# Clinical Protocol and Data Management: (Core 011)

> **NIH NIH P30** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2021 · $83,731

## Abstract

Project Summary/Abstract 
Clinical Protocol and Data Management (CPDM) responsibilities are fulfilled by the USC Norris Clinical 
Investigations Support Office (CISO). As the centralized clinical trials office for USC Norris, CISO 
manages, coordinates and provides a full range of services and helps to assure the conduct of high 
quality cancer clinical research in a safe, compliant and efficient manner. CISO assists investigators in 
protocol development and facilitates the review to activation process. It is also directly responsible for: 1) 
hiring, training and supervising clinical research staff, 2) quality assurance; 3) policies and procedures 
related to clinical trials conduct; 4) support and coordination of clinical research committees (PRMS, 
DSM, Quality Assurance); 5) metrics and reporting. 
 The Medical Director of CISO is Anthony El-Khoueiry, MD, a highly experienced cancer clinical 
trialist. He is supported by Assistant Medical Director, Kevin Kelly, MD. CISO's Associate Director, Kay 
Johnson, RN, announced her retirement in 2014 after more than 20 years of service but continues as a 
consultant to ensure a smooth transition while a national search is on-going. Day to day activities are 
handled by two seasoned managers, the Assistant Director for Clinical Research Operations and 
Assistant Director for Regulatory Affairs. USC Norris has also engaged Huron Consulting to identify 
strategies for improvement and to help CISO respond to the continued growth and complexity of the 
clinical research program. 
 CISO has successfully improved efficiency and effectiveness during the project period. Of particular 
note is USC's decision to implement OnCore enterprise-wide and to revamp the contracting and 
budgeting processes. Protocol turnaround has declined substantially while the number of IITs has 
increased. Accrual to interventional therapeutic trials has shown growth despite the increasing 
complexity of trial eligibility criteria. Other accomplishments include the establishment of a pre-PRMS 
design and feasibility consultation service, the development of standard operating procedures related to 
study conduct, the hiring of an education coordinator, and the national certification of research 
coordinators. 
 In regards to clinical trials participation, USC Norris has continued to build on its successful strategies 
for the inclusion of minorities using a multi-prong approach. Hispanics and Asian Pacific Islanders 
represent the two largest minority communities in the USC Norris catchment area. In 2013, Hispanics 
represented 40.5% of new cancer cases at USC Norris hospitals and 44.8% of accrual to interventional 
therapeutic trials. Asian/Pacific Islanders represented 14.3% of new cancers at USC Norris hospitals and 
11.3% of accrual to interventional therapeutic trials.

## Key facts

- **NIH application ID:** 10303173
- **Project number:** 3P30CA014089-45S7
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** CARYN LERMAN
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $83,731
- **Award type:** 3
- **Project period:** 1996-12-01 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10303173

## Citation

> US National Institutes of Health, RePORTER application 10303173, Clinical Protocol and Data Management: (Core 011) (3P30CA014089-45S7). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10303173. Licensed CC0.

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