0A4F4F9BD490A749D5437F821CF06DF1

Law for Good Clinical Practice (2004)

https://leaux.net/URLS/General/Cyprus_Law_for_Good_Clinical_Practice_2004.pdf

http://leaux.net/URLS/ConvertAPI Text Files/C846F8A056C6C99B9F791A8A7636B68D.en.txt

Examining the file media/Synopses/C846F8A056C6C99B9F791A8A7636B68D.html:

This file was generated: 2020-07-14 08:17:14

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

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalcriminalcriminal2
HealthDrug Usagedrug4
HealthDrug Usagesubstance1
HealthMentally Disableddisability2
HealthMentally Incapacitatedincapable2
SocialAccess to Social Goodsaccess1
SocialIncarceratedrestricted1
SocialMarital Statussingle2
SocialProperty Ownershipproperty1
SocialThreat of Stigmathreat2
SocialTrade Union Membershipunion2
SocialYouth/Minorsminor4
Socialparentsparents1
Socialphilosophical differences/differences of opinionopinion14
General/OtherPublic Emergencyemergency1
General/OtherRelationship to Authorityauthority3

Political / criminal

Searching for indicator criminal:

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p.003213: (a) A person capable of giving the or
p.003213: (b) in the case of a person who is not capable of giving it, his / her lawful.
p.003213: (2) For the purposes of paragraph (1), any person capable of giving it, who -
p.003213: (a) It saves and
p.003213: (b) is not deprived of his ability to give it under any law.
p.003213: For the purposes of paragraph (2), a person who has the brakes saved if at the time of supply
p.003213: the nature of the consensus can understand the nature, significance, impact and theirs
p.003213: risks of clinical trial and to form a reasonable judgment for
p.003213: '·)
p.003213: the? of his interests.
p.003213: (4) which does not usually have the brakes saved, but has
p.003213: save them as far as it can provide consent
p.003213: I.
p.003213: when you save the brakes.
p.003214: 3214
p.003214: (5) A person who usually has brakes but does not have breaks at intervals
p.003214: cannot provide consensus when it does not save the brakes.
p.003214: (6) Two or more persons agreeing to consent when agreeing to the same
p.003214: sense.
p.003214: (7) Consent is free when not caused by.
p.003214: (8) In case the participant is not able to write,
p.003214: may provide oral evidence in the presence of at least one witness,
p.003214: which shall be recorded in writing, with the date and signature of the witness.
p.003214: Definition For the purposes of Regulation 6 coercion means
p.003214: coerced perpetration or threat of perpetration prohibited by him
p.003214: Chapter 154.
p.003214: Criminal whether in or on
p.003214: of 1963 ° or its retention or 41 °
p.003214: 1964 threat of retention of person or property, to 1964 damage to any
p.003214: the intention is to
p.003214: 1965 person consent to attend a 1967 clinic
p.003214: test.
p.003214: of 1967
p.003214: of 1972
p.001972: 1972
p.001972: of 1973
p.001972: 59 of 1974
p.001972: 3 of 1975
p.001979: 1979
p.001981: 1981
p.001982: 1982
p.001982: 86 of
p.001986: 1986
p.001986: 111 of 1989
p.003215: 3215
p.003215: of 1991
p.001994: 1994
p.001996: 1996
p.001996: 1996
p.001997: 1997
p.001998: 1998
p.001998: 1998
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 30 (l) 2000
p.001999: of 2000
p.001999: of 2000
p.002000: 2000
p.002000: 2000
p.002000: 2000
p.002000: of 2001
p.002000: of 2002
p.002000: of 2002
p.002002: 2002
p.002002: of 2002
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003.
p.002002: Definition of mental pressure.
p.002002: 8 .- (1) For the purposes of the Rules of Procedure 6. consent
p.002002: that it was provided as a result of mental stress when the relationships between the person and the participant are
p.002002: such that the person in question is able to dominate her
p.002002: of the participant and to benefit from it in order to secure an unfair advantage against the participant
p.002002: participant.
p.002002: (2) In particular, without prejudice to paragraph (1), that it is capable of dominating
p.002002: of
p.002002: participant, any person who has actual or obvious authority over the participant or is in a relationship
p.002002: trust
p.003216: 3216
p.003216: against it.
...

p.000015: 15
p.000015: for the first time.
p.000015: (3) The Medicines Board ensures that all suspected unexpected serious side effects are recorded
p.000015: notified to the tested medicinal product.
p.000015: (4) The other researchers shall disclose the information referred to in
p.000015: paragraphs (1) and (2).
p.000015: (5) Once a year, throughout the course of the clinical trial, the sponsor shall forward to the Council
p.000015: And the National Committee on Bioethics, a list of all the alleged serious side effects that
p.000015: During this time, a report on their safety was presented
p.000015: of participants.
p.000015: (6) The Medicines Board shall ensure that any suspected unexpected side effect of a drug is tested.
p.000015: of a medicinal product of which it is aware shall be registered immediately with a European database.
p.000015: (7) The Medicines Board shall have access to the information communicated by the contractor to
p.000015: European Agency
p.003233: 3233
p.003233: Drug Evaluation.
p.003233: Free delivery The contractor provides the tested pharmaceuticals free of charge
p.003233: and, where applicable, their mechanism:
p.003233: medicinal products.
p.003233: Provided that, in exceptional cases, the Medicines Council may determine specific and
p.003233: precise conditions for the provision of the tested medicinal products
p.003233: where their delivery mechanism.
p.003233: (2) Where the Council for Medicinal Products makes use of the option reserved to it
p.003233: of paragraph (1) shall inform it
p.003233: Responsibility of contractor, researcher and lead researcher.
p.003233: 25. These Regulations do not constitute the civil and criminal liability of the sponsor, the investigator or
p.003233: of the lead researcher.
p.003233: Entry into force of those present
p.003233: 26.- (1) Subject to the provisions of paragraph (2), these Regulations shall
p.003233: effective from the date
p.003233: in the Official Journal of the Republic.
p.003233: (2) The provisions -
p.003233: (a) Paragraph (3) (b) of Regulation 14,
p.003233: (b) the Rules of Procedure
p.003233: (c) paragraph (3) of Regulation 21 on the obligation to inform the competent authority
p.003233: of the Member States, of the European Agency
p.003234: 3234
p.003234: Evaluation of Medicines and the Commission,
p.003234: (d) paragraph (4) of Regulation 21 on the obligation to inform the competent authorities of the Member States
p.003234: and the Commission,
p.003234: (e) subparagraph (a) of paragraph (1) of Regulation 23, concerning the obligation
p.003234: notification to the competent authorities of
p.003234: members, •
p.003234: (f) of paragraph (2) of Regulation 24.
p.003234: They shall enter into force on the date of its accession
...

Health / Drug Usage

Searching for indicator drug:

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p.002004: legislative, regulatory and administrative.
p.002004: application of good clinical practice in clinical trials of medicines intended for
p.002004: Man »121 of 01.05.2001. p.
p.002004: The Council of Ministers, following a recommendation from the Council of Medicines, exercising the powers vested in it
p.002004: pursuant to the provisions of paragraph (h) of subparagraph (2) of Article 103 of Human Medicines
p.002004: Use (Quality Control, Supply and Price Control) Laws of 2001 to (No. 3) of 2004. Issues
p.002004: the following Regulations:
p.002004: 1. These Regulations will be as for Medicines for Human Use (Good Clinical Practice)
p.002004: 2004 Regulations.
p.002004: 2.-0) In these Regulations, unless the text has a different meaning -
p.002004: "Adverse event" means any harmful event to a patient or participant in which
p.002004: a tested medicinal product which is not necessarily related to the treatment is administered
p.003209: 3209
p.003209: 'Indemnity' includes any insurance policy issued pursuant to paragraph (8) of the Regulation
p.003209: and whatever
p.003209: plan for compensation for damage as a result of medical and / or clinical
p.003209: negligence, which is the responsibility of the researcher and / or principal investigator and / or contractor vis-à-vis a participant
p.003209: and approved by the Council
p.003209: 'Unexpected side effect' means a side effect of a tested medicinal product whose nature is
p.003209: or severity does not coincide with information on the tested medicinal product, such as
p.003209: brochure for the researcher about-
p.003209: a marketing authorization and is under trial or, in the case of a tested medicinal product authorized
p.003209: traffic, the instructions attached to their brief description
p.003209: characteristics of the drug
p.003209: 'Informed free consent' means the consent obtained in accordance with the Rules of Procedure
p.003209: "Researcher's brochure" means the collection of clinical and non-clinical data;
p.003209: concerning a tested medicinal product and which is useful for the study of that tested medicinal product
p.003209: human medicine-
p.003209: 'Ethics committees' has the meaning ascribed to this term in 2001
p.003209: Bioethics and National Operation
p.003209: Commission) Law of 2001;
p.003209: "Investigator" means a registered physician or a person who has been granted the right to conduct investigations in
p.003209: Democracy, because of its scientific knowledge and because it has the experience required for it
p.003209: care and is responsible for conducting a clinical trial on a particular
p.003210: 3210
p.003210: 'Lead researcher' means the researcher, who is in charge of a group, which
p.003210: conducts a clinical trial on a particular
p.003210: 'Non-invasive test' means a test in which the 'tested medicinal product
p.003210: prescribed as usual in accordance with the conditions laid down in the license
p.003210: adult participant, unable to give informed free consent, means a person other than the participant;
p.003210: which, by reason of its relationship with that adult or minor, is eligible to become lawful
p.003210: for the purposes of the clinical trial and agrees to be legal
p.003210: in the absence of such a person, a legal representative of an adult participant,
...

p.003228: risk. The contractor shall immediately inform the Medicines Council of these new incidents and of the measures taken and
p.003228: it shall inform the National Bioethics Committee at the same time.
p.003229: 3229
p.003229: Completion 19 .- (1) Within days of the completion of a clinical trial, fibrin test.
p.003229: notifies in writing to Medicines and
p.003229: National Bioethics Committee, that the clinical trial was completed.
p.003229: (2) If the clinical trial is terminated prematurely, the time limit,
p.003229: referred to in paragraph (1), is reduced to 15 days the contractor shall state clearly the reasons
p.003229: of interruption.
p.003229: Exchange of information.
p.003229: 2O .- (1) The Medicines Council shall ensure the registration of data in a European database.
p.003229: referred
p.003229: below, for clinical trials conducted in its territory
p.003229: Democracy:
p.003229: (a) Details of the application for authorization referred to in paragraph (1) of Regulation 16;
p.003229: (b) any amendments to this application pursuant to paragraph {4) of the Rules of Procedure
p.003229: (c) any amendments to the Protocol in accordance with paragraphs (1), (2) and (3) of the Rules of Procedure
p.003229: (d) the opinion of the National Commission
p.003229: (e) the statement of completion of the clinical trial; and
p.003229: (f) a reference to the inspections carried out pursuant to sections 96 and 96A of the Law for compliance
p.003229: of good clinical practice.
p.003230: 3230
p.003230: (2) Medicinal products, following a reasoned request from a Member State, of the European Union
p.003230: The Drug Evaluation Agency or the Commission shall provide all supplementary information, in addition to that
p.003230: that have already been introduced into the European database for this clinical trial.
p.003230: Suspension .- (1) Where the Medicines Board has
p.003230: clinical trial reasons that the conditions and infringements are no longer fulfilled.
p.003230: the application for authorization referred to in paragraph (1) thereof.
p.003230: the safety or scientific validity of the clinical trial,
p.003230: may suspend or prohibit such clinical trial by informing the contractor.
p.003230: (2) The Council for Medicinal Products, before taking a decision pursuant to paragraph (1), unless
p.003230: imposes an imminent risk, requests the opinion of the contractor and / or the researcher and / or the principal investigator,
p.003230: which should be given within a week.
p.003230: (3) The Council for Medicinal Products shall immediately inform the competent authorities of the Member States, the National Commission.
p.003230: Bioethics, the European Medicines Agency and the Commission in its decision
p.003230: suspension or prohibition of the clinical trial, as well as the cause.
p.003230: (4) In the event that the Medicines Council has reasonable grounds to believe that
p.003230: contractor or researcher or anyone else involved in the clinical trial no longer responds
p.003230: informs him immediately of his obligations and sets out the action plan to implement for
p.003230: to correct the situation. The Board of Medicines shall immediately inform the National Bioethics Committee, the others
p.003230: the competent authorities of the Member States and the Commission on the action plan.
p.003230: Notification of unwanted events.
p.003231: 3231
...

