# Clinical Protocol and Data Management

> **NIH NIH P30** · INDIANA UNIVERSITY INDIANAPOLIS · 2020 · $431,740

## Abstract

ABSTRACT, Clinical Protocol and Data Management (CPDM)
The CTO is critical to the success of all clinical trials conducted through the IUSCC. In 2017, the CTO
managed 367 active trials, 101 of which were Investigator Initiated (IITs). The CTO is led by Associate Director
for Clinical Research, Kathy Miller, M.D. (EDT) and Administrator, Mario Contreraz, MBA, MSN, RN, CCRC,
who provide leadership and oversight of the day-to-day operations to ensure comprehensive high-quality
services and to streamline efforts to open trials and increase accrual.
The Indiana University Melvin and Bren Simon Cancer Center (IUSCC) Clinical Trials Office (CTO) supports and
enhances IUSCC members' ability to conduct clinical cancer research. The CTO provides comprehensive
services to assist investigators in developing, activating and completing scientifically meritorious clinical trials in
a high quality, cost-effective, efficient manner. At the same time, the CTO ensures the validity and integrity of
data in order to fulfill all NCI, federal and local regulatory requirements. The CTO does so, through the following
Specific Aims: Aim 1: To facilitate the efficient development, conduct, and reporting of clinical trials across the
range of therapeutic interventional, correlative and population-based studies by maintaining a centralized
infrastructure and educated workforce; Aim 2: To ensure continued and expanded access to clinical trials,
particularly for the underserved populations within our catchment area and beyond.; and Aim 3: To support
clinical trial accrual through the implementation and coordination of disease-oriented teams (DOTs).
Over the past funding cycle, we have created new positions to better support the increasing clinical trial
complexity driven by the increase in IITs and IUSCC-led multicenter trials. For example, we hired multicenter
coordinators (MCRC) to support continued growth of our investigator-initiated multi-center trials and a second
protocol development specialist to assist with IITs. The CTO has also created positions for Clinical Research
Protocol Specialists (CRPS), who aid in the conduct and management of non-interventional correlative trials
including subject consent, verification of eligibility, collection and submission of key clinical and laboratory data
elements.

## Key facts

- **NIH application ID:** 9987564
- **Project number:** 5P30CA082709-21
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Kathy D. Miller
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $431,740
- **Award type:** 5
- **Project period:** 1999-09-22 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9987564

## Citation

> US National Institutes of Health, RePORTER application 9987564, Clinical Protocol and Data Management (5P30CA082709-21). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9987564. Licensed CC0.

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