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Oklahoma State University
University Research Compliance

A unit in the Division of the Vice President for Research

Biosafety - Records

Records

The Responsible Official (RO) and Alternate Responsible Officials (ARO) must maintain records relating to select agent activities as defined in 42 CFR 73.15. The investigator has responsibility for ensuring that all data and records defined by the regulations are current and accessible. The CDC has approved the method used by OSU for ensuring compliant record keeping procedures. The Office of University Research Compliance coordinates record keeping. Investigators are required to maintain the following records:

Inventory to include:

  • Name and characteristics
  • Quantity acquired, source, and date of acquisition
  • Quantity, volume, or mass destroyed or otherwise disposed of and the date of each such action
  • Where the agents are stored (building, room, and freezer)
  • When the agents are moved from storage and by whom, as well as when the agents are returned to storage and by whom
  • Which select agent is used and the purpose of its use
  • Quantity transferred, the date of transfer, and individual to whom it was transfers (this includes intra-institutional transfers)
  • Any select agent or toxin lost, stolen, or otherwise unaccounted for and written explanation of any discrepancies

Access Records to include:

  • Names of individuals who have accessed the area where select agents are stored or used (name of the escort if applicable)
  • Date and time individual entered the area

Lab Specific Documentation to include:

  • Biosafety Plan
  • Biosecurity Plan
  • Incidence Response Plan
  • Training records