p.003231: to the National Bioethics Committee any additional information requested.
p.003231: (4) The contractor shall keep detailed records of all adverse events reported to him by the investigator.
p.003231: These records are submitted to the Medicines Council, afterwards
p.003231: of.
p.003231: Notification of unexpected serious side effects.
p.003231: 23 .- (1) O
p.003231: (a) Record and notify to the Medicines Council and to the competent authority of each State concerned
p.003231: Member, as well as the National Bioethics Committee, as soon as possible and in any case within 7 days of
p.003231: when updated, all the information about the alleged unexpected serious
p.003232: 3232
p.003232: side effects, which have caused or can cause and
p.003232: (b) thereafter, within a new day, announce information on the follow-up.
p.003232: (2) All other suspected unexpected serious side effects are notified to the Council.
p.003232: And to the National Bioethics Committee as soon as possible and at the latest.
p.000015: 15
p.000015: for the first time.
p.000015: (3) The Medicines Board ensures that all suspected unexpected serious side effects are recorded
p.000015: notified to the tested medicinal product.
p.000015: (4) The other researchers shall disclose the information referred to in
p.000015: paragraphs (1) and (2).
p.000015: (5) Once a year, throughout the course of the clinical trial, the sponsor shall forward to the Council
p.000015: And the National Committee on Bioethics, a list of all the alleged serious side effects that
p.000015: During this time, a report on their safety was presented
p.000015: of participants.
p.000015: (6) The Medicines Board shall ensure that any suspected unexpected side effect of a drug is tested.
p.000015: of a medicinal product of which it is aware shall be registered immediately with a European database.
p.000015: (7) The Medicines Board shall have access to the information communicated by the contractor to
p.000015: European Agency
p.003233: 3233
p.003233: Drug Evaluation.
p.003233: Free delivery The contractor provides the tested pharmaceuticals free of charge
p.003233: and, where applicable, their mechanism:
p.003233: medicinal products.
p.003233: Provided that, in exceptional cases, the Medicines Council may determine specific and
p.003233: precise conditions for the provision of the tested medicinal products
p.003233: where their delivery mechanism.
p.003233: (2) Where the Council for Medicinal Products makes use of the option reserved to it
p.003233: of paragraph (1) shall inform it
p.003233: Responsibility of contractor, researcher and lead researcher.
p.003233: 25. These Regulations do not constitute the civil and criminal liability of the sponsor, the investigator or
p.003233: of the lead researcher.
p.003233: Entry into force of those present
p.003233: 26.- (1) Subject to the provisions of paragraph (2), these Regulations shall
p.003233: effective from the date
p.003233: in the Official Journal of the Republic.
p.003233: (2) The provisions -
p.003233: (a) Paragraph (3) (b) of Regulation 14,
p.003233: (b) the Rules of Procedure
p.003233: (c) paragraph (3) of Regulation 21 on the obligation to inform the competent authority
p.003233: of the Member States, of the European Agency
p.003234: 3234
p.003234: Evaluation of Medicines and the Commission,
p.003234: (d) paragraph (4) of Regulation 21 on the obligation to inform the competent authorities of the Member States
p.003234: and the Commission,
p.003234: (e) subparagraph (a) of paragraph (1) of Regulation 23, concerning the obligation
p.003234: notification to the competent authorities of
p.003234: members, •
p.003234: (f) of paragraph (2) of Regulation 24.
p.003234: They shall enter into force on the date of its accession
...

Searching for indicator substance:

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p.003210: incapable "to give informed free consent, means person, excluding participant, contractor,
p.003210: principal investigator, who is the registered physician or his or her registered physician; or
p.003210: a person proposed by that registered physician or registered dentist;
p.003210: "Law" means the Human Medicines (Quality, Supply and Price Control) Laws of the
p.003210: to (No. 3) of 2004;
p.003210: "Multicenter clinical trial" means a clinical trial conducted on the basis of the same protocol but
p.003210: in different centers and therefore more than one
p.003210: can be - (a) In the Republic,
p.003211: 3211
p.003211: (b) in the Republic and in one or more Member States;
p.003211: (c) in the Republic and in one or more third countries, or
p.003211: (d) in the Republic and in one or more Member States and in one or more thirds
p.003211: "Protocol" means the purpose, the design, the methodology, the
p.003211: statistical aspects and clinical trial organization and includes successive forms and
p.003211: modifications
p.003211: "Serious adverse event" or "serious side effect of a tested medicinal product"
p.003211: means any adverse event or side effect of a tested medicinal product that, regardless of
p.003211: the dose. causes or endangers life requires hospitalization or extension
p.003211: hospitalization and causes significant or permanent disability or disability or causes congenital anomaly or
p.003211: 'Participant' means a person who is in clinical trial as a recipient of a tested medicinal product
p.003211: of a product containing the active substance under test or as a recipient of the virtual form of the test
p.003211: medicinal product
p.003211: "Sub-committees" means the sub-committees referred to in Article 17 of the Bioethics (Establishment and
p.003211: Functioning of the National Commission) Law
p.003211: (2) other terms used in these Regulations and not interpreted
p.003211: otherwise to them,
p.003212: 3212
p.003212: have the same meaning assigned to them by the Law.
p.003212: These Regulations lay down specific provisions for the conduct of clinical trials,
p.003212: including multicentre trials, which are performed
p.003212: of human medicinal products, "especially with regard to the proper application of
p.003212: clinical practice.
p.003212: Scope.
p.002001: 2001
p.002001: 4 .- (1) Regulations 6 to 26 do not apply to non-interference tests.
p.002001: (2) Any clinical trial, including bioavailability studies, and
p.002001: It shall be designed, carried out and notified in accordance with these Regulations.
p.002001: (3) These Regulations shall apply without prejudice to Bioethics (Establishment and Functioning of National
p.002001: Commission; Law and the Data Processing of Personnel
p.002001: of 2003 (Protection of Individuals) Laws of 2001 and 2003.
p.002001: Non-intervention tests.
p.002001: 5. In the case of non-invasive tests -
p.002001: (a) The integration of the patient into a particular
p.002001: strategy is not decided in advance by protocol, but is incorporated into the current one
p.002001: medicine
p.002001: (b) the decision to dispose of a tested medicinal product is clearly separate from that of
p.002001: decision to participate in the clinical trial;
p.002001: (c) does not apply to - additional diagnostics or
p.003213: 3213
p.003213: (d) epidemiological methods of analyzing the collected data shall be used.
p.003213: for
...

Health / Mentally Disabled

Searching for indicator disability:

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p.003210: which, by reason of its relationship with that adult or minor, is eligible to become lawful
p.003210: for the purposes of the clinical trial and agrees to be legal
p.003210: in the absence of such a person, a legal representative of an adult participant,
p.003210: incapable "to give informed free consent, means person, excluding participant, contractor,
p.003210: principal investigator, who is the registered physician or his or her registered physician; or
p.003210: a person proposed by that registered physician or registered dentist;
p.003210: "Law" means the Human Medicines (Quality, Supply and Price Control) Laws of the
p.003210: to (No. 3) of 2004;
p.003210: "Multicenter clinical trial" means a clinical trial conducted on the basis of the same protocol but
p.003210: in different centers and therefore more than one
p.003210: can be - (a) In the Republic,
p.003211: 3211
p.003211: (b) in the Republic and in one or more Member States;
p.003211: (c) in the Republic and in one or more third countries, or
p.003211: (d) in the Republic and in one or more Member States and in one or more thirds
p.003211: "Protocol" means the purpose, the design, the methodology, the
p.003211: statistical aspects and clinical trial organization and includes successive forms and
p.003211: modifications
p.003211: "Serious adverse event" or "serious side effect of a tested medicinal product"
p.003211: means any adverse event or side effect of a tested medicinal product that, regardless of
p.003211: the dose. causes or endangers life requires hospitalization or extension
p.003211: hospitalization and causes significant or permanent disability or disability or causes congenital anomaly or
p.003211: 'Participant' means a person who is in clinical trial as a recipient of a tested medicinal product
p.003211: of a product containing the active substance under test or as a recipient of the virtual form of the test
p.003211: medicinal product
p.003211: "Sub-committees" means the sub-committees referred to in Article 17 of the Bioethics (Establishment and
p.003211: Functioning of the National Commission) Law
p.003211: (2) other terms used in these Regulations and not interpreted
p.003211: otherwise to them,
p.003212: 3212
p.003212: have the same meaning assigned to them by the Law.
p.003212: These Regulations lay down specific provisions for the conduct of clinical trials,
p.003212: including multicentre trials, which are performed
p.003212: of human medicinal products, "especially with regard to the proper application of
p.003212: clinical practice.
p.003212: Scope.
p.002001: 2001
p.002001: 4 .- (1) Regulations 6 to 26 do not apply to non-interference tests.
p.002001: (2) Any clinical trial, including bioavailability studies, and
p.002001: It shall be designed, carried out and notified in accordance with these Regulations.
p.002001: (3) These Regulations shall apply without prejudice to Bioethics (Establishment and Functioning of National
p.002001: Commission; Law and the Data Processing of Personnel
p.002001: of 2003 (Protection of Individuals) Laws of 2001 and 2003.
p.002001: Non-intervention tests.
p.002001: 5. In the case of non-invasive tests -
p.002001: (a) The integration of the patient into a particular
p.002001: strategy is not decided in advance by protocol, but is incorporated into the current one
p.002001: medicine
p.002001: (b) the decision to dispose of a tested medicinal product is clearly separate from that of
...

