An organization requesting IBC review of a new study protocol and site credentials must submit the following:

Study-Specific Materials

  • IBC Study Submission Form (available via IBC portal)
  • Clinical protocol
  • Investigator brochure
  • Informed consent (draft acceptable)
And, if available:
  • Pharmacy manual
  • Safety data sheet for investigational product
  • Any prior correspondence with the NIH RAC

Site-Specific Materials

  • IBC Authorization Form (if Advarra® will serve as the IBC of record for the site)
  • Principal investigator’s full CV with publications
  • OSHA Blood borne pathogen exposure control plan
  • Biohazardous waste/regulated medical waste disposal policy, procedures or permits
  • Standard operating procedures (SOPs) for use of the study agent or any associated supplemental documentation (if available)
  • Floorplan, diagram or pictures of the locations where the study agent will be stored, manipulated or disposed

Log in to Advarra’s IBC portal to submit your materials.

NOTE – These requirements are for human gene therapy research, Advarra IBC also reviews non-clinical studies involving genetically engineered plants or animals. For submission requirements associated with non-clinical studies contact us.

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