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.
"Don't leave home without it!... Given its very affordable price, there is no good reason why every clinical research professional involved in regulatory, legal or budget activities should not have a copy on their desk; maybe two copies, in case one is 'borrowed.' "
Norman M. Goldfarb, Editor, The Journal of Clinical Research Best Practices
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September 2006, Approx 200 pp.,