Key Dates

Related Announcements

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Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this notice is to inform investigative teams funded under the Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional) (RFA-TR-18-020) of the opportunity for continued access to the RDCRN Operational Environment cloud platform once funding ends. This RDCRN Alumni Site includes all databases related to their specific consortium that were active during their tenure as an RDCRC and the ongoing use of network tools. The RDCRN Data Management Coordinating Center (DMCC) (RFA-TR-24-021) will only handle security management, account management, and data storage. Any custom development, setup, additional data, or data management requirements will be the responsibility of the alumni.

While creating opportunities for new research groups is crucial, it is important to continue to provide data access for existing meritorious consortia as they transition from RDCRN support to independence. By providing access to the RDCRN cloud platform NIH can ensure alumni can maintain and finalize their study data in a secure environment. This data environment is intended to foster continued collaboration within the consortia, ensure data access and provide analytic tools. Prior experience has proven that if there is no means or purpose for the individual consortia partners to collaborate, they will more often than not disband, and data may be lost. The RDCRN data environment provides not only access to their data resulting from the NIH grant but also access to resources that can support the consortia in their transition to independence. It is the intent of the RDCRN to promote the sharing of scientific data by providing access to high-value, quality datasets and to promote re-use for future studies. The ultimate goal is for the RDCRN to be able to utilize this data environment to publicly share the RDCRN data.

NCATS will provide data access, tools and storage (provisioned by the DMCC) for up to five years.

This RDCRN Alumni Site will provide prior RDCRN consortia recipients NIH access to all databases and tools related to the work from their specific consortium and RDCRN collaborative projects. Data in the operational environment is considered to be in a pre-sharing condition, meaning the U54 recipients are continuing to clean, organize, and analyze data that they themselves have collected. To ensure compliance with NIH policies and regulations related to human subject research studies, access is only provided for the update and revision of data resulting from studies originated under the prior RDCRC award.

While these applications were all funded prior to the NIH Data Management and Sharing (DMS) policy, it has always been the intent of the RDCRN to promote the sharing of scientific data, as documented in RFA-TR-18-020, by providing accessibility to high-value datasets and promoting reuse for future research studies.

The data from the RDCRN consortia will be shared publicly in the RDCRN-Data Sharing resources which are currently being established.   

Additional Information

No budgetary support will be provided. Alumni are expected to demonstrate their expertise and resources to operate independently within the RDCRN Operational Environment, (e.g., institutional support, PAG support, industry support as needed). Furthermore, successful alumni must show they have the appropriate governance in place to manage the existing RDCRC and the capacity to sign any agreements, Data Use Agreement (DUA), or Memoranda of Understanding established by the NCATS.

The DMCC will provide successful alumni with detailed rules of engagement and program expectations. Alumni are expected to maintain transparency in their activities and meet semi-annually with the DMCC team. Additionally, alumni will be required to incorporate the Network’s platform and operational procedures into their plans and work collaboratively within the DMCC environment, establishing internal policies for effective cooperation.

The DMCC will remain available for consultation on issues such as troubleshooting new accounts or addressing administrative or technical challenges beyond the consortium staff's expertise. However, the consortium, having received training prior to the end of the parent grant, is expected to have acquired sufficient expertise to manage tasks like REDCap projects independently and have financial support for any expenses required.

The RDCRN DMCC will provide all “graduating” and departing consortia a "rolling-off package" containing detailed rules of engagement and expectations for participating in the “RDCRN Alumni Site.”

Examples of tools currently available within the DMCC include:

• Ambra Imagining Platform
• Biospecimen Tracker
• Box
• Cavatica
• Chiron
• JupyterHub
• NIH Toolbox
• Pedigree Drawing Tool
• RedCap
• RStudio
• SAS Studio

Tools for Utility, Communication, and Administration include:

• Atlassian tools (Confluence, DMCC Help Center, JIRA)
• Drupal
• GitHub
• Grants Portal
• Mailchimp
• Members Landing Page
• Moodle
• Protocol Database
• Slack
• StatusPage
• Twilio text messaging
• Vimeo
• YouTube Channel
• Zoom

Any research activities conducted within the RDCRN Operational environment must remain within the scope of the most recent parent grant.  Successful alumni must obtain participant consent and utilize a single IRB consistent with NIH’s Single IRB Policy, as outlined in NOT-OD-16-094, for any protocols involving human subjects research. 

To request access to the RDCRN Alumni Site, please visit the webpage https://ncats.nih.gov/research/research-activities/rdcrn/applicant-information. Requests are due no later than September 30, 2025 and the opportunity to request access will expire on October 1, 2025.

Inquiries

Please direct all inquiries to:

Tiina K. Urv, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-2746 
Email: [email protected]