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Mike's Blog - May 2020

Figuratively – impossible, but virtually – I’m possible!

Switching the Spring CTSA Program meeting from in-person to virtual was not a simple task but I believe we were able to really pull this off.  With CLIC’s coordination and a great effort from the group leads, CLIC coordinators and meeting participants, the virtual gatherings included key topics, lively chats and extremely fruitful discussions. Overall, the level of engagement was palpable (from a safe distance) and contributions from hubs and participants were highly regarded.  A total of 5 virtual gatherings took place between April 14 and 15, with attendance ranging from 57 to 216 participants per gathering. Continue Reading

THE SPOTLIGHT


National COVID Cohort Collaborative (N3C)

The National COVID Cohort Collaborative (N3C) is a complementary and synergistic partnership among the Clinical and Translational Science Award (CTSA) hubs, distributed clinical data networks (PCORnet, OHDSI, ACT/i2b2, TriNetX), and other partner organizations. The N3C aims to improve the efficiency and accessibility of analyses using a very large row-level (patient-level) COVID-19 clinical dataset and demonstrate a novel approach for collaborative pandemic data sharing. Learn more about the N3C in our webinar from this year’s symposium of the American Medical Informatics Association recorded on April, 13th: “Building a Nationwide COVID-19 Cohort Through Informatics: A new initiative being coordinated by CD2H NCATS.”

The N3C welcomes partnership with the scientific community through four work streams that are open to anyone. Each workstream will provide weekly updates in this bulletin. To join the N3C effort and connect with participants, please follow the instructions found at here


WHAT'S NEW


Common Metrics Insights to Inspire (I2I)

Insights to Inspire (I2I), a series of blogs and webinars highlighting success within NCATS' Common Metrics Initiative, will begin its 2020 season soon!!

I2I is meant to foster innovation, encourage collaboration between CTSA Program hubs, and to inspire action! The CLIC team has spent the spring interviewing the “featured” hubs in the most recent Annual Common Metrics Report for the Careers in Clinical & Translational Research metric.

Beginning in June, these featured hubs will be highlighted in a series of blogs on the CLIC website and you will be invited to participate in webinars to hear them share the unique and innovative approaches they successfully implemented to turn their insights into results.

In the meantime, you can get inspired by checking out last year's series of I2I blogs and you can also share your hubs’ “insights” on the CLIC website.

Emergency Competitive Revisions and Administrative Supplements to Clinical and Translational Science Award (CTSA) Program Awards to Address COVID-19 (NOT-TR-20-028)

The National Center for Advancing Translational Sciences (NCATS) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for projects that address the COVID-19 Public Health Emergency. The Clinical and Translational Science Award (CTSA) Program is uniquely qualified to contribute to these efforts. NCATS is soliciting applications for Administrative Supplements (through PA-18-591) and Emergency Competitive Revisions (through PA-20-135) from current Clinical and Translational Science Award (CTSA) UL1 and U24 award recipients.

Applications will be accepted immediately and on a rolling basis through November 10, 2020 by 5:00 PM local time of the applicant organization.

The Research Strategy section of the application is limited to 6 pages. Address assurances that the proposed project can be performed as described under the current Public Health Emergency circumstances.

The project period will generally be limited to 1 year. Project periods up to 2 years will be considered only with strong justification.

For questions, please contact the program officer on your active award.

 

Notice of Change in Eligibility and Activity Codes for NOT-TR-20-011 (NOT-TR-20-018)

The dual purpose of this Notice is to expand the eligibility and activity codes to include U24 parent awards. Changes are in italics.

RFA-TR-17-006 CTSA Program Data to Health (CD2H) Coordinating Center (U24)

RFA-TR-16-021 Coordination Center for the CTSA Program (U24)

RFA-TR-15-002 CTSA Network - Trial Innovation Centers (TICs) (U24)

RFA-TR-15-004 Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs)(U24)

Note concerning the Award Project Period: Recipients may apply for work that is related to your funded project, whether within the scope or outside of the scope of the current project, regardless of the time remaining on the current project. Grants currently in an extension are eligible to apply.

Change in NCATS Prior Approval Process for New CTSA Program Pilot Projects that Involve Human Subjects Research (NOT-TR-20-019)

As of April 9, 2020 NCATS will no longer require CTSA institutions to wait for NCATS approval for new domestic UL1 CTSA Program Pilot Projects involving human subjects that are deemed by the IRB or recipient institution to be non-NIH-defined Clinical Trial minimal risk or exempt (45 CFR 46) studies. The entry of these studies into the eRA the Human Subjects System (HSS) along with modified NCATS-specified documentation continues to be required. Although NCATS prior approval will no longer be provided, non-NIH defined clinical trial minimal risk or exempt (45 CFR 46) studies may not begin until all required documentation has been submitted into the eRA HHS system. Failure to submit the required documentation prior to initiating the pilot project study will result in non-compliance enforcement actions. This guidance applies to CTSA UL1 Pilot Program Projects and does not apply to projects funded under the CTSA KL2 Program. All KL2 Scholar Projects that involve human subjects research continue to require NCATS Prior Approval.

Clinical and Translational Science Award (CTSA) Program Administrative Supplements (NOT-TR-20-014)

National Center for Advancing Translational Sciences (NCATS) is issuing this Notice of Special Interest (NOSI) to seek UL1 Administrative Supplements to add a dedicated quality assurance/quality control position to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process. To facilitate consistency, efficiency, and enhance the submission of successful CTSA-related information packages to NCATS, this Notice seeks CTSA Program UL1 administrative supplements to support an individual to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process. Administrative Supplement Application Receipt Date(s): May 4, 2020; September 11, 2020; April 5, 2021; September 10, 2021; April 4, 2022; September 9, 2022

Administrative Supplements for NIH grants to Add or Expand Research Focused on Maternal Mortality (NOT-OD-20-104

The Office of the Director of the National Institutes of Health (NIH) announces the opportunity for investigators with relevant active NIH-supported grants from the participating Institutes listed in the Notice of Special Interest above to address the scientific priorities that will lay the foundation for the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE), which is in development. Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent: PA-18-591.

Application Due Date(s): June 22, 2020 by 5:00 PM local time of applicant organization. Please direct all NCATS inquiries to Dr. Soju Chang

Fast-Track Program for COVID-19 Test Development and Distribution

Innovative Technologies to Increase U.S. Capacity for COVID-19 Testing NIH POCTRN is now accepting proposals for support on a rolling basis until further notice.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is urgently soliciting proposals and can provide up to $500M across multiple projects to rapidly produce innovative SARS-CoV-2 diagnostic tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics (RADx), is a fast-track technology development program that leverages the National Institutes of Health (NIH) Point-of-Care Technology Research Network (POCTRN). RADx will support novel solutions that build the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches. RADx is structured to deliver innovative testing strategies to the public as soon as late summer 2020 and is an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available to every American.

Additional topics and information:

NCATS Cost Extension Policy: https://ncats.nih.gov/funding/grantees/approval#extensions

Guidance Regarding Adding Foreign Components: https://ncats.nih.gov/funding/grantees/approval#foreign-components 

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