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Materials Required for Submitting a Study

An organization requesting institutional biosafety committee (IBC) review of a new study protocol and site credentials must meet submission requirements.

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

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 Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)

Site-Specific Materials

  • IBC authorization form (if Advarra will serve as the site’s IBC of record)
  • 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 (template provided by Advarra)
  • 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. 

When Is IBC Review Required?

Is Your Site Ready to Conduct Gene Therapy and mRNA-Engineered Vaccine Research?