a life-threatening or debilitating clinical condition
p.000006: from which the incapacitated adult concerned suffers;
p.000006: f) the clinical trial has been designed and will be conducted to minimise pain, anxiety, fear and any other
p.000006: foreseeable risk in relation to the current condition and developmental stage of the subject;
p.000006: g) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually specified,
p.000006: and are continuously monitored;
p.000006: h) the ETT-KFEB supports the protocol from special-ethical aspects in the possession of an expert opinion given
p.000006: in accordance with the disease in question and with the patient group concerned;
p.000006: i) it is reasonably expected that the application of the investigational medicinal product has beneficial
p.000006: effects in excess of the adverse effects for the patient, or does not constitute a risk at all.
p.000006: § 10 Persons enlisted in § 9 may not be involved in clinical trials as healthy volunteers.
p.000006: § 11 If a subject becomes mentally competent as a result of a judicial decision or of the change of his/her state
p.000006: during the clinical trial, he/she must be informed of the clinical trial as soon as possible, and his/her acceptance
p.000006: of its continuation must be acquired with the observance of the contents of § 6. Otherwise the clinical trial may not
p.000006: be continued on the persons involved.
p.000006:
p.000006: Prerequisites of applying for an official authorisation
p.000006:
p.000006: § 12 (1) If another natural or legal entity, or a company without a legal personality is assigned by the sponsor to
p.000006: discharge some or all of its responsibilities related to the trial, the sponsor remains liable for
p.000006: compliance with the provisions of this Decree and with the provisions of a separate law on clinical trials.
p.000006: If the sponsor is not established in one of the states which are party to the EEA-treaty, then its legal representative
p.000006: must be established in a state which is party to the EEA-agreement.
p.000006: (2) – (5)
p.000006:
...
p.000006: provider. In the course of the qualification process, NIP will conduct an on-site inspection. The qualification process
p.000006: must be repeated every three years.
p.000006:
p.000006: Official authorisation of the clinical trial
p.000006:
p.000006: § 13 (1)
p.000006: (2) Use of an investigational medicinal product on humans may be authorised if the personal terms of the principal
p.000006: investigator and the material terms of the investigational site(s) comply with terms
p.000006: specified in Annex 2 to this decree.
p.000006: (3) – (4)
p.000007: 7
p.000007: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000007:
p.000007: § 14 (1) Sponsor notifies the head of the health care provider conducting the clinical trial and the principal
p.000007: investigator about NIP’s decision regarding the approval, and prior to the commencement of the trial submits
p.000007: NIP’s decision and the protocol synopsis in Hungarian to the competent institutional ethics committee (hereinafter
p.000007: referred to as IKEB). If the health care provider is not a health care institution, the IKEB of the
p.000007: institution with the area for emergency healthcare provision where the registered seat of the
p.000007: health care provider conducting the trial is located will have competence.
p.000007: (2) With respect to clinical trials, IKEB responsibilities include the protection of the subjects’ rights
p.000007: and safety. IKEB may not issue a professional-ethical opinion in connection with clinical trials.
p.000007: (3) Along with NIP’s decision, the professional-ethical specialized authority statement will also be sent to the
p.000007: sponsor.
p.000007: 15. §
p.000007:
p.000007: Procedure of the ETT-KFEB
p.000007:
p.000007: § 16 (1) The composition of the ETT-KFEB is subject to Section (6) § 159 of the Health Care Act.
p.000007: (2) The sponsor may ask the ETT-KFEB for an opinion in relation to the clinical trials in any special-ethical issue to
p.000007: which the ETT-KFEB replies within sixty days.
p.000007: § 17 (1) – (7)
p.000007: (8)The ETT-KFEB retains the master file of the trial, and documents relating to the archiving, to
p.000007:
p.000007: the
p.000007: qualification of the investigators, and to the control procedures for three years following the completion
p.000007: of the trial.
p.000007: § 18
p.000007: § 18/A
p.000007:
p.000007: Inspection of clinical trials
p.000007:
p.000007: § 19 (1) A person having a pharmacist's or physician's diploma or an equivalent diploma and certification of a GCP
p.000007: course organised by a university, not older than five years, may be the controller of the NIP. The NIP has a
p.000007: registry of the controllers. Before the commencement of the control the controller presents his/her certificate
p.000007: issued by the NIP and authorising him/her to perform the inspection.
p.000007: (2) – (4)
p.000007: (5) During an approved clinical trial, the subjects and the person authorized to give consent, the investigators,
p.000007: ETT-KFEB, the head of the health care provider conducting the trial, and IKEB may file complaints with NIP
p.000007: if they believe that the clinical trial is conducted contrary to the specifications of the authorisation or the
p.000007: protocol. During an approved clinical trial, IKEB may communicate its remarks to the principal investigator and the
p.000007: head of the health care provider, and forward them to ETT-KFEB, which may initiate an inspection at NIP in justified
p.000007: cases.
