[Schulman ICs are prepared in font size 12] INFORMED CONSENT TITLE: PROTOCOL NO.: SPONSOR: INVESTIGATOR: SITE ADDRESS: 24 HR. TELEPHONE #: INTRODUCTION Before agreeing to participate in this research study, it is important that you read and understand the following explanation of the proposed research study. This consent document describes the purpose, procedures, benefits, risks, discomforts and precautions of the study. It also describes the alternative procedures that are available to you and your right to withdraw from the study at any time. No guarantees or assurances can be made as to the results of the study. If you are not completely truthful with your Investigator regarding your health history, you may harm yourself by participating in this study. BACKGROUND AND PURPOSE You are being asked to participate in this research study because you have [disease/condition]. In lay terminology, describe relevant background information and rationale for conducting this study. The purpose of this research study is to: test the safety and effectiveness of the study drug, [drug name]. insert trial protocol objectives in lay terminology [Include the investigational aspect. For example, if not a marketed product: This is a research study to test a new investigational drug. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). If marketed product: This study drug may be available by prescription for [state indication]. If marketed product, but an investigational use for the study: The use of [drug name] in this study is investigational. An investigational use is one that is
[Schulman ICs are prepared in font size 12] INFORMED CONSENT TITLE: PROTOCOL NO.: SPONSOR: INVESTIGATOR: SITE ADDRESS: 24 HR. TELEPHONE #: INTRODUCTION Before agreeing to participate in this research study, it is important that you read and understand the following explanation of the proposed research study. This consent document describes the purpose, procedures, benefits, risks, discomforts and precautions of the study. It also describes the alternative procedures that are available to you and your right to withdraw from the study at any time. No guarantees or assurances can be made as to the results of the study. If you are not completely truthful with your Investigator regarding your health history, you may harm yourself by participating in this study. BACKGROUND AND PURPOSE You are being asked to participate in this research study because you have [disease/condition]. In lay terminology, describe relevant background information and rationale for conducting this study. The purpose of this research study is to: test the safety and effectiveness of the study drug, [drug name]. insert protocol objectives in lay terminology [Include the investigational aspect. For example, if not a marketed product: This is a research study to test a new investigational drug. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). If marketed product: This study drug may be available by prescription for [state indication]. If marketed product, but an investigational use for the study: The use of [drug name] in this study is investigational. An investigational use is one that is trial
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