# SPIROMICS GIC Support

> **NIH NIH U24** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $1,415,673

## Abstract

SPIROMICS GIC ABSTRACT
This application proposes infrastructure support for the Genomics and Informatics Center (GIC) and assistance
to the clinical sites and investigators for the multi-center Subpopulations and Intermediate Outcome Measures
in COPD Study (SPIROMICS). SPIROMICS I enrolled a cohort of 2,981 participants aged 40-80, including
non-smokers and smokers with or without COPD. Data, CT images and biospecimens were collected at study
visits and participants had quarterly telephone contacts, which are ongoing. A grant application to continue the
study as SPIROMICS II has been reviewed and received a fundable priority score. SPIROMICS II will include
an additional clinic visit and continued telephone follow-up. Because SPIROMICS I was funded through
contracts from NHLBI, the biospecimens and data are the property of the federal government and NHLBI has a
vested interest in ensuring that they are stored and managed appropriately. NHLBI is also committed to the
science being undertaken in SPIROMICS and thus to maintaining contact with participants and supporting
statistical analysis for manuscripts and the infrastructure for the study.
The GIC proposes to continue to manage SPIROMICS data and biospecimens, undertake statistical analyses
of study data, collaborate in operational and scientific aspects of the study, and provide study management
and regulatory oversight. Our principal contributions to the study are grouped into the following specific aims:
  Aim 1: Maintenance and management of biospecimens. Ensure specimens are stored under
 appropriate conditions, manage the process of requesting use of specimens, and pull and ship
 specimens to investigators when approved by the Steering Committee and NHLBI.
  Aim 2: Study management and operational support. Schedule and facilitate meetings and conference
 calls, support study committees, oversee SPIROMICS policies and procedures, maintain a web site for
 the study, support continued contact with study participants, including by providing incentives to
 participants for completion of follow-up telephone calls, continue support for abstraction and
 adjudication of study endpoints, and provide improved systems for maintenance of CT images.
  Aim 3: Data management and statistical support. Manage and distribute study data and conduct
 statistical analyses for manuscripts and presentations.
  Aim 4: Regulatory oversight. Track IRB approvals, manage reporting of serious adverse events,
 ensure use of data and specimens is in accordance with each participant's informed consent, and
 report on study progress to the Observational Study Monitoring Board (OSMB).
The GIC was responsible for most of these activities in SPIROMICS I. Funding this application will enable us
to expand our support for the study, to upgrade procedures, particularly the data management system, and to
increase capacity in terms of undertaking statistical analyses for manuscripts.

## Key facts

- **NIH application ID:** 9993568
- **Project number:** 5U24HL141762-03
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** David J Couper
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,415,673
- **Award type:** 5
- **Project period:** 2018-08-15 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9993568

## Citation

> US National Institutes of Health, RePORTER application 9993568, SPIROMICS GIC Support (5U24HL141762-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9993568. Licensed CC0.

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