|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 http://evs.nci.nih.gov/ftp1/CTCAE/About.html.
|Off Label & Investigational Use |
Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet