Research Resources

UPMC Links

• Laboratory Certificates of Accreditation 
• UPMC Investigational Drug Services 
• UPMC Hillman Cancer Center Investigational Drug Services  
• UPMC Staff: access information about the Office of Sponsored Programs and Research Support (OSPARS) through the UPMC Infonet
  OSPARS contact information: (412) 647-4461 or Email OSPARS@upmc.edu.

Food and Drug Administration (FDA) Regulations

Code of Federal Regulations Title 21

• Title 21 CFR 11: Electronic records; electronic signature 
• Title 21 CFR 54: Financial disclosure by clinical investigators
• Title 21 CFR 50: Protection of human subjects—informed consent
• Title 21 CFR 56: Institutional review boards
• Title 21 CFR 312: Investigational new drugs
• Title 21 CFR 314: FDA approval to market a new drug
• Title 21 CFR 600: Biological products
• Title 21 CFR 601: Licensing
• Title 21 CFR 812: Investigational devices
• Title 21 CFR 814: Pre-market approvals (PMAs) of medical devices

Ethics Documents

• Belmont Report
• Declaration of Helsinki
• Nuremberg Code 

Guidance Documents

• Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance 
• The International Conference of Harmonization—Good Clinical Practices 
• FDA Guidance Documents

Professional Organizations

• Association of Clinical Research Professionals (ACRP)
• Secretary’s Advisory Committee on Human Subject Research Protections (SACHRP)
• Public Responsibility in Medicine and Research (PRIM&R)
• Society of Clinical Research Associates (SoCRA) 
• National Council of University Research Administrators (NCURA)
• American Society of Law, Medicine & Ethics (ASLME) 
• Drug Information Association (DIA)