p.000007:
p.000007: (6) – (7)
p.000007: (8) The inspector as defined in Paragraph (1) must make a written statement about his or her interest in,
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000003:
p.000004: 4
p.000004: PDF Creator - PDF4Free v2.0 http://www.pdf4free.com
p.000004:
p.000004: c)name, position, designation of the scope of the leader of the clinical trial and of the person giving information;
p.000004: d) identifiers of the subject (name, date and place of birth), and, in case of subjects with limited or no capacity to
p.000004: act, also the identifiers of the person authorized to give consent as defined in Section 16 § of the Health Care
p.000004: Act (hereinafter referred to as “the person authorized to give consent”);
p.000004: e) declaration by the subject, or, in the case of subjects with limited or no capacity to act, the person authorized to
p.000004: give consent, that his/her consent to participation in the clinical trial was given after receiving information
p.000004: according to Paragraph (1), voluntarily and freely, in awareness that it may be revoked any time, either
p.000004: verbally or in writing, without justification;
p.000004: f) date of the signature of the informed consent form;
p.000004: g) the signature of the principal investigator or of the person giving information;
p.000004: h) signature of the person consenting the patient.
p.000004: (7)The person giving the information and the subject - as well as the person entitled to make a declaration in case of
p.000004: an incapacitated subject - sign also the written information given in Section (4).
p.000004: (8)In case of a verbal informed consent, two witnesses are required to confirm with their signatures that
p.000004: the subject received the information as defined in Paragraph (4), was advised of the content of the informed consent as
p.000004: defined in Paragraph (6), and consented to it verbally.
p.000004: (9) If any new substantial information becomes available in connection with the clinical trial that would affect the
p.000004: contents of the written information, an amendment of the authorisation must be initiated in accordance with the
p.000004: provisions of Section 18. The subject must be informed again in conformity with the amended written information, and
p.000004: his or her consent must be requested for the continuation of the clinical trial.
p.000004: 6/A. § (1) If a sample is collected during the clinical trial for human genetic testing, the subject must
p.000004: be informed separately about the procedure. Information must also cover the subject’s right to refuse to
p.000004: give a sample, in which case the genetic data of the subject may not be used even anonymously. Refusal to give a
p.000004: sample will not constitute an obstacle to the subject’s participation in the rest of the clinical
p.000004: trial. Information on and consent to the sampling will be included in a separate document.
p.000004: (2) Before collection of a sample for human genetic testing, as part of a genetic consultation, the subject must be
p.000004: advised of
p.000004: a) the purpose and quantitative and qualitative details of the sampling,
...
p.000006:
p.000006: clinical trial either.
p.000006: § 9 With the exception of emergency research as defined in Section 160 of the Health Care Act, even if the provisions
p.000006: of Section 159 (4), Sections 4 through 6 and Section 8 of the Health Care Act are applied, clinical trials may
p.000006: only be conducted on majors placed under guardianship excluding or limiting their capacity if all of the
p.000006: following conditions are met:
p.000006: a) the informed consent of person authorized to give consent must represent the presumed will of a subject and it may
p.000006: be revoked at any time without detriment to the subject;
p.000006: b) the subject was informed of the trial, of its beneficial and adverse effects in a comprehensible manner;
p.000006: c) the investigator and the principal investigator fully takes it into consideration, if the subject capable of having
p.000006: an opinion and evaluating the situation definitely refuses to take part in the clinical trial or wants to
p.000006: withdraw from the trial at any time:
p.000006: d) except for the compensation as per Section 5 (11), no incentives, financial inducements, benefits or fees may be
p.000006: given to a subject;
p.000006: e) the research in question is essential to validate data obtained in clinical trials on persons with capacity to act
p.000006: or by other research methods and relates directly to a life-threatening or debilitating clinical condition
p.000006: from which the incapacitated adult concerned suffers;
p.000006: f) the clinical trial has been designed and will be conducted to minimise pain, anxiety, fear and any other
p.000006: foreseeable risk in relation to the current condition and developmental stage of the subject;
p.000006: g) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually specified,
p.000006: and are continuously monitored;
p.000006: h) the ETT-KFEB supports the protocol from special-ethical aspects in the possession of an expert opinion given
p.000006: in accordance with the disease in question and with the patient group concerned;
p.000006: i) it is reasonably expected that the application of the investigational medicinal product has beneficial
p.000006: effects in excess of the adverse effects for the patient, or does not constitute a risk at all.
p.000006: § 10 Persons enlisted in § 9 may not be involved in clinical trials as healthy volunteers.
p.000006: § 11 If a subject becomes mentally competent as a result of a judicial decision or of the change of his/her state
p.000006: during the clinical trial, he/she must be informed of the clinical trial as soon as possible, and his/her acceptance
p.000006: of its continuation must be acquired with the observance of the contents of § 6. Otherwise the clinical trial may not
p.000006: be continued on the persons involved.
p.000006:
p.000006: Prerequisites of applying for an official authorisation
p.000006:
...
