Prospective planning · high severity
The statistical analysis plan is pre-specified, dated and locked before analysis
The analysis plan is where the endpoint, the population, the model and the sensitivity analyses are fixed. If it is written after the data is visible, none of those choices can be shown to be independent of the result.
The check
Is there a dated statistical analysis plan, fixed before the analysis began?
What the outline has to carry
- a statistical analysis plan
- pre-specified and dated
- before the analysis
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
Name the SAP version, its date and who approved it, and state that it was locked before the analysis or unblinding. Record any change after lock as a dated amendment with its reason.
The source sentence
That is to ensure that the analysis was not cherry-picked to get the best results, but that you really are doing rigorous, prospectively planned, pre-planned science.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.
Protocol and study reporting
The protocol states the objectives, design, population, endpoints, analysis and reporting before the study begins.
International · Read the framework
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.