Abstract: A method and system are described for verifying database entries against corresponding source data collected at a plurality of geographically remote field locations. The invention provides for verification of field data in a manner that is quicker, less labor-intensive and less error-prone as compared with existing methods. The invention is particularly useful in the conduct of adaptive clinical trials of pharmaceutical products.

Abstract: A computer-assisted method is described for continuously assessing the quality of field data in a clinical study, identifying areas of weakness and specific sites where performance may be less than desirable, and flexibly allocating resources to address the problems, including the need to travel to the site to either check data or address problem areas. This method involves specification of key performance indicators that include elements that, preferentially, can be measured from a central location and do not require physical presence at the site to be checked. Such indicators can be continuously evaluated for correlation with desired performance levels, and modified accordingly. This approach thus is both risk-based and adaptive, and specifically enables clinical trial managers to address quality issues without the need to travel to the sites.