Investigational Product (IP) Accountability

  • register IP receipt with IXRS and log in IP accountability log.
  • store IP and supplies according to FDA guidelines and sponsor requirements.
  • dispense assigned IP according to protocol and document in subject IP accountability log and general accountability IP log.
  • where feasible, notate each dosing date on IP kits or provide subjects IP dosing logs to ensure proper dosing.
  • retrieve IP from subject and calculate compliance–document and re-educate subjects on compliance as needed.
  • document and return used and unused IP to sponsor.
  • order supplemental test articles.
  • maintain randomization and emergency codes of test article dispensing.
  • manage DEA controlled drugs appropriately.