# Severe Asthma Clinical Studies Core

> **NIH NIH P01** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $439,236

## Abstract

PROJECT SUMMARY/ABSTRACT
Core C
The Clinical Studies Core is an integral component of the PPG as it is designed to facilitate the conduct of clinical
trials outlined in the three individual projects through economy of scale and coordinated resources. Specific
objectives of the Clinical Studies Core are to 1) Assist investigators in accessing, selecting, recruiting, and
retaining asthma subjects and healthy volunteers, 2) Assist investigators in planning, developing, and execution
of clinical projects and ensuring that all clinical trials meet good clinical practices, 3) Manage IRB and regulatory
submissions along with post-approval filings and compliance, 4) Provide oversight and/or performance of tests
and procedures, 5) Provide oversight to the collection and processing of human specimens, 6) Facilitate the
translation of discoveries made by basic science investigators into clinical investigation, 7) Assist investigators
by entering clinical study data into a Part 11 compliant database, 8) Maintain a bank of data, tissues and samples
collected from current and former patients/subjects, 9) Provide access to databases to all investigators, and 10)
Assist investigators in data analyses and manuscript preparation. This Core makes available our well-
characterized asthma populations in both Indianapolis and Cleveland for clinical studies and facilitates the bench
to bedside translation of ideas from our basic science laboratories. The Core-supported clinical projects also
generate hypotheses that are in turn returned to basic science laboratories for more detailed investigation. The
Clinical Studies Core is staffed with experienced individuals who are experts in their respective fields.

## Key facts

- **NIH application ID:** 10457993
- **Project number:** 5P01HL158507-02
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** JAMES F CHMIEL
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $439,236
- **Award type:** 5
- **Project period:** 2021-08-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10457993

## Citation

> US National Institutes of Health, RePORTER application 10457993, Severe Asthma Clinical Studies Core (5P01HL158507-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10457993. Licensed CC0.

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