# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF NEBRASKA MEDICAL CENTER · 2024 · $133,939

## Abstract

PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT
The Fred & Pamela Buffett (BCC) Clinical Trials Office (CTO), previously referred to as the Centralized
Protocol Data Management Unit (CPDMU), is the centralized office which supports clinical cancer research in
the Cancer Center. The BCC CTO 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 BCC CTO 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 BCC CTO 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 BCC CTO is the resource within the Cancer Center, which
provides support to investigators for all cancer clinical research. It is organized by disease-focused teams (DFT'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 BCC CTO provides BCC investigators support
for protocol development, data management, monitoring for cooperative group studies, and liaison with federal
and industry sponsors and regulatory bodies. The BCC CTO also provides support to the BCC Scientific
Review Committee (SRC), the Data Safety Monitoring Committee (DSMC), and the Audit Committee (AC).
The BCC CTO manages the clinical trials management system (OnCore) which houses protocol data necessary
for planning, reporting and internal oversight, as well as the development of electronic case report forms (eCRF)
and study data reporting in Forte EDC (Electronic Data Capture). The BCC CTO has been active in NCI initiatives
regarding Clinical Trial Reporting Program (CTRP).

## Key facts

- **NIH application ID:** 10927372
- **Project number:** 5P30CA036727-38
- **Recipient organization:** UNIVERSITY OF NEBRASKA MEDICAL CENTER
- **Principal Investigator:** Apar Kishor Ganti
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $133,939
- **Award type:** 5
- **Project period:** 1997-09-05 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10927372

## Citation

> US National Institutes of Health, RePORTER application 10927372, Clinical Protocol and Data Management (5P30CA036727-38). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10927372. Licensed CC0.

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