2012 Consortia for Early Phase Prevention Trials

DCP Acronym List, Consortia 2012 (DOCX, 28.37 KB)

See SOP Documents, DCP Guidance Documents and additional resources linked by topic within the tabs below.

Developing

Regulatory

• SOP 1: Regulatory Documents (DOC, 124.5 KB)
• SOP 1a: Transmittal Form for Submitting Regulatory Documents (DOCX, 31.11 KB)
• FDA Form 1572 (Statement of Investigator) (PDF, 1.4 MB)
• DCP Financial Disclosure Form (PDF, 220.53 KB)
• DCP Delegation of Tasks Log (DOCX, 23.51 KB)

Investigational Agent Distribution

• Policy and Guidelines for Investigational Agent Distribution (DOCX, 19.27 KB)

Study Initiation Meeting

• SOP 2: Study Initiation Meeting (DOCX, 32.68 KB)
• SOP 2a: Study Initiation Meeting Report (DOCX, 50.43 KB)

Recruitment, Retention and Adherence

• SOP 6: Participant Recruitment, Retention and Adherence (DOCX, 40.7 KB)
• Recruitment, Retention and Adherence (RRA) Plan Outline (PDF, 949.91 KB)
• AQuIP Online Accrual Reporting System (OARS)
  • Training Demonstration Webinar | AQuIP OARS User Guide(PDF, 1.1 MB)
• DCP AQuIP Website: www.dcpaquip.com
  • DCP AQuIP Toolkit

Conducting

Source Documentation

• DCP Consortia Source Documentation Guide (DOCX, 47.68 KB)

Baseline and Adverse Event Reporting

• DCP Baseline and Adverse Event (AE) Reporting Guidelines (DOCX, 35.81 KB)

Adverse Events

• SOP 3: Reporting Serious Adverse Events (DOC, 73 KB)
• DCP Serious Adverse Events Reporting Form (DOCX, 101.5 KB)
• DCP Consortia Serious Adverse Events Reporting Form Instructions (DOCX, 70.84 KB)

Protocol Deviations

• SOP 4: Reporting Protocol Deviations (DOCX, 34.36 KB)
• DCP Consortia Protocol Deviation Form (PDF, 2.94 MB)
  (NOTE: This form must be completed using Adobe Acrobat Reader DC. It may be downloaded here: https://get2.adobe.com/reader/otherversions/)

COVID-19 Memorandum for Division of Cancer Prevention Investigators

MEMORANDUM

• COVID Minor Deviation Reporting Form (XLSX, 74.84 KB)
  Date: May 8, 2020

Case Report Forms and SVAR Template

• SOP 5: Case Report Forms (DOCX, 153.56 KB)
• Case Report Forms (CRFs) (DOC, 68.36 KB)
• CRF Instructions (DOCX, 191.4 KB)
• Alcohol and Tobacco Assessment CRFs
  • Alcohol Tobacco Questionnaire Instructions (DOCX, 13.56 KB)
  • Alcohol Assessment - Baseline (DOCX, 38.33 KB)
  • Alcohol Assessment - Follow-up (DOCX, 37.1 KB)
  • Tobacco Assessment - Baseline (DOCX, 41.08 KB)
  • Tobacco Assessment - Follow-up (DOCX, 38.4 KB)
• 2012 Consortia SVAR Template (XLSX, 113.58 KB)

Recruitment, Retention and Adherence

• SOP 6: Participant Recruitment, Retention and Adherence (DOCX, 40.7 KB)
• Recruitment, Retention and Adherence (RRA) Plan Outline (PDF, 949.91 KB)
• AQuIP Online Accrual Reporting System (OARS)
  • Training Demonstration Webinar | AQuIP OARS User Guide(PDF, 1.1 MB)
• DCP AQuIP Website: www.dcpaquip.com
  • DCP AQuIP Toolkit

Communication

• SOP 7: CLO Communication with Participating Organizations (DOCX, 32.84 KB)

DCP Consortia SOPs

• SOP 8: Reviewing and Amending Standard Operating Procedures (DOCX, 29.95 KB)

Monitoring

Monitoring

• SOP 9:  Site Preparations for Monitoring Visits and Quality Assurance Audits (DOCX, 32.56 KB)
• SOP 9a: Site Preparations for Quality Assurance Monitoring Audits (DOCX, 30.1 KB)
• SOP 10: CLO Oversight of Participating Organizations (DOCX, 32.39 KB)

CLO Monitor

• SOP 11: CLO Monitor Qualifications (DOCX, 23.76 KB)
• SOP 11a: CLO Monitor Qualifications Checklist (DOCX, 24.16 KB)
• SOP 12: CLO Monitor Instructions for Conducting Monitoring Visits (DOCX, 40.93 KB)
• SOP 12a: Monitoring Visit Report (DOCX, 75.67 KB)
• SOP 12b: Monitoring Visit Log (DOCX, 29.04 KB)
• SOP 12c: DCP Action Item – Site Response Form (AIF) (DOCX, 25.41 KB)

Closing Out

Closing Out

• SOP 13: Site Preparations for Study Closeout (DOCX, 49.95 KB)
• SOP 13a: Study Closeout Checklist (DOCX, 35.22 KB)
• SOP 13b: Final Dataset and Documentation Submission Summary (PDF, 258.23 KB)
  NOTE: If this document fails to open in your current browser, please (1) try another browser or (2) save the file locally and open it with Adobe Acrobat Reader.
• SOP 13c: Material Transfer Manifest for Biospecimen Submission (XLS, 661.5 KB)
• SOP 13d: Study Unblinding Worksheet (XLS, 59.5 KB)
• SOP 14: CLO Monitor Instructions for Conducting Closeout Visits (DOCX, 39.55 KB)
• SOP 14a: Closeout Visit Report (DOCX, 46.84 KB)
• DCP Protocol Status Update Form (DOCX, 34.27 KB)
• DCP Return Agent Form (DOCX, 17.31 KB)

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