Robustness · medium severity
The plan says in advance what would change the conclusion
If every result can be interpreted after the fact, the analysis has no test to fail. A stated rule is what lets the reviewer see that the sponsor was prepared to be wrong.
The check
Does the outline state, before the result, what evidence would change the conclusion?
What the outline has to carry
- a decision rule
- fixed in advance
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
Write the rule as a sentence: if the estimate is below or above this value, with this interval, the conclusion is X. State the uncertainty that the rule tolerates.
The source sentence
The result does not hinge on one assumption alone or one methodological choice alone.FDA Watch, 31:28 to 32:20
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.
Protocol and study reporting
The protocol states the objectives, design, population, endpoints, analysis and reporting before the study begins.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.