What can go wrong with informed consent documents? Plenty ...
Want us to go on? We could.
Is your informed consent process effective and compliant with FDA and OHRP? If you hesitated for even a moment, kindly accept this invitation to preview — at no risk — the 2012 edition of … Informed Consent for Clinical Trials: A Regulatory Reference Guide.
This brand new guide has been completely updated and includes the following essential references:
Part One – FDA Guidance Documents
Part Two – OHRP Documents
The Challenge of Informed Consent …
Even in routine health care procedures, explaining risks and benefits of any treatment – and obtaining the patient’s consent —is often difficult. But the complexities of explaining risks and benefits of participating in a clinical trial are daunting.
With this 300+ page guide, you will never again wonder if your informed consent process meets federal standards. Don’t roll the dice and ‘hope’ you will get this right … the stakes are too high. Make SURE you know, exactly, what’s required to the letter.
The cost is only about $1.00 per page. Where else can you buy insurance like this that could save you thousands upon thousands in money, time and even worse … lost data or reputation?
Don’t risk it.
Informed Consent for Clinical Trials: A Regulatory Reference Guide is offered by FDAnews in print or PDF format for $377 each.
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your publication? Return the hard copy within 30 days (in resalable condition), and we will refund 100 percent of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.
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