Which document outlines the regulatory requirements for clinical trials?

Which document outlines the regulatory requirements for clinical trials?

• A. The Applying Research Standards Document (ARSD)
• B. The Investigational New Drug Application (IND)
• C. The Clinical Research Approval (CRA)
• D. The Drug Development Guidelines (DDG)

Answer: (B)

The Investigational New Drug Application (IND) is the foundational document that outlines the regulatory requirements for clinical trials, particularly in the context of bringing a new drug to market in the United States. The IND must be submitted to the Food and Drug Administration (FDA) before a clinical trial can commence. This document provides essential information, including data from preclinical studies, the proposed clinical trial protocol, and information on the drug's chemistry, manufacturing, and controls. It is designed to ensure that participants are protected and that the clinical trial is scientifically sound. The other options, while related to clinical research, do not specifically serve the purpose of outlining regulatory requirements for clinical trials. The Applying Research Standards Document may provide guidelines for research practices but does not serve as the regulatory framework for IND submissions. The Clinical Research Approval might refer to institutional review processes rather than regulatory filings. Similarly, the Drug Development Guidelines may offer insights into the broader drug development process but do not specifically address the regulatory submissions necessary for initiating clinical trials like the IND does.

The Investigational New Drug Application (IND) is the foundational document that outlines the regulatory requirements for clinical trials, particularly in the context of bringing a new drug to market in the United States. The IND must be submitted to the Food and Drug Administration (FDA) before a clinical trial can commence. This document provides essential information, including data from preclinical studies, the proposed clinical trial protocol, and information on the drug's chemistry, manufacturing, and controls. It is designed to ensure that participants are protected and that the clinical trial is scientifically sound.

The other options, while related to clinical research, do not specifically serve the purpose of outlining regulatory requirements for clinical trials. The Applying Research Standards Document may provide guidelines for research practices but does not serve as the regulatory framework for IND submissions. The Clinical Research Approval might refer to institutional review processes rather than regulatory filings. Similarly, the Drug Development Guidelines may offer insights into the broader drug development process but do not specifically address the regulatory submissions necessary for initiating clinical trials like the IND does.