State-by-State Clinical Trial Requirements Reference Guide (Serio) - Softcover

John C. Serio

Softcover

ISBN 10: 0988314401 ISBN 13: 9780988314405

Publisher: Parexel Intl Corp, 2012

Synopsis

Although many clinical trial sponsors and investigators focus primarily on FDA regulations related to the conduct and design of clinical trials, their failure to comply with state laws and regulations may expose sponsors, investigators, IRBs, Institutions, or individuals to significant liability risks and call into question the potential integrity of clinical data. 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 and foundational to clinical studies age of consent, capacity to consent, notification of state agencies, experimental drug dispensing requirements, 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 2012 provides totally updated and expanded profiles of the clinical trial standards in all 50 states. This newly updated 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/Capacity to 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
* State-specific benefits afforded clinical research

About this title

About the Author

John C. Serio is a Partner at Seyfarth Shaw in Boston, Massachusetts, where he is a registered patent attorney concentrating his practice in the area of intellectual property concerning biotechnology, pharmaceuticals, medical devices, chemistry, and analytical scientific equipment. His practice involves drafting and prosecution of patents, right to use and patentability opinions, patent litigation, pharmaceutical litigation, licensing of technology, and trademark issues. Mr. Serio also has significant expertise in Food and Drug Law involving both pharmaceuticals and medical devices and in particular the FDA approval and marketing of therapeutic products and labeling of food and dietary supplements. He advises companies on a wide variety of regulatory issues, including the national and international conduct of clinical studies, manufacturing, and FDA enforcement matters. He further assists clients in the preparation and filing of regulatory documents related to new drug applications, abbreviated new drug applications, and 505(b)(2) applications. As a licensed pharmacist, Mr. Serio has a multilateral understanding of complex scientific principles and drug development within the pharmaceutical industry. Mr. Serio is a thought leader on the use of social media in Direct to Consumer Advertising, and was a co-author of a foundational white paper on managing the risks and regulatory issues associated with pharmaceutical social media monitoring and marketing. He has written and lectured extensively on a variety of FDA and patent related topics.

Edition details

• Publisher: Parexel Intl Corp
• Publication date: 2012
• Language: English
• ISBN 10: 0988314401
• ISBN 13: 9780988314405
• Binding: Perfect Paperback
• Edition number: 3
• Number of pages: 220