Searching for indicator incapacity:
(return to top)
p.000001: investigational medicinal product or a control;
p.000001: j) informed consent: the consent of an individual with capacity invited to participate in the trial obtained in
p.000001: accordance with Section 159 (1) e) of the Health Care Act, or with Section 159 (4) d) of the Health Care Act in case
p.000001: of persons with limited or no capacity to act;
p.000001: k) recruitment: public announcement by the health care provider conducting the clinical trial as authorised by the
p.000001: Országos Gyógyszerészeti Intézet (National Institute of Pharmacy, hereinafter referred to as “NIP”) for the
p.000001: inclusion of volunteers into a specific clinical trial as subjects in addition to the patients treated by the health
p.000001: care provider;
p.000001: l) adverse event: any untoward medical occurrence in a patient or clinical trial subject administered a
p.000001: medicinal product and which does not necessarily have a causal relationship with the treatment applied;
p.000001: m) adverse reaction: all untoward and unintended responses to an investigational medicinal product related to any dose
p.000001: administered;
p.000001: n) serious adverse reaction or serious adverse event: any untoward medical occurrence or effect that at any dose
p.000001: results in death, is life-threatening, requires hospitalisation or prolongation of existing
p.000001: hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly
p.000001: or birth defect;
p.000001: o) unexpected adverse reaction: an adverse reaction, the nature or severity of which is not consistent with the
p.000001: applicable product information (e.g. investigator's brochure for an unauthorised investigational product
p.000001: or summary of product characteristics for an authorised product);
p.000001: p) equivalence study: the comparative analysis of the bioequivalence, pharmacodynamic or therapeutic equivalence of the
p.000001: investigational medicinal product with another medicine (based on pharmacokinetic results);
p.000001: q)
p.000001: r) SUSAR: Suspected Unexpected Serious Adverse Reaction;
p.000001: s) Phase I study: the investigation of the tolerability, safety, pharmacokinetics, pharmacodynamic
p.000001: effects of an investigational medicinal product in healthy volunteers or special patient populations. Phase I
p.000001: studies can also be conducted to establish the therapeutic dose range;
p.000001: t) Phase II study: a study of the investigational medicinal product for an indication selected on the basis of its
p.000001: pharmacological effect to establish its efficacy, the relationship between dose and effect, the optimal
p.000001: therapeutic dose as well as safety and tolerability.
p.000001: u) Phase III study: a randomized, controlled, comparative study involving a larger patient population to demonstrate
p.000001: the efficacy, safety and tolerability of the investigational medicinal product;
p.000001: v) Phase IV study: a study to further investigate the risk-benefit ratio, the safety and tolerability of
p.000001: the investigational medicinal product with a marketing authorization when used according to the summary of product
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000005: supervision of drugs destined for human or veterinary treatment purposes, and on the establishment of the
p.000005: European Medicines Agency (hereinafter: EMEA) are observed;
p.000005: h) the clinical trial was planned and is conducted with the minimisation of pain, anxiety, fear and of any other
p.000005: risk foreseeable in connection with the disease and with the state of advancement of the person of minor age;
p.000005: i) the trial is conducted in a way in which both the risk threshold and the extent of pain are individually
p.000005: specified, and are continuously monitored;
p.000005: j) the ECCP OF MRC supports the protocol from special-ethical aspects in the possession of the expert opinion of a
p.000005: paediatrician.
p.000005: Clinical trials on adults with no capacity to act
p.000005:
p.000005: § 8 Persons, who definitely refused to take part in such trials previously when they were mentally
p.000005: competent, may not be involved in any clinical trials. Persons, who refused to accept the given trial previously
p.000005: when they were mentally competent, may not be involved in the given
p.000006: 6
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p.000006:
p.000006: clinical trial either.
