# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · 2022 · $228,620

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT – ABSTRACT
A centralized Clinical Trials Office (CTO) oversees all Clinical Protocol and Data Management (CPDM)
functions at the Stephenson Cancer Center (SCC), with the goal of supporting SCC investigators in the design,
development, conduct and reporting of all aspects of clinical research in an efficient, compliant and
scientifically focused manner. CTO staff perform regulatory and compliance, data management, research
nursing and study coordination, information systems and data support, research finance, and admin support
functions to ensure timely initiation, conduct and completion of trials with effective quality control and training
functions. Over the past five years, the SCC has accrued 8,083 patients to clinical trials, including 2,531
enrollments to interventional treatment, 1,015 to other interventional and 4,537 to non-interventional trials. The
SCC's exceptional track record of accrual to NCTN interventional treatment trials led to its being designated an
NCTN Lead Academic Participating Site (LAPS) in 2014.
The SCC places the highest priority on ensuring the safety of subjects participating in clinical trials and on the
quality of data obtained from clinical and translational research. The SCC has a written Data and Safety
Monitoring Plan (DSMP) that describes the oversight of study conduct, participant safety and integrity of data
for all clinical trials at the SCC, and particularly for IITs and those studies for which a DSMP does not already
exist. A standing DSM Committee meets quarterly to fulfill this important monitoring function.
The SCC places a high priority on the recruitment and retention of women, minorities and other underserved
populations for clinical trial participation as a way to address Oklahoma's significant cancer health disparities.
The SCC has instituted a number of focused initiatives designed to accomplish this aim, with a particular focus
on recruiting the state's large and underserved American Indian (AI) population for clinical trial participation.
The SCC's AI Patient Navigation Program has served 1,554 AI cancer patients from 54 different tribes over the
past five years, helping to facilitate the enrollment of 343 AI patients to interventional and 263 to non-
interventional trials. Other initiatives have been implemented to promote the inclusion of rural, under- and
uninsured, African American, Hispanic, elderly and female patients on clinical trials.
The SCC is committed to the NIH Policy of including children (subjects less than 21 years of age) in all
appropriate clinical research supported by the NIH. A primary goal of the SCC's Pediatric Oncology
Department is recruiting and retaining children to participate in clinical trials as a way of advancing ideas and
raising the standard of care for this population. This group has maintained an active record in the design and
conduct of pediatric cancer clinical trials, both the Children's Oncology Group (COG) and IIT,...

## Key facts

- **NIH application ID:** 10413085
- **Project number:** 5P30CA225520-05
- **Recipient organization:** UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
- **Principal Investigator:** Kathleen N. Moore
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $228,620
- **Award type:** 5
- **Project period:** 2018-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10413085

## Citation

> US National Institutes of Health, RePORTER application 10413085, Clinical Protocol and Data Management (5P30CA225520-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10413085. Licensed CC0.

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