2003 Step 1: Developing a Cancer Prevention Clinical Trial

Forms & Guidelines

• General
• Protocol Submission
• Agreements
• Human Subjects Protection
• Gender and Minority Inclusion
• Informed Consent
• Developing Case Report Forms

General

• Guidelines for Consortia Lead Organization to add Participating to Consortium (doc, 63kb)
• NCI Request for Proposals, Current
• DCP Letter of Intent Submission Form (doc, 85kb)
• FDA Investigator Registration and Supplemental Form for Investigator Registration Financial Disclosure, Form 1572 (please choose the CDER form option)
• FDA Investigational New Drug Application, Form 1571 (please choose the CDER form option)

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Protocol Submission

• DCP Consortia Protocol Template (doc, 298kb)
• DCP Consortia Additional Study Related Documents Template v1.4 (doc, 142kb)
• DCP Consortia Protocol Worksheet (PIO) (pdf, 34kb) (doc, 130kb)
• FDA IND Application Requirements
• FDA Good Clinical Practices
• FDA Form 1572 (pdf)
• DCP Chemoprevention Case Report Forms: Instructions and Templates (pdf, 103kb) (wpd, 348kb)
• DCP Pharmacokinetic and Biomarker Methods Development (pdf, 18kb)
• National Institutes of Health, Guide for Grants and Contracts

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Agreements

• Clinical Trials Agreement
• Model Confidential Disclosure Agreements
• Cooperative Research and Development Agreement (CRADA): Research Plan Financial and Staffing Contribution of the Parties Exception or Modifications to the CRADA

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Human Subjects Protection

• NIH Protecting Human Research Participants
• DHHS/NIH Human Participant Protections Tutorial for Institutions
• DHHS/NIH Human Participant Protections Tutorial for Researchers
• DHHS/NIH IRB Registration and Assurance Filing
• NIH Policy on Required Education in the Protection of Human Research Participants
• DHHS Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)
• NIH OHRP Informed Consent
• NCI Informed Consent Guidelines

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Gender and Minority Inclusion

• Gender and Minority Inclusion in Statistical Design
• NIH Policy on Inclusion of Women and Minorities in a Research Population

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Informed Consent

• NCI Certificates of Confidentiality Template
• NCI Recommendations on Informed Consent
• NIH Q&A on Consent for Human Tissues Research on Human Specimens
• Legal and Ethical Issues Related to Use of Human Specimens in Research
• Model Consent Form for Use of Tissue For Research (pdf, 11k)
• NCI Informed Consent Guidelines

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Developing Case Report Forms

• Case Report Forms (CRFs) (doc 842 kb) and CRF Instructions (doc, 492kb)
• DCP Serious Adverse Events Reporting Form (for DCP IND-sponsored studies) (doc, 96kb)
• Serious Adverse Event Form Instructions for Completion (doc, 135kb)

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