Clinical Trials and Human Research: Complying With New Regulatory Obligations
Navigating New Requirements for Informed Consent, Disclosures, Data-Sharing, and More
Recording of a 90-minute CLE webinar with Q&A
Conducted on Wednesday, January 18, 2017
Recorded event now available
This CLE webinar will provide guidance to counsel for navigating regulatory changes for clinical trials and human research. The panel will examine the practical impact for those sponsoring and conducting clinical trials and will outline compliance strategies to meet the new requirements.
Several important legislative, regulatory and sub-regulatory developments affecting the research community took place in the second half of 2016. These developments include the passage of the 21st Century Cures Act, the issuance of the final rule governing ClinicalTrials.gov, the publication of a joint guidance document by the U.S. Food and Drug Administration and the Office for Human Research Protections on electronic informed consent, and the National Institutes of Health’s (NIH) policy on good clinical practice training for NIH-funded clinical investigators.
Attorneys advising organizations sponsoring, conducting or involved with clinical trials and human research must fully understand the scope and complexity of these developments to ensure clients are in full compliance.
Listen as our authoritative panel examines the changes in the regulatory environment for clinical trials and human research. The panel will provide guidance on the new requirements and discuss the impact on organizations sponsoring or conducting clinical trials and human research. The panel will offer best practices for meeting the changing requirements.
- Regulatory landscape for clinical trials and human research
- Clinical trial registrations and disclosures
- Practical impact of organizations sponsoring, conducting or involved in clinical trials or human research
- What providers and counsel need to do to ensure compliance
- Informed consent
- Secondary research
The panel will review these and other key issues:
- How do the new regulations change the requirements for clinical trials? Human research?
- What will the practical impact be on organizations involved in clinical trials or human research?
- What must organizations sponsoring or conducting clinical research do now to ensure compliance with the new rules?
David Peloquin, Esq.
Ropes & Gray,
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the area of clinical research and health data privacy. Prior to attending law school, he worked as a project manager for a leading supplier of electronic medical records. Mr. Peloquin is a frequent author and lecturer on clinical research/human subject protection issues, among others.
Thomas D. Shrack, Esq.
Hall Render Killian Heath & Lyman,
Mr. Shrack focuses his practice on clinical services and patient care issues, corporate counsel services, medical staff relations, and regulatory and compliance and legal and ethical issues involved in clinical research activities. He also provided counsel on issues including, but not limited to, the development, registration and conduct of clinical investigations, government audits and investigations, the impact of fraud and abuse laws and FCA on research, FDA regulations, the Common Rule, pharmaceutical pricing and clinical trial billing compliance, medical device approval submissions, and various reporting obligations.
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I liked the use of current court cases.
Northwestern Memorial Hopsital
The speakers were well prepared and were able to explain the information in a clear and concise manner.
Columbia University Clinical Trials Office
I thought the webinar was great.
North Shore LIJ Health System
The webinar was very clear & applicable to my practice.
Bon Secours Health System
The speakers were well prepared and knowledgeable.
San Francisco General Hospital
Health Law Advisory Board
Fredrikson & Byron
Faegre Baker Daniels
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo
Wyatt, Tarrant & Combs
McDermott Will & Emery
Foley & Lardner
Foley & Lardner
Buchanan Ingersoll & Rooney
Drinker Biddle & Reath
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