After respective data transfer agreements have been put in place, study data is exported from the study’s electronic data capture system and transferred via a secure FTP server for import into the SALSA tool. The resulting SALSA report is then also returned via the secure FTP server for access by authorised personnel, interpretation and filing.
A set of standard variables is analysed on an individual subject level as well as on site level using tables, graphs and statistical tests to identify implausible data, unexpected values, unusual data patterns and trends and data extremes (outliers). Although these data points are not the key data in most clinical trials, they serve as an indicator for data quality and integrity and are at the same time relevant for subject safety and potentially for dosing calculations for investigational medical product (IMP).
One way to address the challenges for clinical QA is to use the available data to support QA related activities and decision making. Basic data sets, exported from the Electronic Data Capture (EDC) system, consisting of vital signs and electrocardiogram (ECG) data, number of (serious) adverse events and concomitant medications, which are obtained in almost all clinical trials, are analysed using standardised statistical methods. Additional data can be added on a study specific basis, to use the tool for the preparation of investigational site audits, or to decide whether it is necessary to conduct an audit with CRA or site staff involvement.
Information gathered from SALSA, provides an additional and efficient insight into YOUR data quality and integrity and makes YOUR audit results more robust.