DAta | National Center for Advancing Translational Sciences

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17832	NIH expands clinical trials to test convalescent plasma against COVID-19	UPDATE:Results from the CONTAIN COVID-19 trial showed that for people hospitalized with COVID-19, convalescent plasma taken from those who had recovered was not more effective than placebo in delivering clinical improvement. Read a statement about the results published in January 2022.Results from the Passive Immunity Trial for our Nation (PassITON) showed that treatment with convalescent plasma did not improve clinical outcomes in adults hospitalized with COVID-19. Read the journal article published in June 2022.Two randomized, placebo-controlled clinical trials are evaluating convalescent plasma from people who have recovered from COVID-19 as a treatment for those hospitalized with COVID-19. (Alex Edelman/AFP via Getty Images)September 22, 2020Rigorous studies to build on earlier efforts to test the experimental treatmentTwo randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19.Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and neutralize SARS-CoV-2, the virus that causes COVID-19, as well as other components that may contribute to an immune response.“The evidence on convalescent plasma as a treatment for severe cases of COVID-19 is promising but incomplete. We need to carry out rigorous randomized control clinical trials to determine how this therapy can improve outcomes,” said NIH Director Francis S. Collins, M.D., Ph.D. “While the world waits for an effective vaccine, it is vital that we simultaneously expand the options for available treatments for those currently suffering from the worst effects of this disease.”The trials expect to enroll hospitalized patients across the country at academic and community-based hospitals. Participants will be randomly assigned to receive the treatment or a placebo. Outcomes will be compared with respect to clinical improvement measures and resource needs, such as ventilators. Both trials currently are enrolling participants and anticipate results as early as this fall.The trials are receiving $48 million in support through Operation Warp Speed (OWS), a collaborative initiative across federal agencies to advance the development, manufacturing and distribution of COVID‑19 vaccines, therapeutics and diagnostics.The National Center for Advancing Translational Sciences (NCATS), part of NIH, will oversee the grant awards through its Clinical and Translational Science Awards (CTSA) Program research network. The CTSA’s Trial Innovation Network (TIN) will play a key role in working to add study sites and enroll patients, including those from communities disproportionately affected by COVID-19. “The rapid expansion of these vital randomized, controlled convalescent plasma clinical trials demonstrates how nimbly the network of CTSA Program hubs and the TIN can respond to the nation’s research needs and shorten the path from discovery to treatment,” said NCATS Director Christopher P. Austin, M.D.One trial, called Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients, was launched in April by NYU Langone Health in New York, with collaboration from the Albert Einstein College of Medicine and Yale University, New Haven, Connecticut, and with funding from NCATS. To increase enrollment in the trial, NYU is partnering with The University of Texas Health Science Center at Houston and the University of Miami in Florida to enroll participants at sites in these states.With these additional sites, this trial expects to enroll approximately 1,000 hospitalized patients 18 years or older with respiratory symptoms of COVID-19. The trial is primarily assessing clinical improvement at 14 and 28 days and also will be evaluating outcomes based on mortality, intensive care unit admission and patient antibody concentrations. Additional information about this study and participation is available at ClinicalTrials.gov under study identifier NCT04364737.The trial called Passive Immunity Trial of Our Nation for COVID-19 also is expanding to enroll about 1,000 participants. Vanderbilt University Medical Center in Nashville, Tennessee, which launched the trial in April, will have access to about 50 additional clinical trial sites across the CTSA Program. Participants are 18 years or older with acute respiratory infection symptoms and laboratory-confirmed SARS-CoV-2 infection; they may be hospitalized or in an emergency department and likely to be admitted. The trial primarily will assess clinical improvement at 15 days and also will evaluate ventilation use, supplemental oxygen use, acute kidney injury and cardiovascular events. Additional information about this study and participation is available at ClinicalTrials.gov under study identifier NCT04362176.Media Contact: info@ncats.nih.govAbout the National Center for Advancing Translational Sciences (NCATS): NCATS conducts and supports research on the science and operation of translation — the process by which interventions to improve health are developed and implemented — to allow more treatments to get to more patients more quickly. For more information about how NCATS helps shorten the journey from scientific observation to clinical intervention, visit https://ncats.nih.gov.About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.NIH…Turning Discovery Into Health®	Two randomized, placebo-controlled clinical trials are expanding enrollment to test convalescent plasma against COVID-19.	/sites/default/files/CP_900x600px_1.jpg	NIH Expands Clinical Trials for Convalescent Plasma Against COVID-19	Two randomized, placebo-controlled clinical trials are expanding enrollment to test convalescent plasma against COVID-19.	/sites/default/files/CP_900x600px_1.jpg	NIH Expands Clinical Trials for Convalescent Plasma Against COVID-19
17805	Translational Science Interagency Fellowship				Translational Science Interagency Fellowship			Translational Science Interagency Fellowship
17778	NCATS, NRL Create Nanoparticle SARS-CoV-2 Model to Speed Drug Discovery for COVID-19	A team of NCATS and U.S. Naval Research Laboratory scientists has developed a new tool to help see how SARS-CoV-2 infects a cell. Here, the tool, which consists of a fluorescent nanoparticle called a quantum dot combined with a virus protein (in magenta), interacts with ACE2 receptors (in yellow) on cell surfaces. Please direct permission questions related to this article to the ACS. (ACS)September 18, 2020A team of scientists from the NCATS and Naval Research Laboratory (NRL) in Washington, D.C., has developed a new tool that mimics how SARS-CoV-2 — the virus that causes COVID-19 — infects a cell, information that could potentially speed the search for treatments against the disease.The tool is a fluorescent nanoparticle probe that uses the spike protein on the surface of SARS-CoV-2 to bind to cells and trigger the process that pulls the virus into the cell. The probe could be used in tests to rapidly gauge the ability of biologics, drugs and compounds to block the actual virus from infecting human cells. The researchers’ findings appeared online Aug. 26 in ACS Nano.“Our goal is to create a screening system to find compounds that block SARS-CoV-2 from binding to cells and infecting them,” explained Kirill Gorshkov, Ph.D., a translational scientist at NCATS and a co-corresponding author of the study.However, using the actual virus in such screening studies would be difficult and require special facilities. Instead, Gorshkov and Eunkeu Oh, Ph.D., a research biophysicist at NRL and co‑corresponding author of the study, and their colleagues wanted to use nanoparticles to mimic the viral function of binding to and invading the host human cell.The NCATS and NRL researchers collaborated to design and test the probe, combining their complementary skill sets to deliver results far sooner than separate research efforts would have. The NRL team, led by Mason Wolak, Ph.D., an expert in optical nanomaterials, put the initial collaboration together.“We at NRL are experts in nanoparticles, and the NCATS researchers are experts in drug screening using cellular systems,” explained Oh. “So, it was the perfect match.”To create the probe, NRL scientists built a fluorescent nanoparticle called a quantum dot, fashioned from cadmium and selenium. At around 10 nanometers in size, these spherical nanoparticles are 3,000 times smaller than the width of a human hair.The NCATS–NRL research team then studded the quantum dots’ surfaces with a section of the SARS-CoV-2 spike protein that binds to the angiotensin-converting enzyme 2 (ACE2) receptor on human cells. The union of the spike protein with ACE2 is the first step in the pathway to viral infection.The glow from the quantum dots allows scientists to track the dots’ behavior under a microscope. “Because they’re such bright fluorescent objects, the quantum dots give us a powerful system to track viral attachment and effects on the cell in real time,” explained Gorshkov.The investigators tracked how the quantum dot probes interacted with human cells that have ACE2 on their surfaces. They watched the nanoparticle probes attach to ACE2, which combined with the probes and pulled them into the cells. The quantum dot probes did the same in a lung cell line commonly used in coronavirus assays. Safety data showed that the probes were not toxic to the test cells at the concentrations and exposure times used in the study.The quantum dots followed the SARS-CoV-2 pathway into cells, but the research team found the probes also mimicked the virus in the presence of antibodies. Antibodies are proteins made by the immune system that can neutralize viruses such as SARS-CoV-2. The antibodies proved to be potent inhibitors of the quantum dot probes as well, preventing them from binding to ACE2 and entering human cells.That antibody response means the quantum dot probes could help researchers rapidly test the ability of potential therapeutic agents to block the virus from entering and infecting cells. Assays using the probes also could determine the concentrations at which potential treatments may safely and effectively block infection.“Using the quantum dots, we could create tests to use in drug screening and drug repurposing, using libraries of compounds that have activity but that also are approved by the U.S. Food and Drug Administration,” Gorshkov said. “Such assays could rapidly identify promising, safe treatments for COVID-19.”ACE2 may not be the only receptor SARS-CoV-2 targets, and the quantum dot probe’s flexible design will allow researchers to swap in spikes that bind to other receptors. With the probe, researchers also could test how mutations in the spike change the way the virus behaves — and how well treatments work — by adding the mutated spikes to the quantum dots.Beyond SARS-CoV-2, researchers could revise the nanoparticle probe to mimic other viruses and reveal their pathways to infection. The quantum dot probes also could be useful when testing potential therapies for other diseases, Gorshkov said. The quantum dots also might deliver drugs directly to cells, narrowing treatment to specific cell types, organs or cancers.	Researchers from NCATS & the Naval Research Laboratory made a nanoparticle probe that mimics how SARS-CoV-2 infects a cell.	/sites/default/files/Kirill_1200x630px.jpg	NCATS, NRL Create Nanoparticle Model to Speed COVID-19 Drug Discovery	Researchers from NCATS & the Naval Research Laboratory made a nanoparticle probe that mimics how SARS-CoV-2 infects a cell.	/sites/default/files/Kirill_1200x630px_0.jpg	NCATS, NRL Create Nanoparticle Model to Speed COVID-19 Drug Discovery
