Clinical Trial Investigator And Provider Contracts: Know The Issues And New Rules!

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Nov 14, 2013
60 Minutes
Product Description

Know Critical Laws and Rules That Apply To Clinical Trial Contracts

With so many new medications and devices in development, more and more providers find themselves involved in clinical trials, whether as investigators or as sites for testing of subjects or for analysis. Before venturing into this area, however, you need to be aware of the myriad laws and rules that apply, as well as how newer laws like the health reform act and HIPAA impact clinical trial arrangements. Providers may be initially exposed to these requirements when presented with an investigator or clinical trial agreement. These contracts reference many regulatory obligations, and it’s important to understand what is entailed before going forward. Likewise, these agreements are often prepared by the study sponsor, such as a drug manufacturer, and may be overly favorable to the sponsor. For example, the contract may not have enough protections for the provider if the study medication causes harm due to its  composition or manufacture. In addition, other terms in a typical clinical trial agreement may be unfamiliar to the uninitiated.

Join Wayne J. Miller, Esq. in this informative session to get insights on some of the critical laws and rules that apply to clinical trial contracts, including newer statutes. Wayne will describe the types and roles of parties who may be on “the other side of the table” to a participating doctor or hospital. He’ll also highlight critical contract terms that are often negotiable.

Topics to be covered include:

  • What do they do: sponsor, clinical research organization, investigator?
  • Critical laws that apply: FDA, HIPAA, etc.
  • New requirements under health reform and other newer laws
  • Typical main terms in clinical trial agreements
  • Areas of negotiation
  • Reducing liability risk for providers

Who should attend? Hospitals, Physicians, Practice Managers, Medical Groups, Health Care Consultants, Medical Practice And Facility Executives, And Other Parties Involved In Clinical Trials   

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About Our Speaker

Wayne J. Miller - Healthcare Compliance Expert

Wayne J. Miller, Esq., is a founding partner of the Compliance Law Group, Los Angeles, a law firm focused on health care industry legal compliance for clients nationwide. Wayne has practiced healthcare business and regulatory law throughout his 30-year career. His firm represents a wide range of healthcare industry clients throughout the nation. He is a frequent speaker for The Coding Institute national teleconferences on healthcare reimbursement, transactional and regulatory...   More Info
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