Guide to Good Clinical Practice
What is an eBook?
An electronic book (also e-book, ebook, digital book) is a digital publication that you can download and view on your computer, laptop, or mobile device. Now you can easily reference your content from the experts at Thompson anytime, anywhere.
|On Your PC or Laptop||On Your Apple Products||On Other Mobile Devices|
|View your Thompson eBooks on your computer with Adobe® Digital Editions., a free, lightweight platform that takes less than a minute to download and install over a broadband connection. Simply install it to your computer prior to downloading your Thompson eBook.||View your Thompson eBooks on your Mac, iPhone, iPad, and iPod touch with the Bluefire Reader (available in the Apple App Store). Simply authorize your app with your Adobe ID and transfer your Thompson eBooks to your device using the iTunes file sharing feature.||Thompson offers the .ePUB format, which is readable on all devices that support the Adobe™ .ACSM file. You can view Thompson eBooks on your Sony Reader, Nook, Blackberry, Android, and others. For a full list of mobile devices, see Support Devices.|
The Guide to Good Clinical Practice is your one-stop resource for clinical trial regulations and guidelines - everything you need to conduct clinical trials more effectively, streamline the process and ensure human subject protection and trial data integrity. This resource is THE most comprehensive and straightforward resource of its kind.
- Hasten trials with details on laws, regulations and best practices
- Avoid costly errors with trial regulations and guidelines
- Stay in compliance with HIPAA privacy requirements
- Keep up to date with updates and newsletters, as well as online access to federal enforcement and state law and regulation databases*
- Meet national and international clinic trial requirements
- Contact the editor with unanswered questions — a special resource for subscribers
Thompson’s FDA Compliance Expert | Guide to Good Clinical Practice is your one-stop resource for clinical trial regulations and guidelines - everything you need to conduct clinical trials more effectively, streamline the process and ensure human subject protection and trial data integrity. With this online resource, you can:
* Only available to customers with an online subscription.
The Guide to Good Clinical Practice is your one-stop resource for clinical trial regulations and guidelines — everything you need to conduct clinical trials more effectively, streamline the process and ensure human subject protection and trial data integrity.
The Guide to Good Clinical Practice provides sponsors, institutional review boards (IRBs), clinical investigators, monitors and study site staff with the information and tools they need to conduct quality clinical trials of new drugs, devices and biologics. From explanations of laws, federal regulations and international harmonization efforts to an analysis of accepted good clinical practices, the Guide helps clinical researchers avoid costly errors and gain faster product approval. The Guide to Good Clinical Practice includes sample checklists for conducting quality assurance audits, FDA forms, industry guidance documents and information sheets, monthly newsletters, updates, news and analysis on key developments in conducting clinical research, online access to the entire Guide, newsletter archive, as well as clinlaw, an online database of state clinical trial requirements, and additional resources.
The Guide to Good Clinical Practice brings the very latest clinical trial regulations and guidelines to keep your trials in strict compliance. The Guide is updated every month to keep you up-to-date on the changes to federal agency laws and regulations.
Your 12-month subscription comes with our two-volume manual of analysis and advice as well as the key law, regulations, and guidance concerning clinical trials. It also includes monthly updates and monthly newsletters, plus a single-use online access to the manual, newsletter archive and the state law and federal enforcement databases.
• Current information on federal agency mandates
• Questions and answers on meeting FDA, OHRP and international requirements
• Regulations on obtaining informed consent, recordkeeping, reporting, and research misconduct
• How-to information for meeting the revised privacy requirements of HIPAA
• The scientific and legal obligations of sponsors, monitors, investigators, and review boards
• How to avoid protocol violations, transcription errors and changing study accountability
• An online database of state statutes and regulations regarding medical research involving human subjects
• A searchable database of FDA Warning Letters and OHRP Determination Letters
• Much more!
Order today – not knowing can be costly!
- Two-volume manual
- Updates (12 updates)
About Your Subscription
Your annual subscription includes published updates at no additional charge for the 12 month subscription period. If you have any questions about your subscription, please contact Client Services at 800-677-3789 or by e-mailing email@example.com
Gary L. Yingling is a partner with the law firm of Morgan, Lewis & Bockius LLP in Washington, D.C. One of his particular interests has been clinical research/contract research organization/sponsor matters. He served as president of the Food and Drug Law Institute (FDLI) for nine years. He was a recipient of FDLI's 1998 Distinguished Service and Leadership Award, presented annually to honor an outstanding practitioner in food and drug law. He worked at the FDA's Office of the General Counsel for 10 years, first as a trial attorney, and later as associate chief counsel for its Bureau of Veterinary Medicine and the deputy chief counsel for administration. He also was director of over-the-counter drug review in the Bureau of Drugs. In 1974, he received the FDA's Award of Merit, the agency's highest award, for his legal and administrative work on the OTC Review. Prior to joining the FDA, he worked for the National Communicable Disease Center in the Pesticides Program. He received his J.D. from Emory University, an M.S. in pharmacology from Purdue University and a B.S. in pharmacy from the University of North Carolina.
Mary Bernadette Ott is a regulatory affairs and quality assurance consultant specializing in establishing in-house good clinical practice auditing programs for sponsors, conducting audits at clinical investigator sites and training sponsors, contract research organizations and clinical investigators on FDA and international good clinical practice requirements. Formerly, she was an FDA field investigator in the agency's Philadelphia District Office and a supervisory investigator in its Boston District Office. She received a B.S. in biology from Chestnut Hill College in Philadelphia.
Editorial Advisory Board of the Guide to Good Clinical Practice
Mary Bernadette Ott
Co-editor in Chief
RA and QA Consultant
New Hope, Pa.
Gary L. Yingling, Esq.
Co-editor in Chief
Morgan, Lewis & Bockius LLP
John Donahue, Ph.D.
V.P., Planning and Management
Jeffrey N. Gibbs, Esq.
Hyman, Phelps & McNamara
Professor Earl W. Hulihan, B.S., M.Ed.
ewhulihan and associates, inc.
John M. Isidor, Esq.
Chief Executive Officer
Institutional Review Board
Charma A. Konnor, Pharmacist (Ret.)
Executive Director/Consultant, Devices and Drugs
Phoenix Regulatory Associates, Ltd
Charles E. Mueller, R.Ph.
Director, North American Clinical Compliance
Research Triangle Park, N.C.