p.000006: § 9 With the exception of emergency research as defined in Section 160 of the Health Care Act, even if the provisions
p.000006: of Section 159 (4), Sections 4 through 6 and Section 8 of the Health Care Act are applied, clinical trials may
p.000006: only be conducted on majors placed under guardianship excluding or limiting their capacity if all of the
p.000006: following conditions are met:
p.000006: a) the informed consent of person authorized to give consent must represent the presumed will of a subject and it may
p.000006: be revoked at any time without detriment to the subject;
p.000006: b) the subject was informed of the trial, of its beneficial and adverse effects in a comprehensible manner;
p.000006: c) the investigator and the principal investigator fully takes it into consideration, if the subject capable of having
p.000006: an opinion and evaluating the situation definitely refuses to take part in the clinical trial or wants to
p.000006: withdraw from the trial at any time:
p.000006: d) except for the compensation as per Section 5 (11), no incentives, financial inducements, benefits or fees may be
p.000006: given to a subject;
p.000006: e) the research in question is essential to validate data obtained in clinical trials on persons with capacity to act
p.000006: or by other research methods and relates directly to a life-threatening or debilitating clinical condition
p.000006: from which the incapacitated adult concerned suffers;
p.000006: f) the clinical trial has been designed and will be conducted to minimise pain, anxiety, fear and any other
...
p.000006: investigational medicinal product may be signed also before the licensing procedure; however its validity is
p.000006: subject to the official licensing of the clinical trial.
p.000006: (7) Phase I clinical trials may only be conducted at investigational sites qualified by NIP as clinical
p.000006: pharmacological sites. The qualification process must be conducted upon the request of the head of the health care
p.000006: provider. In the course of the qualification process, NIP will conduct an on-site inspection. The qualification process
p.000006: must be repeated every three years.
p.000006:
p.000006: Official authorisation of the clinical trial
p.000006:
p.000006: § 13 (1)
p.000006: (2) Use of an investigational medicinal product on humans may be authorised if the personal terms of the principal
p.000006: investigator and the material terms of the investigational site(s) comply with terms
p.000006: specified in Annex 2 to this decree.
p.000006: (3) – (4)
p.000007: 7
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p.000007:
p.000007: § 14 (1) Sponsor notifies the head of the health care provider conducting the clinical trial and the principal
p.000007: investigator about NIP’s decision regarding the approval, and prior to the commencement of the trial submits
p.000007: NIP’s decision and the protocol synopsis in Hungarian to the competent institutional ethics committee (hereinafter
p.000007: referred to as IKEB). If the health care provider is not a health care institution, the IKEB of the
p.000007: institution with the area for emergency healthcare provision where the registered seat of the
p.000007: health care provider conducting the trial is located will have competence.
p.000007: (2) With respect to clinical trials, IKEB responsibilities include the protection of the subjects’ rights
p.000007: and safety. IKEB may not issue a professional-ethical opinion in connection with clinical trials.
p.000007: (3) Along with NIP’s decision, the professional-ethical specialized authority statement will also be sent to the
p.000007: sponsor.
p.000007: 15. §
p.000007:
p.000007: Procedure of the ETT-KFEB
p.000007:
p.000007: § 16 (1) The composition of the ETT-KFEB is subject to Section (6) § 159 of the Health Care Act.
p.000007: (2) The sponsor may ask the ETT-KFEB for an opinion in relation to the clinical trials in any special-ethical issue to
p.000007: which the ETT-KFEB replies within sixty days.
p.000007: § 17 (1) – (7)
p.000007: (8)The ETT-KFEB retains the master file of the trial, and documents relating to the archiving, to
p.000007:
p.000007: the
p.000007: qualification of the investigators, and to the control procedures for three years following the completion
p.000007: of the trial.
p.000007: § 18
p.000007: § 18/A
p.000007:
p.000007: Inspection of clinical trials
p.000007:
p.000007: § 19 (1) A person having a pharmacist's or physician's diploma or an equivalent diploma and certification of a GCP
p.000007: course organised by a university, not older than five years, may be the controller of the NIP. The NIP has a
p.000007: registry of the controllers. Before the commencement of the control the controller presents his/her certificate
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000006:
p.000006: Official authorisation of the clinical trial
p.000006:
p.000006: § 13 (1)
p.000006: (2) Use of an investigational medicinal product on humans may be authorised if the personal terms of the principal
p.000006: investigator and the material terms of the investigational site(s) comply with terms
p.000006: specified in Annex 2 to this decree.
p.000006: (3) – (4)
p.000007: 7
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p.000007:
p.000007: § 14 (1) Sponsor notifies the head of the health care provider conducting the clinical trial and the principal
p.000007: investigator about NIP’s decision regarding the approval, and prior to the commencement of the trial submits
p.000007: NIP’s decision and the protocol synopsis in Hungarian to the competent institutional ethics committee (hereinafter
p.000007: referred to as IKEB). If the health care provider is not a health care institution, the IKEB of the
p.000007: institution with the area for emergency healthcare provision where the registered seat of the
p.000007: health care provider conducting the trial is located will have competence.
