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
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)