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 OBJECTIVE 3: STUDY AGENTS

Agents for CTSU clinical trials may be provided by:

The Pharmaceutical Management Branch (PMB) of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute
A pharmaceutical company
The Cooperative Group sponsoring the protocol
The standard process (if commercially available, agent is ordered by the site through a third party)
This section reviews:
Investigational New Drug Requirements
Accountability of Study Drug Supply

Module Objectives
1
 Identify specific regulatory documentation, medical records, and laboratory certification that must be maintained according to Federal regulations and Good Clinical Practice
2
 Describe the procedure for submission of data to the CTSU
3
 Implement the procedures to acquire study agents specific for a protocol on the CTSU menu
4
 Demonstrate the procedure for reporting adverse events for patients enrolled through the CTSU
5
 Summarize radiation therapy guidelines that will need to be initiated at the study site prior to enrolling patients on CTSU protocols where radiation therapy is a treatment intervention
6
 Describe the rationale and process for auditing data obtained for patients enrolled on a CTSU protocol
7
 Explain CTSU Quality Assurance
Investigational New Drug Requirements

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Click for NCI's Policies and Procedures for the Requisition of Investigational Agents

Investigational New Drugs (INDs) for NCI's Division of Cancer Treatment and Diagnosis (DCTD) sponsored clinical trials, including trials on the CTSU menu, are usually distributed by the PMB/CTEP/NCI. In some cases the pharmaceutical company may take responsibility for distributing the investigational agent. Commercially supplied agents are never substituted for investigational agents provided for the study, even when the investigational agents are commercially available. Occasionally agents that are commercially available may also be distributed by PMB.

Refer to NCI's Policies and Procedures for the requisition of agents. The Drug Procurement and Tracking forms are available on the Helpful Related Links page in the Resources section of the CTSU Registered Member Web site.

The Food and Drug Administration regulations and Federal law require documentation of receipt, use, and disposition of all investigational agents. The NCI, as the sponsor of an Investigational New Drug trial, must assure the FDA that procedures for drug accountability are enforced.

Accountability of Study Drug Supply

An investigator may delegate responsibility for drug ordering, storage, accountability, and preparation to his/her designee. According to the FDA guidelines, the investigator is ultimately responsible for all agents shipped in his/her name. The intent of drug accountability is to assure that NCI-supplied agents are only used for patients enrolled on an approved NCI trial.

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