Protocol Review and Monitoring System

 

PRMS Overview  

The Protocol Review and Monitoring System (PRMS) of the University of Nebraska Medical Center (UNMC) Fred & Pamela Buffett Cancer Center (BCC) provides central management and oversight functions for all cancer-related trials involving human subjects and conducted by members of the BCC

PRMS Policies

 

If you are conducting a Clinical Trial at UNMC/NM, both IRB requirements and institutional requirements must be met before a research study can be approved and released. You may need to submit a Study Intake Form.

A detailed list of institutional requirements can be found here, and may include billing, coverage analysis, contract/agreement, CTMS and/or OneChart build.

Audit Files  
  Audit Committee Policies
  Audit Committee Meeting and Submission Dates 
DSMC Files  
  DSMC Policies
  DSMC Phase 1 Report Form
  Dose Change Report Form for Phase I Trials
  DSMC Pilot Phase 2 and 3 Report Form for UNMC Single-Site and Multi-Site with UNMC as the Sponsor
  DSMC AE Worksheet (Excel)
  DSMC Meeting and Submission Dates
  DSMC Plan
  Serious Adverse Events Assessment Form for External Sites
SRC Files  
  SRC Policies
  SRC Protocol Format
  SRC Conflict of Interest
  SRC New Project Form
  SRC Continuing Review Form
  SRC Request for Change Form
  SRC Meeting and Submission Dates
  Priority Score and Competing Protocol Table