Summary
Newly updated and expanded for 2007, this industry-leading GCP training and reference guide answers well over 500 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drugs and biologics.
While continuing with a US/FDA focus, this innovative reference pocket guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, Canada, India, and Russia! And our 2007 edition includes a new section on China GCP!
Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards.
In one pocket handbook, you'll have authoritative answers to hundreds of common and emerging questions, in 20+ GCP-related areas, right at your fingertips:
- FDA and ICH GCP Standards for Clinical Research
- Form FDA 1572-Statement of Investigator
- Informed Consent
- Patient Recruitment
- State Standards and GCP
- Source Data/Documentation
- Investigator/Site Requirements
- Clinical Monitoring
- Clinical Study Safety Reporting
- Clinical Trial Protocols/Protocol Changes/Protocol Violations
- Institutional Review Boards
- Quality Assurance Activities/Study Auditing/FDA Inspections
- Investigational Drug Accountability, Administration, and Labeling
- Now includes a new section on China GCP!
- Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!
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