4 ms·
> it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary Do companies redact patient data befo
by smnrchrds 5y ago
> it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary
Do companies redact patient data before submitting it to the FDA? Are they even allowed to? That sounds like the sort of information that the FDA should have access to.
- throwawayboise 5y agoWhy would the FDA need the PII from the patient data?
- smnrchrds 5y agoPII is not just name and SSN. Using all the demographic information recorded for each participant and open-source intelligence, you should be able to uniquely identify them.
- Fomite 5y agoAny dates that have more than the year in them are PHI.
- Brybry 5y ago> FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent#confidentiality https://www.fda.gov/regulatory-information/search-fda-guidan... https://www.fda.gov/media/75185/download https://www.fda.gov/media/75185/download
- BurningFrog 5y agoTo verify that they're not made up?