Health / Mentally Incapacitated

Searching for indicator incapable:

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p.003209: characteristics of the drug
p.003209: 'Informed free consent' means the consent obtained in accordance with the Rules of Procedure
p.003209: "Researcher's brochure" means the collection of clinical and non-clinical data;
p.003209: concerning a tested medicinal product and which is useful for the study of that tested medicinal product
p.003209: human medicine-
p.003209: 'Ethics committees' has the meaning ascribed to this term in 2001
p.003209: Bioethics and National Operation
p.003209: Commission) Law of 2001;
p.003209: "Investigator" means a registered physician or a person who has been granted the right to conduct investigations in
p.003209: Democracy, because of its scientific knowledge and because it has the experience required for it
p.003209: care and is responsible for conducting a clinical trial on a particular
p.003210: 3210
p.003210: 'Lead researcher' means the researcher, who is in charge of a group, which
p.003210: conducts a clinical trial on a particular
p.003210: 'Non-invasive test' means a test in which the 'tested medicinal product
p.003210: prescribed as usual in accordance with the conditions laid down in the license
p.003210: adult participant, unable to give informed free consent, means a person other than the participant;
p.003210: which, by reason of its relationship with that adult or minor, is eligible to become lawful
p.003210: for the purposes of the clinical trial and agrees to be legal
p.003210: in the absence of such a person, a legal representative of an adult participant,
p.003210: incapable "to give informed free consent, means person, excluding participant, contractor,
p.003210: principal investigator, who is the registered physician or his or her registered physician; or
p.003210: a person proposed by that registered physician or registered dentist;
p.003210: "Law" means the Human Medicines (Quality, Supply and Price Control) Laws of the
p.003210: to (No. 3) of 2004;
p.003210: "Multicenter clinical trial" means a clinical trial conducted on the basis of the same protocol but
p.003210: in different centers and therefore more than one
p.003210: can be - (a) In the Republic,
p.003211: 3211
p.003211: (b) in the Republic and in one or more Member States;
p.003211: (c) in the Republic and in one or more third countries, or
p.003211: (d) in the Republic and in one or more Member States and in one or more thirds
p.003211: "Protocol" means the purpose, the design, the methodology, the
p.003211: statistical aspects and clinical trial organization and includes successive forms and
p.003211: modifications
p.003211: "Serious adverse event" or "serious side effect of a tested medicinal product"
p.003211: means any adverse event or side effect of a tested medicinal product that, regardless of
p.003211: the dose. causes or endangers life requires hospitalization or extension
p.003211: hospitalization and causes significant or permanent disability or disability or causes congenital anomaly or
p.003211: 'Participant' means a person who is in clinical trial as a recipient of a tested medicinal product
p.003211: of a product containing the active substance under test or as a recipient of the virtual form of the test
p.003211: medicinal product
...

p.003219: (c) the express desire of the minor to form an opinion and to evaluate
p.003219: refuse to participate or
p.003219: withdraw from the clinical trial at any time, be taken into account by the researcher or, where appropriate, by
p.003219: Mister
p.003219: (d) no other incentives or financial facilities are provided except
p.003219: (e) the clinical trial derives immediate benefits for the patient group only if
p.003219: Specific research is needed to validate clinical data
p.003219: testing on persons capable of knowingly releasing it or from other research
p.003219: methods, and
p.003219: (Ii) this investigation is directly linked to a situation that the minor is or is suffering from
p.003220: 3220
p.003220: of such a nature that it can only be in
p.003220: (f) the relevant scientific evidence has been respected
p.003220: lines issued by the Council on the basis of * its Article
p.003220: (g) (i) clinical trials are designed in such a way as to minimize
p.003220: pains, the
p.003220: risks
p.003220: related to the disease and its stage, and
p.003220: (ii) both the risk threshold and the degree of annoyance are defined separately and monitored
p.003220: (h) the protocol has been approved by the National Bioethics Committee, having regard to the
p.003220: advice
p.003220: for its clinical, ethical and social psychosocial field and
p.003220: (i) his interest always prevails over the interests of science and science
p.003220: society
p.003220: \
p.003220: Clinical trials 13 .- (1) In the case of adults unable to give
p.003220: adult aware free apply all relevant requirements \ incapable to
p.003220: ',. .
p.003220: that for persons not to
p.003220: give it
p.003220: Consent and the requirements of paragraph (2).
p.003220: free consensus.
p.003220: (2) Participation in an adult clinical trial who did not give or refuse to give consciously free
p.003220: of. before losing its consent, it is possible if:
p.003221: 3221
p.003221: (a) informed consent has been provided by his or her legal representative who
p.003221: expresses the expected will of the participant and can be revoked at any time without negative
p.003221: consequences for the participant
p.003221: (b) the adult who is not able to give his informed free consent has
p.003221: be informed, depending on his or her mental state, on research, risks and benefits;
p.003221: (c) the express desire of a participant to be able to form an opinion and
p.003221: evaluate this information, refuse to participate in or withdraw from the clinical trial
p.003221: has at all times been considered by the researcher or, where necessary, by the principal researcher;
p.003221: (d) no incentives or financial facilities other than compensation are provided;
p.003221: (e) (i) this investigation is essential for the verification of data originating from
p.003221: from clinical trials to people capable of giving their informed informed consent or from others
p.003221: research methods, and
p.003221: (ii) directly relates to a clinical situation that is life-threatening or degenerative, from which
p.003221: a specific adult who is unable to give his / her free informed consent;
...

Social / Access to Social Goods

Searching for indicator access:

(return to top)
p.003231: These records are submitted to the Medicines Council, afterwards
p.003231: of.
p.003231: Notification of unexpected serious side effects.
p.003231: 23 .- (1) O
p.003231: (a) Record and notify to the Medicines Council and to the competent authority of each State concerned
p.003231: Member, as well as the National Bioethics Committee, as soon as possible and in any case within 7 days of
p.003231: when updated, all the information about the alleged unexpected serious
p.003232: 3232
p.003232: side effects, which have caused or can cause and
p.003232: (b) thereafter, within a new day, announce information on the follow-up.
p.003232: (2) All other suspected unexpected serious side effects are notified to the Council.
p.003232: And to the National Bioethics Committee as soon as possible and at the latest.
p.000015: 15
p.000015: for the first time.
p.000015: (3) The Medicines Board ensures that all suspected unexpected serious side effects are recorded
p.000015: notified to the tested medicinal product.
p.000015: (4) The other researchers shall disclose the information referred to in
p.000015: paragraphs (1) and (2).
p.000015: (5) Once a year, throughout the course of the clinical trial, the sponsor shall forward to the Council
p.000015: And the National Committee on Bioethics, a list of all the alleged serious side effects that
p.000015: During this time, a report on their safety was presented
p.000015: of participants.
p.000015: (6) The Medicines Board shall ensure that any suspected unexpected side effect of a drug is tested.
p.000015: of a medicinal product of which it is aware shall be registered immediately with a European database.
p.000015: (7) The Medicines Board shall have access to the information communicated by the contractor to
p.000015: European Agency
p.003233: 3233
p.003233: Drug Evaluation.
p.003233: Free delivery The contractor provides the tested pharmaceuticals free of charge
p.003233: and, where applicable, their mechanism:
p.003233: medicinal products.
p.003233: Provided that, in exceptional cases, the Medicines Council may determine specific and
p.003233: precise conditions for the provision of the tested medicinal products
p.003233: where their delivery mechanism.
p.003233: (2) Where the Council for Medicinal Products makes use of the option reserved to it
p.003233: of paragraph (1) shall inform it
p.003233: Responsibility of contractor, researcher and lead researcher.
p.003233: 25. These Regulations do not constitute the civil and criminal liability of the sponsor, the investigator or
p.003233: of the lead researcher.
p.003233: Entry into force of those present
p.003233: 26.- (1) Subject to the provisions of paragraph (2), these Regulations shall
p.003233: effective from the date
p.003233: in the Official Journal of the Republic.
p.003233: (2) The provisions -
p.003233: (a) Paragraph (3) (b) of Regulation 14,
p.003233: (b) the Rules of Procedure
p.003233: (c) paragraph (3) of Regulation 21 on the obligation to inform the competent authority
p.003233: of the Member States, of the European Agency
p.003234: 3234
p.003234: Evaluation of Medicines and the Commission,
p.003234: (d) paragraph (4) of Regulation 21 on the obligation to inform the competent authorities of the Member States
p.003234: and the Commission,
p.003234: (e) subparagraph (a) of paragraph (1) of Regulation 23, concerning the obligation
p.003234: notification to the competent authorities of
p.003234: members, •
...

Social / Incarcerated

Searching for indicator restricted:

(return to top)
p.003226: (7) For the tested medicinal products referred to in paragraph (6). the
p.003226: 90 days deadline
p.003226: may be extended for a further 90 days in the event of consultation by the National Commission
p.003226: Bioethics with ethics committees or subcommittees, according to Bioethics (Establishment and Operation of National
p.003226: Commission Act 2001.
p.003226: (8) In the case of a xenogeneic cell there is no time limit for the deadline
p.003226: approval.
p.003226: Written 17 .- (1) Without prejudice to the provisions of paragraphs (2) and pre-approval.
p.003226: The Medicines Board may require such as this
p.003227: 3227
p.003227: provides written approval for the initiation of clinical trials of tested medicinal products that do not
p.003227: which are listed in Part A of the Annex to the Law, as well
p.003227: and for others
p.003227: specialty pharmaceuticals such as 'tested pharmaceuticals'
p.003227: products whose active ingredient is or contains a biological product of human or animal origin
p.003227: biological elements of human or animal origin or the preparation of which requires the presence of such elements.
p.003227: (2) Written by the Medicines Council is required for the initiation of clinical trials,
p.003227: relate to tested somatic cellular gene products including
p.003227: xenogeneic cell line
p.003227: and tested medicinal products containing genetically modified organisms.
p.003227: (3) It is prohibited to carry out clinical trials of genes that lead to genetic modification.
p.003227: identity
p.003227: of the participant.
p.003227: (4) Written approval is granted without prejudice to the application of the laws in force
p.003227: It aims to bring it into line with the Council Directive of 23 April
p.003227: for genetically restricted use
p.003227: 2003. Modified Micro-organisms and the Genetically Modified Organisms
p.003227: (Liberalization in the Environment) Law of 2003.
p.003227: Modification of clinical trial.
p.003227: 18 .- (1) Following the commencement of a clinical trial, the contractor may make changes to the protocol. When
p.003227: these modifications are material and may affect the safety of the participants or
p.003227: change their interpretation of
p.003228: 3228
p.003228: scientific evidence on which the clinical trial is based, or otherwise
p.003228: Importantly, the contractor shall communicate the reasons for and the content of these amendments to the Council.
p.003228: Medicines and the National Bioethics Committee, in accordance with Regulations 14 and 17.
p.003228: (2) On the basis of the information referred to in paragraph (2) of Regulation 14 and in accordance with its provisions.
p.003228: Rule 15, the National Bioethics Committee shall deliver an opinion on.
p.003228: request for amendment. If this opinion is negative, the Contractor may not modify it
p.003228: protocol.
p.003228: (3) If the opinion of the National Bioethics Committee is favorable to the Medicines Council
p.003228: does not raise reasoned objections to such substantive amendments, O Contractor
p.003228: continues to conduct the clinical trial in accordance with the modified protocol. Otherwise,
p.003228: the contractor takes note of the objections and adjusts the planned
p.003228: modify the protocol or withdraw the request for modification.
p.003228: (4) Without prejudice to the provisions of paragraphs (1), (2) and
p.003228: (3) and depending on the circumstances, and in particular in the event of any new incidents involving
...

