CITI Training Practice Exam

This document notifies FDA of relevant changes in investigators conducting clinical trials under the IND.

1. Form FDA 1571

2. Annual progress report

3. Safety updates

4. Form FDA 1572

The correct answer is: Form FDA 1572

The Form FDA 1572, also known as the Statement of Investigator form, is used to provide FDA with information about the investigator(s) involved in conducting a clinical trial under an investigational new drug application (IND). This document includes personal and professional information about the investigator, such as their qualifications and their statement of commitment to following the protocol and regulations. The other options listed are incorrect because they pertain to different types of reports that may be submitted to FDA during the course of a clinical trial. Form FDA 1571 is used to submit an application for an IND, while an Annual Progress Report is a summary of the progress made in a clinical trial during the previous year. Safety updates, on the other hand, refer to any new safety information discovered during the clinical trial. While these reports may contain information about the investigators, they are not the specific document used to notify FDA of changes