Code of Federal Regulations and Guidances re: Clinical Research

Federal Regulations and Guidances by FDA and DHHS Office of Human Protections

Emergency and Compassionate Use Applications   
In this slide presentation, the FDA provides a succinct summary of what is required for FDA approval of emergency and compassionate use of devices, drugs and biologics on part of 1) the PI, 2) the sponsor, and 3) the IRB.

IRB Responsibilities for Reviewing the Qualifications of Investigators  
Guidance for IRBs, Clinical Investigators and Sponsors
Released in November, 2012, this draft proposes additional IRB Responsibilities for reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an IND/IDE is needed

FDA Frequently Asked Questions re: Clinical Research  
I. IRB Organization   II. IRB Membership    III. IRB Procedures   IV. IRB Records   V. Informed Consent Process  VI. Informed Consent Document Content   VII. Clinical Investigations  VIII. General Questions

Proposed Changes to IRB Function & Structure (Common Rule)   
The table summarized the proposed changes.

Editorial Comment on the Proposed Rules to Streamline Clinical Research in the U.S.  
Ezekiel J. Emanuel, M.D., Ph.D., and Jerry Menikoff, M.D., J.D.  /  NEJM  /  365;12:1148-50, September 22, 2011
The NIH Bioethics Chief and the DHHS Office of Human Research Protections Director review the ANPRM on clinical research and support passage of most of the proposals.

Now is the Time to Comment on Proposed Rules to Streamline Human Protections  
The official Advanced Notice of Proposed Rulemaking (ANPRM) on improving the efficiencies of clinical fesearch is now available for public comment.  The proposed rules include eliminating IRB review of certain types of minimally risky research, streamlining informed consent forms, and increased utilization of CIRBs.  Please read and offer your comments, if not online at least to your IRB.

New FDA Reg re: ADR Reporting by PIs and Sponsors  
Since March 28, 2011, all PIs are now required to report all SAEs, regardless of attribution or causality, to the sponsor, who is required to report those with a reasonable possibility that the agent/drug caused it within 7 days if a death or 15 days if not.
Sherman RB, Woodcock J, Norden J, Grandinetti C, Temple RJ / N Engl J Med / 365(1):3-5;2011

21CFR50 FDA Human Subject Protection Regulations   
Federal regulations affecting general requirements for protection of human subjects

21CFR56 FDA IRB Regulations   
Federal regulations affecting general requirements for Institutional Review Boards

45CFR46 DHHS Office of Human Research Protections  
Federal regulations affecting specific requirements for protection of human subjects

FDA Form 1572 Statement of Investigator  
Investigator Statement required annually by Principle Investigator, Sub-Investigators, and Clinical Research Associates for studies involving investigational drugs and biologics.

Common Toxicity Criteria and Adverse Event Grading  
This is the CTCAE v4.03 spreadsheet version.  A 5"x7" pocket-sized version, as well as the standard 8.5x11" version, are available at

Off Label & Investigational Use  
Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet

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