Social / Marital Status

Searching for indicator single:

(return to top)
p.003223: (g) the correctness and completeness of the written information to be provided, the procedure for
p.003223: give informed consent and justify the investigation to persons unable to give informed consent
p.003223: free of charge, with respect to the specific restrictions referred to in paragraph (3) of Regulation 4 and
p.003223: Rules 6. 7, 8, 9, 10 and 11;
p.003223: (h) the measures foreseen for damages in the event of loss or attributable to
p.003223: clinic
p.003223: (i) any compensation that covers the responsibility of the researcher, the principal investigator and
p.003223: (j) the amount and method of payment to any researcher and / or principal researcher, or
p.003223: Compensation - Participants and any relevant information
p.003224: 3224
p.003224: contract between the contractor of the center where the clinic takes place; and
p.003224: how to select the participants
p.003224: (3) (a) Notwithstanding the provisions of these Rules of Procedure, the Minister may delegate to the Council
p.003224: Examine the particulars referred to in subparagraphs (h), (i) and (j) of paragraph (2) and
p.003224: issue an opinion thereon.
p.003224: (b) When the Minister makes use of the option provided in this paragraph, he shall inform
p.003224: concerning the Commission, the Member States and the European Medicines Agency.
p.003224: (4) The National Bioethics Committee shall, within days of the date of receipt of the application, notify
p.003224: its reasoned opinion to the applicant and to the Medicines Council
p.003224: (5) The National Bioethics Committee may, within the period referred to in paragraph (4), submit
p.003224: a single request for information, other than that already provided by the
p.003224: The deadline is suspended until the supplements are received
p.003224: information.
p.003224: (6) clinical trials cases of tested medicinal products
p.003224: gene or
p.003224: all tested medicinal products containing genetically modified
p.003224: agencies, the period of 60 days referred to in paragraph (4) may be extended by a further 30 days.
p.003224: days.
p.003225: 3225
p.003225: (7) For the tested medicinal products referred to in paragraph (6), the 90-day time limit
p.003225: may be extended for a further 90 days if the National Bioethics Committee consults
p.003225: ethics committees or
p.003225: according to the Bioethics (Establishment and Operation of a National Commission) Law
p.003225: (8) In the case of xenogeneic cell no. there is a time limit
p.003225: approval •
p.003225: Multicenter 15.- (1) In the case of multicenter clinical trials, which
p.003225: only in the territory of the Republic, the National Commission
p.003225: Bioethics issues a single opinion.
p.003225: (2) In the case of multicentre clinical trials conducted simultaneously in the Republic
p.003225: and in a state
p.003225: Member State or in the Republic and in the Member States, the National Bioethics Committee shall issue only one opinion on the
p.003225: conducting multi-center clinical trial in the Republic.
p.003225: Starting a Clinic 16 .- (1) Before starting any clinical trial in the trial.
p.003225: In the Republic, the sponsor submits an application for approval to the Council
p.003225: Medicines.
p.003225: (2) The contractor may only commence a clinical trial if the request for an opinion submitted to
p.003225: The National Bioethics Committee, pursuant to paragraph (1) of Regulation 14, is also provided that the Council
p.003225: He did not notify the medicines
p.003225: justified objections.
p.003225: (3) The decision-making procedures referred to in paragraphs (1) and (2) may,
p.003225: are carried out cm
p.003226: 3226
p.003226: in parallel, if the contractor so wishes.
p.003226: (4) Should the Board of Medicines notify the sponsor of the reasoned objections,
p.003226: contractor may,
p.003226: only once, to amend the content of the application referred to in paragraph (1),
p.003226: take into account objections. In case the contractor does not modify the contractor accordingly
p.003226: due to an application, the application rejected and the clinical trial cannot be started.
p.003226: (5) The examination of an application for approval by the Medicines Council shall be carried out as soon as possible and not later than 60 days.
p.003226: days after receipt of the application. The Medicines Board may however notify the
p.003226: contractor, even before the end of that period, that it has no objections.
...

Social / Property Ownership

Searching for indicator property:

(return to top)
p.003213: (a) It saves and
p.003213: (b) is not deprived of his ability to give it under any law.
p.003213: For the purposes of paragraph (2), a person who has the brakes saved if at the time of supply
p.003213: the nature of the consensus can understand the nature, significance, impact and theirs
p.003213: risks of clinical trial and to form a reasonable judgment for
p.003213: '·)
p.003213: the? of his interests.
p.003213: (4) which does not usually have the brakes saved, but has
p.003213: save them as far as it can provide consent
p.003213: I.
p.003213: when you save the brakes.
p.003214: 3214
p.003214: (5) A person who usually has brakes but does not have breaks at intervals
p.003214: cannot provide consensus when it does not save the brakes.
p.003214: (6) Two or more persons agreeing to consent when agreeing to the same
p.003214: sense.
p.003214: (7) Consent is free when not caused by.
p.003214: (8) In case the participant is not able to write,
p.003214: may provide oral evidence in the presence of at least one witness,
p.003214: which shall be recorded in writing, with the date and signature of the witness.
p.003214: Definition For the purposes of Regulation 6 coercion means
p.003214: coerced perpetration or threat of perpetration prohibited by him
p.003214: Chapter 154.
p.003214: Criminal whether in or on
p.003214: of 1963 ° or its retention or 41 °
p.003214: 1964 threat of retention of person or property, to 1964 damage to any
p.003214: the intention is to
p.003214: 1965 person consent to attend a 1967 clinic
p.003214: test.
p.003214: of 1967
p.003214: of 1972
p.001972: 1972
p.001972: of 1973
p.001972: 59 of 1974
p.001972: 3 of 1975
p.001979: 1979
p.001981: 1981
p.001982: 1982
p.001982: 86 of
p.001986: 1986
p.001986: 111 of 1989
p.003215: 3215
p.003215: of 1991
p.001994: 1994
p.001996: 1996
p.001996: 1996
p.001997: 1997
p.001998: 1998
p.001998: 1998
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 30 (l) 2000
p.001999: of 2000
p.001999: of 2000
p.002000: 2000
p.002000: 2000
p.002000: 2000
p.002000: of 2001
p.002000: of 2002
p.002000: of 2002
p.002002: 2002
p.002002: of 2002
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003.
p.002002: Definition of mental pressure.
p.002002: 8 .- (1) For the purposes of the Rules of Procedure 6. consent
p.002002: that it was provided as a result of mental stress when the relationships between the person and the participant are
p.002002: such that the person in question is able to dominate her
p.002002: of the participant and to benefit from it in order to secure an unfair advantage against the participant
p.002002: participant.
p.002002: (2) In particular, without prejudice to paragraph (1), that it is capable of dominating
p.002002: of
p.002002: participant, any person who has actual or obvious authority over the participant or is in a relationship
p.002002: trust
p.003216: 3216
p.003216: against it.
p.003216: Definition of fraud.
p.003216: Definition of false representation.
p.003216: 9 .- (1) For the purposes of the Fraud Regulation it shall include any of the following acts -
...

Social / Threat of Stigma

Searching for indicator threat:

(return to top)
p.003213: date and signature, voluntarily received; after being thoroughly informed about nature, the
p.003213: importance, the risks after receiving appropriate documentation;
p.003213: (a) A person capable of giving the or
p.003213: (b) in the case of a person who is not capable of giving it, his / her lawful.
p.003213: (2) For the purposes of paragraph (1), any person capable of giving it, who -
p.003213: (a) It saves and
p.003213: (b) is not deprived of his ability to give it under any law.
p.003213: For the purposes of paragraph (2), a person who has the brakes saved if at the time of supply
p.003213: the nature of the consensus can understand the nature, significance, impact and theirs
p.003213: risks of clinical trial and to form a reasonable judgment for
p.003213: '·)
p.003213: the? of his interests.
p.003213: (4) which does not usually have the brakes saved, but has
p.003213: save them as far as it can provide consent
p.003213: I.
p.003213: when you save the brakes.
p.003214: 3214
p.003214: (5) A person who usually has brakes but does not have breaks at intervals
p.003214: cannot provide consensus when it does not save the brakes.
p.003214: (6) Two or more persons agreeing to consent when agreeing to the same
p.003214: sense.
p.003214: (7) Consent is free when not caused by.
p.003214: (8) In case the participant is not able to write,
p.003214: may provide oral evidence in the presence of at least one witness,
p.003214: which shall be recorded in writing, with the date and signature of the witness.
p.003214: Definition For the purposes of Regulation 6 coercion means
p.003214: coerced perpetration or threat of perpetration prohibited by him
p.003214: Chapter 154.
p.003214: Criminal whether in or on
p.003214: of 1963 ° or its retention or 41 °
p.003214: 1964 threat of retention of person or property, to 1964 damage to any
p.003214: the intention is to
p.003214: 1965 person consent to attend a 1967 clinic
p.003214: test.
p.003214: of 1967
p.003214: of 1972
p.001972: 1972
p.001972: of 1973
p.001972: 59 of 1974
p.001972: 3 of 1975
p.001979: 1979
p.001981: 1981
p.001982: 1982
p.001982: 86 of
p.001986: 1986
p.001986: 111 of 1989
p.003215: 3215
p.003215: of 1991
p.001994: 1994
p.001996: 1996
p.001996: 1996
p.001997: 1997
p.001998: 1998
p.001998: 1998
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 30 (l) 2000
p.001999: of 2000
p.001999: of 2000
p.002000: 2000
p.002000: 2000
p.002000: 2000
p.002000: of 2001
p.002000: of 2002
p.002000: of 2002
p.002002: 2002
p.002002: of 2002
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003.
p.002002: Definition of mental pressure.
p.002002: 8 .- (1) For the purposes of the Rules of Procedure 6. consent
p.002002: that it was provided as a result of mental stress when the relationships between the person and the participant are
p.002002: such that the person in question is able to dominate her
p.002002: of the participant and to benefit from it in order to secure an unfair advantage against the participant
p.002002: participant.
p.002002: (2) In particular, without prejudice to paragraph (1), that it is capable of dominating
p.002002: of
p.002002: participant, any person who has actual or obvious authority over the participant or is in a relationship
p.002002: trust
p.003216: 3216
p.003216: against it.
p.003216: Definition of fraud.
p.003216: Definition of false representation.
...