17913	NCATS ASPIRE Challenges Questions and Answers	What is the NIH Helping to End Addiction Long-termSM Initiative, or the NIH HEAL InitiativeSM? What are the NCATS ASPIRE Challenges for Translational Innovation in Pain, Opioid Use Disorder and Overdose? Where can I find information about the winning submissions to the NCATS ASPIRE Design Challenges? May a person, team, or entity apply to the Reduction-to-Practice Challenge without having submitted a design to the NCATS ASPIRE Design Challenges? May a Design Challenge winner apply to the NCATS ASPIRE Reduction-to-Practice Challenge? What is a prize competition? What are some advantages to using the prize competition mechanism? May non-U.S. citizens and/or non-permanent residents participate in the challenge? May federal employees participate in the challenge? Is an account with Challenge.gov required to compete? What will be the method of payment? How will prizes be awarded? May innovators fund development of submissions with federal funds? What are the options for participating in this challenge without using federal funds? Who will evaluate submissions and select winners? Who are the subject matter experts (SMEs)? Who are the federal judges? May innovators participate on multiple teams? What information should be included in a submission? May an innovator’s qualifications statement exceed five pages? What should be included in the qualifications statement? When should teams form, and what is NCATS’ level of involvement with the teams? Are preliminary data required for the planning stage of the Reduction-to-Practice Challenge? Are innovators required to use a particular data set? Will submissions to advance in vivo biological assays be considered? May innovators ask additional questions? What is the NIH Helping to End Addiction Long-termSM Initiative, or the NIH HEAL InitiativeSM? The HEAL Initiative is a trans-agency effort to address the national opioid epidemic. The initiative will bolster research to improve treatments for opioid misuse and addiction and enhance pain management. More information can be found here: www.nih.gov/research-training/medical-research-initiatives/heal-initiative. What are the NCATS ASPIRE Challenges for Translational Innovation in Pain, Opioid Use Disorder and Overdose? Through the NCATS ASPIRE Challenges, NCATS aims to develop innovative and catalytic approaches to help solve the opioid crisis through development of next generation non-addictive analgesics with new chemistries, data-mining and analysis tools and technologies, as well as biological assays that will revolutionize discovery, development and preclinical testing of new and safer treatments of pain, opioid use disorder and overdose. In the NCATS ASPIRE Design Challenges, the first phase, NCATS asked for innovative ideas to be submitted as concept proposals. Prizes were awarded for each of the design challenges. To view the list of winners, please see: ncats.nih.gov/aspire/2018ChallengeWinners. In the distinct, follow-on NCATS ASPIRE Reduction-to-Practice Challenge, the second phase, NCATS is asking for the further scientific and technological development of a comprehensive integrated solution to pain, opioid use disorder, and/or overdose. The ASPIRE Reduction-to-Practice Challenge comprises three stages: planning, prototype development and milestones delivery, and prototype delivery and validation/testing. Reduction-to-practice Challenge: Expected challenge kick-off November 2020 Open to all eligible innovators. Design Challenge winners are encouraged to revise and resubmit their ideas to the reduction-to-practice stage. New teams with innovative ideas are encouraged and will be allowed to enter the challenge at this phase Where can I find information about the winning submissions to the NCATS ASPIRE Design Challenges? Abstracts for the winning designs may be found here: ncats.nih.gov/aspire/2018ChallengeWinners. May a person, team, or entity apply to the Reduction-to-Practice Challenge without having submitted a design to the NCATS ASPIRE Design Challenges? Yes. Innovators in the Reduction-to-Practice Challenge do not need to have submitted a design to the ASPIRE Design Challenges. This Challenge is an open competition and new submissions with novel solutions are encouraged. May a Design Challenge winner apply to the NCATS ASPIRE Reduction-to-Practice Challenge? Yes. Winners of the NCATS ASPIRE Design Challenges are encouraged to apply to the Reduction-to-Practice Challenge. Winners of Challenge 5 (the Integrated Solution Challenge) of the Design Challenges must develop plans such that all four component areas (integrated chemistry database, electronic synthetic chemistry portal, predictive algorithms, and biological assays) are integrated into their comprehensive platforms. What is a prize competition? For a prize competition, or “challenge,” a monetary award is offered to a winning innovator(s) whose solution meets the judging criteria. Success depends on meeting the challenge’s defined scientific goals. The America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Reauthorization Act of 2010 (America COMPETES Act) is the original prize authority. The American Innovation and Competitiveness Act (AICA) updated this federal prize competition authority in December 2016 under the Science Prize Competition Act section. In addition to stimulating innovation that has the potential to advance the agency’s mission, these pieces of legislation encourage public-private partnerships and commercialization of final products. What are some advantages to using the prize competition mechanism? A prize competition provides the best means of achieving the objectives of the NCATS ASPIRE Program because it addresses the intractable problem of transforming synthetic chemistry from an empirical endeavor to a predictive undertaking, While certain capabilities exist under other funding instruments available to NCATS, the constellation of capabilities required to reward and spur the degree of innovation, collaboration and transparency requisite to advance the NCATS ASPIRE Program, at a pace appropriate to address a public health emergency, is best addressed under prize authority. Critical to the success of the program are several capabilities: engage diverse and non-traditional stakeholders, including individuals unaffiliated with an organization, who may not otherwise take advantage of NIH opportunities (e.g., NSF, DARPA and NIST grantees), as well as citizen scientists; ensure high visibility to ignite and sustain interest and momentum through broad advertisement using the federal challenge.gov (www.challenge.gov/) platform to augment traditional means (e.g., the NIH Guide to Grants and Contracts); jumpstart the effort by rapidly identifying successful designs to move toward the immediate scientific objective in the context of the opioid crisis and simultaneously obtain generalizable information to disseminate due to NCATS’ ability to immediately share winning designs with the public; and mitigate risks by awarding cash prizes for completed designs instead of providing funding for yet-to-be-developed designs. May non-U.S. citizens and/or non-permanent residents participate in the challenge? Yes. While non-U.S. citizens and non-permanent U.S. residents are not eligible to win a prize (in whole or in part) under the America COMPETES Act, NIH generally permits non-U.S. citizens and non-permanent U.S. residents to register for and participate in NIH challenges. Such individuals may, for example, participate as part of a team that satisfies the applicable eligibility criteria and may be recognized when the results are announced, but they are not permitted to receive any monetary prizes. In addition, entities may also participate in this Challenge provided they are incorporated in and maintain a primary place of business in the United States. Each team must designate a lead who must be a U.S. citizen or permanent resident and who is responsible for all correspondence regarding this challenge. The official language regarding eligibility can be found on the NCATS Challenge Details page. May federal employees participate in the challenge? Innovators may NOT be a federal entities or federal employees acting within the scope of their employment. Innovators may NOT be employees of HHS acting in a personal capacity. If employed by a federal agency other than HHS, innovators should consult with an ethics official at their respective agencies to determine if participation violates federal ethics rules. Is an account with Challenge.gov required to compete? No. A Challenge.gov account is not necessary to participate in the challenge. The challenge announcement will be posted at Challenge.gov, but submissions will NOT be accepted at Challenge.gov. What will be the method of payment? Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. How will prizes be awarded? Prizes will be awarded directly to each eligible member of the winning team, so award apportionment within a team will need to be specified by the winning teams. All members of winning team(s) will be announced and recognized by NCATS. Winning team members will be listed on the NCATS website and promoted through various other NCATS communications. May innovators fund development of submissions with federal funds? No. Innovators may not fund the work to participate in this challenge using federal grant or contract funds. The challenge announcement states that “Federal grantees may not use Federal funds from a grant award to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.” Additionally, the announcement states that “Federal contractors may not use Federal funds from a contract to develop their Submissions or to fund efforts in support of their Submission.” Therefore, alternative funding must be used to do the work. What are the options for participating in this challenge without using federal funds? Some ideas for alternate funding sources include using development money from the innovator’s institution, starting a crowdfunding campaign, and applying for grants from non-federal organizations with similar goals and missions. Who will evaluate submissions and select winners? All submissions will be evaluated by a team of subject matter experts (SME) who hold expertise and experience directly relevant to the Challenge. The solutions and evaluation statements from the SME team will then be reviewed by federal employees with appropriate expertise and experience who will serve as judges to select the Challenge winners, subject to the final decision by the Award Approving Official. Who are the subject matter experts (SMEs)? The subject matter experts (SMEs) on the review teams and site visit teams as well as the staff members in the NCATS-designated laboratories who will evaluate the prototypes, are scientists with cross-disciplinary expertise that will be necessary to best evaluate the submissions. SMEs will have direct experience in the fields of synthetic chemistry, drug discovery and development, database and/or algorithm development, and/or development of novel physiologically relevant