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
