3/17/2023 0 Comments Define yedToday, no tools exist capable of tracing a data element from the protocol through to the CSR tables, listings, and figures 8. The technology available to support the systematic review of submission datasets has limited support for assessing traceability 7. “Messy data” that is difficult to understand can delay the FDA’s ability to complete the review of a New Drug Application 6 potentially delaying the availability of an important new treatment. The FDA has identified a lack of traceability as one of the top seven data standards issues 4, and it has been cited as a key to the FDA’s ability to successfully review submission data 5. Traceability helps the regulatory reviewer to understand “the relationships between the analysis results, analysis datasets, tabulation datasets, and source data 3”.ĭespite the importance of traceability requirements for regulated clinical research, the ability to easily trace data back to its source remains limited. From a regulatory perspective the US Food and Drug Administration (FDA) has stated that the results presented in a Clinical Study Report (CSR) must be traceable back to the original data elements 2 to preserve an unbroken chain of data from its source to the point of consumption. Traceability plays a critical role in supporting clinical research analysis results because the strength of the study results depend on the source data and the quality and reproducibility of the processes used 1.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |