The RAPS learning platform provider will be upgrading its security posture. This will take the system off-line from 20 July through the end of the day 23 July. This will affect any Online Course, eBook, and Virtual Program Attendance. Thank you for your patience.
Monitoring and Quality Systems in Clinical Trials
Posted 01 July 2008 | By
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.