p.000007: (2) With respect to clinical trials, IKEB responsibilities include the protection of the subjects’ rights
p.000007: and safety. IKEB may not issue a professional-ethical opinion in connection with clinical trials.
p.000007: (3) Along with NIP’s decision, the professional-ethical specialized authority statement will also be sent to the
p.000007: sponsor.
p.000007: 15. §
p.000007:
p.000007: Procedure of the ETT-KFEB
p.000007:
p.000007: § 16 (1) The composition of the ETT-KFEB is subject to Section (6) § 159 of the Health Care Act.
p.000007: (2) The sponsor may ask the ETT-KFEB for an opinion in relation to the clinical trials in any special-ethical issue to
p.000007: which the ETT-KFEB replies within sixty days.
p.000007: § 17 (1) – (7)
p.000007: (8)The ETT-KFEB retains the master file of the trial, and documents relating to the archiving, to
p.000007:
p.000007: the
p.000007: qualification of the investigators, and to the control procedures for three years following the completion
p.000007: of the trial.
p.000007: § 18
p.000007: § 18/A
p.000007:
p.000007: Inspection of clinical trials
p.000007:
p.000007: § 19 (1) A person having a pharmacist's or physician's diploma or an equivalent diploma and certification of a GCP
p.000007: course organised by a university, not older than five years, may be the controller of the NIP. The NIP has a
p.000007: registry of the controllers. Before the commencement of the control the controller presents his/her certificate
p.000007: issued by the NIP and authorising him/her to perform the inspection.
p.000007: (2) – (4)
p.000007: (5) During an approved clinical trial, the subjects and the person authorized to give consent, the investigators,
p.000007: ETT-KFEB, the head of the health care provider conducting the trial, and IKEB may file complaints with NIP
p.000007: if they believe that the clinical trial is conducted contrary to the specifications of the authorisation or the
...
p.000008: Following immediate notification, the investigator provides the sponsor and IKEB with a detailed written report of
p.000008: the event. In the notification and the written report, the subject may only be identified by his or her unique code.
p.000008: (2)The investigator reports to the sponsor all adverse events and abnormal laboratory results regarded to be of
p.000008: particular importance in respect of the safety assessment of the trial in line with the specifications of and within
p.000008: the timeframe provided in the protocol.
p.000008: (3)In case of reported death of the subject the investigator provides all additionally required information
p.000008: to the sponsor and to the IKEB.
p.000008: (4)The sponsor shall keep regular records of each adverse event reported by the investigator. Upon request, this
p.000008: record will be made available to the countries party to the EEA-treaty and whose territory the clinical
p.000008: trials are conducted in.
p.000008:
p.000008: Report on serious adverse reactions
p.000008:
p.000008: § 22 (1) The sponsor ensures that all suspected serious unexpected adverse reactions that are fatal or
p.000008: life-threatening and all related relevant information are reported to the EMEA EudraVigilance database
p.000008: immediately but no later than seven days from obtaining knowledge of such. The sponsor ensures that all suspected
p.000008: serious unexpected adverse reactions occurring at Hungarian investigational sites that are fatal or
p.000008: life-threatening and all related relevant information are reported electronically to NIP, the ETT-KFEB and the
p.000008: competent authority of countries which are party to the EEA-treaty immediately but no later than seven days
p.000008: from obtaining knowledge of such. Within an additional eight days, the sponsor will also report all significant
p.000008: information obtained during the follow-up of the adverse event in question.
p.000008: (2) The sponsor ensures that all other suspected serious unexpected adverse reactions are reported to the
p.000008: EMEA EudraVigilance database immediately but no later than fifteen days from obtaining knowledge of such. The sponsor
p.000008: will report all other suspected serious unexpected adverse reactions occurring at Hungarian investigational sites
p.000008: electronically to NIP, the ETT- KFEB and the competent authority of countries which are party to the EEA-treaty
p.000008: immediately but no later than seven days from obtaining knowledge of such.
p.000008: (3) Periodically, but at least every six months, the sponsor shall provide NIP, ETT-KFEB and all other
p.000008: investigators participating in the clinical trial with a cumulative list in electronic format containing all SUSAR
p.000008: associated with a given investigational medicinal product.
p.000008: (4) Once a year, the sponsor provides NIP, the ETT-KFEB and the competent authority of countries which are party to the
p.000008: EEA-treaty with an electronic report containing all suspected serious adverse reactions occurring over this
p.000008: period and associated with the investigational medicinal product, as well as information on the subjects' safety.
