Informed Consent

A major revision of the NCI Informed Consent Document (ICD) Template was released October 10, 2017. Updates were made on November 27, 2018. This version should be used for trials that have a first IRB approval on or after January 1, 2019. See the cover letters for more details. Comments and suggestions for future revisions should be directed to: NCICTEPComments@mail.nih.gov.

• NCI Informed Consent Template – version 11/27/2018 (MS Word)
  • Change memo form for submitting informed consent documents to CTEP (MS Word)
• Cover Letter from Dr. Jeff Abrams for October 10, 2017 ICD Template Revisions (PDF)
• Cover Letter from Dr. Jeff Abrams for November 27, 2018 ICD Template Revisions (PDF)
• Slides: Overview of NCI ICD Template 2017 Revisions (PDF)
• Resource: Additional ICD Template Schema Samples (MS Word)
• Resource: Using Readability Tools (PDF)
• Resource: Recommendations about Attachments to the ICD (PDF)
• Policy: Informed Consent Form Posting for CTEP-Supported Trials (PDF)

• Tables of Possible Side Effects

  Note: The Tables of Possible Side Effects provided below are designed so they may be cut-and-pasted into the “What possible risks can I expect from taking part in this study?” section of the NCI Consent Form Template.

  • Tables of Possible Side Effects for Commonly-Used Oncology Drugs
  • Tables of Possible Side Effects for Commonly-Used Oncology Regimens
  • Note: Tables of Possible Side Effects for CTEP IND agents will be made available directly to investigators by CTEP.
• Instructions for building Tables of Possible Side Effects:
  • Instructions for building Tables of Possible Side Effects for commercial agents (MS Word)
    • NCI Risk Term Library (MS Excel)
  • Instructions for building Tables of Possible Side Effects for investigational agents (MS Word)
    • NCI Scientific Term CTCAE - IC Term Spreadsheet (MS Excel)