ULACNet Instructions, Forms and Templates

Protocol Development

• Protocol Template (DOCX, 113.33 KB)
• Informed Consent Template (DOCX, 65.53 KB)
• Ancillary Protocol Template (DOCX, 60.81 KB)
• Study Initiation Meeting (SIM) Template (DOCX, 56.49 KB)

Protocol Submission

• Protocol Submission Worksheet (DOCX, 29.28 KB)
• Protocol Status Update Form (DOCX, 32.55 KB)

Program Guidelines

• Publication Guidelines (DOCX, 27.02 KB)
• Program Guidelines (DOCX, 1.66 MB)
• Minimum Data Set (MDS) Guidelines (DOCX, 173.57 KB)
• Guidelines for Change in Principal Investigator (DOCX, 35.18 KB)
• Guidelines for Change in Principal Investigator (PDF, 223.34 KB)

Regulatory Documents

• Delegation of Tasks Log and Registration and Credential Repository (RCR) Guidance (DOCX, 50.5 KB)
• NCI Registration and Credential Repository (RCR)
• RCR Registration Tool (DOCX, 28.85 KB)
• Delegation of Tasks Log (DTL) (DOCX, 30.83 KB)
• Delegation of Tasks Log (DTL) Study Tasks List (DOCX, 23.82 KB)
• Master Documentation File (MDF) Guidance (DOCX, 142.18 KB)
• Study Site Binder (SSB) Guidance (DOCX, 150.05 KB)

Monitoring and Auditing Documents

• Audit Plan for Lead Academic Organizations (LAOs) (PDF, 177.79 KB)
• Audit Plan for Affiliate Organizations (AOs) (PDF, 174.15 KB)
• Study-Specific Monitoring Plan Guidance Document (PDF, 108.2 KB)
• Study Initiation Meeting (SIM) Template (DOCX, 56.49 KB)
• Monitoring Visit Report Template (DOCX, 74.4 KB)
• Monitoring Visit Action Item Site Response Template (DOCX, 26.62 KB)

AQuIP Accrual Reporting

Please see the Accrual Report Training Webinars (English, Spanish, and Portuguese) on the right-hand side of this page.

• The AQuIP Accrual Report Templates, in:
  • English (XLSX, 531.24 KB)
  • Español (XLSX, 538.44 KB)
  • Português (XLSX, 527.03 KB)
• The AQuIP Accrual Report Query Lists, in:
  • English (XLSX, 18.67 KB)
  • Español (XLSX, 20.06 KB)
  • Português (XLSX, 22.42 KB)
• The Recruitment Journal Study Events template (English only) (XLSX, 4.33 MB)
• Lead Academic Organization & Affiliate Organization Responsibilities (English only) (DOCX, 29.21 KB)

Other Documents

• ULACNet Site Activation Checklist for Lead Academic Organization (LAOs) (DOCX, 27.75 KB)