This workshop provides an overview of the applicable regulations for Investigator-Initiated Trials (IITs), including the role and responsibilities of the individual investigator who acts as an investigator and a sponsor in conducting the study. The seminar includes a review of the reporting requirements and essential documentation required for these trials, and illustrates the risks involved. Tips on how to avoid the common pitfalls are addressed, including examples from Food and Drug Administration (FDA) inspections and how to prepare for a possible inspection.

Learning Objectives

• Explain the applicable federal regulations for IITs, including sponsor and investigator responsibilities.
• Recognize the principles involved in quality research.
• State the steps involved in initiating an IIT, and review the regulatory reporting requirement of investigators and sponsors, including safety reporting and investigational product accountability.
• Examine protocol development and compliance.
• Examine informed consent development and Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Discuss required essential documentation and the need to remain “audit-ready” throughout the study.
• Discuss the need for adequate monitoring and a monitoring plan.
• Cite ways to minimize risks associated with IITs.
• Provide examples of regulatory deficiencies as noted in FDA warning letters.
• Discuss the principles of ethics and the quality control process, including possible FDA inspections.

Workshop Outline

• Federal Regulations for Investigator-Initiated Trials (IITs)
• The principles involved in quality research
• Steps involved in initiating an IIT
• Regulatory reporting, including safety and investigational product accountability
• Protocol development and compliance
• Informed consent development and HIPAA authorization
• Essential socumentation
• Adequate monitoring
• Ways to minimize risks associated with IITs
• Regulatory deficiencies and FDA warning letters
• Principles of ethics and euality control process