NCI's Policies and Guidelines for Accountability and Storage of Investigational Drugs are available on the CTEP Website, http://ctep.cancer.gov/requisition/storage.html.

• Drug disposition (drug receipt, transfer, dispensing or return) shall be maintained on the NCI Investigational Agent Accountability Record Form.
• A NCI Investigational Agent Accountability Record Form should be maintained at each location at which a drug is stored (e.g., main pharmacy, satellite pharmacy).
• NCI-supplied investigational agents should be stored in a secure location that is accessible only to authorized personnel. Each agent should be stored and accounted for separately by protocol.
• If a protocol uses more than one NCI-supplied agent or more than one strength or formulation of the same agent, there shall be a separate storage area and NCI Investigational Agent Accountability Record Form for each agent, strength, and formulation.
• Dispensing entries on the Drug Accountability Record Form must include:
  • Name of study agent
  • Date and origin of receipt
  • Number of vials, ampules, tablets dispensed
  • Manufacturer and lot number from vial or package
  • Date dispensed, including the year
  • Patient identification number
  • Patient's initials
  • Dose administered
  • Initials of person recording the information
  • Date, amount, and lot number of medication returned or transferred from site
• The NCI Investigational Agent Accountability Record Form is located in the Resources section of the CTSU Registered Members Website.

Transfers

NCI-supplied investigational agents may be transferred, within an institution (intra-institutional transfer), from a completed NCI-approved protocol to another NCI-approved protocol that utilizes the same agent and formulation.

• Only NCI investigators with an active status in the PMB database may transfer NCI-supplied agents among themselves. To have an active status, an investigator must hold a PMB-assigned NCI investigator number and annually submit a FDA 1572 Form, CV, Financial Disclosure Form, and Investigator Supplemental Data Form to the PMB.
• The transferring investigator MUST be the investigator who originally ordered the agent or the investigator to whom the agent was previously transferred, i.e., "double transfer."
• The receiving investigator MUST be affiliated with the trial to which the agent is being transferred.
• Transfer of agents to non-NCI-sponsored protocols is NOT permitted under NCI and FDA policies and regulations.
• Transfer of NCI-supplied agents for commercial use is both PROHIBITED and ILLEGAL. Replacement of NCI supplied agents with commercial agents is also PROHIBITED and ILLEGAL.
• "Borrowing" of investigational agents is prohibited. Investigational agents should NOT be ordered for one protocol to replace what was "borrowed" from another protocol.
• Refer to the following link for NCI's Policies and Guidelines for the Transfer of Investigational Agents: http://ctep.cancer.gov/requisition/agents.html. The NCI Transfer Investigational Agent Form is located in the Resources section of the CTSU Registered Members Website.
• Procedure for Intra-Institutional Transfer
  • Complete an NCI Transfer Investigational Agent Form for each agent transfer.
  • Fax the Transfer Form to PMB at (301) 402-0429.
  • Submit forms within 72 hours of the actual transfer.
  • Retain a copy for your records.
• Procedure to Transfer from Active Protocol to another Active Protocol
  • PMB approval is required prior to transfer of a NCI supplied investigational agent from an active protocol to another active protocol.
  • Complete an NCI Transfer Investigational Agent Form for each agent.
  • Fax the Transfer to PMB at (301) 402-0429.
  • If a transfer is required during the weekend or holidays, PMB should be notified on the next working day.
  • Restrict these transfers to the following situations:
    • Excessive inventory for a protocol
    • Investigational agent has short dating
    • Medical emergency
• Blinded Study Transfer
  • Agents for blinded studies should NEVER be transferred between protocols.
  • Agents for blinded studies may be transferred between investigators with PRIOR PMB approval.

Returning Agents to the NCI

• Investigators/designees should make every effort to minimize the amount of agent ordered (limit inventories to an 8-week supply or less).
• Regulations require that all agents returned to NCI be destroyed. Agents may not be reused.
• Return only NCI-supplied agents to the NCI. Do NOT ship drugs from other sources to the NCI.
• Return unused NCI-supplied investigational agent(s) to the NCI when:
  • The agent is no longer required because the study is completed or discontinued and the agent cannot be transferred to another NCI-sponsored protocol.
  • The agent is outdated.
  • The agent is damaged or unfit for use.
• Do NOT return opened or partially used vials or bottles to NCI.
• Procedure for Returning an Investigational Agent
  • Complete the Return Drug List. All information must be accurate and complete, (e.g., protocol number, investigator name and number, address).
  • Follow all instructions on the Return Drug List.
  • Double check quantities and lot numbers prior to shipment.
  • Enclose Return Drug List with the returned agents. Keep a copy for your records. Do NOT include any drug accountability records with the Return Drug List.
  • Package the drugs carefully (double bag) to avoid breakage.
  • Ship drugs at room temperature. Blue/dry ice is not required for returns.
  • Send drug returns to the address indicated on the Return Drug List. Express delivery is NOT necessary.
  • C.O.D. or "Collect" shipments will NOT be accepted. The investigator/designee is responsible for the shipping costs.
  • Complete the return receipt section of the Return Drug List to obtain a receipt that documents the amount of drug returned.
• Refer to the following link for NCI's Policies and Guidelines for Investigational Agent Returns: http://ctep.cancer.gov/requisition/guidelines.html. The NCI Return Drug List is located in the Resources section of the CTSU Registered Members Website.