Abstract: The presently disclosed subject matter provides for efficient and effective monitoring, while eliminating practices that may not be of value in assuring human subjects protection and reliable and informative study results. The present disclosure provides methods, computer program products, and systems for data collection and validation for Enhanced Monitoring (EM). The Enhanced Monitoring model disclosed herein increases productivity and efficiency by decreasing the frequency of on-site monitoring visits and employing remote review techniques to focus on the process as compared to individual data points.