# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2020 · $566,220

## Abstract

PROJECT SUMMARY/ABSTRACT (CLINICAL PROTOCOL AND DATA MANAGEMENT)
The Cancer Center Support Grant (CCSG) Clinical and Protocol Data Management (CPDM) requirements at the
University of Michigan Comprehensive Cancer Center (UMCCC) are fulfilled through the Oncology Clinical Trials
Support Unit (O-CTSU). The O-CTSU, in partnership with the Children's CTSU, are the centralized offices that
support the conduct of cancer clinical trials throughout the University of Michigan. The O-CTSU assists
investigators in the creation, submission, review, activation, conduct, oversight, and closeout reporting of
innovative cancer clinical trials in an efficient, regulatory compliant, and scientifically sound manner. By providing
a comprehensive range of centralized services, including standardized policies, procedures, training and
education, informatics, and specimen processing, the O-CTSU helps ensure efficient and effective support for
all cancer clinical trials. The primary unit responsible for executing the Data and Safety Monitoring Plan for
investigator-initiated cancer clinical trials or studies supported on competitive grants is the Data and Safety
Monitoring Committee, with the assistance of the Quality Assurance Review Core. The DSMC has the authority
to take steps to minimize patient risk and maximize the safety of participating patients, suspend protocols based
on data safety findings, and recommend closure to the PRC.

## Key facts

- **NIH application ID:** 9993340
- **Project number:** 5P30CA046592-31
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Scott Michael Schuetze
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $566,220
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9993340

## Citation

> US National Institutes of Health, RePORTER application 9993340, Clinical Protocol and Data Management (5P30CA046592-31). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9993340. Licensed CC0.

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