Dmcc Book Appointment

[Nelida]

ThisFunding Opportunity Announcement (FOA) invites new applications for the Data Management and Coordinating Center (DMCC) for the Rare Diseases Clinical Research Network (RDCRN). Each consortium within the RDCRN is intended to advance the diagnosis, management, and treatment of rare diseases. The DMCC will facilitate and support the activities of each Rare Diseases Clinical Research Consortium (RDCRC) along with trans-network activities that broadly facilitate the advancement of rare disease research via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research and; 4) Engagement and Dissemination.

NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD(S)/PI(S) data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

The Office of Rare Diseases Research (ORDR) within the National Center of Advancing Translational Science (NCATS) along with ICOs listed in Part 1 at the National Institutes of Health (NIH) invites applications in response to this Funding Opportunity Announcement (FOA) for new applications for the Data Management and Coordinating Center (DMCC) for the Rare Diseases Clinical Research Network (RDCRN). Each consortium within the RDCRN is intended to advance the diagnosis, management, and treatment of rare diseases. The DMCC will facilitate and support the activities of RDCRCs along with trans-network activities that enable the advancement of rare disease research via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research; and 4) Engagement and Dissemination.

Despite the advances in our understanding of the causes and mechanisms of many diseases, effective treatments are available for fewer than 5% of rare diseases. Advances in technologies such as gene therapy have recently led to promising and potentially transformative treatments. However, there are several challenges in bringing effective treatments to more people living with rare diseases. First, making a diagnosis can be challenging with many patients experiencing a "diagnostic odyssey" of many months or even years because of limited knowledge of the range of disease manifestations and of genotype-phenotype studies. Second, there are often no high quality natural history datasets documenting how the disease affects patients' functioning, and how it progresses over time. Third, there are often no adequate clinical or biological markers to support the clinical development of new therapeutics. Fourth, the relatively small number of patients and clinicians caring for them cause challenges to the design and implementation of clinical trials. Finally, the resources available for therapeutics development are limited, making it critical to find frameworks for leveraging partnerships between patient groups, industry, academic investigators and Federal funding agencies. In addition, the global burden associated with rare disease necessitates international coordination and collaboration.

To facilitate progress in addressing these challenges the Rare Diseases Act of 2002 (Public Law 107-280) directed ORDR to support regional "Rare Diseases Clinical Research Consortia (RDCRCs) of Excellence" for clinical research into, training in, and demonstration of diagnostic, prevention, control, and treatment methods for rare diseases. Since the enactment of this legislation numerous NIH institutes (NCATS/NCRR, OD(ODS/ORDR), NICHD, NINDS, NIAMS, NHLBI, NIDDK, NIDCR, NIMH, NCI, NIAID and NEI), led by the ORDR at NCATS, have partnered to support the RDCRC.

Since its inception the RDCRN research program has successfully supported 31 individual consortia that conducted research on 238 individual disorders, leading to a greater understanding of rare diseases.

Each RDCRC, within the RDCRN, is intended to advance the diagnosis, management, and treatment of rare diseases. Individual RDCRCs will promote highly collaborative, multi-site, patient-centric, translational and clinical research with the intent of addressing unmet clinical trial readiness needs. Each RDCRC must target at least three rare diseases/disorders/syndromes/conditions/manifestations (referred to in this document as rare diseases). The RDCRCs will provide an outstanding environment for the training of the next generation of rare diseases researchers. Patient and stakeholder (in this document stakeholder refers to parents, caregivers, support and advocacy groups), experiences, perspectives, needs and priorities should be meaningfully incorporated into decisions and activities of the RDCRC. Participants of the RDCRN will also be expected to contribute collectively to a knowledge base that broadly facilitates the advancement of rare disease research. The DMCC will facilitate and support both the activities of RDCRCs along with trans-network activities via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research: and 4) Engagement and Dissemination.

It is imperative that applicants for the DMCC carefully review the companion FOA [Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54) (RFA-TR-18-020) to understand the full mission of the RDCRN.

The DMCC will provide services and resources to the network via the following four cores. Cores may be located at different locations as long as there is a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the RDCRN by working together with both individual RDCRCs and across the RDCRN.

Administrative Core: The administrative core will: 1) provide overall coordination for the RDCRN and management of RDCRN activities including steering committee meetings; 2) provide oversight and ensure coordination of all DMCC Cores; 3) provide support for Coalition of Patient Advocacy Groups (CPAG) meetings, and 4) is responsible for the preparation of the annual report for the External Scientific Panel (ESP).

Deidentified data collected within this Network and housed within cloud services provisioned by NCATS will become a resource for the greater rare disease research community and will be made available to the scientific community, stakeholders and other relevant partners in a timely manner that meets all NIH human subject's protection, data safety and data sharing requirement. RDCRN participants will be required to share their data within the DMCC.

NCATS ITRB will provide access to various public cloud services, and high-performance computing services for the needs of the awardees. This enables the awardees to offer their systems, projects and research in a secure environment with simplified implementation, deployment and operational reliability. Through these services, NCATS ITRB will enable the awardees to gain a self-service capability. NCATS ITRB will provide the following:

NCATS ITRB will provide the awardee with a cloud instance on any of the following public cloud service providers: Amazon Web Services, Microsoft Azure or Google Cloud Platform. This instance would be co-managed by the awardee and NCATS ITRB. Access to the awardees cloud instance would be managed using NCATS' Federated Authorization System and the awardees would have complete rights to all services provided by the Cloud Service Provider.

If requested, at no cost to the awardee, NCATS ITRB would provide access to NCATS' Federated Authorization Service. The awardee could use NCATS' Authorization Service to provide for federated access to any of their systems and applications.

If requested, NCATS IRTB will provide access to and administrative support for various common cloud services including configuration, patching, backups, and user account management. These services include, but are not limited to: Automated Configuration Management Services; Continuous Integration Services; Automated Deployment Services; Code Analysis Services; Log Aggregation and Analysis; Usage and Performance Monitoring Services; Aggregated Search Services; Cache management services; and Message Queue and Notification services.

If requested, NCATS ITRB can also provide a cloud based elastic HPC service designed to automate and scale, giving the scientists the ability to model and deploy their HPC applications in a cloud that can provide the scale and performance needed. The cloud HPC provides resources without undue access restrictions, while addressing the security concerns surrounding cloud deployments. The cloud HPC solution addresses use cases that deal with various storage, hypervisor and network services. The cloud HPC offers higher utilization and operational savings while providing a high speed, secure and federated access.

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