Materials Required for Submitting a Study to the IBC

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

Materials Required for Submitting a Study to the IBC

The following requirements are for human gene therapy research. Advarra’s IBC also reviews non-clinical studies involving genetically engineered plants or animals. For non-clinical study submission requirements, contact us.

Submission Materials Required for New IBC Submission

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