Good Clinical Practice: A Question and Answer Reference Guide 2004 - $39.95
Developed with input from over 100 industry and government clinical trial and GCP experts, this new reference guide answers almost 400 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drug, biologics, and device trials. In one pocket handbook, you'll have the 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
- Source Data/Documentation
- Investigator/Site Requirements
Clinical Monitoring
- Clinical Study Safety Reporting
- HIPAA
- Clinical Trial Protocols/Protocol Changes/Protocol Violations
- Institutional Review Boards
- Quality Assurance Activities/Study Auditing/FDA Inspections
- Investigational Drug Accountability, Administration, and Labeling
- Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!
May 2004, 420 pp., 1-882615-70-0, $39.95
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