Rights and verification · high severity
The source records exist and can be verified, including consent and the protocol
An inspector will ask for the record behind the value. If consent, the protocol or the source document cannot be produced, the data has no verifiable origin, however clean the dataset looks.
The check
Does the outline confirm that the source records, consent forms and protocol can be produced for verification?
What the outline has to carry
- the records
- producible and verifiable
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
State who holds each record, for how long, and how it is produced on request. If any record is missing, disclose the gap and what was done to reconstruct or qualify the affected data.
The source sentence
The investigator who did the study no longer had the informed consent forms. They no longer had the protocol for the study. But they did have the patient data.FDA Watch, 36:02 to 37:50
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.
Essential documents, trial master file and retention
The essential documents are held in a trial master file and retained for the period the applicable law requires.
International · Read the framework
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
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.