Fitness for use · medium severity
The data is converted to the standards FDA can read
The reviewer has to be able to run the analysis from what is submitted. If the dataset arrives in a bespoke structure, the review clock is spent on reconstruction.
The check
Does the outline say the analysis dataset will be converted to CDISC or another accepted standard?
What the outline has to carry
- a standard
- a conversion plan
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 target standard, the version, the mapping specification and who produces it. Say which source variables cannot be mapped and how the gap is disclosed.
The source sentence
Converting submitted data to FDA-supported standards like CDISC where necessary.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
Computer systems, audit trail and data integrity
Computer systems used in the study are validated, access is controlled, changes are recorded in an audit trail, and the data meets the ALCOA+ attributes.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.