SOPs/Forms/Documents

General
UWCCC Standing Meetings SOP Request Form
  Standard Operating Procedure Preparation and Maintenance SOP

 

Protocol Review & Monitoring

For UWCCC Disease-Oriented Working Groups (DOWGs) and Research Groups:
PRMC Protocol Submissions for DOWGs SOP
PRMC Submission Form for Regional Partners
ePRMS Submission Short Form for Initial Review
ePRMS Submitter Workflow
ePRMS Submission Tutorial
PRMC Major Amendment Submission Form: Complete this form to submit a major amendment to an already approved protocol
5 Year Renewal Submission Short Form for DOWGS: Complete this form to submit a 5 Year Continuation Review to PRMC and upload the form in the Documents section of the Submission Console.
Site Addition Form: Complete this form to add an institution to an already approved a protocol
Protocol Status Change Request Form: Complete this form to change the status of your protocol in OnCore.
For All others conducting UW cancer-related research:
PRMC Protocol Submissions for Cancer-Related Research for Other Research Groups SOP
Initial PRMC Submission Webform
5 Year Renewal Submission Short Form
Additional PRMC Forms & Documents for all users:
New Protocol Number Request Form: Complete this form to receive a Cancer Center protocol number prior to submitting your protocol to PRMC.
2014 PRMC Meeting Schedule: The dates the PRMC Committee meets to review protocols
Clinical Research Protocol Document Template: Required elements of a UW investigator initiated clinical research protocol for PRMC Submission
Translational Research Protocol Document Template:  Required elements of a UW investigator initiated translational research protocol for PRMC Submission
Reviewer's Guide to ePRMS

 

Data and Safety Monitoring System (DSMS)
Data and Safety Monitoring Plan (DSMP)
DSMC Meeting Schedule
DSM Protocol Summary Report SOP
DSMP Appendix II: Protocol Template For UWCCC Institutional Trials Monitored By The UWCCC
DSMP Appendix III: Guidelines for establishing and operating an external DSMB
DSMP Appendix VII:  DSMS Elements Table
Quality Assurance Review SOP
Response Review Cover Sheet
Response Reviews 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
Internal Audits SOP
Compliance Review SOP
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
PM List Serve  

 

 

Protocol Conduction and Procedures
Beacon Protocol Build Requests PPO Template
Informed Consent Process SOP Protocol Activation Priority List
PPO Process Flowchart Protocol Activation SOP
Memo of OSR Policy Radiology Imaging Scan Request Instructions
Monitoring Guidelines for Industry Sponsors Document

UWCCC Statement on Part 11 Compliance

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

 

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

 

Regulatory
ECOG LTFU (ELTFU) SOP
State Record Center (SRC) Box Inventory Form (blank):  Subject Research Charts State Record Center (SRC) Box Inventory Form (blank):  Protocol and/or Regulatory Documentation 
Maintaining a Regulatory File SOP HS-IRB FDA Inspection Document
Open Protocols List SUSAR Memo
Protocol Non-Compliance SOP UW OPOC Standard Text
Study Close-Out SOP Study Close-out Checklist

 

Affiliate Network
External Sites Grid ECOG, GOG or RTOG Affiliate Data Requirements Chart
PRMC and IRB Approval for UWCCC Study Sites SOP WON Manual
Regional Partner Data Requirements Chart WON Roster
Regional Partners Off-Site Faculty SOP WON Data Requirements Chart
1 South Park & Johnson Creek Key Personnel WON Weekly Protocol Updates
1SP/JC Consent and HIPAA Template  

 

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

 

Program Manager Committee (PMC) Meeting Minutes
January July
February August
March September
April October
May November
June December