p.000008: (5) NIP keeps a record of all SUSARs reported in connection with a given investigational medicinal product. In the
p.000008: case of non-commercial trials the NIP, and for all other trials the sponsor, will report all received
p.000008: SUSARs in connection with the investigational medicinal product to the EMEA immediately but no later than the
p.000008: deadline specified in Paragraphs (1) and (2).
p.000008: (6) In addition to the provisions in Sections 21 and this Section, the sponsor and the investigator must
p.000008: take all urgent safety measures to protect the subjects against any immediate threat after any new information or
p.000008: event jeopardising subject safety or concerning the continuation of the trial or the development of the
p.000008: investigational medicinal product become known to them. The sponsor shall immediately but no later than 24 hours
p.000008: notify NIP ETT-KFEB of such events and measures taken.
p.000008:
p.000008: Report on the completion of the trial
p.000008:
p.000008: § 23 (1) The sponsor notifies the NIP of the completion of the trial, of the number of patients involved, and of
p.000008: significant events on a data-sheet downloadable from the webpage of the EMEA within ninety days from the completion of
p.000008: the trial. The NIP informs the ETT-KFEB within eight days from the notification.
p.000008:
p.000009: 9
p.000009:
...
General/Other / participants in a control group
Searching for indicator control group:
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Searching for indicator placebo:
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p.000001: to include the patient in the study; and
p.000001: d) no additional diagnostic or monitoring procedure is used on the patient beyond the usual clinical practice, and
p.000001: e) only epidemiological methods will be used for the analysis of the collected data.
p.000001: § 2 (1) In term of this Decree:
p.000001: a) clinical trial: any investigation in human subjects carried out in either one site or multiple sites intended to
p.000001: aa) discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more
p.000001: investigational medicinal product(s),
p.000001: ab) and/or to identify any adverse reactions to one or more investigational medicinal product(s)
p.000001: ac) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal
p.000001: product(s) with the objective of ascertaining its (their) safety and/or efficacy and/or risk- benefit ratio not
p.000001: including non-interventional trials;
p.000001: b) multi-centre clinical trial: clinical trials conducted in line with the same protocol at more than one
p.000001: investigational sites by more than one investigator, where investigational sites may be situated within the European
p.000001: Economic Area (hereinafter referred to as the EEA), or, pursuant to an international treaty concluded with the European
p.000001: Community or the EEA, in a state with a legal status identical to that of EEA states (hereinafter referred to as a
p.000001: state party to the EEA- treaty) and in third countries;
p.000001: c) investigational medicinal product: a pharmaceutical form of an active substance or placebo being tested or used as
p.000001: a reference (comparator) in a clinical trial, including products already with a marketing authorisation but used or
p.000001: assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised
p.000001: indication, or when used to gain further information about the authorised form;
p.000001: d)sponsor: a natural or legal entity, a company without a legal personality which takes responsibility
p.000001: for the initiation, management and/or financing of a clinical trial. The investigator and the
p.000001: sponsor may be the same entity;
p.000001: e) investigator: a person qualified as a physician or a dentist who is responsible for the conduction of
p.000001: the clinical trial at the investigational site;
p.000001: f) principal investigator: the leader responsible for the team if a trial is conducted by a team of individuals at the
p.000001: investigational site;
p.000001: g) investigator’s brochure: a compilation of the clinical and non-clinical data on the
p.000001: investigational medicinal product or products which are relevant to the study of the
p.000001: investigational product or products enabling the physician or the trial supervisor to objectively assess the
p.000001: risk-benefit ratio of the clinical trial. The sponsor must update the brochure at least once a year;
p.000001:
p.000001: 1
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p.000001:
p.000001: h) protocol: a document that describes the objective(s), design, methodology, statistical considerations and
p.000001: organisation of a trial, also specifying the inclusion and exclusion criteria for trial subjects as well as
...
p.000001: for human use, the act on the marketing of medicines for human use, and the act on the personal and material
p.000001: conditions of the production of medicines for human use will be taken into account.
p.000001: (3) With regard to investigational medicinal products, the provisions of the legislation on the qualification
p.000001: criteria for the quality assurance pharmacist will also be applied mutatis mutandis.
p.000001: 3. § (1) Each clinical trial, including bioavailability and bioequivalence studies, must be planned,
p.000001: conducted and reported in line with the principles of Good Clinical Practice (hereinafter referred to as
p.000001: “GCP”) and the Helsinki Declaration on the ethical principles of medical research. The text of the GCP as
p.000001: amended will be published by the NIP in Hungarian language. An announcement regarding the publication and its place be
p.000001: made by the NIP in the Health Care Journal (Egészségügyi Közlöny).
p.000001: (2) At all times, clinical trials must be planned and conducted in accordance with the professional
p.000001: standards, in particular the detailed guides published by the European Commission on clinical trials
p.000001: as amended, which will be published by the NIP in Hungarian
p.000001:
p.000002: 2
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p.000002:
p.000002: translation.
