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Protocol Development
CTEP Home
CTEP Branches
and Offices
Office of the
Associate Director
Clinical Grants and Contracts Branch
Clinical Investigations Branch
Clinical Trials Monitoring Branch
Investigational
Drug Branch
Pharmaceutical Management Branch
Operations and Informatics Branch
Regulatory Affairs Branch
Administrative Resource Center
Last Updated:
12/28/12
Protocol Templates and Guidelines
Suggested Templates for Phase 1 and 2 Clinical Trials
Generic Protocol Documents and Instructions for CTEP Studies
Instructions for Submitting Protocol Documents to CTEP
(MS Word)
Generic Protocol Template
(MS Word)
Generic Informed Consent Template
(MS Word)
Phase 1 Organ Dysfunction - Renal Template Version 4.0 (August 2011)
(MS Word)
Phase 1 Organ Dysfunction - Hepatic Template Version 4.0 (August 2011)
(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