# Urinary Stone Disease Research Network: Scientific Data Research Center

> **NIH NIH U01** · DUKE UNIVERSITY · 2020 · $1,405,254

## Abstract

ABSTRACT
The National Institute for Diabetes and Digestive and Kidney Diseases has solicited applications to initiate a
Urinary Stone Disease Research Network (USDRN) to design and conduct a randomized clinical trial to 1)
investigate the impact of increased fluid intake and increased urine output on urinary stone recurrence in adults
and children; 2) conduct clinical research to understand and mitigate ureteral stent-related pain and symptoms;
and, 3) provide data and collect biological samples from the studies to create a resource for future researchers.
The Duke Clinical Research Institute (DCRI) proposes to serve as the Scientific Data Research Center to
provide cutting edge thought leadership, trial innovation, infrastructure, clinical and research experience, and
operational expertise necessary to support the research activities of the Network. As SDRC for the Network,
the DCRI will support the following Specific Aims: 1) coordinate the overall activities of the USDRN, network
committees and work with the NIDDK and Steering Committee to establish reliable and efficient
communication structures; 2) facilitate pragmatic trial design and creation of a distributed research network
based on prior experience with the NIH Collaboratory; 3) provide thought leadership and operational support
for trial design and protocol development, including identification of relevant clinical endpoints, appropriate
sample size/power calculations, randomization strategies, and the development of economic and patient-
reported outcomes, as appropriate; 4) develop the network Manual of Procedures, provide training and
certification for study personnel at all clinical centers, perform site monitoring and develop performance
trackers; 5) develop and manage an Electronic Data Capture system, including training, quality control, data
storage and reporting; 6) develop detailed and rigorous statistical analysis plans for each study; 7) facilitate
DSMB activities including periodic statistical analysis reports and interim analyses; 8) organize and manage
transfer of biological samples from clinical sites to the NIDDK biorepository; 9) Provide thought leadership in
developing the USDRN dissemination strategy, including website management, editorial, technical and
administrative support for all study publications, and working with the Steering Committee to effectively
disseminate the findings of USDRN studies; and, 10) support ancillary studies and facilitate use of Network
bio-specimens transmitted to the NIDDK Biorepository. Through innovative trial design, novel biostatistical
methods and operational excellence, the DCRI as SDRC will advance the care of urinary stone disease
patients and thereby improve outcomes and reduce the burden of stone disease in the United States.

## Key facts

- **NIH application ID:** 9997690
- **Project number:** 5U01DK110988-05
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Hussein Al-Khalidi
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,405,254
- **Award type:** 5
- **Project period:** 2016-09-01 → 2022-01-03

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9997690

## Citation

> US National Institutes of Health, RePORTER application 9997690, Urinary Stone Disease Research Network: Scientific Data Research Center (5U01DK110988-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9997690. Licensed CC0.

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