By Christopher Hurley, MBA, Justin Sjogren, MS, and James Zuazo, MS, Clinical Programming & Biostatistics
Ingredients: Raw Data (CDASH® brand if possible), CRFs, Protocol, SDTM Implementation Guide, WebSDM (or Open CDISC Validator if you’re on a tight budget), Client Input and 2 to 4 Programmers/Statisticians (4 to 6 for quicker results!).
- Begin with a finely grated selection of CDISC SDTM implementation guidelines (for extra spicy, choose version 3.1.2!)
- Set up trial domains and sprinkle with a dash of consistency to other studies if integration is desired.
- Mix raw data, CRFs, Protocol and Sponsor input together and blend purposefully to create Specifications that capture the flavor of the study design and data that was collected.
- Assign programming teams to the mix and develop SAS-based SDTM data domains utilizing the savory Specifications from above.
- For best results, validate these domain datasets using double-programming. This is the preferred method and will enhance your stew with a hearty and satisfying flavor of quality.
- Reconcile all differences between the source and validation programming of the SDTM domains. Note: allow a little extra time for this step.
- Season the SDTM data domains with CDISC compliance using a pinch of Open CDISC Validator or WebSDM, and update your data domains based on the findings.
- Garnish your SDTM domain datasets with updates based on sponsor review comments. Repeat until a perfect blend is achieved then serve with confidence. Note: this is the ultimate taste test. If you slacked off in Steps 2-7, it will show here. Enjoy your Stew!
SDTM stew serves well on its own or as an appetizer to the analysis! Once the raw data is in SDTM format, the process of creating analysis datasets (ADaM) and/or tables will be a mouth-watering treat for your programming and statistics team! Bon appetite!