When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences

Why Should You Attend:

Do you understand when an IND Exemption may be granted? Do you understand the application process and timeline for the exemption? Do you understand how a study, or future use of data collected in a study, exempted from an IND may be impacted?

If you do not know the answer to one or more of these questions attending this one-hour webinar will help you to be better informed about IND exemptions.

This session will briefly review the purpose of INDs and the process for obtaining an IND. It will explore the circumstances and cases that allow a study to be granted an IND exemption from the FDA. The discussion will center on the pros and cons of requesting an exemption. Understanding what limitations exist when a study is exempt from an IND will help attendees to make more informed decisions about whether seeking an exemption is the right choice. Finally, if an exemption is appropriate, this training will help attendees make sure they understand how to secure the correct approvals, and the timeline for the process.

Learning Objective:

At the end of this webinar, participants will understand criteria for exemption and be able to describe the impact an exemption has on a study.

Areas Covered in the Webinar:

• Review of purpose and process of IND applications.
• Understand exceptions to the IND requirement.
• Process of exemption request.
• Limitations of research carried out under an exemption.
• Future Data Use restrictions.
• How to decide if a request for exemption is prudent.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Investigators
• Coordinators
• Regulatory Specialists
• Industry Sponsors involved in Investigator Initiated Research
• Compliance Officers
• IRB members

Instructor Profile:

Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. Currently employed by UC Health Systems, ([email protected]), she provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Jennifer has extensive experience in training and education and complete a 4 year term as Vice Chair of the ACRP Professional Development Committee in December of 2013.

Topic Background:

While most Clinical Research Professionals understand the role of an IND when a new compound is being developed, there is often confusion around the need of an IND when an “off-label” use of a product is being considered for evaluation or when two marketed compounds are being considered for comparison. Regulations outline when an IND is required and conditions when a study may be exempted from the requirement. However, when seeking an exemption it is important to understand the limitations this may place on the study or future use of the data.

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