Prospective planning · high severity
The estimand, primary endpoint and time zero are defined in advance
An endpoint that can move, and a follow-up clock that starts when convenient, let the same data support more than one answer. Fixing the estimand, the endpoint and time zero in advance is what makes the result reproducible.
The check
Does the outline define the estimand, the primary endpoint and the start of follow-up before any data is seen?
What the outline has to carry
- an estimand or primary endpoint
- a definition
- time zero and the follow-up window
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 estimand in one sentence, name the primary endpoint and its ascertainment window, and state the index date and the end of follow-up. Keep the wording identical in the protocol, the SAP and the report.
The source sentence
An adequately powered clinically meaningful primary endpoint, a large precise effect, and high quality conduct with minimal missing data.FDA Watch, 26:49 to 27:45
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.