# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF COLORADO DENVER · 2024 · $104,710

## Abstract

ABSTRACT 
Overview: The Clinical Protocol and Data Management (CPDM) provides central administration and oversight 
functions for coordinating, facilitating, and reporting on clinical and population sciences trials across the UCCC 
clinical sites serving the catchment. The Data Safety and Monitoring Committee (DSMC) provides a robust 
structure for auditing clinical trials across the UCCC partner sites. DSMC's oversight is prioritized for high-risk 
Phase I and Phase II protocols. Accomplishments: Since 2016, the CPDM substantially improved clinical 
research support as follows: 1) Investigator-initiated trial (IIT) support leading to a 411% increase in IIT accruals 
from 2017-2020 compared to the previous similar period of 2013-2016; 2) Development of the Oncology Clinical 
Research Support Team (OCRST). OCRST provides centralized SOP development, staff and investigator 
training, multi-site coordination, and streamlining of processes for the successful implementation of clinical 
research protocols across the network; 3) Expansion of the Front Range Clinical Trials Network (FRCTN) 
provides clinical trial access to the population of Colorado. The inclusion of 5 UCHealth System clinical research 
sites in the FRCTN presents an enormous opportunity for clinical and population health research given the size 
and diversity of the socioeconomic demographics of the population and its rural/urban mix; 4) CPDM and 
UCHealth implemented the Via Oncology Pathways across the UCHealth system with clinical trials built into the 
pathways to ensure awareness and access to UCCC clinical trials across the catchment area. Quality Control 
and Training: The CPDM initiated an educational curriculum to provide a cohesive and relevant training 
structure to new staff and faculty and ongoing education to ensure those involved in the conduct of clinical 
investigation remain knowledgeable of policies and regulations. A new curriculum was developed that utilizes 
educational resources within the UCCC, UCAMC, the Colorado Clinical and Translational Sciences Institute 
(CCTSI, UL1TR001082) and enhanced by feedback received from trial audits. Trials and Catchment Area 
Demographics: The CPDM oversees an annual average of 527 clinical research studies. In FY2020, 608 
patients were accrued to intervention-treatment studies. Patients seen at UCCC come from all 64 Colorado 
counties. Based on data from 2020, patient accruals were consistent with the state cancer demographics. UCCC 
has a plan to increase Hispanic enrollment to at least 10% and improve clinical trial access to the population at 
large. Taken together, these data demonstrate substantial progress in the CPDM and further demonstrate the 
UCCC's commitment to patients with cancer.

## Key facts

- **NIH application ID:** 10838375
- **Project number:** 5P30CA046934-36
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** RICHARD D SCHULICK
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $104,710
- **Award type:** 5
- **Project period:** 1997-04-04 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10838375

## Citation

> US National Institutes of Health, RePORTER application 10838375, Clinical Protocol and Data Management (5P30CA046934-36). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10838375. Licensed CC0.

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