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 scientific and legal obligations of sponsors, monitors, investigators and IRBs.
• Protocol violations, transcription errors and changing study accountability.
• Questions and answers on meeting FDA, OHRP, and international clinic trial requirements.
• An online database of state statutes and regulations regarding medical research involving human subjects.
• Sample forms, checklists, analyses, explanations, and more.
• How-to information for meeting the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA).
• Regulations on obtaining informed consent, recordkeeping and reporting and research misconduct as well as European Directive 2005/28/EC on the principles and guidelines for good clinical practice.
• Single-user online access to the manual, newsletter archive and clinlaw database.

• Sponsor/Monitor, Clinical Investigator and IRB Obligations
• Adverse Event Reporting Requirements
• FDA Monitoring
• Quality Assurance Audits
• International GCP
• Informed Consent
• Clinical Data Documentation Requirements

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