Fitness for use · high severity
The data is relevant to the question, the population and current care
A data source can be large, clean and well governed and still be the wrong source for this question. Relevance is judged against the population, the endpoint and the care that patients receive today.
The check
Does the outline connect the data source to this question, this population and the care patients receive now?
What the outline has to carry
- a research question
- population and endpoint
- current care
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 question in one sentence, name the target population and the care setting, and say why this data source represents patients treated that way now. Record any group the data cannot represent.
The source sentence
The data has to be relevant to the question and reliable.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.
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
Scope and principles
The standard sets the ethical and scientific quality requirements for designing, conducting, recording and reporting studies, applied in proportion to risk.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.