Fitness for use · high severity
Outcome and exposure definitions are validated, not just coded
A code list is not an outcome. Unless the sponsor shows how the code was checked against the source record, a misclassified outcome can drive the result in either direction.
The check
Does the outline say how each outcome and exposure is identified, and how that identification was validated?
What the outline has to carry
- an operational definition
- a validation result
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
Name the code set and its version, state the validation study or chart review behind it, give the positive predictive value or agreement, and say what happens to a record that does not meet the definition.
The source sentence
That includes validating how outcomes are identified.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
Try it on your outline. The free check applies this rule and quotes the line it read.