# Clinical Protocol and Data Managment

> **NIH NIH P30** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $316,620

## Abstract

ABSTRACT, Clinical Protocol and Data Management (CPDM)
The Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) provides
the clinical research infrastructure to support IUSCCC investigators and enhance their clinical research
productivity. The CTO provides comprehensive services to assist investigators in developing, activating, and
conducting scientifically meritorious cancer clinical trials, recruits and trains research staff, and educates clinical
investigators. At the same time, the CTO ensures the validity and integrity of data to fulfill all National Cancer
Institute (NCI), federal, and local regulatory requirements and coordinates activities with the Protocol Review
Management System, Data and Safety Monitoring Committee, IUSCCC Compliance Office, Institutional Review
Board (IRB), disease-oriented teams, and protocol sponsors. The Compliance Office reports directly to the
Associate Director for Clinical Research and monitors and audits all IUSCCC investigator-initiated trials (IITs) to
ensure subject safety, scientific validity, and data integrity. We accomplish these goals through the following
Specific Aims: Aim 1: 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: Expand access to clinical trials, particularly for underserved
populations, to better reflect and serve our catchment area while reducing the time to study completion; and Aim
3: Maintain regulatory compliance, subject safety, and data quality to instill confidence in clinical trial participation
and results. Over the past funding cycle, the CTO staff has grown by 32% to support the growth and increased
complexity of clinical research at IUSCCC. We have invested in multiple organizational improvements, including
expanding the multi-center team and patient-facing non-licensed clinical research staff, increasing protocol
development services, and adding a Statewide Oncology Research Administrator. While accrual over the entire
current grant period decreased due to the COVID-19 pandemic, interventional accruals recovered and exceeded
pre-pandemic levels in 2022 (1484 vs. 1370 in 2019). Our commitment to therapeutic IITs led to a 27% increase
in IIT accrual for the current grant period (2018-22) over the prior (2013-17) grant period.

## Key facts

- **NIH application ID:** 10934645
- **Project number:** 2P30CA082709-25
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Tim Lautenschlaeger
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $316,620
- **Award type:** 2
- **Project period:** 1999-09-22 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10934645

## Citation

> US National Institutes of Health, RePORTER application 10934645, Clinical Protocol and Data Managment (2P30CA082709-25). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10934645. Licensed CC0.

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