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:
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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