Validation of TFLs (Tables, Figures, and Listings) is a critical step in the clinical trial analysis process. TFLs provide important information about the safety and efficacy of a drug or medical device being studied in a clinical trial.
Validation of TFLs is done to ensure that the results presented in the TFLs are accurate, complete, and consistent with the study data. The purpose of validation is to identify and correct errors, omissions, inconsistencies, and discrepancies in the TFLs before they are submitted to regulatory agencies or made public.
The validation process involves a series of quality checks, such as verifying that the data in the TFLs match the data in the study database, ensuring that the TFLs are consistent with the protocol and statistical analysis plan, checking for missing data or outliers, and verifying that the statistical analyses were performed correctly.
To validate TFLs, SAS programmers often use automated validation tools like Pinnacle 21, which is a software application designed to assist in the validation of clinical trial data in accordance with regulatory requirements. Pinnacle 21 is capable of analyzing TFLs for errors and inconsistencies, as well as checking for compliance with CDISC standards.
In addition to using automated tools like Pinnacle 21, validation of TFLs also involves a manual review of the TFLs by a qualified reviewer who has a good understanding of the clinical trial data and statistical analyses. The reviewer checks that the TFLs are accurate, complete, and consistent with the study data, and that any identified issues are addressed before the TFLs are finalized.
Overall, validation of TFLs is an essential step in the clinical trial analysis process to ensure that the data is accurate, reliable, and ready for regulatory submission.