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Home The Central Committee on Research Involving Human …

WebOn January 31, 2022, the EU Clinical Trial Regulation (CTR) 536/2014 has come into effect with new rules for research with medicinal products in the European Union. From …

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Medical scientific research Human subjects The Central

WebTwo types of research. There are two types of medical research: If you have health problems, you go to a physician. The physician will examine you to determine the cause …

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Development Safety Update Report in research with a medicinal

WebThe sponsor is required to ensure that each year a Development Safety Update Report (DSUR) on the medicinal product is submitted to the reviewing committee (MREC or …

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About CCMO The Central Committee on Research Involving …

WebThe CCMO was created on the 6th of April 1999 and is based in The Hague, the Netherlands. The CCMO executes the WMO and the Embryo’s Act. Research that falls …

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Serious breaches Investigators The Central Committee on

WebSerious breaches. Article 52 of the CTR defines a serious breach as a. “breach likely to affect to a significant degree the safety and rights of a subject or the reliability and …

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Definition of medical research

WebCCMO memorandum – Definition of medical research. 25 November 2005. knowledge largely benefits patients in the long or short term. Scientific research …

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Changes to the research file (amendments) Investigators The

WebMinor changes, such as textual changes, are generally only noted by the reviewing committee (MREC or CCMO). Substantial amendments must undergo further review. …

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Informed consent Human subjects The Central Committee on

WebInformed consent. You only officially become a research subject if you have signed the declaration of consent. You can only do so in writing. Research subjects aged 16 and …

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Codes of conduct Investigators The Central Committee on

WebCode of Conduct for Health Research. Codes of Conduct for Objections. Declaration of Helsinki.

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Research with ionizing radiation Investigators The Central

WebDuring some types of medical scientific research, subjects are exposed to ionizing radiation. Since this can lead to certain health risks for the subjects, it is important to make a …

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European guidance documents Investigators The Central

WebBorderline and Classification; Manual on Borderline: Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v1. Background note on the use of the …

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Rates established for assessment of research under CTR and MDR

WebThe Ministry of Health, Welfare and Sport has set the rates for medical ethical review in the Netherlands of research under the EU regulations for research with …

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L3. Development Safety Update Report Investigators The

WebThe sponsor is required to ensure that each year a Development Safety Update Report (DSUR) on the medicinal product is submitted to the review committee (accredited …

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Your research: Is it subject to the WMO or not

WebResearch is subject to the WMO if the following criteria are met: It concerns medical scientific research and; Participants are subject to procedures or are required to follow …

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Urgent safety measures Investigators The Central Committee on

WebWhere an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the …

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Competent authority: CCMO or Ministry of Health, Welfare and …

WebCompetent authority: CCMO or Ministry of Health, Welfare and Sport? Only amendments and relevant notifications of research with a medicinal product that is subject to the Dutch …

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L1. SUSARs Investigators The Central Committee on Research

WebCriteria. If an adverse reaction arises during a study in the patient/subject, then this is deemed to be a SUSAR if the following three criteria are met: 1. The event must be …

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Questions and answers CTR – The Netherlands

WebNo, the CTR does not provide for this. In order to be able to continue to ensure that the agreements with regard to the publication and termination of the clinical trial are in …

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