Robustness · high severity
Sensitivity analyses are pre-specified, each with the assumption it tests
A sensitivity analysis added after the result is a defence of that result. The same analysis, named in advance with the assumption it tests, is evidence that the result is not an artefact of one choice.
The check
Does the outline name the sensitivity analyses and the assumption each one varies?
What the outline has to carry
- sensitivity analyses
- pre-specified
- the assumption tested
A check is met only when every element above is present. One element on its own is a partly evidenced check, not a pass.
What resolves it
List each sensitivity analysis, the assumption it varies, the values it uses and the result that would make the primary finding fragile. Say which one is the primary sensitivity analysis.
The source sentence
Pre-specifying sensitivity analyses or different ways to look at the data that show your result does not hinge on one assumption alone.FDA Watch, 30:36 to 31:28
The quotation is short and is used to show the sentence the rule is read from. The rule itself is our statement, not the speaker's words.
The legal basis
The held frameworks that bear on this check, with the control each one contributes. The link opens the framework page so the reader can check the source.
Data management and external data
A data management plan covers external data, including real-world data, its quality, its traceability and its coordination with the analysis.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.