SALSA, our statistical tool, gives you an extra layer of confidence when assessing whether the data being collected during your clinical trials is reliable. It was originally developed to facilitate the increasing demand for remote site auditing, by aiding in the selection of investigator sites for audit and in the selection of subjects for review. However, it can be used just as easily as an aid for on-site audits or even separately from planned audits.
SALSA allows you to plan for your future audits by allowing a rapid analysis and visualisation of selected study data at any point during trial conduct. It allows the identification of unusual data patterns and statistical abnormalities that may point to differences between subject populations at different clinical sites, as well as identification of outliers for individual subjects or data points.
SALSA adds value to the efficacy and objectivity of your auditing processes and makes the audit “smarter” as it utilises an evidence-based rationale for the data selected for review at the site and for the questions we ask the site staff and the CRA.
Data (and metadata, if feasible) are first extracted from EDC, IRT and other electronic systems and provided in a format (e.g. Excel) that can be uploaded to SAS.
Data points considered for analysis include “Standard Data” such as Visit Dates, Height, Weight, Vital Signs, ECG, number of Adverse Events, number of Concomitant Medication entries. However, “Protocol-specific Data” such as Primary and Secondary Endpoints can be utilised as well.
The data is then statistically analysed with regards to, for example, digit preference, inliers, outliers, rounding, inter-patient and intra-patient analysis, correlations, under reporting, over reporting, distributions and so on.
The results of this analysis facilitate a general assessment of data quality and integrity and allows for tailored sampling for Source Data Review (or Verification), for remote or on-site investigator site audits.
For companies with central monitoring and statistical analysis, this analysis can also be valuable, to validate central monitoring for the audited site, to confirm that selected data points and thresholds are meaningful and to confirm central monitoring process is adequate and risks controlled.
SALSA can also be combined with a stepwise RISA for remote auditing with or without site/CRO involvement or for just a data review.
Do download our SALSA Concept Paper linked below and also our document Risk-Based Approach to Auditing Implementing RISA and SALSA.
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See www.TheEngagedDB.com and contact TED to arrange an on-line SALSA presentation tailored to your needs.