p.000002: (3) A set of methodology guidelines on significant professional and ethical issues, in particular the
p.000002: definition of and distinction between clinical study phases and the use of placebo in clinical trials will be published
p.000002: by NIP and the Ethics Committee for Clinical Pharmacology of the Medical Research Council (hereinafter referred to as
p.000002: ETT-KFEB), an independent ethics committee as defined in a separate law. An announcement regarding the
p.000002: publication of the guidelines and its place will be placed by the NIP and ETT-KFEB in the Official
p.000002: Gazette (Hivatalos Értesítõ) published as a supplement of the Hungarian Official Journal.
p.000002: (4) This decree will be applied in line with Regulation (EC) No 1901/2006/EC of the European Parliament
p.000002: and of the Council on medicinal products for paediatric use amending Regulation (EEC) No 1768/92, Directive
p.000002: 2001/20/EC, Directive2001/83/EC and Regulation (EC) No 726/2004 as well as EC/1394/2007 of the European Parliament
p.000002: and of the Council of
p.000002: 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and
p.000002: Regulation (EC) No 726/2004.
p.000002:
p.000002:
p.000002:
p.000002: Protection of trial subjects
p.000002:
p.000002: § 4 The rights, safety and welfare of the subject have a priority over the interests of the science and society,
p.000002: therefore the exposure of the subjects to risks must be limited to the minimum extent.
p.000002: §5(1) Clinical trials may be conducted, and investigational medicinal products may be used on humans only in the
p.000002: possession of the NIP's authorisation. Clinical trials may be conducted only according to terms specified in the NIP's
p.000002: approval resolution, and to the requirements given in the approved protocol. Terms specified in the approval
p.000002: resolution of the clinical trial, and the requirements given in the authorized protocol, as well
p.000002: as requirements relating to the commencement and control of clinical trials are qualified as occupational
p.000002: rules.
p.000002: (2) Mentally competent persons may be involved in clinical trials only if terms specified in Sections (1)
p.000002: to (3) of § 159 of the Health Care Act and requirements given in this regulation are met.
p.000002: (3) The clinical trial may not replace studies and medical treatments necessary on the basis of the state of the
p.000002: subject.
p.000002: (4) In the event the use of placebo is planned, the research documentation attached to the application
p.000002: for official authorisation must contain a case-specific justification of the necessity for the use of a control
p.000002: group in the trial. The use of placebo may not pose substantial additional risks to the subject or the threat
p.000002: of irreversible health injury. Placebo may only be used for the shortest time required, the subject’s condition
p.000002: must be continuously monitored throughout the trial, and in case of any symptoms indicating substantial
p.000002: deterioration in the subject’s condition, the subject must immediately receive the best available scientifically
p.000002: accepted therapy.
p.000002: (5) The clinical trial must be planned and conducted in a way which minimises any possible injury, pain, fear
p.000002: or anxiety of the subject. During planning and control of the clinical trial all foreseeable risks relating to
p.000002: the age and health state of the subject must be taken into consideration.
p.000002: (6) The health state of the subject must be carefully controlled and documented before the commencement of
p.000002: the clinical trial, continuously during the clinical trial, and after the trial.
p.000002: (7) If the clinical trial involves the inclusion of persons of reproductive age, during the planning and
p.000002: approval of the clinical trial and the provision of information to subjects, particular attention must
p.000002: be paid to the impact of trial participation on the subject’s reproductive ability and pre-existing
p.000002: or subsequent pregnancy, as well as the health of the embryo or the foetus.
p.000002: (8)Act LXIII of 1992 on the protection of personal data and on the disclosure of data of public interest, and Act
...
p.000003: expected duration, the number of persons to be involved, the process of the clinical trial, the nature and
p.000003: frequency of the proposed interventions
p.000003: c) all other accepted treatment options available to the subject, information regarding the possibility that
p.000003: the clinical trial may interrupt the treatment already in progress, and the potential consequences of suspension of the
p.000003: treatment already in progress for the subject;
p.000003: d) detailed description of the possible and expected consequences, risks and discomforts, as well as reference if
p.000003: adverse events may occur during the clinical trial which are unforeseeable;
p.000003: e) a description of reasonably expected benefits, or in the event participation in the clinical trial involves no
p.000003: benefit for the subject, communication of this fact;
p.000003: f) information on treatment, compensation and indemnification to be offered in case of occurrence of damages
p.000003: arising out of the clinical trial [Section (1) § 21 of the Health Care Act], and on the method of their use, as well as
p.000003: the name and availability of person and organisation in Hungary whom or which the subject may contact in case of
p.000003: occurrence of the damage;
p.000003: g) compensation of the subject for costs if any;
p.000003: h) notification of the fact that the consent is voluntary and uninfluenced, and may be revoked at any time either
p.000003: verbally or in writing without justification and any disadvantages to the subject;
p.000003: i) rules relating to the handling of the data of the subject and to their accessibility;
p.000003: j) detailed information on the essence of the application of the placebo if a placebo is used, and on the likelihood of
p.000003: the subject's getting into the placebo group;
p.000003: k) brief description of the effects of the investigational medicinal product;
p.000003: l) the future healthcare of the subject after completion of the trial, if required;
p.000003: m)
p.000003: n) the name of the insurance company stated in the liability insurance prescribed by Section (5)
p.000003: § 3 of Act XCV of 2005 on drugs to be used on humans and on the modification of other laws regulating the drug market.
