Appendix M of the NIH Guidelines
Reporting Requirements and Best Practices

A WCG | CenterWatch FREE Webinar
Tuesday, June 5, 2018 · 1:30 p.m. - 2:30 p.m. EDT

Biomedical research lives on the cutting edge of knowledge, but biomedical researchers live in the here-and-now. Like everyone, they must play by the rules.

That means understanding the rules … which are pretty complicated.

Take Guidelines Appendix M, extensively revised a year ago. Appendix M-I-A requires registration of protocols with the Office of Science Policy, and Appendix M-I-C requires scheduled and incidental progress and safety. Principal Investigators are responsible for making sure reporting requirements are fulfilled but may delegate some reporting.

Got that? Well then …

Mark your calendar for Tuesday, June 5, when WCG/CenterWatch and FDAnews present a FREE sponsored webinar with a leading biomedical researcher. Daniel Kavanagh Ph.D. is Senior Director-Biosafety and Gene Therapy at WCG Biosafety, a division of the WIRB-Copernicus Group, with dozens of publications and honors to his record.

Over the course of an intense hour, Dr. Kavanagh will walk you through:

  • Requirements of required reporting: Timing and content, including format, timing, and options for delegation
  • OSP registration process: What it is, how it works
  • Appendix M-I-C: What it requires of you
  • The Vaccine Exemption and other HGT protocols that are exempt from reporting
  • PI delegation
  • FDA-approved products
  • Compassionate use
  • And much more!

The NIH is the go-to agency for biomedical research. Understanding its processes means speedier grants, fewer project delays and, ultimately, getting to market first. Sharpen your competitive edge. Sign up now for this FREE webinar.

Who Will Benefit

  • Principal investigators
  • Clinical directors
  • Clinical researchers
  • Study coordinators
  • Medical directors
  • CROs
  • Regulatory affairs
  • Compliance affairs

Sign Up for FREE Below

Meet Your Presenter


Daniel Kavanagh, Ph.D.

Senior Director-Biosafety and Gene Therapy
WCG Biosafety, a division of the WIRB-Copernicus Group

Daniel Kavanagh Ph.D. is Senior Director-Biosafety and Gene Therapy at WCG Biosafety, a division of the WIRB-Copernicus Group. Prior to joining WCG he was Assistant Professor of Medicine at Harvard Medical School, Assistant Immunologist at the Massachusetts General Hospital, and a Principal Investigator studying infectious diseases at the Ragon Institute of MGH, MIT, and Harvard. Research interests focus on factors that modulate the T cell response to infectious diseases and tumors, including antigen processing, TCR signaling, costimulation, and checkpoint signaling integration. He has coauthored 37 peer-reviewed publications, with primary authorship in high-impact journals such as Nature Immunology, Blood, The Journal of Experimental Medicine, and the Journal of Immunology.