# Clinical Protocol and Data Management

> **NIH NIH P30** · THOMAS JEFFERSON UNIVERSITY · 2024 · $425,690

## Abstract

ABSTRACT: CLINICAL PROTOCOL & DATA MANAGEMENT
The overall goal and objective of the Sidney Kimmel Cancer Center Clinical Trials Office (CTO) is to ensure that
patients have access to a wide range of novel clinical trials which will improve the lives of cancer patients. There
are over 150 open to accrual oncology clinical trials being conducted within the center at any one time and the
CTO is the arm of the SKCC that manages and supports this important work. It ensures that trials comply with
all federal, state and institutional regulations and provides an effective, efficient, centralized infrastructure to
support SKCC investigators in developing, implementing, and reporting on all cancer clinical research studies
across the Jefferson Health Enterprise. There over 151 staff members in the CTO that that provide regulatory
support, clinical trial coordination, data management, monitoring, quality assurance, training/education and
clinical trial recruitment/engagement. The Senior Executive Director (Kristin Herman, MBA) oversees the CTO
who reports to the Vice President and Associate Director for Cancer Research Administration (Matthew Huesser,
MBA, DBA), Vice President of the Cancer Services (Alex Khariton, MBA), and Associate Director for Clinical and
Translational Research (Wm Kevin Kelly, DO) all under the direction of the SKCC Center Director, Dr. Andrew
Chapman, DO. The CDPM functions are supported by the Clinical Trials Office (CTO). The CTO is made up five
units with well-defined roles and responsibilities: (1) Cancer Clinical Research Operations (CCRO) oversees the
multidisciplinary disease teams conducting Phase II and III studies; (2) Early Phase Research Operations
(EPRO) oversees most complex early Phase I studies; (3) Community Research Operations and Enrollment
(CROE) oversees community research, screening for trials, and other recruitment services, working closely with
the AD of COE; (4) Research Support Services (RSS) provide regulatory support for clinical trials, maintain data
quality and reporting oversight via OnCore CTMS, and provide the coordination of the Protocol Review and
Monitoring Committee (PRMC); (5) Quality Assurance and Education Unit (QAE) dedicated to the management
of the Center’s Data Safety Monitoring (DSM) functions and CTO staff training.

## Key facts

- **NIH application ID:** 10848053
- **Project number:** 2P30CA056036-24
- **Recipient organization:** THOMAS JEFFERSON UNIVERSITY
- **Principal Investigator:** William K. Kelly
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $425,690
- **Award type:** 2
- **Project period:** 1995-06-22 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10848053

## Citation

> US National Institutes of Health, RePORTER application 10848053, Clinical Protocol and Data Management (2P30CA056036-24). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10848053. Licensed CC0.

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