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

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

1. Study Protocol: This is a detailed plan of the study that includes the study's objectives, design, methodology, statistical considerations, and organization.

2. Informed Consent Form: This is a document that explains the study to potential participants, including its purpose, duration, procedures, risks, benefits, alternatives, and rights. It should also include a statement that participation is voluntary.

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

4. Participant Materials: This includes any surveys, questionnaires, or other materials that will be used to collect data from participants.

5. Investigator's Brochure: This is a document that provides a summary of the clinical and non-clinical data about the investigational product that is relevant to the study.

6. Safety Monitoring Plan: This is a plan that outlines how the safety of participants will be monitored throughout the study.

7. Conflict of Interest Disclosure: This is a document where the investigators disclose any potential conflicts of interest.

8. Data Management Plan: This is a plan that outlines how the data will be collected, managed, analyzed, and reported.

9. Any other documents or information that the IRB may require for the specific study.