Rights and verification · medium severity
The traceability chain is papered through every hand
Every transfer of data is a place where origin can be lost. The chain is only as strong as its least documented hand, and the reviewer will ask for the record at the hand that is missing.
The check
Does the outline show a documented chain from the original record through each partner to the analysis?
What the outline has to carry
- the chain
- the handoffs
- documented
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
Draw the chain from the patient record to the analysis dataset, name the holder and the instrument at each step, and state where the audit trail and the source extract are kept at each hand.
The source sentence
Making sure you have data traceability all the way through the process, understanding where the information originated.FDA Watch, 39:36 to 40:34
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
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.