biological assays. Pain, addiction and overdose experts will be included as well. The names of the SMEs will be posted on the NCATS ASPIRE webpage upon confirmation of their participation. NCATS reserves the right to add technical consultants upon receipt of submissions, if additional expertise is needed. Who are the federal judges? The federal judges will be federal employees who have extensive expertise related to the topics of the challenges, including, but not limited to, a wide spectrum of expertise along the drug discovery and development continuum, 2-D and 3-D biological assay development, stem cell biology, pain biology, bioengineering, and development of tools and technologies for data analysis. The names of the federal judges will be posted on the NCATS ASPIRE Challenges webpage upon confirmation of their participation. NCATS reserves the right to add members to the judging panels upon receipt of submissions, if additional expertise is needed. May innovators participate on multiple teams? Yes. An individual may be a team lead on multiple and clearly distinct submissions and/or a team member on multiple submissions. What information should be included in a submission? Please refer to the announcement and submission template for a full description of information that must be included in submissions. One element that must be included is contact information. If participating singly as an individual or entity, please provide your name and affiliation. If participating as a team, please provide the team lead’s name and affiliation, names and affiliation of other team members, and indicate the name of the challenge in which you are competing. May an innovator’s qualifications statement exceed five pages? What should be included in the qualifications statement? No. The qualifications statement is limited to five (5) pages. For each team member, NCATS suggests including a brief summary of expertise, any accomplishments that were directly relevant to the team members’ abilities to carry out their roles, and any other information directly relevant to a challenge the innovator is entering. When should teams form, and what is NCATS’ level of involvement with the teams? NCATS expects the team formation aspect for challenges to be flexible and of maximum benefit towards addressing the challenge area (i.e., assemble your teams as needed to push the science forward). If you are proposing to incorporate ideas/technology outside your area of expertise, you and the team members with the expertise should agree to work together in advance of submitting the proposal, so that the team members and their expertise can be presented in the ”Research Design and Methods” section of the submission (see the submission template). Teams may also form, add members, divide, or merge at any point during the competition. Any agreements among innovators who decide to collaborate are at the discretion of those involved. NCATS is not overseeing collaborations, and each team is responsible for its own assembly and disassembly. NCATS simply wants to maximize the flexibility for all innovators, in order to have the best chance of achieving the solution. For example, if a non-winning team finds that it is not feasible to move forward, and the team disassembles, we encourage those with expertise and interest to pursue membership with other teams. Are preliminary data required for the planning stage of the Reduction-to-Practice Challenge? No. Preliminary data are NOT required but are allowed. Are innovators required to use a particular data set? No. Data may be aggregated from available public and/or private sources, provided that innovators assure that any data used for the purpose of submitting a submission for the Challenge, were obtained legally through authorized access to such data. Please provide the license and terms under which they are provided for all included datasets. Will submissions to advance in vivo biological assays be considered? No. The assay must be amenable to high throughput screening in the future. May innovators ask additional questions? Questions can be emailed to NCATSASPIREChallenge@mail.nih.gov.	NCATS’ ASPIRE Challenges seek innovative solutions to the opioid crisis.	/sites/default/files/ASPIRE_900x600.jpg	NCATS ASPIRE Challenges Questions and Answers	NCATS’ ASPIRE Challenges seek innovative solutions to the opioid crisis.	/sites/default/files/ASPIRE_900x600.jpg	NCATS ASPIRE Challenges Questions and Answers
17910	2020 NCATS ASPIRE Reduction-to-Practice Challenge	SUBJECT OF THE CHALLENGESUMMARY OF NCATS ASPIRE CHALLENGESSUMMARY OF NCATS ASPIRE REDUCTION-TO-PRACTICE CHALLENGEDATES AND DEADLINESTHE IC'S STATUTORY AUTHORITY TO CONDUCT THE CHALLENGERULES FOR PARTICIPATING IN THE CHALLENGESUBMISSION REQUIREMENTS AND TEMPLATETHE PRIZEBASIS UPON WHICH SUBMISSIONS WILL BE EVALUATED AND WINNERS WILL BE SELECTEDSUBJECT OF THE CHALLENGENCATS has recently established the development of A Specialized Platform for Innovative Research Exploration (ASPIRE) to aid in the discovery and development of novel and effective treatments, while at the same time making the process faster and more cost-effective, with a particular focus on pain, OUD and overdose as part of the the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM. The NCATS ASPIRE Program aims to develop and integrate automated synthetic chemistry, biological screening and artificial intelligence approaches in order to significantly advance our understanding of the relationship between chemical and biological space and enable further access into biologically-relevant chemical space. The ASPIRE platform will utilize currently available knowledge to develop innovative algorithms and predict and synthesize novel structures capable of interacting with specific targets; enable small-scale synthesis of the predicted molecules; and incorporate in-line, rapid biological testing of the molecules. Any new data obtained through this process would then be fed back into the system to further improve design, synthesis and biological characteristics of molecules.Over 25 million people in the United States experience pain every day (2012 National Health Interview Survey data) and need safe, addiction-free treatments to alleviate their suffering. This clinical demand is of tremendous importance given that overprescribing of opioids for managing acute and chronic pain has fueled the current epidemic of opioid use disorder and overdose deaths, and the effectiveness of opioids for long-term pain management is being questioned. Safe, effective, and non-addictive drugs (small molecules and biologics) to treat pain, mitigate addiction and reverse overdose are key to addressing the opioid crisis. Given failures and limitations of previous drug development efforts, drugs that recognize novel targets, have novel structures, and can be identified in human-based, physiologically relevant in vitro systems are needed. To further advance the NCATS ASPIRE Program and build on the innovations of the ASPIRE Design Challenges, and reward and spur innovative solutions to the development of new drugs for pain, addiction, and overdose, NCATS is issuing this Reduction-to-Practice Challenge to highly collaborative innovators interested in developing working prototypes of novel approaches that would lead to efficacious and non-addictive pain treatments and/or novel treatments for addiction and overdose.The ultimate goal of the NCATS ASPIRE Program under the HEAL Initiative is the development of a platform that a wide spectrum of scientists can use to advance their translational science relevant to development and preclinical testing of new and safer treatments of pain, OUD, and overdose. Further, it is essential that the approach developed in this phase is applicable to any translational problem.Back to TopSUMMARY OF NCATS ASPIRE CHALLENGESThe National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), is inviting novel solutions for the Reduction-to-Practice Challenge for the NCATS A Specialized Platform for Innovative Research Exploration (ASPIRE) Program. The overall goal of the NCATS ASPIRE Challenges is to reward and spur innovative and catalytic approaches towards solving the opioid crisis through development of: (1) novel chemistries; (2) data-mining and analysis tools and technologies; and (3) biological assays that will revolutionize discovery, development and preclinical testing of next generation, safer and non-addictive analgesics to treat pain, as well as new treatments for opioid use disorder (OUD) and overdose. The first phase of these prize competitions was implemented through a suite of concurrent companion design challenges that comprised a separate challenge in each of four areas: chemistry database, electronic laboratory knowledge portal for synthetic chemistry, algorithms, and biological assays; and an additional challenge for a combined solution to at least two challenge areas. For this first phase, innovators submitted designs, not final products or prototypes. Details about the winning submissions to the 2018 ASPIRE Design Challenges can be found at https://ncats.nih.gov/aspire/challenges.In this second phase, the follow-up reduction-to-practice challenge, the goal is for an open competition to integrate the best designs for a chemistry database, electronic laboratory knowledge portal for synthetic chemistry, algorithms, and biological assays into a single comprehensive platform. Innovators should invoke further scientific and technological development of a comprehensive and integrated solution for the development of new treatments for pain, opioid use disorder and overdose. Innovators design and then demonstrate their integrated solutions and working prototypes, from which winners will be selected.The NCATS ASPIRE Challenges are part of the of the the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the the initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.Back to TopSUMMARY OF NCATS ASPIRE REDUCTION-TO-PRACTICE CHALLENGE: Development of a Comprehensive Integrated Platform for Translational Innovation in Pain, Opioid Use Disorder and OverdoseThe goal of this Challenge is to combine the best solutions and develop a working platform that integrates four component areas: Integrated Database, Electronic Synthetic Chemistry Portal, Predictive Algorithms and Biological Assays. The first stage of this Challenge requires submission of a plan for the reduction-to-practice of a platform that integrates the four component areas into a comprehensive solution. The second stage of this Challenge requires the construction and development of a working prototype of this integrated platform. The third stage of this Challenge involves independent testing of the working prototype. In this Challenge, the functionality and degree of integration of the components in the integrated platform/solution will be evaluated. It is anticipated that successful teams for this Challenge will consist of large, multi-disciplinary groups with expertise in all four component areas.Component Area 1 relates to the development of an open source, controlled access database that incorporates all currently available chemical, biological and clinical data of known opioid and non-opioid based analgesics, drugs of abuse, and drugs used to treat drug abuse.Component Area 2 relates to the development of a next-generation open source electronic lab