Social / Trade Union Membership

Searching for indicator union:

(return to top)
p.003228: risk. The contractor shall immediately inform the Medicines Council of these new incidents and of the measures taken and
p.003228: it shall inform the National Bioethics Committee at the same time.
p.003229: 3229
p.003229: Completion 19 .- (1) Within days of the completion of a clinical trial, fibrin test.
p.003229: notifies in writing to Medicines and
p.003229: National Bioethics Committee, that the clinical trial was completed.
p.003229: (2) If the clinical trial is terminated prematurely, the time limit,
p.003229: referred to in paragraph (1), is reduced to 15 days the contractor shall state clearly the reasons
p.003229: of interruption.
p.003229: Exchange of information.
p.003229: 2O .- (1) The Medicines Council shall ensure the registration of data in a European database.
p.003229: referred
p.003229: below, for clinical trials conducted in its territory
p.003229: Democracy:
p.003229: (a) Details of the application for authorization referred to in paragraph (1) of Regulation 16;
p.003229: (b) any amendments to this application pursuant to paragraph {4) of the Rules of Procedure
p.003229: (c) any amendments to the Protocol in accordance with paragraphs (1), (2) and (3) of the Rules of Procedure
p.003229: (d) the opinion of the National Commission
p.003229: (e) the statement of completion of the clinical trial; and
p.003229: (f) a reference to the inspections carried out pursuant to sections 96 and 96A of the Law for compliance
p.003229: of good clinical practice.
p.003230: 3230
p.003230: (2) Medicinal products, following a reasoned request from a Member State, of the European Union
p.003230: The Drug Evaluation Agency or the Commission shall provide all supplementary information, in addition to that
p.003230: that have already been introduced into the European database for this clinical trial.
p.003230: Suspension .- (1) Where the Medicines Board has
p.003230: clinical trial reasons that the conditions and infringements are no longer fulfilled.
p.003230: the application for authorization referred to in paragraph (1) thereof.
p.003230: the safety or scientific validity of the clinical trial,
p.003230: may suspend or prohibit such clinical trial by informing the contractor.
p.003230: (2) The Council for Medicinal Products, before taking a decision pursuant to paragraph (1), unless
p.003230: imposes an imminent risk, requests the opinion of the contractor and / or the researcher and / or the principal investigator,
p.003230: which should be given within a week.
p.003230: (3) The Council for Medicinal Products shall immediately inform the competent authorities of the Member States, the National Commission.
p.003230: Bioethics, the European Medicines Agency and the Commission in its decision
p.003230: suspension or prohibition of the clinical trial, as well as the cause.
p.003230: (4) In the event that the Medicines Council has reasonable grounds to believe that
p.003230: contractor or researcher or anyone else involved in the clinical trial no longer responds
p.003230: informs him immediately of his obligations and sets out the action plan to implement for
p.003230: to correct the situation. The Board of Medicines shall immediately inform the National Bioethics Committee, the others
p.003230: the competent authorities of the Member States and the Commission on the action plan.
p.003230: Notification of unwanted events.
...

p.003233: and, where applicable, their mechanism:
p.003233: medicinal products.
p.003233: Provided that, in exceptional cases, the Medicines Council may determine specific and
p.003233: precise conditions for the provision of the tested medicinal products
p.003233: where their delivery mechanism.
p.003233: (2) Where the Council for Medicinal Products makes use of the option reserved to it
p.003233: of paragraph (1) shall inform it
p.003233: Responsibility of contractor, researcher and lead researcher.
p.003233: 25. These Regulations do not constitute the civil and criminal liability of the sponsor, the investigator or
p.003233: of the lead researcher.
p.003233: Entry into force of those present
p.003233: 26.- (1) Subject to the provisions of paragraph (2), these Regulations shall
p.003233: effective from the date
p.003233: in the Official Journal of the Republic.
p.003233: (2) The provisions -
p.003233: (a) Paragraph (3) (b) of Regulation 14,
p.003233: (b) the Rules of Procedure
p.003233: (c) paragraph (3) of Regulation 21 on the obligation to inform the competent authority
p.003233: of the Member States, of the European Agency
p.003234: 3234
p.003234: Evaluation of Medicines and the Commission,
p.003234: (d) paragraph (4) of Regulation 21 on the obligation to inform the competent authorities of the Member States
p.003234: and the Commission,
p.003234: (e) subparagraph (a) of paragraph (1) of Regulation 23, concerning the obligation
p.003234: notification to the competent authorities of
p.003234: members, •
p.003234: (f) of paragraph (2) of Regulation 24.
p.003234: They shall enter into force on the date of its accession
...

Social / Youth/Minors

Searching for indicator minor:

(return to top)
p.003209: brochure for the researcher about-
p.003209: a marketing authorization and is under trial or, in the case of a tested medicinal product authorized
p.003209: traffic, the instructions attached to their brief description
p.003209: characteristics of the drug
p.003209: 'Informed free consent' means the consent obtained in accordance with the Rules of Procedure
p.003209: "Researcher's brochure" means the collection of clinical and non-clinical data;
p.003209: concerning a tested medicinal product and which is useful for the study of that tested medicinal product
p.003209: human medicine-
p.003209: 'Ethics committees' has the meaning ascribed to this term in 2001
p.003209: Bioethics and National Operation
p.003209: Commission) Law of 2001;
p.003209: "Investigator" means a registered physician or a person who has been granted the right to conduct investigations in
p.003209: Democracy, because of its scientific knowledge and because it has the experience required for it
p.003209: care and is responsible for conducting a clinical trial on a particular
p.003210: 3210
p.003210: 'Lead researcher' means the researcher, who is in charge of a group, which
p.003210: conducts a clinical trial on a particular
p.003210: 'Non-invasive test' means a test in which the 'tested medicinal product
p.003210: prescribed as usual in accordance with the conditions laid down in the license
p.003210: adult participant, unable to give informed free consent, means a person other than the participant;
p.003210: which, by reason of its relationship with that adult or minor, is eligible to become lawful
p.003210: for the purposes of the clinical trial and agrees to be legal
p.003210: in the absence of such a person, a legal representative of an adult participant,
p.003210: incapable "to give informed free consent, means person, excluding participant, contractor,
p.003210: principal investigator, who is the registered physician or his or her registered physician; or
p.003210: a person proposed by that registered physician or registered dentist;
p.003210: "Law" means the Human Medicines (Quality, Supply and Price Control) Laws of the
p.003210: to (No. 3) of 2004;
p.003210: "Multicenter clinical trial" means a clinical trial conducted on the basis of the same protocol but
p.003210: in different centers and therefore more than one
p.003210: can be - (a) In the Republic,
p.003211: 3211
p.003211: (b) in the Republic and in one or more Member States;
p.003211: (c) in the Republic and in one or more third countries, or
p.003211: (d) in the Republic and in one or more Member States and in one or more thirds
p.003211: "Protocol" means the purpose, the design, the methodology, the
p.003211: statistical aspects and clinical trial organization and includes successive forms and
p.003211: modifications
p.003211: "Serious adverse event" or "serious side effect of a tested medicinal product"
p.003211: means any adverse event or side effect of a tested medicinal product that, regardless of
p.003211: the dose. causes or endangers life requires hospitalization or extension
p.003211: hospitalization and causes significant or permanent disability or disability or causes congenital anomaly or
...

p.003217: the legal one
p.003218: 3218
p.003218: he should be given the opportunity, through a previous interview with the researcher or research team member, to
p.003218: Understand the objectives of the clinical trial, the risks and the
p.003218: disadvantages and the conditions under which it takes place. The participant must also have
p.003218: be informed * of leaving the clinical trial at any time.
p.003218: (6) The participant or, if the participant is not. in
p.003218: legal- '
p.003218: has given his informed free consent after being informed of the nature, significance, extent and
p.003218: the risks of the clinical trial.
p.003218: (7) The Participant may, at any time and without any adverse consequence, withdraw from it.
p.003218: from the clinical trial after withdrawing it for free.
p.003218: (8) Each researcher, principal investigator and contractor shall issue and maintain such
p.003218: involving liability to a participant for an adverse event or a serious adverse event.
p.003218: (9) The medical care provided to the participants and the medical decisions taken against them,
p.003218: are the responsibility of a duly qualified registered doctor or, where appropriate, a duly qualified physician
p.003218: a registered dentist.
p.003218: The lead investigator designates a person, from the clinical trial team, as the link to whom
p.003218: participant
p.003218: may request further information.
p.003219: 3219
p.003219: Clinical Trials In addition to any relevant restrictions, clinical trial on minors
p.003219: is carried out if:
p.003219: (a) An informed free consent has been provided by the parents or the legal representative of the minor;
p.003219: which reflects the juvenile's alleged will and
p.003219: can be revoked at any time without adverse consequences for him
p.003219: a test, in a way he can understand, by staff
p.003219: minors' experience of study, risks and benefits-
p.003219: (c) the express desire of the minor to form an opinion and to evaluate
p.003219: refuse to participate or
p.003219: withdraw from the clinical trial at any time, be taken into account by the researcher or, where appropriate, by
p.003219: Mister
p.003219: (d) no other incentives or financial facilities are provided except
p.003219: (e) the clinical trial derives immediate benefits for the patient group only if
p.003219: Specific research is needed to validate clinical data
p.003219: testing on persons capable of knowingly releasing it or from other research
p.003219: methods, and
p.003219: (Ii) this investigation is directly linked to a situation that the minor is or is suffering from
p.003220: 3220
p.003220: of such a nature that it can only be in
p.003220: (f) the relevant scientific evidence has been respected
p.003220: lines issued by the Council on the basis of * its Article
p.003220: (g) (i) clinical trials are designed in such a way as to minimize
p.003220: pains, the
p.003220: risks
p.003220: related to the disease and its stage, and
p.003220: (ii) both the risk threshold and the degree of annoyance are defined separately and monitored
p.003220: (h) the protocol has been approved by the National Bioethics Committee, having regard to the
p.003220: advice
p.003220: for its clinical, ethical and social psychosocial field and
p.003220: (i) his interest always prevails over the interests of science and science
p.003220: society
p.003220: \
p.003220: Clinical trials 13 .- (1) In the case of adults unable to give
p.003220: adult aware free apply all relevant requirements \ incapable to
p.003220: ',. .
p.003220: that for persons not to
p.003220: give it
p.003220: Consent and the requirements of paragraph (2).
p.003220: free consensus.
p.003220: (2) Participation in an adult clinical trial who did not give or refuse to give consciously free
p.003220: of. before losing its consent, it is possible if:
p.003221: 3221
p.003221: (a) informed consent has been provided by his or her legal representative who
p.003221: expresses the expected will of the participant and can be revoked at any time without negative
p.003221: consequences for the participant
p.003221: (b) the adult who is not able to give his informed free consent has
...

Social / parents

Searching for indicator parents:

(return to top)
p.003217: the legal one
p.003218: 3218
p.003218: he should be given the opportunity, through a previous interview with the researcher or research team member, to
p.003218: Understand the objectives of the clinical trial, the risks and the
p.003218: disadvantages and the conditions under which it takes place. The participant must also have
p.003218: be informed * of leaving the clinical trial at any time.
p.003218: (6) The participant or, if the participant is not. in
p.003218: legal- '
p.003218: has given his informed free consent after being informed of the nature, significance, extent and
p.003218: the risks of the clinical trial.
p.003218: (7) The Participant may, at any time and without any adverse consequence, withdraw from it.
p.003218: from the clinical trial after withdrawing it for free.
p.003218: (8) Each researcher, principal investigator and contractor shall issue and maintain such
p.003218: involving liability to a participant for an adverse event or a serious adverse event.
p.003218: (9) The medical care provided to the participants and the medical decisions taken against them,
p.003218: are the responsibility of a duly qualified registered doctor or, where appropriate, a duly qualified physician
p.003218: a registered dentist.
p.003218: The lead investigator designates a person, from the clinical trial team, as the link to whom
p.003218: participant
p.003218: may request further information.
p.003219: 3219
p.003219: Clinical Trials In addition to any relevant restrictions, clinical trial on minors
p.003219: is carried out if:
p.003219: (a) An informed free consent has been provided by the parents or the legal representative of the minor;
p.003219: which reflects the juvenile's alleged will and
p.003219: can be revoked at any time without adverse consequences for him
p.003219: a test, in a way he can understand, by staff
p.003219: minors' experience of study, risks and benefits-
p.003219: (c) the express desire of the minor to form an opinion and to evaluate
p.003219: refuse to participate or
p.003219: withdraw from the clinical trial at any time, be taken into account by the researcher or, where appropriate, by
p.003219: Mister
p.003219: (d) no other incentives or financial facilities are provided except
p.003219: (e) the clinical trial derives immediate benefits for the patient group only if
p.003219: Specific research is needed to validate clinical data
p.003219: testing on persons capable of knowingly releasing it or from other research
p.003219: methods, and
p.003219: (Ii) this investigation is directly linked to a situation that the minor is or is suffering from
p.003220: 3220
p.003220: of such a nature that it can only be in
p.003220: (f) the relevant scientific evidence has been respected
p.003220: lines issued by the Council on the basis of * its Article
p.003220: (g) (i) clinical trials are designed in such a way as to minimize
p.003220: pains, the
p.003220: risks
p.003220: related to the disease and its stage, and
p.003220: (ii) both the risk threshold and the degree of annoyance are defined separately and monitored
p.003220: (h) the protocol has been approved by the National Bioethics Committee, having regard to the
p.003220: advice
p.003220: for its clinical, ethical and social psychosocial field and
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

