Abstract: A system for assessing a clinical trial site's subject event reporting rate includes a subject event and visit count processor and a site subject event rate processor. The subject event and visit count processor receives subject event and subject visit data from a plurality of clinical trial sites and calculates for each clinical trial site a total visit count and a total subject event count. The site subject event rate processor receives the total visit count and total subject event count for each clinical trial site, calculates a trial-level subject event rate for the clinical trial, calculates for each clinical trial site an expected total subject event count based on the clinical trial site's total visit count and the trial-level subject event rate, and compares for each clinical trial site the expected total subject event count to the total subject event count to assess the probability that the clinical trial site is under-reporting or over-reporting subject events.

Abstract: A method for remote site monitoring includes receiving data from a clinical data site, calculating a site-metric risk indicator for each metric, and aggregating the site-metric risk indicators to generate a site-level data quality score. The site-metric risk indicator is calculated using a metric risk profile, which is based on historic clinical study data and study data received from clinical data sites. In some embodiments, each metric risk profile is based on experience levels of the sites. An apparatus for remote site monitoring is also described.

Abstract: A method for remote site monitoring includes receiving data from a data site, converting those data into a site-level quality score using a metric risk profile, and calculating a risk indicator based on the site-level quality score. The metric risk profile may be based on historic data and study data, where the study data is received from a plurality of data sites. In some embodiments, converting the data includes normalizing a value of a metric by applying to it the metric risk profile and aggregating the normalized metric values to calculate the site-level quality score. An apparatus for remote site monitoring is also described.