Registering “Applicable Trial” Data on Managing Disclosure of Negative or Non-significant Results

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Three little words, “applicable clinical trial.”  How have they become so difficult to understand when it comes to registering trials on

With reports of industry “cherry picking” on the rise — and new rules currently in development — now’s the time to get expert guidance.

While the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the National Institutes of Health’s (NIH) website, many are accused of cherry-picking and only reporting positive trial outcomes.

Yet, is it cherry picking or confusion on what constitutes an applicable clinical trial?

Regardless of your answer, the NIH, FDA and OIG are ramping up enforcement of the requirements and are increasing pressure on firms to report all applicable clinical trials. In 2010, three firms were mandated to comply with registration and reporting requirements through OIG corporate integrity agreements.

It’s a looming crisis for the clinical trials community. Fortunately, help is at hand.

Mark your calendar for Tuesday, Jan. 24, when Scott Cunningham conducts a webinar that focuses on the new essentials of reporting. In 90 fast-paced minutes, you’ll discover:

  • What the FDAAA says, and how its provisions impact your clinical trials;
  • Current status of the proposed FDAAA 801 rulemaking;
  • Best practices to manage disclosure of negative or non-significant results;
  • Avoiding mistakes when applying the regulatory exemptions;
  • Strategies to assure compliance with the potentially conflicting requirements of, state and international agencies;
  • Untangling FDAAA clinical trials disclosure requirements;
  • How to avoid overstepping the 12-month deadline for applicable clinical trials;
  • Reassessing audit and monitoring processes for results posting;
  • And much more.

Register Today

Like every FDAnews webinar, Registering Study Data on is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.

Simply submit your questions via email, and you’ll have answers by the time the session ends.

Everyone in your organization with a role in clinical trials deserves to take part in this event — and they can do so at a cost that won’t break the budget. You only pay one low registration fee per facility, regardless of how many participate − so spread the word.

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

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

Scott Cunningham Esq is a partner at Covington & Burling LLP, where he is a member of the FDA practice group and both a frequent speaker and writer. Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Mr. Cunningham graduated cum laude from the University of Pennsylvania Law School.

Register now!

Date: Jan. 30 – Feb. 17, 2012
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
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The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
with any questions.

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Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Registrations may not be cancelled. Please contact customer service to make any substitutions.

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