(return to top)
p.003218: (6) The participant or, if the participant is not. in
p.003218: legal- '
p.003218: has given his informed free consent after being informed of the nature, significance, extent and
p.003218: the risks of the clinical trial.
p.003218: (7) The Participant may, at any time and without any adverse consequence, withdraw from it.
p.003218: from the clinical trial after withdrawing it for free.
p.003218: (8) Each researcher, principal investigator and contractor shall issue and maintain such
p.003218: involving liability to a participant for an adverse event or a serious adverse event.
p.003218: (9) The medical care provided to the participants and the medical decisions taken against them,
p.003218: are the responsibility of a duly qualified registered doctor or, where appropriate, a duly qualified physician
p.003218: a registered dentist.
p.003218: The lead investigator designates a person, from the clinical trial team, as the link to whom
p.003218: participant
p.003218: may request further information.
p.003219: 3219
p.003219: Clinical Trials In addition to any relevant restrictions, clinical trial on minors
p.003219: is carried out if:
p.003219: (a) An informed free consent has been provided by the parents or the legal representative of the minor;
p.003219: which reflects the juvenile's alleged will and
p.003219: can be revoked at any time without adverse consequences for him
p.003219: a test, in a way he can understand, by staff
p.003219: minors' experience of study, risks and benefits-
p.003219: (c) the express desire of the minor to form an opinion and to evaluate
p.003219: refuse to participate or
p.003219: withdraw from the clinical trial at any time, be taken into account by the researcher or, where appropriate, by
p.003219: Mister
p.003219: (d) no other incentives or financial facilities are provided except
p.003219: (e) the clinical trial derives immediate benefits for the patient group only if
p.003219: Specific research is needed to validate clinical data
p.003219: testing on persons capable of knowingly releasing it or from other research
p.003219: methods, and
p.003219: (Ii) this investigation is directly linked to a situation that the minor is or is suffering from
p.003220: 3220
p.003220: of such a nature that it can only be in
p.003220: (f) the relevant scientific evidence has been respected
p.003220: lines issued by the Council on the basis of * its Article
p.003220: (g) (i) clinical trials are designed in such a way as to minimize
p.003220: pains, the
p.003220: risks
p.003220: related to the disease and its stage, and
p.003220: (ii) both the risk threshold and the degree of annoyance are defined separately and monitored
p.003220: (h) the protocol has been approved by the National Bioethics Committee, having regard to the
p.003220: advice
p.003220: for its clinical, ethical and social psychosocial field and
p.003220: (i) his interest always prevails over the interests of science and science
p.003220: society
p.003220: \
p.003220: Clinical trials 13 .- (1) In the case of adults unable to give
p.003220: adult aware free apply all relevant requirements \ incapable to
p.003220: ',. .
p.003220: that for persons not to
p.003220: give it
p.003220: Consent and the requirements of paragraph (2).
p.003220: free consensus.
p.003220: (2) Participation in an adult clinical trial who did not give or refuse to give consciously free
p.003220: of. before losing its consent, it is possible if:
p.003221: 3221
p.003221: (a) informed consent has been provided by his or her legal representative who
p.003221: expresses the expected will of the participant and can be revoked at any time without negative
p.003221: consequences for the participant
p.003221: (b) the adult who is not able to give his informed free consent has
p.003221: be informed, depending on his or her mental state, on research, risks and benefits;
p.003221: (c) the express desire of a participant to be able to form an opinion and
p.003221: evaluate this information, refuse to participate in or withdraw from the clinical trial
p.003221: has at all times been considered by the researcher or, where necessary, by the principal researcher;
p.003221: (d) no incentives or financial facilities other than compensation are provided;
p.003221: (e) (i) this investigation is essential for the verification of data originating from
p.003221: from clinical trials to people capable of giving their informed informed consent or from others
p.003221: research methods, and
p.003221: (ii) directly relates to a clinical situation that is life-threatening or degenerative, from which
p.003221: a specific adult who is unable to give his / her free informed consent;
p.003222: 3222
p.003222: (f) (i) the clinical trial is designed to minimize pain,
p.003222: disturbances, fears and other foreseeable risks associated with the disease and its stage
p.003222: her, and
p.003222: (Ii) both the risk threshold and the degree of annoyance have been explicitly defined and monitored
p.003222: Bioethics Committee, after being consulted on clinical, ethical and
p.003222: problems in the field of the disease in question and the group in question
p.003222: (h) the interest of the patient always outweighs the interests of the official and
p.003222: and
p.003222: (i) there are reasonable expectations that its receipt
p.003222: The product offers the patient benefits that outweigh the risks or that there is no risk whatsoever.
p.003222: The National Bioethics Committee shall deliver its opinion before
p.003222: Commission commencement of each clinical trial for which the contractor submits bioethics.
p.003222: Application
p.003222: (2) For its opinion, the National Bioethics Committee shall take into account the following:
p.003222: (a) The suitability of the clinical trial and design
p.003223: 3223
p.003223: (b) whether the evaluation of the expected benefits and risks, as required by
p.003223: paragraphs (3) and (4) of the Rules of Procedure are satisfactory and whether the conclusions are
p.003223: (c)
p.003223: (d) the competence of the researcher and the collaborators
p.003223: (e) the brochure for him
p.003223: (f) the quality of
p.003223: (g) the correctness and completeness of the written information to be provided, the procedure for
p.003223: give informed consent and justify the investigation to persons unable to give informed consent
p.003223: free of charge, with respect to the specific restrictions referred to in paragraph (3) of Regulation 4 and
p.003223: Rules 6. 7, 8, 9, 10 and 11;
p.003223: (h) the measures foreseen for damages in the event of loss or attributable to
p.003223: clinic
p.003223: (i) any compensation that covers the responsibility of the researcher, the principal investigator and
p.003223: (j) the amount and method of payment to any researcher and / or principal researcher, or
p.003223: Compensation - Participants and any relevant information
p.003224: 3224
p.003224: contract between the contractor of the center where the clinic takes place; and
p.003224: how to select the participants
p.003224: (3) (a) Notwithstanding the provisions of these Rules of Procedure, the Minister may delegate to the Council
p.003224: Examine the particulars referred to in subparagraphs (h), (i) and (j) of paragraph (2) and
p.003224: issue an opinion thereon.
p.003224: (b) When the Minister makes use of the option provided in this paragraph, he shall inform
p.003224: concerning the Commission, the Member States and the European Medicines Agency.
p.003224: (4) The National Bioethics Committee shall, within days of the date of receipt of the application, notify
p.003224: its reasoned opinion to the applicant and to the Medicines Council
p.003224: (5) The National Bioethics Committee may, within the period referred to in paragraph (4), submit
p.003224: a single request for information, other than that already provided by the
p.003224: The deadline is suspended until the supplements are received
p.003224: information.
p.003224: (6) clinical trials cases of tested medicinal products
p.003224: gene or
p.003224: all tested medicinal products containing genetically modified
p.003224: agencies, the period of 60 days referred to in paragraph (4) may be extended by a further 30 days.
p.003224: days.
p.003225: 3225
p.003225: (7) For the tested medicinal products referred to in paragraph (6), the 90-day time limit
p.003225: may be extended for a further 90 days if the National Bioethics Committee consults
p.003225: ethics committees or
p.003225: according to the Bioethics (Establishment and Operation of a National Commission) Law
p.003225: (8) In the case of xenogeneic cell no. there is a time limit
p.003225: approval •
p.003225: Multicenter 15.- (1) In the case of multicenter clinical trials, which
p.003225: only in the territory of the Republic, the National Commission
p.003225: Bioethics issues a single opinion.
p.003225: (2) In the case of multicentre clinical trials conducted simultaneously in the Republic
p.003225: and in a state
p.003225: Member State or in the Republic and in the Member States, the National Bioethics Committee shall issue only one opinion on the
p.003225: conducting multi-center clinical trial in the Republic.
p.003225: Starting a Clinic 16 .- (1) Before starting any clinical trial in the trial.
p.003225: In the Republic, the sponsor submits an application for approval to the Council
p.003225: Medicines.
p.003225: (2) The contractor may only commence a clinical trial if the request for an opinion submitted to
p.003225: The National Bioethics Committee, pursuant to paragraph (1) of Regulation 14, is also provided that the Council
p.003225: He did not notify the medicines
p.003225: justified objections.
p.003225: (3) The decision-making procedures referred to in paragraphs (1) and (2) may,
p.003225: are carried out cm
p.003226: 3226
p.003226: in parallel, if the contractor so wishes.
p.003226: (4) Should the Board of Medicines notify the sponsor of the reasoned objections,
p.003226: contractor may,
p.003226: only once, to amend the content of the application referred to in paragraph (1),
p.003226: take into account objections. In case the contractor does not modify the contractor accordingly
p.003226: due to an application, the application rejected and the clinical trial cannot be started.
p.003226: (5) The examination of an application for approval by the Medicines Council shall be carried out as soon as possible and not later than 60 days.
p.003226: days after receipt of the application. The Medicines Board may however notify the
p.003226: contractor, even before the end of that period, that it has no objections.
p.003226: (6) clinical trial cases of tested pharmaceuticals
p.003226: listed in paragraph (2) of Regulation 17, the time limit referred to in paragraph
p.003226: (5) may be extended for a further 30 days.
p.003226: (7) For the tested medicinal products referred to in paragraph (6). the
p.003226: 90 days deadline
p.003226: may be extended for a further 90 days in the event of consultation by the National Commission
p.003226: Bioethics with ethics committees or subcommittees, according to Bioethics (Establishment and Operation of National
p.003226: Commission Act 2001.
p.003226: (8) In the case of a xenogeneic cell there is no time limit for the deadline
p.003226: approval.
...

