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)
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
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