Fitness for use · high severity
Data source fit is assessed, with the limits written down
Existing health data was not collected for research. The reviewer wants to see that the sponsor knows where the source is thin, rather than discovering it in a reviewer question.
The check
Is there a feasibility or fit-for-purpose assessment that names the limitations of this source?
What the outline has to carry
- a data source
- a fit assessment
- its limitations
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
Summarise the feasibility work: the source, the years covered, the size, the key variables, the known coding changes, and the specific limitations that could affect this question. State what was done about each.
The source sentence
The data must be accurate, complete, and traceable back to the source.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
Decentralised elements and real-world data
Decentralised elements, remote monitoring and data captured outside the site are governed by the same quality and consent requirements.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.