Investigator's Handbook A Manual for Participants in Clinical Trials of Investigational Agents 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

Appendix XIV.

Policy for Group C Distribution

See also (internal link): http://ctep.cancer.gov/requisition/compassion.html

Policy for Group C Drug Distribution
Group C agents are investigational agents provided by the National Cancer Institute to properly trained physicians for the treatment of individual patients who meet the eligibility criteria. Agents within this category have been approved by the Food and Drug Administration for the treatment of the specific cancer identified in the guideline protocol.

Group C drugs are provided for the treatment of patients as indicated below:

Drug	Approved Group C Use
Azacytidine*	Refractory Acute Myelogenous Leukemia (AML) Single agent use only.

Original Agent request:
Physicians may obtain any agent listed by telephoning the Clinical Research Pharmacy Section, http://ctep.cancer.gov/about/pmb.html, of the Pharmaceutical Management Branch. The telephone number is (301) 496-5725. (Monday - Friday 9 - 4:30pm EST)

Agent Reorders:
Additional agent may be requested by completing a Clinical Drug Request Form and sending it by fax to 301-480-4612. You may only reorder agent for a patient previously registered on this protocol. The patient's first name and initial of last name must be indicated on the Clinical Drug Request Form. A blank request form is enclosed in each agent shipment for use with reorders. Telephone orders will not be accepted.

* The FDA has granted a waiver from local IRB Approval. However, you should check with your IRB to determine whether its local policy requires approval.

National Cancer Institute Procedures for Management of Investigational Agents Acquired for Treatment / Group C Protocol Use in Individual Patients

1. Investigator Registration:
   A physician must be registered with the National Cancer Institute as an investigator by having completed a "Statement of Investigator" FDA Form 1572, Supplemental Investigator Data Form (SIDF), Financial Disclosure Form (FDF), and a CV. Forms are available at: http://ctep.cancer.gov/forms/index.html. If you are NOT currently registered, a Form 1572, SIDF, and FDF are enclosed, with the understanding you will complete and return these registration forms within 10 working days of their receipt.
2. Informed Consent:
   Written informed consent must be obtained from all patients treated with Group C agents and kept on file by the physician. For your convenience, a model informed consent document is included in the enclosed protocol.
3. Institutional Review Board Approval:
   NCI has obtained an exemption from FDA eliminating the requirement for IRB approval. However, you should check with your IRB to determine whether its local policy requires approval.
4. Treatment Reports:
   You may be required to provide patient reports if specified in the enclosed protocol. If required, patient specific forms would be sent to you separately and samples of these forms would be included in the protocol. Complete and return these reports to the EMMES Corp.: Clinical Trials Support Unit, EMMES Corp., 11325 Seven Locks Rd., Suite 214, Potomac, MD 20854.
5. Group C Protocol Adverse Event Reporting Requirements:
   Reporting of adverse events is required for all NCI Special Exception and Group C protocols. The following is a summary of the procedures. For more detailed instructions, computer based training, and the tools used below please see the CTEP home page at http://ctep.cancer.gov/, (click on Reporting Guidelines) or call 301-230-2330.

   All reports should be mailed to:
   Investigational Drug Branch, P.O. Box 30012, Bethesda, Maryland 20824

   Definitions
   Adverse Event Expedited Reporting System (AdEERS) – An electronic system for expedited submission of adverse event reports.
   Adverse Event - Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medical treatment or procedure regardless of whether it is considered related to the medical treatment or procedure.
   Attribution – The determination of whether an adverse event is related to a medical treatment or procedure. Attribution categories include Definite, Probable, Possible, Unlikely and Unrelated.
   When reporting in AdEERS use the patient’s first name and last initial for the patient ID in the patient information section.

   Procedure

   • Identify the event using the Common Toxicity Criteria version 2.0 (CTC V2.0).
   • Determine the grade or severity of the event by using the CTC criteria. The severity is graded between 1 – 5
   • Determine Attribution of the event (definite, probable, possible, unlikely or unrelated).
   • Determine how the event should be reported by the chart below*:

   Unexpected Event		Expected Event
   Grades 2 – 3 Attribution of Possible, Probable or Definite	Grades 4 and 5 Regardless of Attribution	Grades 1 – 3	Grades 4 and 5 Regardless of Attribution
   Expedited report using AdEERS within 10 working days. (Grade 1 Routine Reporting on treatment summary report).	Report by phone to IDB within 24 hrs. Expedited report using AdEERS to follow within 10 working days. This includes all deaths within 30 days of the last dose of treatment with an investigational agent regardless of attribution. Any late death attributed to the agent (possible, probably or definite) should be reported with 10 working days.	Routine reporting on the treatment summary report. Expedited reporting not required.	Expedited report, including Grade 5 Aplasia in leukemia patients, within 10 working days. This includes all deaths within 30 days of the last dose of treatment with an investigational agent regardless of attribution. Any late death attributes to the agent (possible, probably or definite) should be reported within 10 working days. Grade 4 Myelosuppression not to be reported, but should be submitted as part of the treatment summary report.

   • *For Hospitalization only - Any medical event equivalent to CTC Grade 3, 4, 5 which precipitated hospitalization (or prolongation of existing hospitalization) must be reported regardless of expected or unexpected and attribution.
   • Telephone reports to the Investigational Drug Branch at 301-230-2330 available 24 hours daily (recorder between 5 pm and 9 am EST).
   • Expedited reports are to be submitted using AdEERS or the paper templates available at http://ctep.cancer.gov/. The NCI Guidelines for expedited adverse event reporting are also available at this site. If paper templates are used, they should be mailed to Investigational Drug Branch (IDB), PO Box 30012, Bethesda, MD 20824 or by fax to 301-230-0159.
   • A list of agent specific expected adverse events will be included in the agent shipment.
6. Investigational Agent Accountability:
   NCI Investigational Drug Accountability Records must be maintained for Group C agents and kept on file by the physician
7. Quality Assurance:
   Records to confirm that the patient has been treated according to the Group C protocol must be maintained by the physician. NCI or FDA may have access to these records upon request.
8. Failure to comply with any of the above procedures may result in suspension of investigator status and prevent further agent shipments.
9. Agent Reorders:
   Additional agent may be requested by completing a Clinical Drug Request Form. You may only order more agent for the patient specifically named on this protocol. The patient's first name and initial of last name should be indicated on the Clinical Drug. Request. A blank request form is enclosed in each agent shipment. Telephone orders will not be accepted.

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