External control · high severity
The endpoint and its ascertainment are the same in both arms
If the trial measures response at one interval and the external data captures it at another, the arms are not measuring the same thing. The comparison can move on the measurement schedule alone.
The check
Are the endpoint definition, measurement and follow-up window identical in the trial and the external control?
What the outline has to carry
- an endpoint
- a harmonised definition
- ascertainment
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 endpoint definition, the assessment schedule and the follow-up window for both arms, and show where the external data had to be adapted. Report the comparison under the closest matching window.
The source sentence
Match the trial eligibility criteria and endpoint definitions.FDA Watch, 32:20 to 33:15
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
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.