SOPs/Forms/Documents

General
SOP Template SOP Request Form
Standard Operating Procedure Preparation and Maintenance SOP

 

Protocol Review & Monitoring
For All others conducting UW cancer-related research:
PRMC Protocol Submissions for Cancer-Related Research for Other Research Groups SOP
Additional PRMC Forms & Documents for all users:
Translational Research Protocol Document Template:  Required elements of a UW investigator initiated translational research protocol for PRMC Submission

 

Data and Safety Monitoring System (DSMS)
Data and Safety Monitoring Plan (DSMP)
DSMP Appendix II: Protocol Template For UWCCC Institutional Trials Monitored By The UWCCC
DSMP Appendix III: Guidelines for establishing and operating an external DSMB
Quality Assurance Review SOP
SAE Reporting Workflow - 1SP, JC and WON Affiliates
SAE Reporting Workflow-UWCCC
SAE Routing Form
SAE SOP
SAE Tutorial
Sponsor-Investigator AE Assessment Form
UWCCC Audit Training Manual
UWCCC External Query Fax Form
UWCCC Internal Query Fax Form
Reportable Events SOP
DSMS Reporting Guidelines SOP

 

Protocol Development
IND Annual Template Sponsor-Investigator IND Submission SOP
IND Personnel Addition Template NCI LOI Document
MTA Guidance Tool NCI LOI Pre-Solicitation Letter

 

 

Protocol Conduction and Procedures
Beacon Protocol Build Requests PPO Template
Informed Consent Process SOP Weekly List Template
PPO Process Flowchart Radiology Imaging Scan Request Instructions
Memo of OSR Policy UWCCC Statement on Part 11 Compliance
Monitoring Guidelines for Industry Sponsors Document

Subject Ineligibility Policy Document

Processing Outside Safety Reports SOP UWHC Medicaid Enrollment Process Document
Processing Outside Safety Reports Guidance Review Process for Amended Pre-Printed Physician Orders (PPO)
PPO Review Process Tips Processing of Outside Safety Reports Supplement
Review Requirements PPO & PRL Chart Outside Safety Report Cover Sheet
Review Process for Amended Beacon Protocols Source Documentation SOP
Health Link & PPO Tracking Log Template Self-Monitoring for DOWGs Guidance Document
Health Link & PPO Tracking Log SOP Protocol Activation SOP
Adverse Event Assessment and Documentation SOP Protocol Maintenance SOP
Research Kit Instructions UWHC Surgical Pathology Archived Tissue Request Form
Note-to-File SOP Off Treatment Tasks Cheat Sheet

 

HealthLink
Accessing Patient Lists in HealthLink Instructions HealthLink FAQs
OnCore and HealthLink Interface User SOP Research Documentation Guideline
How to Discontinue a Treatment Plan  

 

Regulatory
ECOG LTFU (ELTFU) SOP UW OPOC Standard Text
Maintaining a Regulatory File SOP Study Close-Out SOP
Open Protocols List Study Close-out Checklist

 

Affiliate Network
External Sites Grid PRMC and IRB Approval for UWCCC Study Sites SOP

 

Publications
Publications on cancer.wisc.edu

 

Administration
DOWG Requirements and Responsibilities SOP Checklist for New UWCCC Employees
HIPAA Training and Certification SOP CITI Human Subjects Training and Certification SOP
UWCCC Clinical Research Training Request Form Student Hiring SOP