SOPs/Forms/Documents

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)
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
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
Monitoring Guidelines for Industry Sponsors Document UWCCC Statement on Part 11 Compliance
PPO Review Process Tips  
Note-to-File SOP Review Process for Amended Pre-Printed Physician Orders (PPO)
Review Requirements PPO & PRL Chart Subject Ineligibility Policy Document
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
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
UW OPOC Standard Text

 

Administration

DOWG Requirements and Responsibilities SOP UWCCC Clinical Research Training Request Form
HIPAA Training and Certification SOP CITI Human Subjects Training and Certification SOP
Student Hiring SOP