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An analysis dataset should be more than an intermediate file produced by a statistical program. The ADaM plan connects the analysis objective, population and derivation decisions to a structure that another reviewer can understand and use to reproduce the intended analysis.
Fix the analysis question
FDA technical conformance resources help teams plan analysis datasets. Identify the data needed for each endpoint, population, time point and summary measure in the analysis plan. The presence of a standard variable does not explain the scientific justification for a particular derivation used in the study.
Specify derivations
Specify inputs, derivation rules, flags and analysis-inclusion logic. Baseline, visit windows and strategies for intercurrent events should be explicit. When derivation order affects the result, make that order part of the documented decision rather than leaving it hidden inside a sequence of programs.
Review boundary cases
Exercise equally distant visits, missing pretreatment measurements and rescue treatment using example records. Independent review should examine more than a second implementation of the same code. Seek consistency between clinical interpretation, the analysis plan and the variables that the process actually produces.
- Connect each output to its analysis variables.
- Illustrate baseline and visit-window rules with example records.
- Reconcile population flags against table denominators.
Verify analysis consistency
Reconcile table denominators against analysis populations. If results differ, inspect dataset, program and analysis-plan versions together. A derivation change may require affected analyses to be regenerated with an explanation; manually correcting one final table breaks the chain needed to understand the reported result.
Frequently asked questions
- Can ADaM simply copy SDTM?
- Design the derivations and traceability required by the analysis; an unchanged copy may be insufficient.
- Should a final table be corrected manually?
- Fix derivation or programming issues at their source and regenerate affected outputs traceably.