3 ms·
Why would the FDA need the PII from the patient data?
by throwawayboise 5y ago
Why 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?