This 1-hr virtual seminar will help you understand the key issues and challenges associated with investigator-initiated trials. Investigator initiated trials are especially important as they are important connection for the translation of research from bench to bedside. I will discuss the role of sponsor-investigator and ways we can ensure the protection of human subjects in an investigator-initiated trials before and during the pandemic of COVID-19.

Course Objectives:

This webinar will introduce the learners regarding main areas of investigator-initiated trials and the necessary steps taken to ensure compliance with federal regulations and the International Conference on Harmonization and upon completion of this webinar, attendees should be able to:

• Recognise the importance of investigator-initiated trials
• Identify way to ensure human subject protections
• Identify the investigator deficiencies
• Identify what are the site responsibilities in investigator-initiated trials
• Identify the approaches or concerns of Institutional Review boards
• Recognise the resources available to help the investigator in the conduct of investigator-initiated trials during outbreak of COVID-19

Why Should You Attend:

Investigators initiated trials are very essential of any research to be translated from bed to bedside. The inception of these research is only done with a scientific interest in a new or existing drug or device, generate new ideas, and mostly involve collaborative research between different departments and different types of researchers.  Despite availability of an ample amount of resources that are available for some studies, but are lacking in the studies that are innovatory, collective, or questionable. To ensure protection of human subjects in clinical trials participation how sponsors, investigators and site can ensure vigilance in this process.

Course Outline:

• What are the Investigator Initiated trials?
• Responsibilities of Sponsor-investigator
• Reviewing the Principles of ICH Good Clinical Practice
• What can Sponsor-Investigator do to ensure human subjects protections?

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This topic applies to personnel / companies doing research or involved in the clinical trials. The following will benefit most include:

• Principle Investigators
• Senior Clinical Research Associates(CRAs)
• Clinical Research Project Manager
• Research Assistants
• Clinical Research Coordinator (SC)
• Contract Research Organizations (CROs)
• Institutional Review Boards (IRBs)
• Site Management Organizations (SMOs)