RADx-UP Coordination and Data Collection Center (CDCC) is led by the Duke Clinical Research Institute (DCRI) and the Center for Health Equity Research at UNC-Chapel Hill (UNC-CHER), in partnership with Community Campus Partnership for Health (CCPH). Our coordination of project teams includes a wide range of education, training, implementation guidance, and facilitating connections
Here is what you can expect from us at the RADx-UP CDCC:
- Dedicated support from your assigned CDCC Engagement Impact Team (“EIT”) that will be your main point of contact with the
- Ready access to community engagement, data, and testing experts who are committed to the success of your
- Steadfast assistance from throughout the CDCC to optimize engagement, outreach, testing strategies, data collection and integration.
- Co-learning opportunities between and among RADx-UP projects and to the communities that we serve.
Administration & Coordination Core
The CDCC Administration & Coordination Core provides high-level support to the CDCC, including committee oversight; support on the development and implementation of processes, policies and procedures; evaluation of CDCC initiatives; as well as overall project management, facilitation and communication. Specific activities and resources include project-wide meetings, a steering committee, and program-wide communications.
- Project-wide Meetings The CDCC holds monthly RADx-UP Project-wide team meetings to provide a virtual live forum for the CDCC to share information and updates on RADx-UP, answer questions, and foster engagement between and among our projects. Each month we feature a timely discussion topic of relevance to the program timeline, as well a presentation by a project, community partnership, or NIH representative. Meeting recordings are available online.
- Steering Committee The RADx-UP Steering Committee, which includes representatives from the CDCC, NIH, and RADx-UP projects, makes strategic decisions regarding overarching program goals and vision. The committee meets monthly and members share their experiences, expertise, and insight to help the program achieve its goals.
Translation services for RADx-UP materials and meeting interpretation Many communities served by RADx-UP speak languages other than English and we know that primary language materials are important for conveying public health and testing information. The CDCC can provide translation services for participant-facing forms, documents, and other materials produced by the CDCC and shared across the RADx-UP program.
- For example, we can produce translations in Spanish and other commonly requested languages for the RADx-UP Common Data Elements (CDEs), Informed Consent Data Sharing Template Language, and educational materials created by the CDCC for widespread use across the RADx-UP community.
- Materials and languages that fall outside the scope for the CDCC will be the responsibility of the individual project teams to manage and support.
- The CDCC is available to work with projects to identify vendors to provide translation services that fall outside the scope of what the CDCC supports. Please contact your EIT with your questions.
- Working groups who need simultaneous interpretation of their meetings can request it in advance by submitting a request to the Community Engagement core via the Communications Request Form.
- Tracking and Evaluation Team The Tracking and Evaluation Team assesses how the RADx-UP program increases the reach, access, uptake, and sustainability of COVID-19 testing in underserved populations. Through the evaluation of CDCC activities, the team improves the catalytic effect of the center on RADx-Up program impacts. Find out more here.
RADx-UP Communications The CDCC manages several public and private communications channels in order to share important program information as well as promote co-learning between and among projects and the communities that we serve.
- RADx-UP.org: the public website for the program, featuring resources, news and project spotlights and profiles.
- @RADxUP: a public social media channel on Twitter for sharing RADx-UP news and opportunities and for engaging with the larger community-engaged research community.
- RADx-UP projects Slack channel: a virtual “breakroom” on the Slack app for collaboration, conversations, and making connections within the RADx-UP community.
- myRADx-UPhome: a secure “one-stop shop” for important documents and resources, project profiles, contact directories, and data submissions tools.
- The latest news and information from the CDCC is summarized in a biweekly e-newsletter that is sent to the entire RADx-UP community. These digital newsletters are archived.
Community Engagement Core
The RADx-UP CDCC Community Engagement Core assists RADx-UP projects with identifying, aligning, and strengthening strategic partnerships across the RADx-UP program. The core also provides technical assistance in community engagement and developing a shared understanding and strategy to advance testing equity through translating findings into action. In addition to DCRI and UNC CHER, the Community Engagement core is led by CCPH, which offers its expertise and leadership in harnessing partnerships between communities and academic institutions to create heath equity, offering a strong resource to all projects served by the RADx-UP CDCC. This core manages the Engagement Impact Teams, the RADx-UP working groups, Evidence Academy, mini-grant programs, and the engagement resource center.
