Rights and verification · medium severity
The data partner is obliged to give access, retain records and allow inspection
The sponsor's obligation to produce the source does not survive contact with a partner who has no duty to keep it. The duty has to be in the contract, with a retention period that outlasts the submission.
The check
Does the outline say the data partner must give access, keep the records and allow inspection?
What the outline has to carry
- a partner
- the obligations
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
List the partner duties: access for verification, retention period, correction of errors, notice before destruction, and cooperation with an inspection. Tie each to the clause that creates it.
The source sentence
Do you have the source records? Can they be verified? All of that is actually usually packaged up in some sort of legal relationship.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.
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
Processor
A processor is engaged under a contract that sets the subject matter, duration, nature and purpose of the processing, and the processor's duties.
European Union · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.