notebook (eLN) that collects, organizes and analyzes data relevant to the chemical synthesis and analyses of known opioid and non-opioid-based analgesics, drugs of abuse and molecules used to treat drug abuse into an electronic laboratory knowledge portal for synthetic chemistry (electronic synthetic chemistry portal; eSCP). Component Area 3 relates to the development of open source, advanced machine learning algorithms that would facilitate the discovery of novel, efficacious and non-addictive analgesics and/or treatments for drug abuse by utilizing the data collected in open source databases (Component Area 1), eSCPs (Component Area 2), and biological assays (Component Area 4).Component Area 4 relates to the development of novel, physiologically relevant biological assays that accurately replicate the safety profile and effectiveness of existing drugs to treat addiction and/or overdose, and that can be reliably used in predictive risk assessments of new analgesics or drugs to treat addiction and/or overdose; and/or be able to anticipate the degree of addictiveness of an analgesic prior to clinical testing.It is anticipated that this Challenge would require large, multi-expert teams. These teams may be assembled from the innovators from the 2018 Design Challenge areas and others who did not participate in the 2018 Design Challenges. All winners of the 2018 ASPIRE Design Challenges are highly encouraged to participate in this ASPIRE Reduction-to-Practice Challenge. Winners of the 2018 ASPIRE Design Challenges may choose to work with other winners from other Challenge areas or to find additional, new collaborators. All submissions, including those from the winners of Challenge 5 from the ASPIRE Design Challenges must propose plans for a solution that integrates all four challenge areas into a comprehensive platform.Evaluation criteria that judges and technical reviewers will be asked to address are specified below.Back to TopDATES AND DEADLINESStage 1: Planning Comprehensive Integrated PlatformsChallenge begins: November 30, 2020 Submission period: November 30, 2020-February 28, 2021 Judging period: March 1-31, 2021 Winners announced: April 2021Plans for Integrated Platforms must be submitted to NCATSASPIREChallenge@mail.nih.gov by 5:00 pm Eastern Time on February 28, 2021.The Reduction-to-Practice stages will occur from November 2020 to July 2022Stage 2: Prototype Development and Milestones DeliveryFirst milestone delivery and site visits: June-August 2021Second milestone delivery and site visits: January-April 2022Third milestone delivery: July 2022Stage 3: Prototype Delivery, Independent Testing and ValidationDelivery of prototypes for validation and testing by one or more NCATS-designated laboratories: July – September 2022Winner and runner-up announced: September 2022FOR FURTHER INFORMATION CONTACT Dobrila D. Rudnicki, Ph.D., NIH, 301-594-2080. dobrila.rudnicki@nih.gov or send an email to NCATSASPIREChallenge@mail.nih.govBack to TopTHE IC'S STATUTORY AUTHORITY TO CONDUCT THE CHALLENGEThe main mission of NCATS is to coordinate and develop resources that leverage basic research in support of translational science and to develop partnerships and work cooperatively to foster synergy in ways that do not create duplication, redundancy, and competition with industry activities (42 USC 287(a)). In order to fulfill its mission, the NCATS supports projects that will transform the translational process so that new treatments and cures for diseases can be delivered to patients faster by understanding the translational process in order to create a basis for more science-driven, predictive and effective intervention development for the prevention and treatment of all diseases. The NCATS is also conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, 15 U.S.C. 3719 (LINK). In line with these authorities, this Challenge will lead to innovative prototypes for developing technology to revolutionize discovery, development and preclinical testing of new and safer treatments of pain, OUD, and overdose; the result will be generalizable tools that will be widely available to fill longstanding gaps that have impeded the marriage of basic and translational sciences, especially in the field of automated and synthetic chemistry.Back to TopRULES FOR PARTICIPATING IN THE CHALLENGENCATS refers to participants in the NCATS ASPIRE Challenges as “innovators” because all solutions will require highly innovative approaches to achieve success. Innovators may be individuals, 18 years of age or older, participating singly or as part of one or more teams. Teams are not limited in the number of members. Each team must designate a lead who must be a U.S. citizen or permanent resident who is responsible for all correspondence regarding this Challenge. Teams may also merge, collaborate, subdivide, or otherwise organize themselves and their members as needed to prepare a solution to submit to this Challenge. Innovators may also be entities, provided they are incorporated in and maintain a primary place of business in the United States. For purposes of this announcement, “innovator” refers to a participating single individual, a participating team, or a participating entity.To be eligible to win a prize under this challenge, an innovator (whether an individual, team of individuals, or entity)—Shall have complied with all the requirements set forth in this announcement;Shall be 18 years of age or older at the time of this announcement;In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced.May not be a Federal entity or federal employee acting within the scope of their employment;May not be an employee of the Department of Health and Human Services (HHS, or any component of HHS) acting in their personal capacity;Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this challenge;May not be a judge of the challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, stepparent, child, or stepchild). Federal grantees may not use Federal funds from a grant award to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.Federal contractors may not use Federal funds from a contract to develop their submissions or to fund efforts in support of their submission.Submissions must not infringe upon any copyright or any other rights of any third party.By participating in this Challenge, each innovator agrees to assume any and all risks and waive claims against the Federal government and its related entities (as defined in the COMPETES Act), except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no innovator participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.By participating in this Challenge, each innovator agrees to indemnify the Federal government against third party claims for damages arising from or related to Challenge activities.An innovator shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during the Challenge if the facilities and employees are made available to all individuals and entities participating in the Challenge on an equitable basis.By participating in this Challenge, each innovator grants to the NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the submission on the web or elsewhere. Each innovator will retain all other intellectual property rights in their submissions, as applicable.NIH reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, and/or (b) not award any prizes if no entries are deemed worthy.Each innovator agrees to follow all applicable federal, state, and local laws, regulations, and policies.By participating in this Challenge, each innovator warrants that he or she is the sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the innovator (or is an improved version of an existing work that the innovator has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the innovator is aware. To receive an award, innovators will not be required to transfer their intellectual property rights to NIH, but innovators must grant to the federal government a nonexclusive license to practice their solutions and use the materials that describe them. This license must grant to the United States government a nonexclusive, nontransferable, irrevocable, paid-up, royalty-free license to practice or have practiced for or on behalf of the United States throughout the world any invention made by the innovators that covers the submission. In addition, the license must grant to the federal government and others acting on its behalf, a fully paid, nonexclusive, irrevocable, worldwide license in any copyrightable works that the submission comprises, including the right to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly said copyrightable works. To participate in the Challenge, each innovator must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of innovator’s rights to the federal government.Each innovator must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such innovator’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.By participating in this Challenge, each innovator agrees to allow NCATS to publicly display (e.g., on web sites) solution abstracts, as submitted by innovators in the submission package.By participating in this Challenge, each innovator assures NCATS that any data used for the purpose of submitting an entry for this Challenge, were obtained legally through authorized access to such data.Back to TopSUBMISSION REQUIREMENTS AND TEMPLATEDetails on submission requirements for Stage 1 are provided below. Details on submission requirements for Stage 2 of this Challenge will be available to Stage 1 winners no later than 30 days after the Stage 1 winners are announced. Details on submission requirements for Stage 3 of this Challenge will be available to Stage 2 winners no later than 30 days after Stage 2 winners are announced.Instructions for submission for Stage 1: Please format the submission using the Submission Template and submit it to NCATSASPIREChallenge@mail.nih.gov as a PDF. Brief instructions on the submission process can be found below. Detailed instructions are provided in the submission template.Each submission for Stage 1 requires a complete “Submission Package.” The Submission Package includes a Cover Page (up to 1 page), a written proposal (up to 12 pages) that describes the prototype, qualifications statements (up to 5 pages each), and references (up to 1 page). Detailed instructions on the content of the Submission Package can be found in the submission template.Back to TopTHE PRIZEAmount of the Prize; Award Approving Official. The total prize purse is $2,875,000. Prize amounts at each stage for each winning innovator are below. As stated in the Rules for Participating in the Challenge, “innovator” refers to a participating single individual, a participating team, or a participating entity.Stage 1: Planning: Up to $120,000 per innovator (maximum of 5 innovators). Only the winners of Stage 1 will be invited to participate in Stage 2 of the Challenge.Stage 2: Prototype Development and Milestones Delivery: Up to four (4) innovators will receive $150,000 upon completion of Milestone 1. Up to three (3) innovators will receive $200,000 for achievement of Milestone 2 and will advance to Stage 3 after completion of Milestone 3. Only the winners of Stage 2 will be invited to participate in Stage 3 of the Challenge.Stage 3: Prototype Delivery, Independent Validation and Testing: Innovators must successfully complete Milestone 3 before a prototype will be accepted at one or more NCATS-designated laboratories for Stage 3. One (1) grand prize winner will be awarded $750,000, and one (1) runner-up winner will be awarded $325,000.The NIH reserves the right to cancel, suspend, and/or modify this Challenge at any time through amendment to this notice. In addition, the NIH reserves the right to not award any prizes if no solutions are deemed worthy. The Award Approving Official will be Lawrence A. Tabak, D.D.S., Ph.D., Principal Deputy Director of the National Institutes of Health (NIH).Payment of the Prize. Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.Back to TopBASIS UPON WHICH SUBMISSIONS WILL BE EVALUATED AND WINNERS WILL BE SELECTEDUpdate: July 15, 2022In order to accommodate the complex needs in transferring the componentry related to the biological assays, it has been decided that the Stage 3 demonstration of the prototypes of the modular systems will be done virtually in order to fit within the timeline of the Challenge, based on the criteria listed below. As such, Stage 2, Milestone 3 will include plans for the virtual demonstration in Stage 3. The documents for Stage 2, Milestone 3 will be reviewed by a team of subject matter experts at NCATS as they prepare for the Stage 3 Demonstration, which is being conducted via a video call.Update: March 18, 2022Due to ongoing COVID-19 related restrictions, and at the judgement of the ASPIRE Team, the Stage 2, Milestone 2 evaluation process has been modified to better accommodate evaluations in a virtual manner:A team of program staff and subject matter experts with expertise directly relevant to the Challenge will conduct evaluations of the progress towards the deliverables outlined for Stage 2, Milestone 2 in a virtual manner via submission of a pre-recorded video demonstrating relevant progress. Summaries and scoring will be prepared by the reviewers, and the Challenge winners will be selected by the Program Team based on those. Challenge winners are subject to the final decision by the Award Approving Official.Update: August 4, 2021Due to the ongoing COVID-19 Pandemic, the Stage 2 Milestones judging process has been altered to accommodate the site visits in a virtual manner:A team of program staff and subject matter experts will conduct site visits to evaluate the Stage 2 prototypes based on progress towards achievement of the milestones described below. Site visits will occur three times during Stage 2. The site visits will be conducted virtually via a video call as long as the travel guidance related to the ongoing COVID-19 pandemic is in place, and at the judgement of the ASPIRE Team.A team of federal technical reviewers and program staff with expertise directly relevant to the Challenge will conduct the virtual site visits. Summaries and scoring will by prepared by the reviewers, and the Challenge winners will be selected based on that by the Program Team. Challenge winners are subject to the final decision by the Award Approving Official.Stage 1 (Planning):The goal of this stage of the Challenge is to design a solution that integrates the four component areas (Integrated Database, Electronic Synthetic Chemistry Portal, Predictive Algorithms and Biological Assays) that can be elaborated into a working prototype in the second stage of the Challenge. This integrated solution is expected to incorporate each of the requirements and desired features as detailed in the individual component areas. It is anticipated that this challenge will require a large, multi-expert team that is likely to be in multiple locations. Only complete submissions will be reviewed.A panel of technical experts with subject matter expertise directly relevant to each of the four component areas will evaluate the Stage 1 designs based on ability to fulfill the criteria listed below. The Stage 1 winners will be selected by a panel of federal judges, which may include program staff, subject to the final decision by the Award Approving Official. The NCATS will provide feedback from the technical experts and judges to the winners and non-winners on their respective submissions.Evaluation Criterion 1: Overall Impact and Innovation (30 points)How comprehensive and innovative is the combined solution overall?What is the potential impact of the solution on the development of novel treatments for pain, OUD, and/or overdose?What are major strengths and weaknesses of the designed platform?Are the solutions to the component areas well integrated and form a logical workflow?How likely is it that the integrated solutions can be successfully deployed in the ensuing reduction-to-practice stage?Does the team represent an outstanding group of innovators with a wide spectrum of expertise that can tackle multiple problems simultaneously?Did the team identify potential roadblocks and suggest additional expertise they would utilize to facilitate resolutions?To what degree is the plan for a working prototype adaptable to future translational problems, beyond those focusing on treatments of pain, OUD, and overdose?To what degree are the basic principles generalizable to additional and/or new translational questions?Evaluation Criterion 2: Design of Individual Components (40 points)Reviewers will evaluate how well individual components integrate into the comprehensive platform design as a whole while considering the essential design features of the individual components.Design FeaturesComponent 1: Integrated Chemistry Database for Translational Innovation in Pain, Opioid Use Disorder and OverdoseThe solution provides the required information necessary for development of novel treatments and therapies for pain, drug/addiction and/or overdoseThe database includes bioactivity results (Component 4) and experimental results (Component 2), that are incorporatedThe data contained within the database can be mined by the machine learning algorithms developed in Component 3The web portal front-end or complete API enables clear and easy management and retrieval of data and tools. This dashboard/portal integrates with Component Areas 2 (eSCP) and 3 (algorithms/machine learningThe solution is based on well-designed strategies for data curation and updates, e.g. indicating how will new data be incorporatedThe structural and functional variability/complexity of currently available pain drugs, opioids and treatments for addiction and overdose is well represented in the databaseThe collected data meet the FAIR* requirements (findable, accessible, inter-operable, and reusable: https://www.nature.com/articles/sdata201618)Component 2: Electronic Synthetic Chemistry Portal for Translational Innovation in Pain, Opioid Use Disorder and OverdoseThe molecular design capabilities of the portal are optimized to advance the highest quality hypothetical attributes of target molecules and their utilized synthetic execution planThe data collected will enable further mechanistic understanding that is essential to control and optimize chemical reactions so that by-products are reduced, yields are increased, and reaction specificities are improvedThe eSCP is designed to utilize high quality data from both positive and negative experiments for future discovery and development of novel structures and chemistries of relevance to the treatment of pain and opioid use disorderAll deposited data, including chemical structures, are in a format that can be easily accessible to advanced machine learning algorithms and/or applications, such as Component 3The deposited data integrate with the chemistry database (Component 1)The solution provides a dashboard that is integrated with the portals/dashboards associated with the database (Component 1) and machine learning algorithms (Component 3). The eSCP parses reaction information to include precise, unambiguous ontological annotation and reaction role descriptors (e.g. solvent, catalyst, other specific additive roles etc.)This information is well organized, e.g. information is organized in a manner to provide comprehensive reaction analytics (similar, but not limited to: breakdown of reaction types represented; most commonly used reagents and catalysts; time related patterns associated with reaction development, including reaction networks that summarize typical reaction steps and reaction pathway associations with common intermediates or final targets)The eSCP can integrate chemical data with those from biological screening assays (Component 4)It is easy to extract the data from the eSCP document and record in database tables with appropriate metadata suitable for mining and analysis with advanced machine learning applications (Component 3)The eSCP integrates retrosynthetic tools, machine learning, and computational chemistry tools in a manner that facilitates future upgrades and additional links to bioassay data (Component 4) and related chemical structure and synthesis information. User interfaces are appealing and designed for intuitive useThe eSCP includes documentation and management of laboratory chemical/sample inventory, equipment management, usage and label printing and barcodesComponent 3: Predictive Algorithms for Translational Innovation in Pain, Opioid Use Disorder and OverdoseThe solution uses its own, initial, structurally diverse training datasets that can be used to demonstrate the algorithms’ functionality on the setThe demonstration of why/how this solution can outperform existing algorithmsThe demonstrated ability to provide critical information necessary for the development of novel treatments and therapies for pain, drug/addiction and/or overdoseThe algorithms make use of the database (Component 1) and bioassay data (Component 4). In other words, it is easy to adjust the model or training set as additional data becomes availableThe algorithms are documented for completing a task on a training set and making predictions on a new set of compounds, and the steps are precisely statedThe algorithms are implemented with open source codes/packages or commercial software packagesThe web portal or tool/platform used by the algorithms interfaces/integrates well with that for Component 1The innovators have explained how their algorithms meet the criteria of precision, uniqueness, finiteness, definiteness, input, output, and effectivenessThe algorithms can identify or prioritize molecules for synthesis or suggest reaction conditions (Component 2), and can identify structural and/or functional similarities in a diverse set of moleculesThe algorithms can compare the mechanism of action between multiple drugs and identify structural/functional similarities between themThe algorithms are successful in identifying structurally diverse drugs with similar pharmacological effectThe algorithms can provide additional context for drug activity that can be used to identify or anticipate off-target effectsComponent 4: Biological Assays for Translational Innovation in Pain, Opioid Use Disorder and OverdoseThe utilized assay is creative, original and biologically and physiologically relevantThe utilized assay will accelerate discovery, development and preclinical testing of new and safer treatments of pain and/or OUD, and overdoseThe assay is designed to be amenable for validation taking into consideration the target being studied using appropriate drugs/compounds and controlsThe data collection and analysis is automated. For example, assay results are stored