- Engagement Impact Teams The EITs as the primary point of contact for all RADx-UP projects by fielding all project questions, concerns, successes, and need requests. EITs assist project teams with all aspects of proposed studies, including testing, community engagement, data collection and sharing needs. Each project’s EIT will assist by reviewing project plans and return the CDCC’s assessment on data readiness and gaps. They will also work with the project team to address testing implementation barriers, vendor selection, and management. The EITs can also provide access to a network of consultants to assist with community engagement efforts. In addition to connecting your project team with resources within the CDCC, the EIT can facilitate connections between RADx-UP projects to optimize opportunities, troubleshoot shared challenges, and create channels for sharing tools and best practices.
RADx-UP Working Groups The CDCC supports Working Groups (WGs) focused on cross-cutting themes of interest to RADx-UP projects. These WGs provide a space for tackling specific topics and challenges that may commonly occur among similar populations across the country. RADx-UP working groups provide an opportunity for RADx-UP awardees and their community partners to share ideas, develop cross-awardee collaboration, and provide feedback to the CDCC and NIH. The teams consider and develop solutions for specific RADx-UP populations or high-priority issues. Some of these issues include guidance on deploying emerging technologies in underserved communities, engagement best practices in specific populations, and data stewardship considerations. To learn more about the Working Groups (listed below), recommend new themes, or to sign up to participate, contact your EIT or complete this form.
- Building Community Capacity and Impact. Monthly meetings are scheduled every SECOND TUESDAY.
- Child Health. Bimonthly meetings occur the FOURTH THURSDAY of every other month.
- Engaging Black/African Americans. Monthly meetings are scheduled every FOURTH WEDNESDAY.
- Engaging Hispanic/Latino/Latinx Populations. Monthly meetings are scheduled every SECOND MONDAY.
- Understanding Social Determinants of COVID-19 Testing and Vaccination. Monthly meetings are scheduled every FOURTH MONDAY.
- COVID-19 Equity Evidence Academy The RADx-UP CDCC hosts the annual COVID-19 Equity Evidence Academy. An Evidence Academy is an engaged conference approach to understand the state-of-the-science, or the current evidence of COVID-19 testing and related factors in the populations most impacted. The inaugural Evidence Academy, Translating Innovations in Testing, was held in February 2021, and the next Evidence Academy will be held in Winter 2021/2022. Explore the materials, recordings, and accompanying report here.
- The RADx-UP CDCC Community Collaboration Mini-Grant Program The CDCC Community Engagement Core oversees the Community Collaboration Mini-Grant Program (C2G) with awards of up to $50,000 for a 12-month period to help advance capacity, training, support, and community experience with COVID-19 testing initiatives. Applications are open to community serving organizations, faith-based organizations, and tribal nations and organizations. This webinar explainer provide a good starting point for learning more about the C2G grants.
- Engagement Resource Center RADx-UP brings together resources —project profiles, explainer videos, one-page handouts, study results— around community engagement, testing, and data to support projects and their partners. This library serves as a central collection of RADx-UP resources and valued external resources to be shared with RADx-UP projects and the broader scientific and lay communities. Our goal is to ensure resources are appropriate for sharing across the RADx-UP community, are relevant to the program, and are responsive to the diverse needs of the RADx-UP projects. Explore the Resources page and if you have resources to contribute or suggest please submit them with this form.
COVID-19 Testing Core
The CDCC Testing Core team provides expert review of projects, technical support with test methods, guidance on FDA regulatory issues, guidance with scientific and study design, and procurement support as needed. They also advise about emerging or existing testing technologies. Because testing is key to every the RADx-UP project, the testing core maintains a robust FAQ page. However, questions or needs to and from the testing core are communicated through the project EIT.
Protocol Review and Testing Plan The CDCC Testing Core has developed a process to facilitate expert review of each RADx-UP protocol. Following protocol review, the Testing Core provides project teams with a “COVID-19 Testing Plan Review” report, which serves as a guidance and informational document. After project launch, the Testing Core will continue to monitor projects to assist with continued study success. The COVID-19 Testing Core uses the COVID-19 Testing Plan Review report to communicate:
- concerns related to proposed testing strategies
- suggested potential testing strategies to better align the project’s protocol goals and objectives
- potential options for testing
- testing procurement assistance
- gaps or outstanding questions that need to be addressed by the project
- specific guidance on regulatory topics
- Repository of Emerging Technologies In a partnership with Arizona State University, the CDCC is able to offer access to an online repository of existing and emerging COVID-19 testing technologies. The repository is available on our RADx-UP website. The CDCC can advise through project EITs on the availability of testing methods and the appropriate technology matched with the target population. Additionally, a COVID-19 Testing Tips page now provides information for new applicants as well as current awardees.
