Guide To FDA Financial Disclosure Requirements

PDF Edition - Guide to the FDA’s Financial Disclosure Requirements for Clinical Investigators

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June 2013
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Guide to the FDA’s Financial Disclosure Requirements for Clinical Investigators

Clinical trial sponsors are playing under new conflict-of-interest rules. So here’s a little test of your knowledge. Under the FDA’s just-promulgated regulations:

  • What’s the new definition of clinical trial sponsor?
  • How must sponsors now treat employees for conflict reporting purposes?
  • How must sponsors now handle so-called significant payments of other sorts (SPOOS)?
  • What are the new FDA procedures for reviewing conflict-of-interest disclosures?
  • What does the FDA now require mitigation plans to say and do?
  • What do you do if your firm is unable to collect and/or report clinical investigator financial data?
  • Which investments are reportable and which are not?

Scratching your head? It’s no surprise.

But worry not. You’ll find all the answers — and more — in this management report from FDAnews.

The FDA rules are subtle and complex. For example, while the agency doesn’t bar all conflicts of interest, it does demand they be properly managed. While most types of financial disclosure are required, certain types are not. Some rules on reporting and conflict-of-interest mitigation are new, others remain unchanged. The report covers all this — and more — with:

  • Detailed explanation of sponsor obligations for financial disclosure, including definitions of key terms
  • Explanations of primary financial categories for disclosure
  • Breakdowns of amounts that require reporting
  • Required disclosure forms that each investigator must file
  • Case studies in implementing disclosure programs
  • Answers to frequently asked questions
  • And appendices with all necessary guidance, regulation and forms

Here’s a report that’s super-timely for anyone involved in clinical-investigator disclosure, including but not limited to:

  • Sponsors
  • Clinical Investigators
  • Compliance Officers
  • Risk Management
  • In-house and Outside Counsel …
  • And many others, both in and outside your organization.

If your firm relies on clinical trials — and which FDA-regulated firm does not? — you owe it to yourself, your employees, your customers, your shareholders … and, most of all, to your end-users … to understand the FDA’s disclosure rules. Don’t risk a product failure that could cost millions — not when help is at hand.


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Table of Contents

  • Introduction
  • New Guidance
  • Important Definitions
  • Financial Disclosure Categories
  • Responsibilities under the Law
  • And More …

View the entire TOC

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