Resources

Quick Links to GCP

Buy this tool. Created by P. Kasper & Associates for clinical research professionals to link electronically to worldwide GCP regulations. [380KB pdf]
Price: $29.95

Site Visit Follow-up Resources

Managing Site Follow-up
Corrective and Preventive Action Form (can be edited in Word)
Quality Monitoring Checklist Form (can be edited in Word)

US Resources

Agency for Healthcare Research and Quality
Library of Congress
National Institutes of Health
Clinical Trials
US Department of Health and Human Services
US Food and Drug Administration
US Food and Drug Administration Approved Drug Products
US Food and Drug Administration Code of Federal Regulations
US Food and Drug Administration News

International Resources

CANADA

Health Canada

EUROPE

European Union National Regulatory Authorities
European Agency for the Evaluation of Medicinal Products
United Kingdom Medical Devices Agency
United Kingdom Medicines and Healthcare products Regulatory Agency

Professional Societies and Associations

Association of Clinical Research Professionals (ACRP)
American Society for Quality
Biospace
Drug Information Association
Regulatory Affairs Professionals (RAPS)
Society of Clinical Research Associates (SoCRA)

	"Patty is such a knowledgeable and experienced clinical research professional and consultant. I always look forward to meeting with her as I can always get the guidance I need from her. She is definitely one of the best mentors any one could wish to have." – Shirley Feng, student