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PROTOCOL INFORMATION OFFICE

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Resources for Investigators

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• Clinical Trials Resource Website
• The Belmont Report
• Certificates of Confidentiality
• FDA Investigational New Drug (IND) Requirements
• Good Clinical Practice (GCP) in FDA-Regulated Clinical Trials
• Investigator Form 1572
• IRB Registration and Assurance Filing
• Model Informed Consent for Storage & Use of Human Tissues
• Research on Human Specimans
• Legal and Ethical Issues
• National Bioethics Advisory Commission publications
• NCI Common Toxicity Criteria Version 2
• NCI Booklet: "Taking Part in Clinical Trials: Cancer Prevention Studies; What Participants Need to Know"
• NCI Informed Consent Recommendations and Template
• NCI Research Resources
• NIH Data and Safety Monitoring Requirements
• NIH Policy on Inclusion of Women and Children in Clinical Trials
• Required Education in the Protection of Human Research Partipants

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