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

HIPAA Authorization Template

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

Study Staff Transition

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

Assent/Consent/Parental Permission of Subjects at Children's Wisconsin with Limited English Proficiency

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

Institutional Review Boards

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

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

Lead/Coordinating Center Protocol Template

Records Review Protocol