p.003227: biological elements of human or animal origin or the preparation of which requires the presence of such elements.
p.003227: (2) Written by the Medicines Council is required for the initiation of clinical trials,
p.003227: relate to tested somatic cellular gene products including
p.003227: xenogeneic cell line
p.003227: and tested medicinal products containing genetically modified organisms.
p.003227: (3) It is prohibited to carry out clinical trials of genes that lead to genetic modification.
p.003227: identity
p.003227: of the participant.
p.003227: (4) Written approval is granted without prejudice to the application of the laws in force
p.003227: It aims to bring it into line with the Council Directive of 23 April
p.003227: for genetically restricted use
p.003227: 2003. Modified Micro-organisms and the Genetically Modified Organisms
p.003227: (Liberalization in the Environment) Law of 2003.
p.003227: Modification of clinical trial.
p.003227: 18 .- (1) Following the commencement of a clinical trial, the contractor may make changes to the protocol. When
p.003227: these modifications are material and may affect the safety of the participants or
p.003227: change their interpretation of
p.003228: 3228
p.003228: scientific evidence on which the clinical trial is based, or otherwise
p.003228: Importantly, the contractor shall communicate the reasons for and the content of these amendments to the Council.
p.003228: Medicines and the National Bioethics Committee, in accordance with Regulations 14 and 17.
p.003228: (2) On the basis of the information referred to in paragraph (2) of Regulation 14 and in accordance with its provisions.
p.003228: Rule 15, the National Bioethics Committee shall deliver an opinion on.
p.003228: request for amendment. If this opinion is negative, the Contractor may not modify it
p.003228: protocol.
p.003228: (3) If the opinion of the National Bioethics Committee is favorable to the Medicines Council
p.003228: does not raise reasoned objections to such substantive amendments, O Contractor
p.003228: continues to conduct the clinical trial in accordance with the modified protocol. Otherwise,
p.003228: the contractor takes note of the objections and adjusts the planned
p.003228: modify the protocol or withdraw the request for modification.
p.003228: (4) Without prejudice to the provisions of paragraphs (1), (2) and
p.003228: (3) and depending on the circumstances, and in particular in the event of any new incidents involving
p.003228: conducting the clinical trial or developing the test medicinal product when
p.003228: this new event may affect the safety of the participants, the contractor and the researcher receive the
p.003228: appropriate emergency measures to protect participants from immediate
p.003228: risk. The contractor shall immediately inform the Medicines Council of these new incidents and of the measures taken and
p.003228: it shall inform the National Bioethics Committee at the same time.
p.003229: 3229
p.003229: Completion 19 .- (1) Within days of the completion of a clinical trial, fibrin test.
p.003229: notifies in writing to Medicines and
p.003229: National Bioethics Committee, that the clinical trial was completed.
p.003229: (2) If the clinical trial is terminated prematurely, the time limit,
p.003229: referred to in paragraph (1), is reduced to 15 days the contractor shall state clearly the reasons
p.003229: of interruption.
p.003229: Exchange of information.
p.003229: 2O .- (1) The Medicines Council shall ensure the registration of data in a European database.
p.003229: referred
p.003229: below, for clinical trials conducted in its territory
p.003229: Democracy:
p.003229: (a) Details of the application for authorization referred to in paragraph (1) of Regulation 16;
p.003229: (b) any amendments to this application pursuant to paragraph {4) of the Rules of Procedure
p.003229: (c) any amendments to the Protocol in accordance with paragraphs (1), (2) and (3) of the Rules of Procedure
p.003229: (d) the opinion of the National Commission
p.003229: (e) the statement of completion of the clinical trial; and
p.003229: (f) a reference to the inspections carried out pursuant to sections 96 and 96A of the Law for compliance
p.003229: of good clinical practice.
p.003230: 3230
p.003230: (2) Medicinal products, following a reasoned request from a Member State, of the European Union
p.003230: The Drug Evaluation Agency or the Commission shall provide all supplementary information, in addition to that
p.003230: that have already been introduced into the European database for this clinical trial.
p.003230: Suspension .- (1) Where the Medicines Board has
p.003230: clinical trial reasons that the conditions and infringements are no longer fulfilled.
p.003230: the application for authorization referred to in paragraph (1) thereof.
p.003230: the safety or scientific validity of the clinical trial,
p.003230: may suspend or prohibit such clinical trial by informing the contractor.
p.003230: (2) The Council for Medicinal Products, before taking a decision pursuant to paragraph (1), unless
p.003230: imposes an imminent risk, requests the opinion of the contractor and / or the researcher and / or the principal investigator,
p.003230: which should be given within a week.
p.003230: (3) The Council for Medicinal Products shall immediately inform the competent authorities of the Member States, the National Commission.
p.003230: Bioethics, the European Medicines Agency and the Commission in its decision
p.003230: suspension or prohibition of the clinical trial, as well as the cause.
p.003230: (4) In the event that the Medicines Council has reasonable grounds to believe that
p.003230: contractor or researcher or anyone else involved in the clinical trial no longer responds
p.003230: informs him immediately of his obligations and sets out the action plan to implement for
p.003230: to correct the situation. The Board of Medicines shall immediately inform the National Bioethics Committee, the others
p.003230: the competent authorities of the Member States and the Commission on the action plan.
p.003230: Notification of unwanted events.
p.003231: 3231
p.003231: 22.- (1) The investigator shall immediately notify the sponsor of any serious adverse events, except those which
p.003231: appear in the protocol or leaflet for the researcher as being in immediate need
p.003231: notification. The immediate notification shall be followed by detailed, written reports. So inside
p.003231: This notification, as in subsequent reports, identifies the participants with
p.003231: password
p.003231: unwanted-
p.003231: the results of the analyzes, which are designated in the Protocol as crucial for the evaluation of safety,
p.003231: are notified to the contractor, in accordance with the notification requirements and within the time limits specified
p.003231: in the protocol.
p.003231: (3) In the case of a notified participant, the researcher shall provide the contractor with and
p.003231: to the National Bioethics Committee any additional information requested.
...

General/Other / Public Emergency

Searching for indicator emergency:

(return to top)
p.003227: these modifications are material and may affect the safety of the participants or
p.003227: change their interpretation of
p.003228: 3228
p.003228: scientific evidence on which the clinical trial is based, or otherwise
p.003228: Importantly, the contractor shall communicate the reasons for and the content of these amendments to the Council.
p.003228: Medicines and the National Bioethics Committee, in accordance with Regulations 14 and 17.
p.003228: (2) On the basis of the information referred to in paragraph (2) of Regulation 14 and in accordance with its provisions.
p.003228: Rule 15, the National Bioethics Committee shall deliver an opinion on.
p.003228: request for amendment. If this opinion is negative, the Contractor may not modify it
p.003228: protocol.
p.003228: (3) If the opinion of the National Bioethics Committee is favorable to the Medicines Council
p.003228: does not raise reasoned objections to such substantive amendments, O Contractor
p.003228: continues to conduct the clinical trial in accordance with the modified protocol. Otherwise,
p.003228: the contractor takes note of the objections and adjusts the planned
p.003228: modify the protocol or withdraw the request for modification.
p.003228: (4) Without prejudice to the provisions of paragraphs (1), (2) and
p.003228: (3) and depending on the circumstances, and in particular in the event of any new incidents involving
p.003228: conducting the clinical trial or developing the test medicinal product when
p.003228: this new event may affect the safety of the participants, the contractor and the researcher receive the
p.003228: appropriate emergency measures to protect participants from immediate
p.003228: risk. The contractor shall immediately inform the Medicines Council of these new incidents and of the measures taken and
p.003228: it shall inform the National Bioethics Committee at the same time.
p.003229: 3229
p.003229: Completion 19 .- (1) Within days of the completion of a clinical trial, fibrin test.
p.003229: notifies in writing to Medicines and
p.003229: National Bioethics Committee, that the clinical trial was completed.
p.003229: (2) If the clinical trial is terminated prematurely, the time limit,
p.003229: referred to in paragraph (1), is reduced to 15 days the contractor shall state clearly the reasons
p.003229: of interruption.
p.003229: Exchange of information.
p.003229: 2O .- (1) The Medicines Council shall ensure the registration of data in a European database.
p.003229: referred
p.003229: below, for clinical trials conducted in its territory
p.003229: Democracy:
p.003229: (a) Details of the application for authorization referred to in paragraph (1) of Regulation 16;
p.003229: (b) any amendments to this application pursuant to paragraph {4) of the Rules of Procedure
p.003229: (c) any amendments to the Protocol in accordance with paragraphs (1), (2) and (3) of the Rules of Procedure
p.003229: (d) the opinion of the National Commission
p.003229: (e) the statement of completion of the clinical trial; and
p.003229: (f) a reference to the inspections carried out pursuant to sections 96 and 96A of the Law for compliance
p.003229: of good clinical practice.
p.003230: 3230
p.003230: (2) Medicinal products, following a reasoned request from a Member State, of the European Union
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.003214: Chapter 154.
p.003214: Criminal whether in or on
p.003214: of 1963 ° or its retention or 41 °
p.003214: 1964 threat of retention of person or property, to 1964 damage to any
p.003214: the intention is to
p.003214: 1965 person consent to attend a 1967 clinic
p.003214: test.
p.003214: of 1967
p.003214: of 1972
p.001972: 1972
p.001972: of 1973
p.001972: 59 of 1974
p.001972: 3 of 1975
p.001979: 1979
p.001981: 1981
p.001982: 1982
p.001982: 86 of
p.001986: 1986
p.001986: 111 of 1989
p.003215: 3215
p.003215: of 1991
p.001994: 1994
p.001996: 1996
p.001996: 1996
p.001997: 1997
p.001998: 1998
p.001998: 1998
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 1999
p.001999: 30 (l) 2000
p.001999: of 2000
p.001999: of 2000
p.002000: 2000
p.002000: 2000
p.002000: 2000
p.002000: of 2001
p.002000: of 2002
p.002000: of 2002
p.002002: 2002
p.002002: of 2002
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003
p.002002: of 2003.
p.002002: Definition of mental pressure.
p.002002: 8 .- (1) For the purposes of the Rules of Procedure 6. consent
p.002002: that it was provided as a result of mental stress when the relationships between the person and the participant are
p.002002: such that the person in question is able to dominate her
p.002002: of the participant and to benefit from it in order to secure an unfair advantage against the participant
p.002002: participant.
p.002002: (2) In particular, without prejudice to paragraph (1), that it is capable of dominating
p.002002: of
p.002002: participant, any person who has actual or obvious authority over the participant or is in a relationship
p.002002: trust
p.003216: 3216
p.003216: against it.
p.003216: Definition of fraud.
p.003216: Definition of false representation.
p.003216: 9 .- (1) For the purposes of the Fraud Regulation it shall include any of the following acts -
p.003216: (a) The representation of an untrue event as true, by a person who does not believe that it is true;
p.003216: (b) the active concealment of an event by a person who
p.003216: or believe it,
p.003216: (c) any act of fraud;
p.003216: (d) any act or omission that is defined by any law as fraud. "'
p.003216: (2) Simple silence on events that may affect a person's willingness to provide
p.003216: not
p.003216: / is fraud, unless the circumstances are such that,
p.003216: thereby the person who is silent has an obligation to declare them or unless the silence
p.003216: That in itself is equivalent to a statement.
p.003216: 10. For the purposes of Regulation 6, a false representation shall include -
p.003216: (a) In a manner not justified by the person's information
p.003216: affirming, untrue, although the person affirming believes that it is true,
p.003216: (b) any breach of duty which, without intent to deceive, benefits the offender
p.003216: or to
p.003217: 3217
p.003217: who claims by deceiving another to harm it or to harm anyone
p.003217: who claims through it,
p.003217: Ί
p.003217: (c) the challenge, even if it is mistaken, of consent.
p.003217: Protection A clinical trial is performed only if participants are satisfied.
p.003217: (2), (3), (4), (5), (6), (7) and (8).
p.003217: (2) This Regulation shall apply with due regard to the participant's right to respect
...

