Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

The DMID Good Clinical Practice (GCP) Resource Guide contains selected regulations and guidelines for GCP. GCP standards are well-established practices for the appropriate conduct of clinical trials. The documents in this guide are among the most important GCP regulations and guidelines but are not all inclusive and may be subject to change.

Good Clinical Practice Resource Guide (PDF)

• Section I: Human Subjects Protection (PDF)
  
  
• Section II: Informed Consent (PDF)
  
  
• Section III: Subject Recruitment (PDF)
  
  
• Section IV: Research on Human Specimens: Are You Conducting Research Using Human Subjects? (PDF)
  
  
• Section V: Investigational New Drug Application (PDF)
  
  
• Section VI: International Conference on Harmonisation of Technnical Requirements for Registration of Pharmaceuticals for Human Use - ICH Harmonised Tripartite Guideline for Good Clinical Practice (PDF)
  
  
• Section VII: Investigational Devices: Title 21 - Food and Drugs, Department of Health and Human Services - Part 812 - Investigational Device Exemptions (PDF)
  
  
• Section VIII: Useful Internet Sites (PDF)