Abstract
Obtaining complete and correct data from a clinical study is the aim of everyone involved in clinical research and drug registration, but a permanent “audit” or “monitor” presence on the study site is not feasible and probably not wanted. This article describes an experience with a “Watchdog,” a protocol specific guidance and data entry software system implemented on laptops used by the investigator, and how this Watchdog was accepted by investigators and pharmaceutical companies.
Keywords
Get full access to this article
View all access options for this article.