The Investigator's Handbook

A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI

Please note that this is the new version (Version 4) of the Investigator's Handbook. Although there are a few minor typographical errors, the content is correct. All of the Appendices are not available in this new version. Please contact Dale Shoemaker (shoemakerd@ctep.nci.nih.gov, 301-496-7912) if you have questions concerning the text of the Investigator's Handbook or require one or more of the Appendices.

Handbook in PDF   |   Appendices in PDF

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

Table of Contents Introduction  |  Appendices

Part A: Sponsors, Research Bases, and the Investigator

 1. Introduction

 2. The Sponsor

 3. The Research Base and the Investigator

Part B: The Development of a Clinical Trial

 4. Phase 1 Trials

 5. Phase 2 Trials

 6. Phase 3 Trials

Part C: The Planning and Execution of a Clinical Trial

 7. Drafting of a Protocol

 8. Protocol Review and Approval at CTEP

 9. Ordering Investigational Agents from NCI

10. Responsibility for Reporting Results to CTEP

11. Adverse Events

Part D: The Organization of a Clinical Trial

12. The Investigator and Protocol Chair: Roles and Responsibilities

13. Affiliate Investigators

14. Who May Administer Investigational Agents

15. Accountability and Storage of Investigational Agents

16. Monitoring and Quality Assurance

Part E: Nonresearch or Treatment Referral Protocol Use of Investigational Drugs

17. Group C

18. Special Exceptions

19. Treatment Referral Center (TRC)

Part F: Appendices

Guidelines

Forms

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