# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF PENNSYLVANIA · 2022 · $1,063,795

## Abstract

PROJECT SUMMARY – CPDM, DSM, Women and Minorities, Lifespan 
The CPDM is the administrative home for support and monitoring of all clinical research conducted in the ACC 
regardless of the type of intervention or sponsor. The CPDM creates, directs and enforces the operational 
policies and expectations for the conduct of all cancer-related clinical research within the ACC across the 
University of Pennsylvania. The CPDM scope is of necessity broad, encompassing and implementing policies 
and procedures, education and training, supervision of data managers and research nurses, and oversight 
over the specialty clinical research units (CRUs) that are a vital part of our Center. The CPDM oversees first- 
stage and second-stage protocol review, manages our centralized clinical trials management system (Velos), 
performs monitoring and auditing of clinical trials, and manages the complex activities of our mandatory clinical 
research review committees. Key elements within the CPDM are the Department of Operations, Compliance 
and Monitoring (DOCM), the Protocol Review and Monitoring System (PRMS, known as the Clinical Trials 
Scientific Review and Monitoring Committee [CTSRMC]), the Data and Safety Monitoring Committee (DSMC), 
and Office of Legal Affairs, along with our disease and discipline-specialized CRUs. The DSMC is responsible 
for ensuring that all cancer-related human subjects studies abide by all Federal regulations and institutional 
policies as well as our NCI-approved ACC Data and Safety Monitoring Plan (DSMP) to ensure subject safety 
and study integrity. The DSMC complements yet functions completely independently of CTSRMC. The DSMC 
has independent oversight responsibility for all activated CTSRMC-approved protocols, serves as the parent 
committee for the ACC DSMP, and sets policies, standards and expectations for all aspects of monitoring, 
auditing and pharmacovigilance for adult and pediatric studies. Key initiatives in the current funding period 
include improved times for protocol activation (50% shorter compared to 2015), improved data tracking 
systems, enhanced operations of the CRUs, and a new leader and coordinator for NCTN trials. The result 
overall has been a 116% increase in average annual accruals to interventional trials during this funding period 
compared to the last (20% increase for treatment; 314% increase in non-therapeutic interventional). Ensuring 
the inclusion of Women and Minorities in clinical trials continues to be a central goal for the ACC, part of our 
commitment to address the cancer burden in minority and underserved populations in our catchment area. 
Extensive efforts during this funding period have resulted in exceptional representation of minorities on ACC 
clinical trials and doubling of the percentages of Black subjects enrolled on trials, now exceeding the 
percentage of Black patients seen at the ACC. Lifespan. The ACC supports participation of patients of all ages 
in clinical trials. Our CT...

## Key facts

- **NIH application ID:** 10330976
- **Project number:** 5P30CA016520-46
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** DAN TOBY VOGL
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,063,795
- **Award type:** 5
- **Project period:** 1997-01-15 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10330976

## Citation

> US National Institutes of Health, RePORTER application 10330976, Clinical Protocol and Data Management (5P30CA016520-46). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10330976. Licensed CC0.

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