in the database (Component 1)The length of time it takes to perform the assay in full is appropriate. The timing of the assay is appropriate. (An assay’s development cycle time is reasonable)Secondary/specificity/selectivity assays are used to confirm the initial dataInstrumental, computational and data storage requirements are specified The protocols are well described, sufficiently clear and detailed to facilitate inter- and intra-laboratory utility and reproducibilityAppropriate experiments that will address the stability of the assay components and reagents have been developedEvaluation Criterion 3: Integration, Adaptability, User-friendliness and Accessibility (30 points)How well is each of the single components (Integrated Database, Electronic Synthetic Chemistry Portal, Predictive Algorithms and/or Biological Assays) integrated in the overall solution?How feasible and straightforward is the proposed workflow?Does the workflow proposed capture all four components, for example: does the predictive algorithm generate a hypothesis based on data from the integrated chemistry database, which then puts the resulting reactions in the eSCP? Are biological assay results stored in the chemistry database?What are major strengths and weaknesses of the overall solution presented?Which component(s) are the most and least developed?How likely is it that any weaknesses in the approach/design can be successfully addressed?How user-friendly are the individual components and the integrated platform as a whole?Are there possibilities to further simplify the approaches/processes used in the prototype?To what extent are there features incorporated or planned to be incorporated that would allow remote access to the platform?To what is extent is the team strongly focused on user-friendliness and dedicated to simplifying the solution for eventual use by non-expert scientists?Stage 2 (Prototype Development and Milestones Delivery):A team of program staff and subject matter experts will conduct site visits to evaluate the Stage 2 prototypes based on progress towards achievement of the milestones described below. Site visits will occur three times during Stage 2. While a general timeframe for the site visits is indicated above, the exact dates will be based on availability of program staff and subject matter experts. The comprehensive platform must be presented at a single, central location during the site visits.A team of non-federal technical reviewers and program staff with expertise directly relevant to the Challenge will conduct site visits. The summaries prepared by the site visit team will then be reviewed by federal employees serving as judges, who will select the Challenge winners, subject to the final decision by the Award Approving Official.A general description of milestones follows; however, additional details on milestones for Stage 2 will be available to Stage 1 winners no later than 30 days after the Stage 1 winners are announced:Milestone 1Deliverable 1: Successful implementation and scaling of the biological assay to high-throughput format.Deliverable 2: Quantifiable progress towards the development of the database that will be used to manage and retrieve data from the chemical syntheses and biological assays.Milestone 2Deliverable 1: Quantifiable progress towards the identification of a new molecular entity with activity against a biological target relevant to pain, opioid-use disorder or overdose.Deliverable 2: Documented use of the eSCP during the execution of a chemical synthesis. Deliverable 3: Documented use of the machine learning algorithms to provide critical information for the design or synthesis of novel treatments and therapies for pain, drug addiction, and/or overdose.Milestone 3Deliverable 1: Detailed description and requisite documentation for the successful transfer of the comprehensive platform to one or more NCATS-designated laboratories for independent validation and testing. This document should include detailed shipping/transfer plans and set-up procedures for the platform.Deliverable 2: Detailed description of how the prototype performs in one or more workflows specified by the innovator. This document should include thorough operating instructions for executing the workflow using the platform. Stage 3 (Prototype Delivery, Independent Validation, and Testing):Prototypes will be transferred to one or more NCATS-designated laboratories for independent testing and evaluation of the extent to which the criteria below have been met. At the conclusion of this validation and testing stage, representatives from one or more of the NCATS-designated laboratories will create a report evaluating the prototype based on the criteria described below. These reports will be evaluated by a panel of federal judges who will select the grand prize winner and runner-up, subject to the final decision by the Award Approving Official. Evaluation Criterion 1: Overall Impact and Innovation (40 points)What is the potential impact of the solution on the development of novel treatments for pain, OUD, and/or overdose?To what extent does this platform outperform existing solutions or workflows for drug discovery?What are major strengths and weaknesses of the prototype?How well does the working prototype reflect an improvement over the initial design? Does the final prototype incorporate new developments or insights from the field?Given that innovation is considered using a groundbreaking or paradigm-shifting approach or using existing approaches in an innovative way, to what degree is the platform innovative, creative, and original?Evaluation Criterion 2: Performance (60 points)Is each of the four components (Integrated Database, Electronic Synthetic Chemical Portal, Predictive Algorithms, and Biological Assays) operational and show seamless integration?Are the operating instructions developed in Milestone 3 clear, accurate and easy to follow?Does the platform’s workflow capture and integrate all four components, for example: does the predictive algorithm generate a hypothesis based on data from the integrated chemistry database, which then puts the resulting reactions in the eSCP? Are biological assay results stored in the chemistry database?Does the platform support a diverse set of use cases or is it a specialized solution?Has the platform identified 5-10 structurally diverse molecules or molecular series with biological activity against a target relevant to pain, OUD, or overdose? Are these molecules suitable for future pharmaceutical development or is additional optimization needed?Evaluation Criterion 3: Integration, Adaptability, User-friendliness and Accessibility (50 points)How well is each of the single components (Integrated Database, Electronic Synthetic Chemistry Portal, Predictive Algorithms and Biological Assays) integrated in the overall solution? Are the solutions to the component areas synergistic?What are major strengths and weaknesses of the overall solution presented?Which component(s) are the most and least developed?To what degree is the working prototype adaptable to future translational problems, beyond those focusing on treatments of pain, OUD, and overdose?To what degree are the basic principles amendable to additional and/or new translational questions?How user-friendly are the individual components and the integrated platform as a whole?Are there possibilities to further simplify the approaches/processes used in the prototype?To what extent are there features incorporated or planned to be incorporated that would allow remote access to the platform?To what is extent is the team strongly focused on user-friendliness and dedicated to simplifying the solution for eventual use by non-expert scientists?What is the anticipated overall cost of use, for example: are there consumable, storage or web-hosting costs associated with this platform?Did the team consider how the platform might be improved or built onto in the future? For example, could the platform be integrated with an automated synthetic chemistry module in the future?Evaluation Criterion 4: Portability, Robustness and Reproducibility (50 points)Is the use case as presented the most optimal way to demonstrate the functional utility of the comprehensive platform?Are the documentations provided sufficient to transfer and replicate the system to an independent facility?How accessible are team members to assist the one or more NCATS-designated laboratories in setting up and operating the prototype?What is the footprint of the system? How specialized or available are the components and equipment?Have the investigators presented strategies to troubleshoot potential problems?How reproducible are the bioassay results?How robust is the platform? How well does it stand up to frequent or continuous use?What is the throughput of the system? Have the innovators considered ways to increase the throughput?For more information about the ASPIRE Challenges, view the Frequently Asked Questions.Back to Top	NCATS’ 2020 ASPIRE Challenge seeks innovative solutions to the opioid crisis.	/sites/default/files/ASPIRE_900x600.jpg	2020 NCATS ASPIRE Reduction-to-Practice Challenge	NCATS’ 2020 ASPIRE Challenge seeks innovative solutions to the opioid crisis.	/sites/default/files/ASPIRE_900x600_0.jpg	2020 NCATS ASPIRE Reduction-to-Practice Challenge
17625	N3C Data Overview	The NCATS National COVID Cohort Collaborative (N3C) Data Enclave is a centralized, secure, national clinical data resource with powerful analytics capabilities that the research community can use to study COVID-19, including potential risk factors, protective factors and long-term health consequences.Participating institutions release data to N3C under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Read more about the HIPAA Privacy Rule and the data participating institutions send to N3C.Data DashboardsFor the most up-to-date information about N3C’s data, visit the N3C Dashboards. The Dashboards are frequently updated and provide a sense of the scope and size of information in the N3C Data Enclave. The resource includes information about participating institutions, research projects and recent publications related to N3C. There also is an interactive public health data browser, which allows you to explore N3C data on COVID-19 and specific topics, including long COVID, reinfection, diabetes, smoking and medication.Data TypesThe N3C systematically and regularly collects data derived from the electronic health records of people who were tested for COVID-19 or who had related symptoms, as well as data from individuals infected with pathogens that can support comparative studies, such as SARS 1, MERS and H1N1. The data set includes such information as demographics, symptoms, lab test results, procedures, medications, medical conditions, physical measurements and more.For detailed information about the data elements, download the N3C data dictionary.NCATS asks medical institutions and health care organizations to contribute this information as a limited data set, pursuant to the requirements in the HIPAA Privacy Rule.Read more about the data N3C receives and the HIPAA Privacy Rule requirements.A limited data set is defined as protected health information that excludes certain direct identifiers of an individual or of relatives, employers or household members of the individual — but may include city, state, ZIP code and elements of dates. A limited data set can be disclosed only for purposes of research, public health or health care operations.Three levels of data are available for analysis:• Limited Data Set (LDS): Consists of patient data that retain the following protected health information — o Dates of service o Patient ZIP code• De-identified Data Set: Consists of patient data from the LDS with the following changes — o Dates of service are algorithmically shifted to protect patient privacy. o Patient ZIP codes are truncated to the first three digits or removed entirely if the ZIP code represents fewer than 20,000 individuals or represents Tribal lands.