p.003230: (4) In the event that the Medicines Council has reasonable grounds to believe that
p.003230: contractor or researcher or anyone else involved in the clinical trial no longer responds
p.003230: informs him immediately of his obligations and sets out the action plan to implement for
p.003230: to correct the situation. The Board of Medicines shall immediately inform the National Bioethics Committee, the others
p.003230: the competent authorities of the Member States and the Commission on the action plan.
p.003230: Notification of unwanted events.
p.003231: 3231
p.003231: 22.- (1) The investigator shall immediately notify the sponsor of any serious adverse events, except those which
p.003231: appear in the protocol or leaflet for the researcher as being in immediate need
p.003231: notification. The immediate notification shall be followed by detailed, written reports. So inside
p.003231: This notification, as in subsequent reports, identifies the participants with
p.003231: password
p.003231: unwanted-
p.003231: the results of the analyzes, which are designated in the Protocol as crucial for the evaluation of safety,
p.003231: are notified to the contractor, in accordance with the notification requirements and within the time limits specified
p.003231: in the protocol.
p.003231: (3) In the case of a notified participant, the researcher shall provide the contractor with and
p.003231: to the National Bioethics Committee any additional information requested.
p.003231: (4) The contractor shall keep detailed records of all adverse events reported to him by the investigator.
p.003231: These records are submitted to the Medicines Council, afterwards
p.003231: of.
p.003231: Notification of unexpected serious side effects.
p.003231: 23 .- (1) O
p.003231: (a) Record and notify to the Medicines Council and to the competent authority of each State concerned
p.003231: Member, as well as the National Bioethics Committee, as soon as possible and in any case within 7 days of
p.003231: when updated, all the information about the alleged unexpected serious
p.003232: 3232
p.003232: side effects, which have caused or can cause and
p.003232: (b) thereafter, within a new day, announce information on the follow-up.
p.003232: (2) All other suspected unexpected serious side effects are notified to the Council.
p.003232: And to the National Bioethics Committee as soon as possible and at the latest.
p.000015: 15
p.000015: for the first time.
p.000015: (3) The Medicines Board ensures that all suspected unexpected serious side effects are recorded
p.000015: notified to the tested medicinal product.
p.000015: (4) The other researchers shall disclose the information referred to in
p.000015: paragraphs (1) and (2).
p.000015: (5) Once a year, throughout the course of the clinical trial, the sponsor shall forward to the Council
p.000015: And the National Committee on Bioethics, a list of all the alleged serious side effects that
p.000015: During this time, a report on their safety was presented
p.000015: of participants.
p.000015: (6) The Medicines Board shall ensure that any suspected unexpected side effect of a drug is tested.
p.000015: of a medicinal product of which it is aware shall be registered immediately with a European database.
p.000015: (7) The Medicines Board shall have access to the information communicated by the contractor to
p.000015: European Agency
p.003233: 3233
p.003233: Drug Evaluation.
p.003233: Free delivery The contractor provides the tested pharmaceuticals free of charge
p.003233: and, where applicable, their mechanism:
p.003233: medicinal products.
p.003233: Provided that, in exceptional cases, the Medicines Council may determine specific and
p.003233: precise conditions for the provision of the tested medicinal products
p.003233: where their delivery mechanism.
p.003233: (2) Where the Council for Medicinal Products makes use of the option reserved to it
p.003233: of paragraph (1) shall inform it
p.003233: Responsibility of contractor, researcher and lead researcher.
p.003233: 25. These Regulations do not constitute the civil and criminal liability of the sponsor, the investigator or
p.003233: of the lead researcher.
p.003233: Entry into force of those present
p.003233: 26.- (1) Subject to the provisions of paragraph (2), these Regulations shall
p.003233: effective from the date
p.003233: in the Official Journal of the Republic.
p.003233: (2) The provisions -
p.003233: (a) Paragraph (3) (b) of Regulation 14,
p.003233: (b) the Rules of Procedure
p.003233: (c) paragraph (3) of Regulation 21 on the obligation to inform the competent authority
p.003233: of the Member States, of the European Agency
p.003234: 3234
p.003234: Evaluation of Medicines and the Commission,
p.003234: (d) paragraph (4) of Regulation 21 on the obligation to inform the competent authorities of the Member States
p.003234: and the Commission,
p.003234: (e) subparagraph (a) of paragraph (1) of Regulation 23, concerning the obligation
p.003234: notification to the competent authorities of
p.003234: members, •
p.003234: (f) of paragraph (2) of Regulation 24.
p.003234: They shall enter into force on the date of its accession
...


Orphaned Trigger Words



p.003211: medicinal product
p.003211: "Sub-committees" means the sub-committees referred to in Article 17 of the Bioethics (Establishment and
p.003211: Functioning of the National Commission) Law
p.003211: (2) other terms used in these Regulations and not interpreted
p.003211: otherwise to them,
p.003212: 3212
p.003212: have the same meaning assigned to them by the Law.
p.003212: These Regulations lay down specific provisions for the conduct of clinical trials,
p.003212: including multicentre trials, which are performed
p.003212: of human medicinal products, "especially with regard to the proper application of
p.003212: clinical practice.
p.003212: Scope.
p.002001: 2001
p.002001: 4 .- (1) Regulations 6 to 26 do not apply to non-interference tests.
p.002001: (2) Any clinical trial, including bioavailability studies, and
p.002001: It shall be designed, carried out and notified in accordance with these Regulations.
p.002001: (3) These Regulations shall apply without prejudice to Bioethics (Establishment and Functioning of National
p.002001: Commission; Law and the Data Processing of Personnel
p.002001: of 2003 (Protection of Individuals) Laws of 2001 and 2003.
p.002001: Non-intervention tests.
p.002001: 5. In the case of non-invasive tests -
p.002001: (a) The integration of the patient into a particular
p.002001: strategy is not decided in advance by protocol, but is incorporated into the current one
p.002001: medicine
p.002001: (b) the decision to dispose of a tested medicinal product is clearly separate from that of
p.002001: decision to participate in the clinical trial;
p.002001: (c) does not apply to - additional diagnostics or
p.003213: 3213
p.003213: (d) epidemiological methods of analyzing the collected data shall be used.
p.003213: for
p.003213: Free consent.
p.003213: Know free consent means written decision to participate in a clinical trial, with
p.003213: date and signature, voluntarily received; after being thoroughly informed about nature, the
p.003213: importance, the risks after receiving appropriate documentation;
p.003213: (a) A person capable of giving the or
p.003213: (b) in the case of a person who is not capable of giving it, his / her lawful.
p.003213: (2) For the purposes of paragraph (1), any person capable of giving it, who -
p.003213: (a) It saves and
p.003213: (b) is not deprived of his ability to give it under any law.
p.003213: For the purposes of paragraph (2), a person who has the brakes saved if at the time of supply
p.003213: the nature of the consensus can understand the nature, significance, impact and theirs
p.003213: risks of clinical trial and to form a reasonable judgment for
p.003213: '·)
p.003213: the? of his interests.
p.003213: (4) which does not usually have the brakes saved, but has
p.003213: save them as far as it can provide consent
p.003213: I.
p.003213: when you save the brakes.
p.003214: 3214
p.003214: (5) A person who usually has brakes but does not have breaks at intervals
p.003214: cannot provide consensus when it does not save the brakes.
p.003214: (6) Two or more persons agreeing to consent when agreeing to the same
p.003214: sense.
p.003214: (7) Consent is free when not caused by.
p.003214: (8) In case the participant is not able to write,
p.003214: may provide oral evidence in the presence of at least one witness,
p.003214: which shall be recorded in writing, with the date and signature of the witness.
p.003214: Definition For the purposes of Regulation 6 coercion means ...

p.003216: against it.
p.003216: Definition of fraud.
p.003216: Definition of false representation.
p.003216: 9 .- (1) For the purposes of the Fraud Regulation it shall include any of the following acts -
p.003216: (a) The representation of an untrue event as true, by a person who does not believe that it is true;
p.003216: (b) the active concealment of an event by a person who
p.003216: or believe it,
p.003216: (c) any act of fraud;
p.003216: (d) any act or omission that is defined by any law as fraud. "'
p.003216: (2) Simple silence on events that may affect a person's willingness to provide
p.003216: not
p.003216: / is fraud, unless the circumstances are such that,
p.003216: thereby the person who is silent has an obligation to declare them or unless the silence
p.003216: That in itself is equivalent to a statement.
p.003216: 10. For the purposes of Regulation 6, a false representation shall include -
p.003216: (a) In a manner not justified by the person's information
p.003216: affirming, untrue, although the person affirming believes that it is true,
p.003216: (b) any breach of duty which, without intent to deceive, benefits the offender
p.003216: or to
p.003217: 3217
p.003217: who claims by deceiving another to harm it or to harm anyone
p.003217: who claims through it,
p.003217: Ί
p.003217: (c) the challenge, even if it is mistaken, of consent.
p.003217: Protection A clinical trial is performed only if participants are satisfied.
p.003217: (2), (3), (4), (5), (6), (7) and (8).
p.003217: (2) This Regulation shall apply with due regard to the participant's right to respect
p.003217: his physical and / or mental privacy, in accordance with the provisions
p.003217: for the protection of his personal
p.003217: in accordance with the Personal Data Processing (Protection of Individuals) Laws of 2001 and
p.003217: 2003. ''
p.003217: (3) A clinical trial if the risks and adverse effects are present
p.003217: weighted against the individual benefit of participants, patients, and future patients.
p.003217: (4) A clinical trial only begins when the National Bioethics Committee and the Medicines Council
p.003217: agree that the expected benefits, in terms of public health,
p.003217: outweigh the risks, and only continue if it is constantly monitored for
p.003217: This requirement and the Council for Medicinal Products do not provide reasoned information
p.003217: (5) The participant or, in the event that the participant is not capable of knowingly giving free consent,
p.003217: the legal one
p.003218: 3218
p.003218: he should be given the opportunity, through a previous interview with the researcher or research team member, to
p.003218: Understand the objectives of the clinical trial, the risks and the
p.003218: disadvantages and the conditions under which it takes place. The participant must also have
p.003218: be informed * of leaving the clinical trial at any time.
p.003218: (6) The participant or, if the participant is not. in
p.003218: legal- '
p.003218: has given his informed free consent after being informed of the nature, significance, extent and
p.003218: the risks of the clinical trial.
p.003218: (7) The Participant may, at any time and without any adverse consequence, withdraw from it.
p.003218: from the clinical trial after withdrawing it for free.
p.003218: (8) Each researcher, principal investigator and contractor shall issue and maintain such
p.003218: involving liability to a participant for an adverse event or a serious adverse event.
p.003218: (9) The medical care provided to the participants and the medical decisions taken against them, ...

Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
authorityRelationship to Authority
criminalcriminal
disabilityMentally Disabled
drugDrug Usage
emergencyPublic Emergency
incapableMentally Incapacitated
minorYouth/Minors
opinionphilosophical differences/differences of opinion
parentsparents
propertyProperty Ownership
restrictedIncarcerated
singleMarital Status
substanceDrug Usage
threatThreat of Stigma
unionTrade Union Membership

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers
drug['substance']
substance['drug']

Trigger Words

coercion

consent

developing

ethics

harm

protect

protection

risk


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalcriminalcriminal2
HealthDrug Usagedrug4
HealthDrug Usagesubstance1
HealthMentally Disableddisability2
HealthMentally Incapacitatedincapable2
SocialAccess to Social Goodsaccess1
SocialIncarceratedrestricted1
SocialMarital Statussingle2
SocialProperty Ownershipproperty1
SocialThreat of Stigmathreat2
SocialTrade Union Membershipunion2
SocialYouth/Minorsminor4
Socialparentsparents1
Socialphilosophical differences/differences of opinionopinion14
General/OtherPublic Emergencyemergency1
General/OtherRelationship to Authorityauthority3