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October 27, 2014, Dockets Management Branch (HFA305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA2006D0031: Draft Informed Consent Information Sheet: Guidance

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What is fda2006-d-0031 draft informed consent?

FDA2006-D-0031 draft informed consent is a document that outlines the information provided to participants in a clinical trial, including the risks and benefits of participation.

Who is required to file fda2006-d-0031 draft informed consent?

Investigators conducting clinical trials are required to file fda2006-d-0031 draft informed consent.

How to fill out fda2006-d-0031 draft informed consent?

Filling out fda2006-d-0031 draft informed consent involves providing details about the study, risks, benefits, and procedures in a clear and understandable manner.

What is the purpose of fda2006-d-0031 draft informed consent?

The purpose of fda2006-d-0031 draft informed consent is to ensure that participants are fully informed about the clinical trial before deciding to participate.

What information must be reported on fda2006-d-0031 draft informed consent?

Information reported on fda2006-d-0031 draft informed consent includes details about the study, risks, benefits, procedures, and participant rights.

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