ACCOUNTABILITY AND STORAGE OF INVESTIGATIONAL DRUGS

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Detailed guidelines for the requisition and management of NCI-sponsored agents are available on the CTEP web site. You may link directly to the drug accountability instructions by linking to the NCI's Policies and Guidelines for Accountability and Storage of Investigational Drugs http://ctep.cancer.gov/requisition. The NCI Investigational Drug Accountability Record Form is located on the Helpful Related Links page in the Resources section of the CTSU Registered Member Web Site.
Maintain history of drug disposition (drug receipt, transfer, dispensing or return) shall be maintained on the NCI Investigational Agent Accountability Record Form.
Maintain an NCI Investigational Agent Accountability Record Form at each location at which a drug is stored (e.g., main pharmacy, satellite pharmacy).
Store NCI supplied investigational agents in a secure location that is accessible only to authorized personnel and appropriate to preserve the stability of the agent (i.e. controlled temperature). 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, maintain 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 study agent 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
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 following practices apply:
The transferring investigator MUST be the investigator who originally ordered the agent.
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. Do not order investigational agents 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) 480-4612.
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) 480-4612.
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:
 
Excessive inventory for a protocol
Investigational agent has short dating
Medical emergency

Blinded Study Transfer

NEVER transfer agents for blinded studies.
Transfer of agents for blinded studies between investigators MUST have PRIOR PMB approval.
Returning Agents to the NCI
Make every effort to minimize the amount of agent ordered (limit inventories to an 8-week supply or less).
Regulations require that all agents be destroyed once they have been returned to NCI. 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,number, and 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 Member Web site.
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