Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 2, Guidance

Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic:
* FDA Overview and Orientation
* Introduction to GCP
* Part I: General
* Part II: Institutional Review Boards (IRBs) and Informed Consent
* Part III: Drugs and Biologics
* Part IV: Medical Devices
* Part V: Manufacturing Requirements for Investigational Products
* Part VI: Electronic Data
Reference Tools
* Part VII: Combined Glossary and Index for all Quality Guidance Documents