Protocol Amendments

A protocol amendment is a written description of a change to or formal clarification to some aspect of the study that is described in the protocol.

Protocol amendments must be submitted in writing to the designated IRB and must be approved before they can be implemented with the exception of changes to eliminate immediate hazards or involving logistics or administrative aspects of the trial. If the study involves a product regulated by the FDA, the amendment must be submitted to the FDA as well prior to its implementation.

Depending on the nature and extent of the amendment, the informed consent may have to be revised and participants will have to review and sign a new form. The trial subjects of the trial must generally be informed of any protocol amendments.

Source: Food and Drug Administration (FDA). (2020, May). E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). US Department of Health & Human Services.