Overview
Before initiating a clinical investigation to study a drug or biologic, review these steps to determine how to comply with Food and Drug Administration (FDA) requirements. This page is intended for UCSF investigators who will initiate their own research protocol and do not have an industry sponsor.
Steps for investigator-initiated drug studies
Step1
Confirm whether your study is a clinical investigation of a drug or biologic
Only clinical investigations of drugs or biologics require compliance with Investigational New Drug (IND) requirements (21 CFR 312).
A Clinical investigation of a drug/biologic means any experiment in which a drug/biologic is administered or used involving one or more human subjects, except for the use of an approved drug/biologic in the course of medical practice.
Step2
Explore whether your study may be exempt from the IND requirement.
Unsure? The UCSF Regulatory Support team can help you determine whether the IRB is likely to agree that your study is IND exempt or requires an IND application. Request a consult.
Is your study IND exempt?Step3
Consider a Pre-IND meeting with the FDA.
Pre-IND meetings with the FDA can increase the likelihood of a successful IND application.
Pre-IND MeetingsStep4
Review the IND Responsibilities Checklist
The IND Responsibilities Checklist is intended to prepare UCSF sponsor-investigators for studies conducted under an IND.
Please refer to the following sample SOPs for clinical investigations:
Step5