- Published
- Updated
- Sources checked
An SDTM mapping plan should inform collection design rather than become a retrospective explanation after database lock. Early mapping makes missing source concepts and ambiguous fields visible while the team can still address them without disruptive late transformations.
Understand the source concept
Use FDA study-data resources and the technical conformance guide together when planning submission structures. Do not select an SDTM domain solely from a field name. The subject, timing and clinical meaning of a measurement are important inputs into how the observation should be represented.
Write mapping specifications
A mapping entry should identify the source field, target variable, transformation, terminology version and treatment of missing values. Include external laboratory, diary and device data. Where multiple sources contribute to one target variable, specify the precedence rule so a programmer does not have to invent it.
Review representative records
Exercise repeated measurements, unscheduled visits and partial dates before the final delivery. Clinical and programming reviewers should examine the same examples. A record that passes technical rules may still impede review if it represents the wrong timing or clinical concept for the source observation.
- Link source and target variables through explicit transformation rules.
- Exercise unscheduled-visit and partial-date examples.
- Compare metadata with the produced datasets.
Explain departures
Explain the reason and review impact of departures in the relevant documentation. When a source changes late, update specifications, metadata and reviewer explanations alongside code. A final check should demonstrate that an example observation can be followed from its source into the generated SDTM record.
Frequently asked questions
- Should SDTM planning wait for database lock?
- No. Early planning reveals missing or ambiguous source concepts.
- Does a clean validation report prove correct mapping?
- Not alone. It does not establish that clinical meaning was represented correctly.