When studies involve drugs or devices not approved by the Food & Drug Administration (FDA), or drugs or devices used for purposes not approved by the FDA which pose an increased risk, investigators are required to get clearance from the FDA prior to enrolling subjects in their study.
Sponsor-Investigator Responsibilities under an IND
Sponsor-Investigator Responsibilities under an IDE
- BCM's Human Research Protections Manual
- IND Frequently Asked Questions (FAQ)
- IDE Frequently Asked Questions (FAQ)
- Principal Investigator Responsibilities for Investigator- Initiated Studies
- Sponsor-Investigator Responsibilities in Clincial Trials and Institutional Support - Video (Requires BCM ECA authentication)