Fitness for use · high severity
Every value is traceable from the source to the analysis dataset
Traceability is what lets a reviewer, or an inspector, stand at a value in the analysis and walk back to the record it came from. Without it, the dataset cannot be checked.
The check
Does the outline describe an audit trail from the source record to the analysis dataset?
What the outline has to carry
- traceability
- source to dataset
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
Describe the data management plan, the transformation steps, the audit trail that records additions, deletions and changes, and where the raw extract is held against the final analysis dataset.
The source sentence
Traceable back to the source to allow us to do source data verification or source data validation.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.
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
Audit trail requirements
A secure, computer-generated, time-stamped audit trail records who created, modified or deleted a record, and the trail cannot be turned off by the people it records.
United States · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.