CITI Training Practice Exam

What are the three types of protocol amendments?

1. New sponsor protocol, a change in protocol, and adding a new investigator

2. Budget amendments, personnel changes, and study extensions

3. Study site changes, study design modifications, and consent form revisions

4. Data amendments, safety updates, and final reports

The correct answer is: New sponsor protocol, a change in protocol, and adding a new investigator

Protocol amendments typically fall into three categories sponsor protocol resources that are designed to support the study; change in protocol which details any modifications made to the study procedures or other important aspects of the study; and adding investigations, such as adding a new study site or investigator. The other options may be related to changes within a study, but they do not cover the three main types of protocol amendments as outlined in the correct answer A. Budget amendments may be covered under A as a change in protocol, but they are not a specific type of protocol amendment. Personnel changes and study extensions may also be covered under A. Study site changes and study design modifications are also covered under A as changes in protocol. Consent form revisions may fit under change in protocol or adding a new investigator.