In this section
Investigator resources
Investigator Manual for Conducting Research at Children's Wisconsin
Forms
Amendment form - for use with protocols in IRBNet
Annual Status or Closure Report - for use with reliances on IRBs other than MCW
Appendix M Variance for State Radiation Approval
Attestation for Local Principal Investigator at Children's Wisconsin for Multi-site Projects
Consultation with Children's Wisconsin HRPP Request
Conflict of Interest Disclosure - Supplement for Research at Children's Wisconsin
Engagement Determination Request
HIPAA Request for Waiver of Authorization
HUD Information and User Attestation - Children's Wisconsin
Human Subjects Research Determinations
MRI Safety and Plan for MRI for Research Outside of Children's Wisconsin
PHI of Decedents Attestation Form
Pre- Submission Checklist
Protocol Feasibility Checklist
Protocol Feasibility Checklist 2
Reportable Events Forms - Full Version (for use in IRBNet)
Reportable Events CW Supplement Form - For use in eBridge - CW studies
Guidance
GUIDANCE DOCUMENTS
Assent/Parental Permssion/Consent of Research Participants with Limited English Proficiency
Consent of a Research Participant who Reached the Age of Majority
Corrective and Preventative Action Plans (and Root Cause Analysis)
Departmental Sign Off for Research at Children's Wisconsin
Exemption Categories Reference Tool
Expanded Access (Compassionate Use) IDE Applications (Treatment use of Investigational Devices for a Single Patient at Children's Wisconsin)
Expanded Access (Compassionate Use) IND Applications (Treatment use of Investigational Drug for a Single Patient at Children's Wisconsin)
Expedited Review of Research Categories
Human Subject Research Determinations
Human Subject Research Determinations - Operations v. Research
Imaging for Research - Process at Children's Wisconsin
Imaging in Research at Children's Wisconsin - Flow Chart
Informed Consent Discussion Checklist
MRI Plan and Safety- Research MRI Outside of Children's Hospital
Multi-Site Projects and Investigator Responsibilities
Quality Program - Children's Wisconsin Human Research Protection Program
Recruitment for Human Subject Research at Children's Wisconsin
Reliance Agreements - Establishing a Reliance Between CW and an External IRB
Safety Committee Review - Research at Children's Wisconsin
Training Requirements for Key Personnel Conduction Human Subject Research at Children's Wisconsin
ARTICLES FROM CONNECT INTRANET
Assent in Human Subject Resarch at Children's Wisconsin
Engagement in Human Subject Research
Expanded Access (Compassionate Use) Treatment Use of Investigational Products
HUD - Humanitarian Use Devices at Children's Wisconsin
Human Research Protection Program - What Is The Role?
Human Subject Research Determination Requests
Human Subject Research v. Other Activities
Multi-Site Human Subject Research
Quality Monitoring of Human Subject Research at Children's Wisconsin
Radiation and Imaging in Research at Children's Wisconsin
Regulatory and Ethical Framework of Human Subjects Research
Review Pathways for Human Subject Research
Risk Levels in Pediatric Human Subject Research
Policies
Change of IRB of Record Notification
Children's Wisconsin Human Research Protection Program (HRPP) SOP Manual
CRI- HRPP Conduct of Research on Human Subjects
Protocol Templates
Clinical Trial - Interventional Protocol Template
Data Coordinating Center Protocol Template