Protocol Templates and Guidelines

Suggested Templates for Phase 1 and 2 Clinical Trials

• Phase 1 Single Agent Template Version 4.0 (MS Word)
• Phase 1 Combination Template Version 4.0 (MS Word)
• Phase 1 Organ Dysfunction - Renal Template Version 3.0 (MS Word)
• Phase 1 Organ Dysfunction - Hepatic Template Version 3.0 (MS Word)
• Phase 2 Single Agent Template Version 4.0 (MS Word)
• Phase 2 Combination Template Version 4.0 (MS Word)
• AE Template Phase 1 Single Agent Version 1.1 (MS Word)
• AE Template Phase 1 Combination Version 1.1 (MS Word)
• AE Template Phase 2 Single Agent Version 1.1 (MS Word)
• AE Template Phase 2 Combination Version 1.1 (MS Word)

Policies and Guidelines for Protocol Development

• 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)
• Guidelines for Correlative Studies in Clinical Trials