developed by DataGen

The purpose of the CT-CDQC Utility is to perform quality control of clinical data. The smallest unity of data entry is a single data entry field, a data entry item. The Utility collects randomly a specified portion of data items, displays the collected items on-line or prints them on a report for off-line quality control. Several parameters, like sample size, data entry window, empty or non-empty data items, can be specified. Selected subjects, CRF pages, panels and/or data entry fields can be selected individually. The incorrect items can be entered in the data review form in order to calculate the proportion of incorrect items compared to the total number of items of the sample. From this final number, a decision can be taken if the quality of data entry is acceptable or not.

The CT-CDQC Utility is a MS Office application, with an ODBC link directly to the Oracle database of Clintrial^® and therefore independent of the Clintrial environment. The software is fully validated according to a software validation plan.