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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 — 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.
Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.
Need Extra Print Copies?
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. Simply choose the quantity you wish to order the discount will be calculated automatically.
3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%
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