2012 Consortia for Early Phase Prevention Trials

Regulatory

• SOP 1: Regulatory Documents (DOC, 125 KB)
• SOP 1a: Transmittal Form for Submitting Regulatory Documents (DOC, 31 KB)
• FDA Form 1572 (Statement of Investigator) (PDF, 1.4 MB)
• DCP Financial Disclosure Form (PDF, 221 KB)
• DCP Delegation of Tasks Log (DOC, 24 KB)

Investigational Agent Distribution

• Policy and Guidelines for Investigational Agent Distribution (DOC, 19 KB)

Study Initiation Meeting

• SOP 2: Study Initiation Meeting (DOC, 33 KB)
• SOP 2a: Study Initiation Meeting Report (DOC, 50 KB)

Recruitment, Retention and Adherence

• SOP 6: Participant Recruitment, Retention and Adherence (DOC, 41 KB)
• Recruitment, Retention and Adherence (RRA) Plan Outline (PDF, 950 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

Source Documentation

• DCP Consortia Source Documentation Guide (DOC, 48 KB)

Baseline and Adverse Event Reporting

• DCP Baseline and Adverse Event (AE) Reporting Guidelines (DOC, 36 KB)

Adverse Events

• SOP 3: Reporting Serious Adverse Events (DOC, 73 KB)
• DCP Serious Adverse Events Reporting Form (DOC, 209 KB)
• DCP Consortia Serious Adverse Events Reporting Form Instructions (DOC, 69 KB)

Protocol Deviations

• SOP 4: Reporting Protocol Deviations (DOC, 34 KB)
• DCP Consortia Protocol Deviation Form (PDF, 3 MB)
  (NOTE: This form must be completed using Adobe Acrobat Reader DC. It may be downloaded here: https://get2.adobe.com/reader/otherversions/)

Case Report Forms and SVAR Template

• SOP 5: Case Report Forms (DOC, 154 KB)
• Case Report Forms (CRFs) (DOC, 68 KB)
• CRF Instructions (DOC, 191 KB)
• 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)
• 2012 Consortia SVAR Template (XLS, 114 KB)

Recruitment, Retention and Adherence

• SOP 6: Participant Recruitment, Retention and Adherence (DOC, 41 KB)
• Recruitment, Retention and Adherence (RRA) Plan Outline (PDF, 950 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 (DOC, 33 KB)

DCP Consortia SOPs

• SOP 8: Reviewing and Amending Standard Operating Procedures (DOC, 30 KB)

Monitoring

• SOP 9:  Site Preparations for Monitoring Visits and Quality Assurance Audits (DOC, 33 KB)
• SOP 9a: Site Preparations for Quality Assurance Monitoring Audits (DOC, 30 KB)
• SOP 10: CLO Oversight of Participating Organizations (DOC, 32 KB)

CLO Monitor

• SOP 11: CLO Monitor Qualifications (DOC, 24 KB)
• SOP 11a: CLO Monitor Qualifications Checklist (DOC, 24 KB)
• SOP 12: CLO Monitor Instructions for Conducting Monitoring Visits (DOC, 41 KB)
• SOP 12a: Monitoring Visit Report (DOC, 76 KB)
• SOP 12b: Monitoring Visit Log (DOC, 29 KB)
• SOP 12c: DCP Action Item – Site Response Form (AIF) (DOC, 25 KB)

Closing Out

• SOP 13: Site Preparations for Study Closeout (DOC, 49 KB)
• SOP 13a: Study Closeout Checklist (DOC, 35 KB)
• SOP 13b: Final Dataset and Documentation Submission Summary (PDF, 258 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, 62 KB)
• SOP 13d: Study Unblinding Worksheet (XLS, 60 KB)
• SOP 14: CLO Monitor Instructions for Conducting Closeout Visits (DOC, 40 KB)
• SOP 14a: Closeout Visit Report (DOC, 47 KB)
• DCP Protocol Status Update Form (DOC, 34 KB)
• DCP Return Agent Form (DOC, 17 KB)