Using SALSA to support site selection and the auditing process
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.
Why is SALSA relevant for you?
SALSA – answers all your questions!
- SALSA supports QA activities, specifically auditing.
- SALSA supports the decision of whether to audit or not and helps the process of site selection
- SALSA supports auditor preparation prior to conduct of an on-site investigator audit or a Remote Investigator Site Audit (RISA)
- SALSA supports a full or stepwise RISA when a full RISA is not possible, necessary or wanted and with or without site and/or CRO involvement or in the case of just a data review
- SALSA helps the auditor to select subjects and data to be reviewed during the audit, the equipment and equipment documentation to be scrutinized at audit and processes and procedures to be discussed in detail with site staff.
- SALSA can be used for ongoing site compliance, quality status monitoring either routine or to remotely review effectiveness of CAPAs after an inspection or audit.
Information gathered from SALSA, provides an additional and efficient insight into YOUR data quality and integrity and makes YOUR audit results more robust.
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