Investigator's Handbook A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI Table of Contents Part A 1 2 3 Part B 4 5 6 Part C 7 8 9 10 11 Part D 12 13 14 15 16 Part E 17 18 19 Appendices Part C: The Planning and Execution of a Clinical Trial 9. Ordering Investigational Agents from NCI 9.1 How to Place Agent Orders 9.2 Particular Points to Note 9.3 Routing of Agent Requests 9.4 Affiliates and Agent Orders 9.5 Requests for Nonresearch (Treatment) Use of Investigational Agents 9.6 Requests for Nonclinical (Laboratory) Use of Investigational Agents 9.7 Status of Investigational Agents Following FDA Marketing Approval 9. Ordering Investigational Agents from NCI The DCTD will provide investigational agents for use in CTEP-approved protocols as well as for Special Exception and Group C guideline requests (see Section 17 and Section 18) to registered investigators with a current FDA Form 1572, Supplemental Investigator Data Form, Financial Disclosure Form, http://ctep.cancer.gov/forms/index.html, and CV on file with PMB (see Section 12.1). Except for NCI Cooperative Groups, agents will not be sent to assistant investigators who are not named on the protocol or who have not filed a FDA Form 1572. Investigational agents supplied by DCTD will be used only for treatment of patients entered onto CTEP - approved protocols. 9.1 How to Place Agent Orders Complete the Clinical Agent Request Form NIH-986, http://ctep.cancer.gov/forms/index.html, which provides the following information: Investigator name and NCI-assigned investigator number Telephone and fax numbers of investigator and/or individual preparing form NCI-assigned protocol number NSC number, current inventory as indicated on Agent Accountability Record, agent name, strength and dose form, and quantity The investigator or designee must date and sign the agent request form. No matter who may be delegated to sign this form (e.g. the pharmacist), the investigator is responsible for the disposition of all investigational agent shipped under his or her name Only one agent may be entered on each line on the form If there is more than one protocol per agent, use a separate line for each protocol Indicate the one official shipping address to which the agent is to be sent Orders should be submitted to the Pharmaceutical Management Branch (PMB) by fax at 301-480-4612 or mailed. The mailing address is listed in Appendix IV (see section 9.4). 9.2 Particular Points to Note The clinical agent request form should be completed in full and typed. If it is not complete, the form will be returned. All clinical agent requests should use this form, including those for Special Exception and Group C use. Normal PMB processing time is two (2) working days. Orders will be shipped within two working days, based on the agent's availability and provided there are no shipping restrictions (e.g. holidays or in the case of thermolabile agents which are generally shipped Monday through Thursday, unless special arrangements are made for weekend delivery (must fax the order and call PMB to confirm receipt of the order). Generally allow one week for delivery of faxed orders. Do not order more than a 2-month supply at a time. Avoid ordering excessive quantities. CTEP will reduce the quantity shipped if the order is excessive in relation to protocol requirements, or if the inventory at CTEP is insufficient at that time. Requests for next day delivery must be received by PMB by 2:00 PM Eastern Time. Next day delivery must be stated on the order and an express courier account number must be provided. Please telephone PMB (301-496-5725) to confirm receipt of orders requesting next day delivery. 9.3 Routing of Agent Requests Investigators should submit agent requests directly to the Pharmaceutical Management Branch (See Appendix IV). Cooperative Groups: Some Cooperative Groups require that agent requests be routed through the operations office. Check with your Cooperative Group operations office to determine its policies. 9.4 Affiliates and Agent Orders Investigators at affiliated institutions or clinics of a research base should order CTEP-supplied investigational agents directly from PMB. The PMB policy of shipping investigational agents to the investigator's institution or practice site assures that all investigators receiving investigational agents are registered with PMB, simplifies agent tracking and accountability, minimizes delays in correspondence in emergencies, assures agent integrity, reduces administrative workload and eliminates secondary shipping expenses. PMB policy does allow for investigational agents to be received by a centralized pharmacy for re-distribution to local satellite institutions and affiliated investigators who are registered with PMB and have designated the "central pharmacy" as their shipping address. Such arrangements should be arranged with the PMB. The central pharmacy must ensure that all investigators receiving investigational agents have a current FDA Form 1572 on file with PMB and satellite dispensing records must be maintained. Local satellite institutions or affiliates must be serviced by couriers or the central pharmacy staff. CTEP-supplied investigational agents must not be repackaged or forwarded by mail or express courier. Institutions that are separated geographically, requiring mailing of investigational agents are not considered satellites for agent accountability purposes and should receive investigational agents directly from PMB. These sites may order directly or in some situations, the central pharmacy may fax the orders to PMB for delivery to the participating investigators. CTEP policy does not permit secondary distribution of investigational agents to other physicians or the transfer of investigational agents between institutions. CTEP intends that IND agents be distributed directly to investigators. If under exceptional circumstances emergency transfer seems justified, explicit pre-approval by the Pharmaceutical Management Branch is required. If investigators wish to incorporate the potential of having a local oncologist administer some of the treatments for late Phase 2 or Phase 3 trials, the procedures for handling such situations must be incorporated in the protocol. Investigators should contact the Pharmaceutical Management Branch for assistance in developing the procedures. In such situations, the local oncologist(s) must register with PMB, they must be covered by an appropriate IRB, and PMB will ship the agents directly to the local investigator. Finally, CTEP may approve a special distribution arrangement for certain unusual circumstances. 9.5 Requests for Nonresearch (Treatment) Use of Investigational Agents Requests for use of DCTD investigational agents under Group C or Special Exception categories must satisfy certain requirements. These considerations are detailed in Section 17 and Section 18 of this handbook. 9.6 Requests for Nonclinical (Laboratory) Use of Investigational Agents Investigational agents for non-clinical or laboratory use cannot be taken from supplies received for CTEP sponsored clinical trials. Requests for nonclinical use of investigational agents for preclinical or laboratory experiments should be directed to the Pharmaceutical Management Branch. (See Appendix IV for the address). A signed Material Transfer Agreement is required prior to sending the agent. 9.7 Status of Investigational Agents Following FDA Marketing Approval In many instances, the DCTD continues to evaluate antineoplastic agents in ongoing clinical trials after they have received FDA marketing approval, in an attempt to identify more effective therapeutic regimens. In addition, physicians who have initially registered a patient to receive an agent under a Group C, TRC, or Special Exception protocol before an agent is approved by FDA may continue to receive the agent at no cost from CTEP for the registered patient. This is not a firm policy; it depends on the cooperation of the manufacturer (sponsor) supplying the agent. Commercially-available agents supplied to investigators or physicians under an NCI protocol, including a Group C, TRC, or Special Exception protocol, are still considered investigational. Therefore, the same accountability requirements for investigational agents in place prior to the agent's approval continue to apply. Table of Contents Part A 1 2 3 Part B 4 5 7 Part C 7 8 9 10 11 Part D 12 13 14 15 16 Part E 17 18 19 Appendices

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