Research Administration

Human Subject Research (IRB):
Good Clinical Practice

What is Good Clinical Practice, GCP? GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.  Compliance with GCP assures that the rights, safety, and wellbeing of trial subject are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trail data are credible.

Statement from DHHS: The Good Clinical Practice Guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.

GCP Links

• DHHS GCP Guidance Document:
  http://www.fda.gov/cder/guidance/959fnl.pdf
  
  
• FDA Regulations relating to CGP and Clinical Trials
  http://www.fda.gov/oc/gcp/regulations.html
  
  
• Canada - Good Clinical Practice Guideline
  http://www.ncehr-cnerh.org/
  
  
• World Health Organization GCP Booklet for Investigators
  http://www.who.int/tdr/publications/publications/pdf/investigator.pdf
  
  
• Section 8 of the Good Clinical Practice Consolidated Guidance, Essential Documents for the Conduct of Clinical Trials, deals with the record management of a clinical trial. 
  
• Commonly asked questions about GCP

GCP Tools

• Sample Drug/Device Inventory Control Sheet

Have a question about GCP? Send it to DTemple@lifespan.org. 

We will answer your question via email.

Back