Prospective planning · medium severity
The analysis populations and eligibility rules are fixed in advance
If the population can be narrowed after the data is seen, the primary result can be made to appear in whichever subgroup behaves best. The population has to be a decision made before the cohort exists.
The check
Are the analysis population and the inclusion and exclusion rules defined before the cohort is assembled?
What the outline has to carry
- a population
- 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
State the index date, the washout, the minimum follow-up, and every inclusion and exclusion rule, with the code lists that implement them. Say what happens to a patient who meets some but not all of the rules.
The source sentence
The analysis was not cherry-picked to get the best results.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.