Fitness for use · high severity
Missing data is characterised and handled by a stated method
Missingness is a property of the data, not a nuisance to be dropped. If the analysis ignores it, the reviewer cannot tell whether the result is carried by the patients who were observed.
The check
Does the outline describe how much is missing, why, and what the analysis does about it?
What the outline has to carry
- missingness
- a handling method
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
Report the missing share for every key variable, state the assumed mechanism, and name the primary handling method plus at least one sensitivity analysis that varies it.
The source sentence
The data must be accurate, complete, and traceable back to the source.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.