Answer
What rights do I need to use real-world data in a submission?
You need the right to use the data in the regulatory submission, not only for the research, and you need the source records to exist and be verifiable. The recorded episode ties this to a legal relationship: a data use agreement, a purchase or a partnership, with data traceability through the process, the source records retained, and privacy and human subject protections built into the plan. In
You need the right to use the data in the regulatory submission, not only for the research, and you need the source records to exist and be verifiable. The recorded episode ties this to a legal relationship: a data use agreement, a purchase or a partnership, with data traceability through the process, the source records retained, and privacy and human subject protections built into the plan.
In practice that means the agreement names the permitted use, the term and the parties; the data partner is obliged to give access, retain records and allow inspection; consent or a waiver covers each cohort; and the chain from the patient record to the analysis dataset is documented at every hand. A licence that stops at research leaves the sponsor unable to file the evidence it paid to generate.
Where this comes from
The checks behind this answer are on the rule set, each with the timestamp in the recorded source. The legal basis is on the basis page. Run the free check on your own outline.