PIO Instructions and Tools
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- Protocol Development
- Study Status and Amendments
- Adverse Events and Protocol Deviation
- Agents/Drugs
- Investigator Registration
- Monitoring
- Reports
- Minimum Data Set Instructions (pending)
- Quarterly Reports (pending)
- Annual Report (pending)
- Good Clinical Practice in FDA-Regulated Clinical Trials
- DCP Letter of Intent Submission Form (doc, 85kb)
- DCP Consortia Protocol Submission Worksheet (doc, 89kb)
- DCP Consortia Protocol Template (doc, 294kb)
- DCP Consortia Additional Study Related Documents Template (doc, 161kb)
- Recruitment, Retention and Adherence Plan Template (doc, 50kb)
- Pharmacokinetic and Biomarker Method Development Report (doc, 74kb)
- Case Report Forms (CRFs) (doc 838 kb) and CRF Instructions (doc, 493kb)
- Data Management Plan (DMP) (doc, 81kb)
- Multi-Institutional Monitoring Plan (MIMP) (doc, 94kb)
- Data and Safety Monitoring Plan (DSMP) (doc, 30kb)
- DCP Serious Adverse Events Reporting Form (doc, 80kb)
- Serious Adverse Event Form
Instructions for Completion (doc, 135kb)
- DCP Policy and Guidelines for Investigational Agent Distribution (doc, 32kb)
- DCP Guidelines for Submitting Clinical Drug Requests (doc, 27kb)
- DCP Return Agent Form (doc, 65kb)
- DCP Guidelines for Submitting Study Site Inventory (doc, 26kb)
- DCP Form for Submitting Study Site Inventory (doc, 67kb)
- DCP Delegation of Tasks Form (doc, 45kb)
- DCP Financial Disclosure Form (pdf, 104kb)
- FDA Form 1572 (pdf, 330kb)
- FDA Form 1571 (Investigational New Drug Application) (pdf, 324kb) (doc, 117kb)
- DCP Study Status Update Form (doc, 28kb)
- DCP Multi-Center Guidelines for Chemoprevention Trials (pdf, 78kb) (doc, 30kb)
- DCP Consortia Protocol Deviation Form (doc, 92kb)
- DCP Drug Request Form (doc, 49kb)
- Standard Operating Procedures (SOP) Documents
- DCP Document Transmittal Form (doc, 41kb)
- Checklist for Initial Submission of Regulatory Documents (doc, 194kb)
- Checklist for Subsequent Submission of Regulatory Documents (doc, 79kb)
- Screening Log (doc, 41kb)
- Summary of Reporting Responsibility for Serious Adverse Events (doc, 40kb)
- DCP Policy for DCP Consortia Studies: Case Report Form (CRF) Versioning Policy (doc, 54kb)
- Site Monitoring Training Checklist (doc, 50kb)
- Attendance Sheet (doc, 36kb)
- Site Monitoring Visit Log (doc, 46kb)
- Clinical Initiation Visit Report (doc, 171kb)
- Site Visit Report Delivery Timeline (doc, 60kb)
- Clinical Site Annual (Interim) Monitoring Visit Report (doc, 130kb)
- Pharmacy Visit Report (doc, 82kb)
- Per PID Finding Sheet for On-Site Chart Review (doc, 45kb)
- Preliminary Report of Monitoring Findings (doc, 47kb)
- Examples of Major and Lesser Deficiencies (doc, 104kb)
- Clinical Site Close-Out Visit Report (doc, 57kb)
- Checklist for Study Close-Out (doc, 67kb)
- DCP OC-RDC CLO Data Lock Checklist/Request (doc, 62kb)
- Manuscript Guidelines (doc, 26kb)
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