protocol deviation reporting.
too late or too early
lost or destroyed
The eCRF.bizTM system contains many useful tools to facilitate monitoring of clinical trials and observational studies. One of the newest feature is protocol deviation tracker - a module that allows Monitor quick reporting of protocol deviations, precise categorization of deviations, as well as generating deviation reports directly within the eCRF.bizTM system.
Traditionally, protocol deviation log is a paper documentation or an Excel file. This new approach s designed to automate subsequent activity throughout the entire study process.
The tool is complementary and does not replace the requirement of reporting of potential, major protocol violations to the Sponsor or Regulatory Authority.
The deviation database includes a set of information for the location of deviation (patient ID, visit, page, question, information from the Monitor - content and classification, with metadata).
These data are available in the eCRF system as report or listing.