There is a lot of buzz in the industry about the CDISC SDTM standard. Before you make a decision to convert your existing data to SDTM, you should consider both the advantages and disadvantages of doing so. Here are a few of the things you should keep in mind:
- More efficient and timely review. The FDA review process may be more timely and efficient if the FDA reviewer is able to utilize standard tools and checks.
- FDA encourages the use of SDTM. Currently, the FDA is encouraging sponsors to submit clinical data in SDTM format.
- Uniformity across studies. SDTM is a standard that the FDA, the industry, and several of our clients are embracing because it provides a uniform standard from study to study to ease data exchange internally and across vendors. Additionally, since SDTM specifies standard variable names, controlled terminology values, and data set structures, others (from a biostatistician to an FDA reviewer) benefit if data sets are in SDTM format. They know what to expect and gain efficiencies from the familiarity that comes with working with data in SDTM format.
- Additional documentation is necessary. When submitting in SDTM format, additional documentation, such as file definition in XML format and readme documentation, is required to support SDTM data sets.
- CDISC SDTM standard is still evolving. The SDTM standard is still evolving. Consider how future releases of the guidance coincide with your program time line and how they could affect your submission deliverable.
- Additional effort, time, and cost. Data may need to be significantly restructured to fit into SDTM format. Converting to the CDISC SDTM standard requires additional effort, time, and cost.