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1. ICH-GCP & GCP-NL
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. The details of ICH-GCP & GCP-NL can be viewed in the documents you find below.
The Central Committee on Research Involving Human Subjects (CCMO) protects subjects taking part in medical research by reviewing the research on the basis of the statutory provisions laid down for them and taking account of the interests of medical progress. This is captured in The Medical Research Involving Human Subjects Act (WMO) and/or the Embryos Act information. For this obligatory review a standard research file must be provided for submission of a research proposal to a WMO review committee. This file contains standardized items that can be viewed in the document you find below.
The Medical Research Involving Human Subjects Act (WMO) covers medical scientific research in which people are subjected to interventions or have to follow established behavioural rules. The WMO (version March 1, 2006) has been in force since 1 December 1999. The WMO is being revised to take account of the implementation of the EU Clinical Trials Directive (2001/20/EC). The amended Act is in force since March 1, 2006. The amended WMO changes the rules governing drugs trials in the Netherlands.
The WMO was created to offer additional (legal) protection to research subjects:
a. Study participants must be given written information about the study
b. A doctor not involved in the study must be available to give information to the research subjects
c. Research subjects must give written consent to take part in the study
d. Insurance must be taken out to cover damage suffered by research subjects as a result of the study
e. The law imposes requirements as to how the study must be reviewed
f. The law imposes additional requirements on research involving children and incapacitated adults
The details of this law can be viewed in the documents you find below.