Change in Protocol
An IND Sponsor-Investigator is expected to submit a protocol amendment when there are changes in the existing protocol that significantly affect safety of subjects, scope of the investigation, or scientific quality of the study.
Examples of IND Protocol Amendments include:
- Any increase in drug dosage or duration of exposure of individual subjects to the drug beyond that described in the current protocol, or any significant increase in the number of subjects under study.
- Any significant change in the design of a protocol (such as the addition or elimination of a control group).
- Addition of a new test or procedure intended to improve monitoring for, or reduce the risk of, a side effect or adverse event; or elimination of a test intended to monitor safety.
Exception for immediate hazards: a protocol change intended to eliminate an apparent immediate hazard to human subjects may be implemented immediately, provided that FDA is subsequently notified by protocol amendment and the reviewing IRB is also notified.
Submitting IND Changes to FDA
Sponsor-Investigators of IND applications are responsible for sending periodic updates and reports related to their applications to FDA.
Depending on the submission type, include:
- Form 1571 (PDF - 830KB) external site (opens in a new window) should accompany all amendments or reports.
- Form 3674 (PDF - 3MB) external site (opens in a new window) should be submitted for all new clinical trials.
- Form 1572 (PDF - 718KB) external site (opens in a new window) should be included if the amendment concerns change in application sponsor, addition of a new investigator, or transfer of IND obligations.