• Qualifications of the BSO are the ability to perform required functions as listed below:
    • The BSO must be available to attend initial and continuing review IBC meetings
    • The BSO must be available to answer questions including:
      • Facility concerns, for example
        • eye wash stations – checked and flushed weekly (and documented)
        • Insect/rodent control plan in place
        • hand washing facilities in each room (or hand sanitizers available)
        • information on where study drug will be administered (i.e. exam room details)
      • Site Procedures, for example
        • Biohazardous waste disposal
        • Spill procedures
        • Biohazard shipping procedures (i.e. IATA procedures)
        • Sharps Injury procedures
      • Study Drug Handling, for example

— study agent storage (locked, limited access, temperature monitoring)
— drug transfer within facility or between facilities

      • Staff Information, for example

—    study staff training or qualifications as necessary (i.e. OSHA, Blood borne pathogen training [i.e. protective clothing and equipment, Universal Precautions, Post-exposure evaluation and follow up, etc])
— Vaccinations as necessary (i.e. Hepatitis B)

    • The BSO must ensure the IBC is notified of critical events, such as
      • SAEs (the IBC provides a form)
      • Any biohazard situations (i.e., spills)
    • The BSO must ensure annual reports are provided to the IBC (the IBC will prompt the site for these reports).  The annual reports primarily consist of changes in staff or facilities and any critical events occurring during the year.

 

“The BSO will be the eyes and ears for the IBC at the site.”