An organization requesting IBC review of a new study protocol and site credentials must submit the following:
- IBC Study Submission Form (available via IBC portal)
- Clinical protocol
- Investigator brochure
- Informed consent (draft acceptable)
- Scientific abstract
- Non-technical abstract
And, if available:
- Pharmacy manual
- Safety data sheet for investigational product
- Any prior correspondence with the NIH RAC
Note: Documents must address the requirements set forth in Appendix M of NIH Guidelines Requirements for Protocol Submission.
- IBC Authorization Form (if Advarra® will serve as the IBC of record for the site)
- Principal investigator’s full CV with publications
- 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
Ready for Solutions That Are Altogether Better?
Tell us what you’d like Advarra to do for your research program.