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When it comes to labeling unexpected events during a clinical trial, most investigators agree: The answer isn’t always obvious. The definitions – and the required responses -- vary from one agency to the next.
And the reporting process only adds more stress. Misjudge a problem and you’ll pay a steep price for failure to report to the FDA.
Clinical Trials Adverse Event Reporting Reference Guide is the most up-to-date, comprehensive collection of rules, regulations and guidances available in a murky area where change happens fast.
The first edition of the Guide sold out. But, that was three years ago. Look at all that has changed:
A newly issued guidance from OHRP on IRB Continuing Review of Research
Another new guidance on Reporting Incidents to OHRP
A new FDA guidance, Safety Reporting Requirements for INDs and BA/BE Studies
Plus numerous new enforcement cases involving adverse event reporting
The Clinical Trials Adverse Event Reporting Reference Guide, Second Edition provides official OHRP and FDA answers to nagging questions, including:
How to determine if an adverse event needs to be reported
When does an expected adverse event become an unanticipated adverse event
How do adverse events differ from unanticipated problems
How to assess if an event is unexpected
How to assess whether an event is related to research
What needs to be included in adverse event reports
And much more
Also featured — analysis of relevant warning letters, illustrating ways adverse event reporting requirements often are misconstrued or overlooked.
Whether you’re in drugs or devices ... a CRO or a clinical trial site operator ... the Clinical Trials Adverse Event Reporting Reference Guide, Second Edition belongs on your bookshelf or desk, in easy reach. When those tough calls arise, you’ll find yourself referring to it again and again.
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