Rights and verification · high severity
The right to use the data covers the submission, not only the research
A licence that covers the research but not the submission leaves the sponsor unable to file the evidence it paid to generate. The right has to be written for the use that matters.
The check
Does the outline say the sponsor has the right to use the data in the regulatory submission?
What the outline has to carry
- a right to use
- the submission
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
Quote the clause that grants use in a regulatory submission, name the licensor and the agreement, and confirm that the right survives a change of control or a change of data partner.
The source sentence
Making sure you have the right to the research, you have the right to use the data, not only for the research itself, but also in the submission.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.