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Consortia Organizational Rosters
- Guidelines for Modifying a Consortium Roster (DOC, 23 KB)
Protocol Development
- Task Order Technical Proposal Submission Form (DOC, 37 KB)
- DCP Consortia Protocol Submission Worksheet (
DOC ,64 KB ) - DCP Consortia Protocol Template (
DOC ,122 KB ) - Protocol Appendix: Alcohol and Tobacco Assessment CRFs
- Alcohol Tobacco Questionnaire Instructions (DOC, 14 KB)
- Alcohol Assessment - Baseline (DOC, 38 KB)
- Alcohol Assessment - Follow-up (DOC, 37 KB)
- Tobacco Assessment - Baseline (DOC, 41 KB)
- Tobacco Assessment - Follow-up (DOC, 38 KB)
- National and Local Resources to Help with Alcohol Abuse and Alcoholism (DOC, 20 KB)
- Consortia Informed Consent Letter (DOC, 43 KB)
- DCP Informed Consent (IC) Template (DOC, 150 KB)
- DCP Consortia Additional Study Related Documents Template
- Recruitment, Retention, and Adherence Plan Outline Template (PDF, 950 KB)
- Pharmacokinetic and Biomarker Method Development Report (DOC, 69 KB)
- Case Report Forms (CRFs) (DOC, 187 KB)
- CRF Instructions (DOC, 350 KB)
- Data Management Plan (DMP) (DOC, 77 KB)
- Multi-Institutional Monitoring Plan (MIMP) (pending)
- Data and Safety Monitoring Plan (DSMP) (pending)
Protocol Status and Amendments
- DCP Protocol Status Update Form (DOC, 37 KB)
- Revision or Amendment Submission Checklist For DCP Chemoprevention Studies (DOC, 31 KB)
Adverse Events and Protocol Deviation
- DCP Consortia Serious Adverse Events Reporting Form (DOC, 208 KB)
- DCP Consortia Serious Adverse Events Reporting Form Instructions for Completion (DOC, 68 KB)
- DCP Consortia Protocol Deviation Form (PDF, 2.03 MB)
(NOTE: This form must be completed using Adobe Acrobat Reader DC. It may be downloaded here: https://get.adobe.com/reader/otherversions/)
Agents/Drugs
- DCP Policy and Guidelines for Investigational Agent Distribution (DOC, 30 KB)
- DCP Guidelines for Submitting Clinical Drug Requests (DOC, 27 KB)
- DCP Return Agent Form (DOC, 30 KB)
- DCP Guidelines for Submitting Study Site Inventory (DOC, 26 KB)
- DCP Form for Submitting Study Site Inventory (DOC, 42 KB)
- DCP Drug Request Form (DOC, 42 KB)
Investigator Registration
- FDA Form 1572 (Statement of Investigator) (PDF, 1.4 MB)
- DCP Financial Disclosure Form (PDF, 221 KB)
- DCP Delegation of Tasks Log (DOC, 75 KB)
Monitoring
Reports
- Minimum Data Set Instructions (DOC, 426 KB)
Please e-mail dcphelpdesk@dcpais.com if you have any questions or concerns.