- Vendor Managementand Supply Chain The NIH is working with the RADx-UP CDCC to foster collaboration among the RADx programs (RADx-UP, RADx Tech, and RADx-ATP). We want to ensure that all RADx-UP projects have the resources they need to fulfill the goals of their projects. If partnering with RADx Tech or RADx-ATP is the best approach for a project, the CDCC can facilitate that connection. Further, the RADx-UP Testing Core will serve as a resource for reviewing the companies and new test methods identified by RADx Tech or RADx-ATP to help provide an understanding of how new technologies are appropriately matched to specific project needs and goals. RADx TECH and RADx-ATP companies are NIH-supported companies. The RADx-UP website lists the RADx TECH and RADx-ATP companies with FDA EUA COVID-19 assays for preferred matching to NIH-awarded projects. The Testing Core also provides similar support to projects working with vendors outside of the RADx program.
- RADx-UP CDCC Rapid Research Pilot Program The CDCC Testing Core oversees the Rapid Research Pilot Program. These $200,000 grant opportunities are open to universities and non-profits both within and outside of the RADx-UP network, and will support the implementation of novel or emerging testing technologies in communities.
Data Science & Biostatistics Core
One of the priorities for RADx-UP is contributing data to the RADx Data Hub, a national resource of RADx-generated research data that will help researchers and public health officials better understand the impact of the pandemic, including the outcomes, the disparities, and the possible solutions. The CDCC Data Science & Biostatistics Core provides technical support by standardizing data representation, data harmonization, security and privacy, and data exchange. While many answers to standard questions can be found on the data FAQ page, all other questions and requests for the data teams are channeled through project EITs.
- Standard Data Representation The NIH, with support from the CDCC, defined a set of Common Data Elements (CDEs) to ensure consistency in how RADx-UP projects collect data for this program, and ultimately the RADx Data Hub. With very few exceptions, each research project will use these CDEs to help standardize and integrate and simplify the analysis of that data. When using these NIH CDEs, the CDCC will be able to integrate your data with data collected across all RADx projects and populations as part of the RADx Hub, for example, by pooling data from projects that have similar populations.
- Data Harmonization The RADx-UP CDCC is responsible for collecting de-identified participant data and transmitting it to the NIH RADx Hub. The CDCC works with RADx-UP projects and the NIH to support cross-consortium collaboration. Data submitted to the CDCC will be available to all consortium members (following approvals by relevant groups/committees within RADx-UP) and the CDCC is working to encourage projects ask the required Common Data Elements related to COVID-19 questions across the consortium and beyond.
- Data Transfer For secure, private data transfers, the CDCC Data Core will be using a PowerApps/PowerBI portal connected to Microsoft Azure. The portal and the database will be housed on the Microsoft Cloud. The secure, cloud-based portal will require individual credentials and sign-in to access the data upload feature. Credentials will be assigned by the CDCC unless the institution has federated credentials through In Common in which case their access will be granted via that method. The data transfer will include automatic acceptance/rejection criteria, such as the type of file that is being uploaded (ex. CSV is accepted, GIF and JPG will be rejected) and checks to ensure it is not a blank file. Following an upload, additional checks will be performed before the file is incorporated into the database. The CDCC will be granting projects access to the RADx-UP CDCC data portal on a rolling basis.
- Data Stewardship Committee The CDCC convenes and oversees a Data Stewardship Committee which comprised of Native and non-Native investigators, including the Director and Assistant Director of the NIH Tribal Health Research Office. The Data Stewardship Committee advises the CDCC on data sovereignty and sharing issues as well as best practices. While the concerns are clear for data sovereignty with tribal nations, there are other populations where there may be particular issues of sensitivity around data. The Data Stewardship Committee works to ensure that the CDCC is inclusive of those considerations as well.
- Data and Safety Monitoring Board (DSMB) The CDCC will help determine safety monitoring requirements for each project, including the requirements for a Data and Safety Monitoring Plan (DSMP) and whether a DSMB is required to be convened for a project. For projects that require a DSMB, the CDCC will help convene the DSMB for the project or fulfill project needs as requested (e.g. helping find DSMB members).