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Adverse Event Compliance in Device and Diagnostics Clinical Trials

$337.00
December 2007
978-1-60004-178-5
139
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From FDAnews:
Adverse Event Compliance in Device and Diagnostics Clinical Trials

Find clear, concise guidelines on adverse event reporting — specifically for device and diagnostics trials.

Make sense of all the whats, whens and hows surrounding adverse event reporting as you:

  • Discover the most common adverse event reporting errors — and how to avoid them
  • Untangle the key rules and requirements of the FDA and OHRP
  • Find out (once and for all) what the FDA considers a reportable effect, so that you can avoid the often-made mistake of misinterpreting this rule
  • Understand the real risks of underreporting and overreporting
  • Build IRB best practices into your UADE compliance program
  • Better grasp the consequences of not meeting your reporting obligations 
  • And more

Once an adverse event happens, it’s too late: you have just 10 working days to submit to the IRB and 10 days after that to get results to the FDA. Stay in control, even when unanticipated events happen, place your order now for Adverse Event Compliance in Device and Diagnostics Clinical Trials.

Patient Safety? Premarket Reporting?
For Adverse Event Answers You Can Use Right Away, Look Here

Whether you have device or diagnostics research in progress or you need workable strategies for your next clinical trial, you’ll find it in Adverse Event Compliance in Device and Diagnostics Clinical Trials, including how to:

  • Manage adverse events in premarket safety reporting, both in scope and severity
  • Keep your clinical trial patients safe
  • Spot a serious adverse event — and comply with all the different rules that govern it, including the FDA, OHRP, IRBs and others
  • Avoid noncompliance penalties
  • Spell out your responsibilities (and those of your team members) so that no adverse event reporting slips through the cracks
  • And much more

Adverse Event Compliance in Device and Diagnostics Clinical Trials: click here to order.

Buy Now!
With this management report from FDAnews, you won’t have to lose sleep over adverse events — or stockpile every event in fear of an FDA sanction from an overlooked reportable event. Available in print or PDF format, Adverse Event Compliance in Device and Diagnostics Clinical Trials is priced at $337 each.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

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