Fitness for use · high severity
Source data verification is planned, and the records can be retrieved
FDA inspects the sites where the data was collected and compares the submission to the source. A plan that never secures access to the source is a plan that cannot survive that visit.
The check
Does the outline say who will verify source data, on what sample, and that the records can be produced?
What the outline has to carry
- verification
- records and access
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 sites or data partners, the share of records to be verified, the verification method, who performs it, and the contractual right to produce the records. Say where the records are held and for how long.
The source sentence
FDA will go out and inspect these sites to where you collect the data from to make sure that the data that you collect matches up with source documentation.FDA Watch, 36:02 to 36:56
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.
Investigator duties and source document verification
The investigator is qualified and resourced, and source documents are kept and made available for verification.
International · Read the framework
Sponsor, quality management, monitoring and vendors
The sponsor runs a quality management system, monitors the study in proportion to risk, and oversees any vendor or data partner.
International · Read the framework
Record protection, retention and inspection readiness
Records can be produced in a readable form for the whole retention period, and are available for inspection when asked for.
United States · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.