CTEP Branches and Offices
Last Updated: 08/22/24
Protocol Templates and Guidelines
Broadening / Modernizing Eligibility Criteria
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 August 22, 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 August 22, 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)