The monitoring burden per patient in oncology trials greatly exceeds that in many other indications. There is a large complex set of factors that are collected related to the patients cancer and prior therapies. However, one of the greatest hurdles is the collection of the adverse event data which is much more voluminous per patient than most other indications. Also, many studies have rather restrictive enrollment criteria that requires more sites with less patients per site. The sites therefore each have a smaller number of patients on the individual study being monitored and often require significant attention to maintain high quality data capture. Strong relationships with the site staff and well-developed monitoring processes can help handle this burden.