p.000003: (5)
p.000003: (6)The subject's informed consent must contain at least the followings:
p.000003: a)identification data of the clinical trial;
p.000003: b)designation of the health service provider where the clinical trial will be conducted;
p.000003:
p.000004: 4
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p.000004:
p.000004: c)name, position, designation of the scope of the leader of the clinical trial and of the person giving information;
p.000004: d) identifiers of the subject (name, date and place of birth), and, in case of subjects with limited or no capacity to
p.000004: act, also the identifiers of the person authorized to give consent as defined in Section 16 § of the Health Care
p.000004: Act (hereinafter referred to as “the person authorized to give consent”);
p.000004: e) declaration by the subject, or, in the case of subjects with limited or no capacity to act, the person authorized to
...
Orphaned Trigger Words
p.000004: sample into an archived collection,
p.000004: f) the subject’s right to learn about the genetic data generated during the human genetics testing,
p.000004: g) the option to decide about depositing the sample in a biobank and about the manner of deposition, including
p.000004: (ga) storage with personal identification information, (gb) storage with data encryption,
p.000004: (gc) storage with pseudonymised data, meaning the code that replaces personal identification
p.000004: information will be known only to the subject,
p.000004: (gd) storage with anonymised data, meaning all personal identification information of the subject has been made
p.000004: unsuitable for identification.
p.000004: (3) The subject must be informed of the option to include the sample deposited in the biobank for
p.000004: further investigations. In this case, the subject must make a statement regarding whether he or she consents to
p.000004: the use of the sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes,
p.000004: depending on the primary purpose of the sampling.
p.000004: 6/B. § (1) If a sample is collected during the trial for human genetic testing, a separate informed
p.000004: consent will be prepared.
p.000004: (2) The subject’s informed consent will include the following as a minimum:
p.000004: a) identifiers of the clinical trial;
p.000004: b) name of the health care provider where the clinical trial is to be conducted;
p.000004: c) name, position and funcion of the principal investigator and/or the person providing the information;
p.000004: d) identifiers of the subject (name, date and place of birth), and, in case of subjects with limited or no
p.000004: capacity to act, also the identifiers of the person authorized to give consent as
p.000004:
p.000005: 5
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p.000005:
p.000005: defined in Section 16 of the Health Care Act (hereinafter referred to as “person authorized to give consent”);
p.000005: e) declaration by the subject, or, in the case of subjects with limited or no capacity to act, the person authorized
p.000005: to give consent, that his/her consent to participation in genetic testing for pharmacology purpose was given
p.000005: after accepting or declining the provision of information as specified in Section 6/A, voluntarily and freely, in
p.000005: awareness that it may be revoked any time, either verbally or in writing, without justification;
p.000005: f) consent to the collection of sample in the quantity and quality specified in the information and to the use of the
p.000005: data of the subject,
p.000005: g) the statement on the storage of samples, with the option to deposit the sample provided by him or her in a biobank
p.000005: in the required manner, including storage in accordance with Section 6/A (2) g).
p.000005: h) the statement of the subject regarding the inclusion of the sample deposited in the biobank for further
p.000005: investigations; in this case, the subject must make a statement regarding whether he or she consents to the use of the
p.000005: sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes, depending on
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| control group | participants in a control group |
| disability | Mentally Disabled |
| drug | Drug Usage |
| embryo | embryo |
| emergency | Public Emergency |
| family | Motherhood/Family |
| foetus | Fetus/Neonate |
| healthy volunteers | Healthy People |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| substance | Drug Usage |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| control group | ['placebo'] |
| disability | ['mentally'] |
| drug | ['substance'] |
| healthy volunteers | ['volunteers'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| mentally | ['disability'] |
| placebo | ['controlXgroup'] |
| substance | ['drug'] |
| volunteers | ['healthyXvolunteers'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input