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e-Book State-by-State Clinical Trial Requirements Reference Guide: November 2006 epub download

e-Book State-by-State Clinical Trial Requirements Reference Guide: November 2006 epub download

Author: John C. Serio and Dorothy L. Puzio
ISBN: 1882615808
Pages: 194 pages
Publisher: Parexel Intl Corp; 1 edition (November 1, 2006)
Language: English
Category: Medicine
Size ePUB: 1965 kb
Size Fb2: 1585 kb
Size DJVU: 1523 kb
Rating: 4.3
Votes: 721
Format: lit doc lit doc
Subcategory: Medicine

e-Book State-by-State Clinical Trial Requirements Reference Guide: November 2006 epub download

by John C. Serio and Dorothy L. Puzio



Find out why New Drug Development is pharma/biotech's go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes. Format Hardback 212 pages.

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Publisher: Barnett Educational Services. Publication Date: 2012.

In addition to federal requirements, some states have proposed additional legislation effectively increasing .

In addition to federal requirements, some states have proposed additional legislation effectively increasing requirements. While the issue of preemption is undetermined, understanding state concerns and motivations for legislating may prove useful for determining whether a company wishes to disclose additional information beyond the federal requirements. Information about laws related to elder abuse.

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Physicians and health care providers can use it as a reference book. I would recommend this book. The organization and structure is good and logical. Also, it provides a list of references at the end of each chapter. This was recommended to me by my colleagues who have had many years in the clinical industry.

Appendix A: Draft Interview GUIDE14,15.

Today's US-based clinical trials must meet not just federal requirements, but an increasingly complex array of state-specific requirements as well. In fact, many areas critical to clinical studies age of consent, drug dispensing, genetic testing, and legal representatives, among many others are driven by state, and not federal, laws. How do you monitor the requirements of all 50 states? State-by-State Clinical Trial Requirements Reference Guide 2006 provides totally updated and expanded profiles of the clinical trial standards in all 50 states. This all-new resource breaks down each state's requirements in more than a dozen practical areas critical to your clinical research programs, including: * State statutory structures for clinical trials * Required notifications to state officials/offices * Legal representative standards * Age of consent * Drug dispensing/administration requirements * Informed consent, IRB, and clinical protocol requirements * State licensing authorities (medical, nursing, pharmacy) * Special state rules for cancer research * State HIV testing rules * State requirements for genetic testing. Our 2006 edition has been updated and expanded to address additional areas of state law applicable to clinical research. Among the additions to this year's new edition is a new section on state-by-state requirements applicable to the emerging area of genetic testing.