CITI Training Practice Exam 2025 - Free CITI Training Practice Questions and Study Guide

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What must be provided to investigators before they begin conducting trials?

Consent forms

Protocol and Investigator's Brochure

The required protocol and Investigator's Brochure must be provided to investigators prior to conducting trials. This information outlines the specific objectives and procedures of the trial, as well as important safety information and potential risks to participants. While consent forms are necessary for participants to review and sign, they do not need to be provided to investigators before the trial begins. A list of potential side effects may be included in the protocol or brochure, but it is not the only information that needs to be provided. FDA approval may be necessary for the trial to begin, but it is not specifically required for investigators to have before conducting the trial.

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A list of potential side effects

FDA approval letter

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