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Investigational Product (IP) Management SOP Considerations

There are several variances on study drug handling that must be reviewed before writing this procedure. These are some topics to consider:

  • Provide all study-specific documents to sponsor or sponsor representative that required for IP to be released to site.
  • Confirm the quantity and condition of the initial receipt of IP on site.
  • File the signed and dated receipt of acknowledgement in the investigator site file.
  • Store the IP appropriately as required by the protocol and/or investigational brochure (IB).
  • Site designee should complete IP logs to document the IP kits received in shipment.
  • The above procedures should be followed for all additional shipments of IP.
  • IP will be administered or dispensed as required by the protocol.
  • Subject IP dispensing, return, and handling will be documented in the source documentation and accountability logs as required per protocol.
  • Temperature of IP storage will be monitored and documented daily excluding weekends and when the site is closed for holidays.
  • Temperature excursion should be fixed in accordance with IP guides, IP put on quarantine until authorization from customer about future utilization. The site must have a procedure for temperature deviations. In case of refrigerate IP for example, refrigerator alarm in case of power failure, power generator and back up refrigerator.
  • The site pharmacy must have a process to follow IP excursions, and establish a communication with the Sponsor/ CRO when these excursions happen, for making sure the integrity of the IP is kept.
  • The site should have also a process on how to decrease the risk of having temperature excursions, such as alarms in the equipment, back up refrigerator and power generator.
  • The destruction of IP will be completed as required by the protocol or as directed by the sponsor or sponsor representative.
  • Also handling of IP at site by blinded and un-blinded staff as applicable.