Monitoring

Monitoring is an essential instrument for the quality assurance of research subject to the ‘Dutch Medical Research involving Human Subjects Act’ (WMO; Wet Medisch-wetenschappelijk Onderzoek met mensen WMO. CTCM offers a comprehensive monitoring service to ensure that your study is conducted in accordance with the study protocol and complies with laws and regulations, the rights and well-being of research participants are protected and data quality is guaranteed. Our team of experienced clinical monitors, who are extensively trained in relevant legislation and regulations, provide guidance and support during your research. CTCM provides monitoring in a 'risk-based' manner; the frequency and intensity of monitoring is tailored to the degree of risk of the study. Monitoring can be offered by CTCM both on-site and remotely. 

Monitoring by CTCM includes the follwing:
  • determination of risk classification 
  • drawing up study-specific risk-based Monitoring Plan
  • site monitoring, including Site Initiation Visit (SIV), Interim Monitoring Visits (IMV) and Close-out Visit (COV), both on-site and remote
  • site management
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