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 Updated 1/8/2002

• NCI - Cooperative Group - Industry Relationship Guidelines
  
  
• Special Article : Commentary Concerning Demonstration of Safety and Efficacy of Investigational Anticancer Agents in Clinical Trials
  
  
• Policy Statement: The Conduct of Phase 1 Trials in Children
  
  
• Key Contact Addresses and Telephone Numbers
  
  
• Instructions for Completing Statement of Investigator (FDA 1572 Form), Supplemental Investigator Data Form, and Financial Disclosure Form
  
  
• Guidelines for Submitting Letter of Intent and Completing Letter of Intent Forms
  
  
• Informed Consent Checklist
  
  
• Protocol Submission Worksheet
  
  
• CTEP Glossary
  
  
• Clinical Drug Request (NIH - 986)
  
  
• Adverse Event Expedited Reporting System (AdEERS)
  
  
• NCI Investigational Drug Accountability Record Form
  
  
• National Study Commission on Cytotoxic Exposure: Recommendations for handling Cytotoxic Agents
  
  
• Policy for Group C Drug Distribution
  
  
• National Cancer Institute Procedure of Investigational Drugs Acquired for Compassionate (Special Exception ) Treatment of Individual Patients
  
  
• Guidelines for Treatment Regimens EXPRESSION AND NOMENCLATURE
  
  
• Status of the NCI Preclinical Antitumor Agent Discovery Screen, Principles and Practice of Oncology Updates
  
  
  
  

  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

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