Protocol Templates and Guidelines

Broadening / Modernizing Eligibility Criteria

• CTEP Memo- Broadened Eligibility Criteria Initiative
• CTEP Broadened Eligibility Criteria Guidance

Suggested Templates for Phase 1 and 2 Clinical Trials

• Generic Protocol Documents and Instructions for CTEP Studies
  • Instructions for Submitting Protocol Documents to CTEP (PDF)
  • Step by Step Guide for Submitting eSubmission Ready Documents to CTEP (PDF)
  • Generic Protocol Template (MS Word) — updated February 5, 2024
  • Generic Informed Consent Template
    • NCI Informed Consent Template for CTEP Trials (MS Word) — This is a Generic NCI Template with a blank Summary of Changes cover memo for CTEP submission.
• Protocol Template for Organ Dysfunction Studies (MS Word) — updated February 5, 2024

Policies and Guidelines for Protocol Development

• NCTN Streamlined Data Standard Practices for IND-exempt Trials
• CTEP Multicenter Guidelines for Protocols NOT Conducted Through the CTSU/OPEN
• Policy on the Issuance of Waivers for Protocol Deviation(s)
• Guidelines Regarding Trials Involving Potentially Teratogenic Agents in Men and Women of Reproductive Potential
• Guidelines Regarding the Inclusion of Cancer Survivors and HIV-Positive Individuals on Clinical Trials
• Guidelines Regarding the Inclusion of Pregnant and Breast-Feeding Women on Cancer Clinical Treatment Trials
• Gender and Minority Accrual Data
• The Office of Management and Budget (OMB) Directive No. 15
• Instructions and Forms for reporting Target and/or Enrollment data
  • PHS 398 Instructions (PDF) - text pages 22-24
  • PHS 2590 Instructions (PDF) - text pages 9-10
  • PHS 398 and 2590 Forms (PDF) - Target/Planned Enrollment Report Format Page and/or Inclusion Enrollment Report Format Page
• Guidelines for Treatment Regimens: Expression and Nomenclature (09/97)
• Guidelines for Preparing Pharmaceutical Sections (01/06)