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Home » Food & Drug Regulation Library
Guide to Good Clinical Practice
Guide to Good Clinical Practice Authors:  Gary Yingling  Mary Bernadette Ott
Board:  Editorial Advisory Board

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.

 
Look Inside

Print Online
  • 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
  • Online access
  • Newsletter Archive
  • Updates (12 updates)
  • Special reports
  • Email Notifications
  • Fully searchable
  • Hyperlinking
  • ClinLaw database
  • FDA Warning Letter Database
  • Additional Resources
$699.00
Plus $29.50 Shipping and Handling
Order by Fax
$699.00
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About This Publication
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 laws and regulations plus a complete guide to interpretations, analysis and advice.  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
•    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!

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.

Audio Conferences

Thursday, September 09 2010
Clinical Trial SOPs: Ensure Your Procedures are Compliant and Followed Correctly

Tuesday, September 14 2010
A Drug Recall Case Study: Lessons Learned from a Widespread Drug Recall at a Major Pharmaceutical Company

Tuesday, September 21 2010
False Claims Act Liability for Pharmaceutical and Medical Device Companies: How Will Recent Changes Affect You?

Tuesday, September 28 2010
How Health Care Reform and Other New Legislation Will Affect the Regulation of Advertising and Promotion

Thursday, September 30 2010
FDA's Changes to the 510(k) Process: Are You Prepared?

Tuesday, October 05 2010
Device Complaint Handling: Implications for CAPA, Reporting, Recalls and More


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