Regulations & Guidances current as of :

(GCP-1) good clinical practice

GCP in FDA-Regulated Drug and Biologics Clinical Trials

US code of federal regulations title 21: food and drugs
  • part 11—electronic records; electronic signatures
  • part 50—protection of human subjects
  • part 54—financial disclosure by clinical investigators
  • part 56—institutional review boards
  • part 312—investigational new drug application
  • part 314—application for FDA approval to market a new drug
  • part 600—biological products: general
  • part 601—licensing
  • part 610—general biological products standards
  • part 630—requirements for blood and blood components intended for transfusion or for further manufacturing use
  • part 640—additional standards for blood and blood products
  • part 660—additional standards for diagnostic substances for laboratory tests
  • part 680—additional standards for miscellaneous products
  • part 1270—human tissue intended for transplantation
  • part 1271—human cells, tissues, and cellular and tissue-based products
ICH guidelines (as included in the us code for federal regulations)
  • Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • Integrated Addendum to Good Clinical Practice
  • General Considerations for Clinical Trials