Instructions, Templates and Forms
Consortia
- DCP Letter of Intent Submission Form v7.0 (doc, 87kb)
- DCP Consortia Protocol Worksheet (pdf, 114kb) (doc, 153kb)
- DCP Consortia Protocol Template (doc, 294kb)
- DCP Informed Consent Template for Chemoprevention Trials (doc, 150kb)
- DCP Consortia Additional Study Related Documents Template (doc, 142kb)
- Recruitment, Retention and Adherence Plan Template (doc, 68kb)
- Pharmacokinetic and Biomarker Method Development Report
- Case Report Forms (CRFs) and Attachments
- Data Management Plan (DMP) (doc, 79.5kb)
- Multi-Institutional Monitoring Plan (MIMP) (doc, 84kb)
- Data and Safety Monitoring Plan (DSMP)
- DCP Serious Adverse Events Reporting Form (for DCP IND-sponsored studies) (doc, 92kb)
- DCP Policy and Guidelines for Investigational Agent Distribution (doc, 32kb)
- DCP Guidelines for Submitting Clinical Drug Requests (doc, 33kb)
- DCP Return Agent Form (pdf, 116kb)
- DCP Guidelines for Submitting Study Site Inventory (doc, 32kb)
- DCP Form for Submitting Study Site Inventory (doc, 68kb)
- DCP Guidelines for Agent Returns (doc, 32kb)
- DCP Pharmacy Audit Report (pdf, 21kb)
- FDA Form 1572 (Statement of Investigator) (pdf, 266kb) (doc, 50kb)
- FDA Form 1571 (Investigational New Drug Application) (pdf, 324kb) (doc, 118kb)
- DCP Study Status Update Form (doc, 36kb)
- DCP Site Monitoring Manual, Section 5.5 (pdf, 35kb)
- DCP Multi-Center Guidelines for Chemoprevention Trials (pdf, 78kb) (doc, 30kb)
- DCP Consortia Protocol Deviation Form (doc, 98kb)
- DCP Drug Request Form (pdf, 92kb)
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CCOP
- DCP CCOP Cancer Control Research Checklist (pdf, 41kb) (doc, 27kb)
- DCP Protocol Submission Worksheet v4.0 (Under Development)
- DCP CCOP Procedure for Ancillary Studies (pdf, 79kb) (wpd, 24kb)
- FDA Form 1572 (Statement of Investigator) (pdf, 266kb) (doc, 50kb)
- FDA Form 1571 (Investigational New Drug Application) (pdf, 324kb) (doc, 118kb)
- DCP Study Status Update Form (doc, 36kb)
- DCP Informed Consent Template for Chemoprevention Trials (doc, 105kb)
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Master Agreement Holders
- Protocol Deviation Notification Form (doc, 86kb)
- Protocol Deviation Reporting Instructions (pdf, 35kb)
- DCP Protocol Submission Worksheet v2.0 (doc, 110kb)
- DCP Protocol Template (pdf, 98kb) (wpd, 233kb)
- DCP Informed Consent Template for Chemoprevention Trials (doc, 53kb)
- DCP Recruitment Manual (pdf, 31kb) (doc, 113kb)
- DCP Adherence and Retention Manual (pdf, 90kb) (doc, 187kb)
- DCP Pharmacokinetic and Biomarker Methods Development (pdf, 18kb (doc, 31kb)
- DCP Study Site Monitoring Manual (pdf, 2.79mb)
- DCP Chemoprevention Case Report Forms: Instructions and Templates (pdf, 102kb) (wpd, 102kb)
- DCP Investigator Technical Progress Reports (ITPR) v4 (pdf, 345kb) (doc, 973kb)
- DCP Guidelines for Completing the ITPR Excel Worksheet v3.0 (pdf, 87kb) (doc, 128kb)
- DCP ITPR Sample Excel Spreadsheet (xls, 273kb)
- DCP Instructions for Progress Reports (pdf, 38kb) (wpd, 71kb)
- DCP Instructions for Final Reports (pdf, 49kb) (doc, 188kb)
- DCP Serious Adverse Events Reporting Form (doc, 36kb)
- FDA Form 1572 (Statement of Investigator) (pdf, 266kb) (doc, 50kb)
- FDA Form 1571 (Investigational New Drug Application) (pdf, 324kb) (doc, 118kb)
- DCP Study Status Update Form (doc, 36kb)
- DCP Drug Request Form (pdf, 92kb)
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Grants
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