0A4F4F9BD490A749D5437F821CF06DF1
Legislation Concerning Medicinal Products of Human Use (Good Clinical Practice) No. 452/2004 Article 11 (8)
https://leaux.net/URLS/General/Cyprus_Legislation_Concerning_Medicinal_Products_of_Human_Use_Good_Clinical_Practice_No._4522004_Article_11_8.pdf
http://leaux.net/URLS/ConvertAPI Text Files/805FFE13D453DFB2F253C050C0ED0CD7.en.txt
Examining the file media/Synopses/805FFE13D453DFB2F253C050C0ED0CD7.html:
This file was generated: 2020-07-14 08:18:01
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
(return to top)
p.003213: (a) A person capable of giving the or
p.003213: (b) in the case of a person who is incapable of giving it, his legal status.
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 consensus
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 concerning 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:
(return to top)
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 the severity does not coincide with information on the medicinal product being tested, 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 needed 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, at the justified request of 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 concerning 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:
(return to top)
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 it is part of 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 diagnoses or
p.003213: 3213
p.003213: (d) epidemiological methods are used to analyze the collected data.
p.003213: for
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
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 it is part of 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:
(return to top)
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 needed 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.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 it is part of 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 diagnoses or
p.003213: 3213
p.003213: (d) epidemiological methods are used to analyze the collected data.
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 obtained; 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 incapable of giving it, his legal status.
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 consensus
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.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 concerning 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: provide 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 a biological product of human or animal origin or contains
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 substantial 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: (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 consensus
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 obtained; 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 incapable of giving it, his legal status.
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 consensus
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, at the justified request of 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 concerning 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 needed 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: he 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: can be contacted for 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: he 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: can be contacted for 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: he 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: can be contacted for 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 are 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 substantial 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, at the justified request of 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: are listed 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 substantial 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, at the justified request of 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, even though the person affirming believes it to be 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: are listed 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 concerning 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.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, even though the person affirming believes it to be 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: he 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
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| criminal | criminal |
| disability | Mentally Disabled |
| drug | Drug Usage |
| emergency | Public Emergency |
| incapable | Mentally Incapacitated |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
coercion
consent
developing
ethics
harm
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input