Quick Links

Step 2: Conducting a Cancer Prevention Clinical Trial

Forms & Guidelines

• NCI/DCP/PIO Instructions for Progress Reports (under development)
• Serious Adverse Events Reporting Form (for DCP IND-sponsored studies) (doc, 92kb)
• NIH Guidelines on Gender and Minority Inclusion in Clinical Trials
• OMB Classification of Federal Data on Race and Ethnicity
• FDA Certification: Financial Interest and Arrangements of Clinical Investigators, Form 3454
• FDA Disclosure: Financial Interest and Arrangements of Clinical Investigators Form 3455
• FDA Good Clinical Practice: Consolidated Guideline
• DCP Recruitment Manual Template (pdf, 90kb) (doc, 186kb)
• FDA Guidance For Handling Recruitment Strategies Of Clinical Trial Participants
• DHHS Fraud and Scientific Misconduct Policy
• DCP Policy and Guidelines for Investigational Agent Distribution (doc, 32kb)
• DCP Guidelines for Submitting Clinical Drug Requests (doc, 33kb)
• Clinical Drug Requests (DCP Version of NIH Form 986) (doc, 70kb)
• DCP Return Drug List Form (doc, 71kb)
• Policy and Guidelines for the Transfer of DCP Supplied Investigational Agents (doc, 24kb)
• DCP Transfer Investigational Agent Form (doc, 48kb)
• DCP Requirements for Data Management (doc, 58kb)
• DCP Guidelines for Submitting Study Site Inventory (doc, 32kb)
• DCP Form for Submitting Study Site Inventory (doc, 68kb)