• Synthetic Data Set: Consists of data that are computationally derived from the LDS and that resemble patient information statistically but are not actual patient data.Access Requirements for Researchers by Data Level Additional Access RequirementsN3C data may be used only for COVID-19 research purposes. Before researchers can request access to the data, their institutions must execute a Data Use Agreement (DUA) with NCATS. Once a DUA is in place, researchers can submit a Data Use Request (DUR) through the N3C Data Enclave. In the DUR, researchers will need to include, among other information, the project research title, names of project personnel, a non-confidential research statement, the project proposal and the requested data access level. Additional DUR requirements include reviewing and agreeing to comply with the N3C Data User Code of Conduct. The N3C Data Access Committee reviews and approves DURs.Learn more about how to apply for data access or see FAQs about using the data.Data Stewardship and ProtectionAs the steward of the data, NCATS is taking every reasonable precaution to guarantee the confidentiality, security and integrity of the data. NCATS oversees the use of the enclave through user registration, federated login, data use agreements with institutions and data use requests with users. All work must be done within the enclave, and no data may be downloaded. The N3C Data Enclave’s secure, cloud-based environment is certified through the Federal Risk and Authorization Management Program, or FedRAMP, which provides standardized assessment, authorization and continuous monitoring for cloud products and services, ensuring the validity of the data while protecting patient privacy. NCATS monitors the data protections in place on an ongoing basis and may adjust or augment them. Additionally, in conjunction with the U.S. Department of Health and Human Services, NCATS participates in ongoing security testing of multiple aspects of the enclave.For more information• Read about N3C’s four pillars of data security – Regulatory and Policy, Privacy Measures, Security Testing and Monitoring, and Researcher Responsibilities.• Read our FAQs about privacy and security.Data Sources and HarmonizationNCATS has established a COVID-19 Data Transfer Agreement (DTA) that provides terms and conditions for data transfer and outlines the general terms of data use. Institutions contributing data sign the DTA, then work with NCATS to transfer a limited data set relevant to COVID-19 in the institution’s preferred common data model (derived from electronic health records) to the N3C Data Enclave on a recurring basis. The N3C data harmonization team ingests the limited data set, runs quality checks and transforms different data models into a harmonized OMOP analytics data set. For detailed information about the data set, download the N3C data dictionary. See a list of institutions that have executed DTAs with NCATS.Privacy Preserving Record LinkagePrivacy Preserving Record Linkage (PPRL) is a means of connecting records using secure, pseudonymization processes in a data set that refer to the same individual across different data sources while maintaining the individuals’ privacy. NCATS is piloting PPRL technology to determine if linking multiple data sets enhances COVID-19 real-word data research in the N3C.All organizations contributing data to the N3C Data Enclave must have an approved Data Transfer Agreement (DTA). In addition to the DTA, these organizations have the option of signing the Linkage Honest Broker Agreement (LHBA) to participate in the PPRL pilot. The LHBA is an agreement between the organization, NCATS and The Regenstrief Institute, which serves as the linkage honest broker. A linkage honest broker in the PPRL’s infrastructure is a party that holds de-identified tokens and operates a service that matches tokens generated across disparate data sets to formulate a single Match ID for a specific use case. The data remains under the complete control of the organizations that provide data to N3C and is never accessible by or under the control of the linkage honest broker.PPRL enables three functions within N3C: Deduplication of patient records, linkage of a patient’s records from different sources and cohort discovery. Deduplication is a requirement for any organization that participates in the LHBA because of its importance to the data quality of the N3C Data Enclave and its scientific mission. Organizations participating in the LHBA have the option of participating in linking multiple data sets and cohort discovery as well.Learn how N3C’s PPRL initiative enables data connectivity while maintaining security.Read frequently asked questions about PPRL and the LHBA.Watch a demonstration of N3C’s PPRL initiative.			N3C Data Overview			N3C Data Overview
17628	Applying for N3C Data Access	.vidcontainer{ display: flex; } .fixed{ margin-bottom: -4px; } .flex-item{ flex-grow: 1; margin-left: 15px; margin-right: 15px; } .card { box-shadow: 0 4px 8px 0 rgba(0,0,0,0.2); margin-bottom: 15px; border: solid 1px rgba(0,0,0,0.2); border-radius: 10px; } The NCATS National COVID Cohort Collaborative (N3C) Data Enclave represents one of the largest, most secure clinical data resources for accelerating research on COVID-19. It also includes a powerful analytics platform and tool set for online discovery, visualization and collaboration. The data set and analytics capabilities will grow over time.The steps to access the N3C data include registering with the N3C, completing required training and submitting a Data Use Request within the N3C Data Enclave.For further assistance, contact the N3C Support Desk.Step 1: Determine if an Institutional Data Use Agreement has been executed.Before researchers can request access to the data, their home institutions must have an Institutional Data Use Agreement (DUA) in place with NCATS. If researchers attempt to register with the N3C before their institution executes a DUA, they will be notified that their requests will not be reviewed until their institution has a DUA in place.See the list of institutions with active DUAs.Note: DUAs can only be signed by Authorized Institutional Officials who have the authority to bind all users at their institution to the terms of the DUA. With the exception of citizen scientists not associated with institutions, individual researchers cannot sign their own DUAs with NCATS. Step 2: Register with N3C.Once a DUA is in place, researchers need to register with N3C. Citizen scientists must register using the same email address that they used for their DUA. During registration, researchers can request an N3C Data Enclave account. Upon approval, researchers will receive an email with directions for signing into their N3C Data Enclave account.Step 3: Log into the N3C Data Enclave.Following the directions provided in the account creation email, researchers need to log into the N3C Data Enclave to access their account and resources for learning about using the N3C Data Enclave. Having an N3C Data Enclave account does not on its own enable access to the N3C data, however.Step 4: Complete required training.The N3C Data Enclave is hosted by NCATS, and all researchers must complete the “Information Security, Counterintelligence, Privacy Awareness, Records Management Refresher, Emergency Preparedness Refresher” course, which can be accessed at NIH’s information security training website, before submitting a Data Use Request. It will take approximately 60-90 minutes to complete the entire course. Users should save evidence of completion for their records (a screenshot or copy of the certificate of completion). Researchers who will request access to de-identified data or to the Limited Data Set also must have completed their home institution’s human subjects research training requirements. Researchers will be required to provide the date they completed training in their Data Use Request.Step 5: Submit the Data Use Request.After satisfying the training requirements, researchers must fill out and submit a Data Use Request through the N3C Data Enclave. Researchers will need to provide a project title, a public research statement, a description of their research project plan, the level of data they intend to access and other information. Researchers also must read and attest to the DUA and to the N3C Data User Code of Conduct. If requesting access to the Limited Data Set, researchers will need to provide a copy of their institution’s Human Research Protection Program IRB determination letter.After a researcher submits a Data Use Request, it will be reviewed by the N3C Data Access Committee (DAC). The DAC is composed of federal staff from NIH and is responsible for reviewing and approving all Data Use Requests. Researchers will receive a DAC determination by email and, if approved, instructions for accessing the data. Data Use Requests will be effective for one year from the date access is granted and will be renewable.Learn more about the DAC and the Data Use Request review and approval timeline in the Use the Data FAQs. For more detail about applying for access, visit these resources from the NCATS-supported National Center for Data to Health:N3C Data Enclave FAQsN3C Registration ChecklistN3C Data Use Request ChecklistIf you still have questions or need assistance, please contact the N3C Support Desk.	Overview of the steps required to access data in the NCATS N3C Data Enclave.		Applying for N3C Data Access	Overview of the steps required to access data in the NCATS N3C Data Enclave.		Applying for N3C Data Access
