What information should be provided to an IRB for review at the initiation of a study? Choose the best response.

When initiating a study, the following information should be provided to an Institutional Review Board (IRB) for review:

1. Study Protocol: This includes the purpose of the study, the methodology, the type of data to be collected, and how it will be collected and analyzed.

2. Informed Consent Forms: These forms should provide potential participants with information about the study, including its purpose, duration, procedures, risks, benefits, alternatives, and confidentiality.

3. Recruitment Materials: This includes any advertisements or other materials that will be used to recruit participants for the study.

4. Participant Materials: This includes any surveys, questionnaires, or other materials that participants will be asked to complete.

5. Investigator's Brochure: This document provides a summary of the clinical and non-clinical data relating to the investigational product.

6. Risk/Benefit Analysis: This analysis should detail the potential risks and benefits to participants, and explain why the benefits outweigh the risks.

7. Confidentiality Protections: This should detail how participants' privacy will be protected, including how data will be stored and who will have access to it.

8. Conflict of Interest Statement: This statement should disclose any potential conflicts of interest that the investigators may have.

9. Data Monitoring Plan: This plan should detail how data will be monitored to ensure its integrity and validity.

10. Any other information that the IRB may require to ensure that the study is ethical and that participants' rights and welfare are protected.