Clinical Trial Disclosure Compliance Strategies

Held Dec. 13, 2012

As of October, the FDA began policing compliance with clinical trial submission requirements for The FDA is now identifying incorrect or fraudulent submissions and seeking out unsubmitted trial results.  And the penalties could seriously derail your clinical trials.

Civil monetary penalties include:

Any person who fails to properly disclose trial information shall be subject to a civil monetary penalty up to $10,000.  If a violation is not corrected within 30 days following notification — in addition to the above penalties — persons can be subject to penalties up to $10,000 for each day of the violation after such period until the violation is corrected.

If your trial is funded in any way by a federal agency, and you fail to properly disclose trial data, you could see your trial come to a grinding halt.

Section 801 of FDAAA allows for:

Any agency of the HHS, including FDA, NIH, or the Agency for Healthcare Research and Quality to withhold funding grants for trials currently in progress until disclosure requirements are met.  And, the law allows government agencies to cut off future grants to companies or organizations that it feels are not in compliance.

If you aren’t 100 percent sure you are compliant in your reporting, the cd and transcript of our Dec. 13 webinar is a must-have tool to help you get on the right track.

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Isn’t it about time you gained piece of mind over clinical trial disclosures?

In just 90 minutes, Barbara Godlew, clinical trial disclosure expert and president of FAIRE Consulting, delivers best practices for meeting the FDA’s expectations based on her extensive experience managing numerous pharmaceutical companies and academic medical centers.

This CD/Transcript is intended for anyone who wants to understand the legal requirements and tips and techniques to assure compliance. Stop worrying about clinical trial disclosure here and abroad.

Ms. Godlew focuses on the new essentials of reporting. In 90 fast-paced minutes, you’ll discover:

  • Recent events that may affect future clinical trial disclosure requirements
  • Update on the current regulations and requirements for the US, Europe, ICMJE, and beyond
  • Why including key stakeholders is critical to successful disclosure initiatives
  • What the correct grant applications/progress reports for academic medical centers/research organizations are
  • New informed consent changes specific to disclosure
  • Implications of noncompliance for industry and academia
  • FDA field audit focus on disclosure
  • Practical advice and tips on making the registration and results reporting process go smoother
  • And much more.

Why risk fines, penalties or worse, when preparing for these new reporting rules could be so painless? Don’t wait another minute.

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Spread the word throughout your organization. Make particularly sure to notify the following key staff:

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers
  • Clinical Trial Managers
  • Clinical Trial Study Coordinators
  • Clinical Trial Office Operations Staff
  • Medical Communications Groups
  • Scientific Publications
  • Medical Writing Groups
  • Academic Clinical Investigators
  • Independent Investigators
  • Statisticians
  • Regulatory Affairs Personnel

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Barbara Godlew, RN, BA is the president of The FAIRE Company, LLC, and specializes in clinical trial disclosure consulting and medical writing. She is a recognized senior-level clinical trial disclosure expert and consultant for several major pharmaceutical companies and academic medical centers. She has worked with numerous small, medium, and large pharmaceutical, biotechnology, and medical device companies to assess and streamline their clinical trial disclosure operations, policies and processes.  Ms. Godlew has authored numerous journal articles and has been an industry speaker about clinical trial disclosure issues. She is the recipient of the 2012 Drug Information Association Outstanding Service Award.

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