Arrangement Of Medical-Scientific Research In Humans

Original Language Title: Regeling medisch-wetenschappelijk onderzoek met mensen

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Regulation of the Minister of health, welfare and Sport of 9 July 2015, containing rules for medical-scientific research in humans (settlement of medical-scientific research with humans) the Minister of health, welfare and Sport, having regard to Council Directive No. 2001/20/EC of the European Parliament and of the Council of 4 april 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use its European regulations, articles 13 h, paragraph 1, 13i, sixth paragraph, 13r, 27a and 28 , first paragraph, of the law of medical-scientific research with people and articles 2, paragraph 2, and 3, second paragraph, of the decision scientific research on medicinal products;
Decision: paragraph 1. : General provision Article 1 In this regulation, the following definitions shall apply: a. law: the law of medical-scientific research with people;
b. decision: the decision scientific research with medicines.

Paragraph 2. : Rules for scientific research on medicinal products Article 2 At an application, as referred to in article 13 of the law and in the case of a notification referred to in article 13i, second paragraph, of the law are provided the following elements: – the to scientific research with medicaments eudractnummer granted;
– a copy of the completed and signed application form, the model for which has been established by the European Commission;
– the research protocol;
-information on the investigational medicinal product for the evaluation of the application, including all relevant clinical and non-clinical data;
– the written information provided to the test subject;
-information on those who perform scientific research with drugs and the law referred to in article 9 of the doctor;
– information on the scientific research with medicines available facilities;
-information on compensation in the event of injury or death of the test subject as a result of the scientific research on medicinal products as referred to in article 7 of the law;
– information about the coverage of liability of the person who carries out scientific research with medicines or scientific research with medicaments;
-information on the on the subjects and to those who perform scientific research with medicines to pay fees;
– other for the assessment of scientific research with medicines relevant documents.

Article 3 1 a notification of a substantial amendment of the research protocol referred to in article 13 k, paragraph 2, of the law to the pursuant to article 2, paragraph 2, of the Law Committee responsible shall contain the following information:-a completed and signed form ' notification amending the scientific research on medicinal products ', the model of which is laid down by the European Commission;
– a copy of the modified version of the completed and signed application form, referred to in article 2, if the change of the research leads to a change in the information contained on this form;
– a description of the change of scientific research with medicines and the reason thereof;
– the amended documents;
-information on the impact of the change;
– the other for the assessment of scientific research with medicines relevant documents.
2 a notification of a substantial amendment of the research protocol referred to in article 13 k, paragraph 2, of the law to the pursuant to article 13i, first or fifth paragraph, of the law referred to contains the following information:-a completed and signed form ' notification amending the scientific research on medicinal products ', the model of which is laid down by the European Commission;
– a copy of the modified version of the completed and signed application form, referred to in article 2, if the change of the research leads to a change in the information contained on this form;
– a description of the change of scientific research with medicines and the reason thereof.

Article 4 1 a message saying that the scientific research on medicinal products is terminated as referred to in article 1-3 l of the law contains the following information:-a completed and signed form ' termination scientific research on medicinal products ', the model of which is laid down by the European Commission;
– the date on which the scientific research on medicinal products as a whole is ended.
2 the person who carried out the research on medicinal products shall ensure that within one year after termination of the research a summary of the results of the research will be submitted to the Central Committee or the Minister of health, welfare and Sport, in the case of the fifth paragraph of article 13i of the law applies, and pursuant to article 2 , second paragraph, of the Law Committee.

