CDISC’s SDTM data standards will be required for all clinical data sent to FDA’s CDER, CBER, IDEs, ANDAs, NDAs, BLAs, PMAs and 510(k)s starting in 2017! Will you be ready?
ShujuMetrics biostatisticians have extensive experience transforming legacy data into SDTM data standards which are compatible for electronic submissions.
If you legacy data is not already in SDTM formatted SAS tables, your data needs to be transformed into this format as part of an electronic submission requirement for NDA submissions beginning in May of 2017 and IND submissions beginning in May of 2018. Those that submit data to the FDA via eSubmissions in a standard format are going to get “a different review” from those that are in non-standard format. Submissions not using standard data run the risk of receiving a Refusal to File letter from the agency. All sponsors will “immediately” need to describe their intent to use standardized data in the IND application. If you legacy data is not already in SDTM formatted datasets, ShujuMetrics can help.
New studies built by ShujuMetrics follow the FDA panel recommends in that all studies create case report forms using CDASH standardized formats with compatable variable names. It is also recommended that datasets are mapped to SDTM formats at the beginning of the study and adhere as closely as possible to the standard. The benefits of having ShujuMetrics build your trial from the beginning with mapping to SDTM Datasets include: