Adverse Events Home Page
IND Decision Tool
IND Exemption Form
Highlights of FDA History
What FDA Regulates
FDA Authorities
FDA Centers
Clarifying the "new" in IND
Assessing Preclinical Data
Properties of the Study Drug
How the Data is Used
IND Submission
IND Holder Reponsibilities

IND Holder Responsibilities

Once submitting an IND, the IND holder is responsible for:

  • Selecting qualified investigators
  • Ongoing monitoring of all studies submitted to the IND
  • The validity of the data from all sites conducting research under the IND
  • Maintaining adequate records of receipt, shipment, and disposition of the investigational drug
  • For multi-site studies, ensuring that all sites are kept informed of adverse events and safety updates

The IND holder must notify the FDA of any of the following:

Protocol Amendments
Any changes to the protocol or any new protocols using the investigational agent
Any new sub-investigators or changes to investigators (with a revised FDA Form 1572)
Safety Data
IND Safety Reports
IND Annual Reports (includes a summary of all study findings and adverse events to date)
Investigational Drug Updates
Any changes to the chemistry, manufacturing, and controls
Changes to the Investigational Brochure
Closing Out the IND