17499	Rare Diseases Are Not Rare: Gallery of Creative Work Raises Awareness of Rare Diseases	Jacob Thompson, who won first place in the NCATS Rare Diseases Are Not Rare! 2020 Challenge, describes living with a rare disease. (Jacob Thompson)August 25, 2020Approximately 30 million people in this country — or 1 in every 10 people — have some form of a rare disease. With nearly 7,000 known rare disorders — each affecting up to 200,000 people in the United States — rare diseases are hardly rare. To raise awareness of rare diseases in novel and creative ways, the NCATS Office of Rare Diseases Research (ORDR) launched its second Rare Diseases Are Not Rare! Challenge this year just after Rare Disease Day at NIH.“We want to raise awareness of all rare diseases and bring to light their potential impact on public health,” said ORDR director Anne Pariser, M.D. “There is a misunderstanding that rare diseases don’t have as much of an impact on the American people as more common diseases, but they affect many more people and have a larger impact on the community than many people may realize.”The 2020 Challenge entrants created a gallery of social media and art submissions, from videos and poems to spoken-word performances and personal stories. One additional focus this year was on fostering collaborations across the community. For some, that meant reaching out to rare diseases advocacy groups, doctors or researchers. Others partnered with people in schools and organizations who had an interest in the topic and wanted to get involved. This year’s Challenge participants had the added burden of a global pandemic, which, in some cases, added to their stories.Of this year’s 26 entries, judges selected three winners to receive monetary awards and five honorable mentions. These entries are available on the NCATS website. The winners include:First place, $3,000: Jacob Thompson for “Keep on Fighting.” Thompson was diagnosed in college with Friedreich’s Ataxia, a rare disease. An aspiring athlete at the time of his diagnosis, he wanted to describe his experiences and raise awareness of rare diseases through a variety of media, including spoken-word poetry.Second place, $1,500: Caroline Gainey for “How ‘Rare’ Are Rare Diseases?” Gainey didn’t know much about rare diseases when she decided to participate in the Challenge. She collaborated with the Castleman Disease Collaborative Network, a rare disease advocacy group, because of its dedication to treating many rare diseases. Together, they developed a video that creatively uses facts and figures to describe how common rare diseases are.Third place, $500: Erica Barnes, Andrea Douglas and Jimmy Douglas for “Rare is not Rare.” The group worked with a rare disease advocacy group, along with a Minnesota high school student club interested in rare diseases, to create an animated GIF that provides facts about rare diseases.“The people who participated wanted to spread the word about rare diseases in their own unique ways,” said ORDR project officer Alice Chen Grady, M.D., who organized the Challenge. “NCATS stresses community engagement and involvement with the work — and the science — we do. The challenge is to find effective ways of sharing that message.”	NCATS selected winners to a Challenge seeking creative ways to raise awareness about rare diseases and the need for research and patient support.	/sites/default/files/RDANR_Video_ScreenCap_800x483_0.jpg	Rare Diseases Are Not Rare: Gallery of Creative Work Raises Awareness	NCATS selected winners to a Challenge seeking creative ways to raise awareness about rare diseases and the need for research and patient support.	/sites/default/files/RDANR_Video_ScreenCap_800x483_1.jpg	Rare Diseases Are Not Rare: Gallery of Creative Work Raises Awareness
17493	NCATS Rare Diseases Are Not Rare! 2020 Challenge Winners and Honorable Mentions	.video-container { position: relative; padding-bottom: 56.25%; padding-top: 30px; height: 0; overflow: hidden; } .video-container iframe, .video-container object, .video-container embed { position: absolute; top: 0; left: 0; width: 100%; height: 100%; } hr.startquote { margin-top: 0; margin-bottom: 5px; } hr.endquote { margin-top: 5px; margin-bottom: 0; } .quotetext { margin-left: 0; margin-right: 0; font-size: 14px; } .quotebox { margin-left: 0; margin-right: 0; margin-bottom: 16px; width: 100%; } #second-place-quotebox, #third-place-quotebox { margin-top: 14px; } /* blockquote.solid-gray { font-family: 'Lora', serif; height: auto; border: 2px solid hsla(0, 0%, 0%, 0.5); border-radius: 5px; background-color: #f2f2ed; padding: 16px; margin: 0; font-size: 16px; font-family: 'Lora', serif; font-style: italic; line-height: 1.2; } */ blockquote { font-family: 'Lora', serif; height: auto; border-radius: 5px; padding: 16px; margin: 0; font-size: 16px; font-family: 'Lora', serif; font-style: italic; line-height: 1.2; } blockquote.shadow-purple { box-shadow: 5px 5px 30px #662e6b; } blockquote.shadow-teal { box-shadow: 5px 5px 30px #0e6378; } p.placed-names { margin-top: 12px; } table.names { padding: 0; } table.names tr { padding: 0; } table.names tr td { border: none; padding: 0 !important; } p.descriptions { margin-top: 12px; } @media (max-width: 991px) { div.quotebox { margin-bottom: 32px; } table.names { width: 40%; } } @media (max-width: 767px) { table.names { width: 50%; } } @media (max-width: 599px) { table.names { width: 70%; } } @import url(https://fonts.googleapis.com/css?family=Lora); Participants nationwide showcased their creativity for NCATS’ second Rare Diseases Are Not Rare! Challenge to raise awareness of all rare diseases and the importance of research. NCATS selected 3 winners and 5 honorable mentions from an extraordinary gallery of submissions. Browse the winning and honorable mention entries below and read more about the 2020 Challenge.First Place“Keep on Fighting”Jacob Thompson“When I was 24 years old, about 2 years ago, I was diagnosed with the rare disease known as Friedreich’s Ataxia (FA). When my dreams of playing a sport in college ended, I needed something else to apply myself to. This began my journey as a hip-hop and spoken word artist. When I was diagnosed, it felt as though my dreams for the future had died. In many instances, I felt like giving up on my journey as an artist. Instead, I now have a new vision for my art: both to encourage those who are challenged, whether with rare disease or in general, and to raise awareness for rare disease.”A version of this video with audio description is available.Learn more about Jacob Thompson’s experience with FA and what makes him hopeful for the future.Second Place“How ‘Rare’ Are Rare Diseases?”Caroline Gainey“I wanted to take the ‘Rare Diseases Are Not Rare’ Challenge and to face it head on. Not knowing much about rare diseases myself, I found that I was able to utilize information about rare diseases to create a video that would educate the general public about just how common ‘rare’ diseases actually are.”A version of this video with audio description is available.Third Place“Rare is not Rare”Erica BarnesAndrea DouglasJimmy Douglas“Often, when someone from the general public hears the phrase ‘rare disease,’ they conceive of a tiny segment of the population and assume that rare diseases don’t rise to the level of a public priority. This entry seeks to address the problem of the general population thinking about rare diseases in isolation by introducing the basic but fundamental facts about rare diseases in a digestible and engaging way.”A version of this video with audio description is available.Click here to download in .gif format.Honorable Mentions(in alphabetical order)A Concept for a "Rare Disease Photo Challenge”Ramona BehshadAli JavaheriSoroosh BehshadTo help raise awareness about rare diseases, this proposed social media challenge would ask people who see the “Did You Know?” image on social media to participate by posting a photo of themselves along with one of the commonly used misnomers shown in the poster — such as a piece of French toast or a guinea pig — and tagging friends to spread the word!Learn about team member Ramona Behshad, M.D., and how rare diseases research has impacted her life.“Funding Inequality”Michael RaymondLaura PaiceThis infographic raises awareness by depicting the difference in funding between research on rare diseases and research on cancer.“Life, Love, and Rare Disease”Amanda MontalbanoDeeJo MillerKelly RanalloMindy BridgesBryce HeeseTomi PastinenTom CurranAndy PollardLaurie EllisonThe short video connects the viewer to the life behind a rare disease diagnosis, provides information about the prevalence of rare diseases and shows the impact research can have on the quality of life for patients and families.A version of this video with audio description is available.“NCATS Rare Diseases Are Not Rare!”Danielle KinseyJonathan BathThis poem is from the perspective of a person with a rare disease. It includes references to multiple diseases to help many people with rare diseases feel understood. The quilt featured in the video was donated to the person who inspired the project.A version of this video with audio description is available.“The Rare Majority Project”Rachael BakerAmy WilstermannKarisa Vander WeeleEmily VinkGrace OngSamantha ErmerOlivia CernyElle HazlettDale HulstChristine LeeSavannah TaylorAdrian Van SteeGreta WodnyThe photos and quotes help raise awareness of rare diseases and the experiences of people affected by them. Team members involved in the Rare Majority Project collaborate with members of the rare diseases community by conducting interviews and sharing photos on social media with the hashtag #RareMajority.Learn about team member Rachael Baker, Ph.D., and why she encourages people to get involved with rare diseases research. If you need an accessible version of any of the non-video entries, please contact Enrique Lagos.	Winners and honorable mentions of the Rare Diseases Are Not Rare! 2020 Challenge submitted creative approaches to raising awareness about rare diseases and the need for medical research.	/sites/default/files/RDANR_Challenge_2020_OG_0.png	NCATS Rare Diseases Are Not Rare! 2020 Challenge Winners and Honorable	Winners and honorable mentions of the Rare Diseases Are Not Rare! 2020 Challenge submitted creative approaches to raising awareness about rare diseases and the need for medical research.	/sites/default/files/RDANR_Challenge_2020_OG_1.png	NCATS Rare Diseases Are Not Rare! 2020 Challenge Winners and Honorable
17361	National COVID Cohort Collaborative Forms and Resources	Accessing N3C DataIndividual researchers can access N3C data in the N3C Data Enclave only after their home institutions have signed a Data Use Agreement (DUA) with NCATS. Once an institution has executed a DUA with NCATS, researchers can register with the N3C and apply for data access.See our collection of forms and resources related to accessing N3C data for both institutions and individuals, including the DUA form, a list of DUA signatories, the Data User Code of Conduct, and how to cite and acknowledge the N3C in publications.Contributing Data to the N3CNCATS has established a Data Transfer Agreement (DTA) that provides terms and conditions for data transfer and outlines the general terms of data use. Institutions sign the DTA, then work with NCATS to transfer a Limited Data Set relevant to COVID-19 derived from electronic health records to the N3C Data Enclave.See our collection of forms and resources related to contributing data to the N3C, including the DTA form, the Linkage Honest Broker Agreement form, a list of DTA signatories, and the N3C’s data dictionary.Participating in the N3C CommunityThe N3C encourages researchers to participate in the broader N3C community by joining Domain Teams to engage with others who have similar COVID-19 research interests.Learn about each of the more than 30 clinical and crosscutting N3C Domain Teams. The Domain Teams cover diverse topics, such as machine learning, rural health, nursing and cardiovascular disease.All members of the N3C community should read the Community Guiding Principles. This document outlines expectations for members, including institutions and individuals who use N3C resources and data.	Resources for accessing or contributing data to the National COVID Cohort Collaborative (N3C) and for participating in the N3C community.		N3C Forms and Resources	Resources for accessing or contributing data to the National COVID Cohort Collaborative (N3C) and for participating in the N3C community.		N3C Forms and Resources

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