# Continuation of the Scientific Data Research Center (SDRC) for the NIDDK Gastroparesis Consortium

> **NIH NIH U24** · JOHNS HOPKINS UNIVERSITY · 2021 · $1

## Abstract

Project Summary/Abstract
 This proposal from the Johns Hopkins University is to continue as the Scientific Data
Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC) to
support the clinical centers as they continue to gather biospecimens and data for patients with
gastroparesis and related disorders in the Gastroparesis Registry 2 and future treatment trials.
In addition, the SDRC will support the Pathological Basis of Gastroparesis Study conducted by
Dr. Farrugia at the Mayo Clinic in Rochester, MN for identification of the molecular factors
involved in pathogenesis of gastroparesis. The goal of the GpCRC sponsored by the NIDDK
since 2006 is to focus on the etiology, treatment strategies, and clinical course of gastroparesis
that will provide the basis for understanding the natural history and developing means of better
diagnosis, treatment, and clinical management of patients with gastroparesis.
 In the next phase of the GpCRC, the studies initiated during the previous funding cycle will
be completed, and new therapeutic trials will be initiated. The SDRC will provide the GpCRC
with leadership, expertise in biostatistical analysis, study design, data management, multicenter
coordination, quality assurance, project support, communication and organization, and will be
responsible for supporting all future protocol development or modifications, including providing
sample size calculations, statistical advice, development of questionnaires, and data analysis.
The SDRC will support development, implementation, and maintenance of a database of clinical
information and a digital repository for autonomic function, wireless motility capsule, and
scintigraphy studies. The SDRC will work with the centers and the NIDDK Repository to track
and maintain an inventory of all biospecimens obtained. The SDRC will develop or modify any
data monitoring plans, support manuscript preparation, and coordinate the activities and
meetings of the Steering Committee (SC). The SDRC will prepare or modify protocols for
submission to the Data and Safety Monitoring Board (DSMB) and the SC for their approval prior
to the implementation of any study protocols or protocol changes. The SDRC will be
responsible for preparation of documents for submission to the Food and Drug Administration
(FDA) in support of Investigational New Drug (IND) or Investigational Device Exemption (IDE)
applications on behalf of the GpCRC. The SDRC will prepare all reports including data reports
for review by the DSMB at their meetings. The SDRC will be responsible for acquiring and
administering subcontracts as needed. The SDRC and will continue to work with the NIDDK
Biosample, Genetic, and Data Repositories, and the clinical centers to coordinate procedures
for coding, shipping, processing, receipt, and storage of study samples that are to be
maintained in the Repositories.
 The GpCRC is poised to continue to have major impact on the field and directly advance the
mission o...

## Key facts

- **NIH application ID:** 10071160
- **Project number:** 5U24DK074008-15
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** James A Tonascia
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1
- **Award type:** 5
- **Project period:** 2006-05-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10071160

## Citation

> US National Institutes of Health, RePORTER application 10071160, Continuation of the Scientific Data Research Center (SDRC) for the NIDDK Gastroparesis Consortium (5U24DK074008-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10071160. Licensed CC0.

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