Investigator’s Handbook

A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI. The 2014 version 1.2 of the Investigator’s Handbook is a bookmarked PDF file available for download.

• Investigator's Handbook (PDF)
  Note: Section: 14.2, "Writing Patient-specific Orders", of the Investigator Handbook (2014 version 1.2) has been updated as of September 7, 2021. The revision is that patient orders for study agents, including investigational agents (INDs) and standard of care agents, may be written by qualified Advanced Practice Providers (APPs) without a physician cosignature. Review documents below for complete information on this policy change.
• Memorandum on Study Agent Ordering and Advanced Practice Providers (PDF Sept. 7, 2021)
• Updated Policy on Advanced Practice Providers and Study Agent Orders (PDF Sept. 7, 2021)
  • Brief slide set on Advanced Practice Providers updated policy (PDF Sept. 7, 2021)
• Guideline for Shipping Oral IND Agents to Clinical Trial Subjects (PDF) (01-JAN-2022)