Investigator resources

Investigator Manual for Conducting Research at Children's Wisconsin

Forms

Amendment form - for use with protocols in IRBNet

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

Continuing Review/Status Report - for use with reliances on IRBs other than MCW

Conflict of Interest Disclosure - Supplement for Research at Children's Wisconsin

Engagement Determination Request

Federal Assurance (FWA) for Children's Wisconsin

HIPAA - Request for Waiver of Authorization

HIPAA Authorization Template

Human Subjects Research Determination Request

Imaging Department Intake Form for use of Children's Wisconsin Imaging Resources

MRI Safety and Plan for MRIs Outside of Children's Wisconsin - Supplemental Form for Children's Wisconsin

PHI of Decedents Attestation

Reportable Event Form - FULL VERSION for IRBNet

Reportable Event Form - Supplement for Children's Wisconsin for eBridge

Guidance Documents

Assent - Obtaining Assent of Minors at Children's Wisconsin for Research Participation

Children's Wisconsin HRPP Quality Program

Children's Wisconsin Operations v. Research - Is my project human subject research

Consent - Obtaining Consent of Research Participants at Children's Wisconsin who Reach the Age of Majority

Consent/Parental Permission - Obtaining Consent/Parental Permission of Research Participants at Children's Wisconsin with Limited English Proficiency

Corrective and Preventative Action (CAPA) Plans

Departmental Sign Off for Research at Children's Wisconsin

Exempt Review of Research Categories

Expanded Access/Treatment Use of Investigational Products

Expanded Access/Compassionate Use - IND Application (Drug) for a SIngle Patient

Expanded Access/Compassionate Use - IDE Application (Device) for a Single Patient

Expedited Review of Research Categories

Feasibility Checklist

Human Research Protection Program and Local Context 

Human Subjects Research Determinations

Human Subject Research v Operations

Imaging Review of Research at Children's Wisconsin

Multi-Site Projects and Investigator Responsibilities

Multi-Site Research at Children's Wisconsin

Pre- Submission Checklist

Protocol Feasibility Checklist

Radiation and Imaging in Research at Children's Wisconsin

Radiation and Imaging in Research at Children's Wisconsin - Flow Chart

Recruitment of Research Subjects at Children's Wisconsin

Safety Committee Review of Research Conducted at Children's Wisconsin

Study Staff Transition

Training Requirements of Individuals Conducting Research at Children's Wisconsin

Policies

Protocol Templates

Clinical Trial - Interventional Protocol Template

Data Coordinating Center Protocol Template

Lead/Coordinating Center Protocol Template