Monitoring Data Discrepancies during Clinical Trials

Balancing the requirements of high quality data and timely completion of a clinical study is thankless task. On one hand the data must accurately reflect the trial conducted and on the other hand are the business needs that must be considered. Given enough time, all clinical trials would be able to have very high quality data with few if any errors. However, this is not a luxury that many will ever experience. Rather there are pressures to get the trial completed, with attention towards quality, but with the define pressure of deadlines that are often set outside the clinical realm. To ease the burden of cleaning and correcting the data in clinical trials of long duration and those that use the same personnel, a different style of handling data was put forth in order to redress the problem of recurring systemic problems. What is outlined below is not a panacea to cure all the data ills of clinical trials., but rather one approach towards the problem of achieving, maintaining, and enhancing the quality of data at all phases of the clinical trial. The requirements of this approach are not insignificant, and include the willingness to critically analyze all segments of the trial, disseminate, and act on that information.