Guide to Good Clinical Practice

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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.

You’ll find…
• 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)
• Newsletters
• Online access
• Newsletter archive
• Special Reports
• Email Notifications
• Fully searchable
• Hyperlinking
• ClinLaw Database
• FDA Warning Letter Database
• Additional Online Resources
• Access to online content

  With your subscription, you receive access to this product's online content, so you can get fast, up-to-date answers anytime, anywhere. You can quickly search all articles for key terms, and bookmark pages so you can easily return to them again. Stay ahead of the game with updates full of news, analysis, and practice tools, and easily view previous ones.

About Your Subscription

You can review this product for 30 days. Your annual subscription includes published updates at no additional charge for the 12 month subscription period. 12 updates are expected. If you cancel your subscription within 30 days of receipt, you will receive a full credit upon return of the product together with a request for cancellation.

Gary L. Yingling is a partner with the law firm of K&L Gates 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
K&L Gates LLP
Washington, D.C.

John Donahue, Ph.D.
V.P., Planning and Management
Bristol-Myers Squibb
Princeton, N.J.

Jeffrey N. Gibbs, Esq.
Hyman, Phelps & McNamara
Washington, D.C.

Earl W. Hulihan, B.S., M.Ed.
V.P., Global Regulatory Affair and Quality Assurance
Medidata Solutions, Inc.
New York, N.Y.

John M. Isidor, Esq.
Chief Executive Officer
Schulman Associates
Institutional Review Board
Cincinnati, Ohio

Charma A. Konnor, R.Ph., RAC
Executive Director/Consultant
Phoenix Regulatory Assocs. Ltd.
Sterling, Va.

Charles E. Mueller, R.Ph.
Director, North American Clinical Compliance
GlaxoSmithKline Inc.
Research Triangle Park, N.C.