Article 5 1 a report of a suspected unexpected serious adverse reaction as referred to in article 13p of the law contains the following information: – the to scientific research with medicinal products, stating the suspicion was raised by the unexpected serious adverse reaction, the eudractnummer;
– the number of the user of the scientific research done on the research protocol;
– the number of the user of the research done on the unexpected serious adverse reaction;
– the name and address of the person making the report;
– a description of the suspected unexpected serious adverse reaction of the investigational medicinal product;
– the investigational medicinal product that the suspected unexpected serious adverse reaction has caused;
– code number, age and sex of the test subject, whose unexpected, serious side effect occurred;
– a summary of the progress of the unexpected, serious side effect and the treatment thereof;
– a review by the provider of the impact of the reported unexpected serious adverse reaction in respect of the implementation of the scientific research;
– other for the assessment of the reporting of suspected unexpected serious adverse reaction relevant data.
(2) if the law referred to in article 13p suspected unexpected serious adverse reactions to direct can affect the safety of subjects, who are involved in other scientific research of the same provider with the same medicine, these suspicions in accordance with article 13p of the law reported to the pursuant to article 2, paragraph 2, of the law competent committees, those that have reviewed scientific research.
3 the one who carries out scientific research shall ensure that once per half a year a summary list of all suspected unexpected serious adverse reactions to an investigational medicinal product which he is aware, is submitted pursuant to article 2, paragraph 2, of the law competent committees, which scientific research of the same provider and with the same medicine as which the presumption is raised , have rated. The master list of all suspected unexpected serious adverse reactions to an investigational medicinal product contains a brief explanation in which the main conclusions.

Article 6 1 to the list of all suspected serious adverse reactions as referred to in article 13q of the law, is an aggregate summary table of all reported serious side effects arranged by organ system per research.
2 a report on the safety of the subjects referred to in article 13q of the law consists of a full security analysis and an evaluation of the balance between efficacy and harmfulness of the investigational medicinal product.

Article 7 in the application of the principles of good clinical practice and the documentation and archiving of scientific research on medicinal products shall take into account the detailed guidelines that the Commission of the European communities has published in ' The rules governing medicinal products in the European Union '.

Article 8 1 a change to a form established by the European Commission shall enter into force for the application of articles 2, 3 and 4 in effect as of the date on which such amendment enters into force.
2 a modification of a in ' The rules governing medicinal products in the European Union ' included detailed guideline shall enter into force for the application of article 7 in effect as of the date on which such amendment enters into force.

Paragraph 3. : Notification of serious adverse events Article 9 1 a report of a serious adverse event as referred to in article 10, first paragraph, of the law contains the following information: – a description of the incident;
– an assessment of the severity of the incident;
– an assessment of the causal link between the serious adverse event and the acts to which the test subject is subject to that person, or the manner of conduct imposed in the framework of the scientific research;
– other data relevant to the assessment of the notification.
2 a report of a serious adverse event referred to in article 10, paragraph 2, of the law includes: – the data referred to in paragraph 1;
– an assessment by the one that the scientific research of the effects of the message for the implementation of the scientific research.

Article 10


The one that makes the scientific research carried out for the reporting referred to in article 10, paragraph 2, of the law, only use the appropriate internet portal of the Central Committee.

Paragraph 4. : Monitoring article 11 The Chief Inspectors, inspectors and officials under their responsibility of the Dutch health care Inspectorate are responsible for monitoring, referred to in article 28 of the Act.

Paragraph 5. : Other provisions article 12 [Red: modifies the Control scientific research with medicines.]

Article 13 the settlement scientific research with medicines and the settlement monitoring WMO be withdrawn.

Article 14 this regulation is cited as: arrangement of medical-scientific research with humans.

Article 15 1 this Regulation shall enter into force on the date on which the law of 4 June 2015 amending law medical-scientific research with people in connection with an extension of the compulsory notification of serious adverse events (2015, Stb. 240) enters into force, with the exception of article 12.
2. Article 12 shall enter into force on the date on which article I, part K, of the law of 4 June 2015 amending law medical-scientific research with people in connection with an extension of the compulsory notification of serious adverse events (2015, Stb. 240) enters into force and works back to 1 July 2012.
This scheme will be placed with the notes in the Government Gazette.
The Minister of health, welfare and Sport, E.I. SA

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