# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF NEBRASKA MEDICAL CENTER · 2020 · $93,589

## Abstract

Project Summary/Abstract: Clinical Protocol and Data Management (CPDM) 
The Office for Cancer Clinical Research (OCCR), previously referred to as the Centralized Protocol Data 
Management Unit (CPDMU), is the centralized office that supports clinical cancer research in the Fred and 
Pamela Buffett Cancer Center (FPBCC) at the University of Nebraska Medical Center (UNMC). The OCCR 
provides centralized support for investigator-initiated trials (IIT), NCI National Clinical Trials Network and 
cooperative group trials (Main Member of Alliance, Children's Oncology Group, NRG) multi-institutional 
consortium trials (BIG10 Cancer Consortium, ACCRU) and industry-sponsored studies. The mission of the 
OCCR is to assist with the planning, development, conduct, quality assurance, monitoring and compliance of 
with regulatory agency requirements for clinical trials involving cancer treatments and care, and to provide 
regulatory support for cancer-related population science studies as well. The OCCR assures the highest 
quality of research and adherence to relevant regulations by primary upfront coordination of the study and 
ongoing review of research compliance. The OCCR is a resource within the FPBCC to provide investigators 
support for all cancer-related clinical research. It is composed of disease-oriented teams (DOT's) that 
coordinate study management activities (including screening subjects, coordination of treatment and care, and 
collecting and recording study data), as well as the regulatory management teams responsible for submitting 
and maintaining all regulatory documents and applications. The OCCR provides investigators with support and 
study data management, as well as protocol development, monitoring for cooperative group studies, and 
liaison with federal and industry sponsors and regulatory bodies. The OCCR provides resource support to the 
FPBCC Scientific Review Committee (SRC), the Data Safety Monitoring Committee (DSMC), and the Audit 
Committee (AC). The OCCR manages the clinical trials management system (CPDM database) which houses 
protocol data necessary for planning, reporting and internal oversight, as well as eCRF development and study 
data reporting in C3D and MediData RAVE. The FPBCC OCCR has been active in NCI initiatives regarding 
the Clinical Trial Reporting Program (CTRP) and has been an early adopter of C3D and Medidata Rave.

## Key facts

- **NIH application ID:** 9981654
- **Project number:** 5P30CA036727-34
- **Recipient organization:** UNIVERSITY OF NEBRASKA MEDICAL CENTER
- **Principal Investigator:** Apar Kishor Ganti
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $93,589
- **Award type:** 5
- **Project period:** 1997-09-05 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9981654

## Citation

> US National Institutes of Health, RePORTER application 9981654, Clinical Protocol and Data Management (5P30CA036727-34). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9981654. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*