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

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Program Materials

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.

Description

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.

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Outline

  1. Regulatory landscape for clinical trials and human research
    1. Clinical trial registrations and disclosures
    2. IRBs
  2. Practical impact of organizations sponsoring, conducting or involved in clinical trials or human research
  3. What providers and counsel need to do to ensure compliance
    1. Informed consent
    2. Disclosures
    3. Data-sharing
    4. Secondary research
    5. Others

Benefits

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?

Faculty

David Peloquin, Esq.
David Peloquin, Esq.

Ropes & Gray

Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the...  |  Read More

Thomas D. Shrack, Esq.
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...  |  Read More

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