Monitoring and Quality Systems in Clinical Trials

| 01 July 2008

The enormous task of monitoring clinical trials is a primary regulatory responsibility and major expense for sponsors. This task is frequently contracted out to Contract Research Organizations (CROs), which remove it from the sponsor's direct control. Ultimately, however, the sponsor retains the regulatory responsibility. Recent FDA Warning Letters to clinical trial sponsors continue to cite "Failure to ensure proper monitoring of the investigation" among the top violations. Unfortunately, the regulations are not specific regarding what sponsors should do to "monitor the progress of the investigation." The Investigational New Drug (IND) regulations do not require written procedures or a monitoring plan1 (medical device regulations do2). This leaves sponsors with six key FDA guidance documents upon which to base their regulatory compliance plans.


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