What is RADx-UP?The National Institutes of Health (NIH)-supported Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) aims to ensure that all Americans have access to COVID-19 testing, with a focus on communities most affected by the pandemic. Community-engaged RADx-UP projects will help us to understand and alleviate the barriers to COVID-19 testing across the nation.RADx-UP is part of a $1.4 billion NIH-supported initiative to help speed innovation in the development and implementation of COVID-19 testing. There are three other programs: RADx Tech, RADx Advanced Technology Platforms (RADx-ATP) and RADx Radical (RADx-rad).Read more about the other RADx programs here What is the RADx-up Coordination and Data Collection Center?Projects Officer to the Parent Grant Program Officer for approval. Once the Parent Grant Program Officer has approved the change or correction of project name,the Program Officer can inform CDCC. Information about the role of the RADx-UP CDCC and our core focus areas in testing, data science and biostatistics, and community engagement is available here. How do we become a "featured project" on the RADx-UP website or in other communication channels?We will be featuring the stories and updates of projects in various ways, including through rotation in our "featured project" section of the RADx-UP website. Contribute your news by using this form to alert the CDCC to news, resources, or otherinformation coming out of your project. Will projects get a sub-page on RADx-UP.org? What website support is available?
We are pleased to profile all of the RADx-UP community engaged research projects on our program website. We are unable to accommodate sub-pages for all funded projects. To assist you in building a be spoke web presence for your project, theRADx-UP Toolkit offers logos, templates, and draft language that can help you build your own presence. We will continue to update that page with resources. The CDCC communications team can also consult and provide guidance on your website content and design as needed. Once you are live, we will also link to your project page or site from RADx-UP.org. We encourage projects to do the same, linking out to our site where relevant. We can share news, materials and updates via web and social media (once we launch our channel.) Submit materials and news here.
In Brief: 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. (Watch this 3:04m video about the administration core.)How often will RADx-UP projects and the CDCC have meetings? The CDCC hosts monthly RADx-UP Project-Wide Team Meetings to provide a live forum for the CDCC to share information and updates on RADx-UP, answer questions, and foster engagement between and among our teams. Meeting recordings will be made available after each meeting on the Toolkit. RADx-UP projects establish regular meetings with their assigned CDCC Engagement Impact Team more frequently.What is the role of the RADx-UP Steering Committee and how were members selected? The RADx-UP Steering Committee makes strategic decisions regarding overarching program goals and vision. The committee meets monthly and members leverage their experiences, expertise, and insight to help the program achieve its goals. The steering committee members were nominated and selected in early 2021 and include representatives from the CDCC, NIH, and RADx-UP projects.Where can I find a directory of NIH RADx-UP awarded projects? A list of all NIH RADx-UP awarded projects can be found on our projects page. Projects must ensure their directory information is accurate and should contact their EIT if they have trouble updating their contact information on myRADx-UPhome.Could you provide short bios of CDCC leadership? CDCC leadership bios can be found on the radx-up.org about page.If our project name is listed incorrectly on the RADx-UP Projects website, or if the website reflects the name of a larger parent grant, how do we have that changed? Requests for a change of name or correction of project name must be submitted through the parent grant sponsored projects officer to the parent grant program officer for approval. When updated, the program officer will inform the CDCC.How do we become a "featured project" on the RADx-UP website or in other communication channels? We feature the stories and projects updates in a variety of waysÂ¾the website, the newsletter, project-wide meetings, reports, and social media posts. Contribute your news by using this form to alert the CDCC Communications team to news, resources, or other information coming out of your project. Let your EIT know that you are interested in sharing with the broader RADx-UP community. Please follow @RADxUP on Twitter and tag us in your posts.Will projects get a sub-page on RADx-UP.org? What website support is available? We are pleased to profile all of the RADx-UP community engaged research projects on our program website.
In Brief: 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. Watch a short video about the RADx-UP CDCC Community Engagement Core.Are there opportunities for our community partners to serve in RADx-UP leadership and governance boards? The RADx-UP Steering Committee makes strategic decisions regarding overarching program goals and vision. The CDCC solicited nominations process for academic partners and community partners to self-nominate to join the programâ€™s Steering Committee in December 2020 and announced membership in early 2021. The committee meets monthly and members leverage their experiences, expertise, and insight to help the program achieve its goals. The Steering Committee includes representatives from the CDCC, NIH, and RADx-UP projects. There are also ongoing and ad hoc opportunities for community partners to contribute to the development or review of CDCC activities and programs. For more information on available opportunities or to volunteer, please reach out to your EIT.How you ensured that CDCC leadership and staff is diverse? Yes, the structure and leadership of the CDCC is intentionally diverse, as well as the staff.How can recently funded RADx-UP projects get information on lessons already learned from the first wave of RADx-UP projects funded? The CDCC Engagement Impact Teams regularly discuss what they learn from each of the RADx-UP projects and they are helping to inform these FAQs, recent RADx-UP presentations and communications, and plans for upcoming events. We will address common challenges and success stories at the monthly RADx-UP project-wide meetings and through our website. EITs can also connect your project to other projects as desired. Working groups also provide an opportunity to share lessons learned and develop implementable strategies across RADx-UP projects. To participate in a working group or learn more, please complete this survey or reach out to your EIT.Is there a way for projects to share information with each other, such as tools and resources generated? Projects can share resources through the resource library and the CDCC newsletter by submitting them here. Projects can also always reach out to their EIT with any resources for consideration and review the resources page for existing tools and resources shared with the RADx-UP community.If you have a COVID-19 data collection tool for consideration, submit that resource to the NIH Public Health Emergency and Disaster Research Response (DR2) data collection repository here. More broadly, projects can share resources through the Resource Library and the CDCC newsletter by submitting them here. Projects can also always reach out to their EIT with any resources for consideration.What services and resources can RADx-UP projects access through the CDCC? The RADx-UP CDCC offers a number of different resources and services for consultation related to applying community engagement practices, systems mapping, partnership, and others in addition to the testing and data expertise and assistance available to the projects. You can read more about these resources and services here. There are a range of capacity building opportunities that will be available to all projects and additional opportunities for consultations or services directly tailored to your projectâ€™s needs. The resource page will continue to be updated as new services are available and you can also reach out to your EIT who can connect you with these services. The biweekly newsletter will highlight additions to the CDCC service offerings.How can we connect to Federally Qualified Health Center partners? Some funded projects in the RADx-UP family are based on Federally Qualified Health Center (FQHC) relationships. We are interested to hear how you would like to connect to FQHC partners and if there are specific needs that you hope to address through these collaborations. Building a Community of Practice around FQHC engagement is one way to learn from each other and enhance our ability to interact with FQHCs. Please reach out to your CDCC Engagement Impact Team to further discuss your specific needs.Will the NIH Tribal Health Research Office play a role in the research projects involving American Indian communities? The CDCC coordinates with the Tribal Health Research Office (THRO) in the development of the RADx-UP program, and are in close communication and coordination with the THRO primarily through the work of the Data Stewardship Committee.
DATA DISSEMINATION PLANSFive years from now, what kind of questions will the RADx-UP data weâ€™re collecting be able to answer?
Despite the critical problems of collecting a long survey and incentivizing people to take it, this is a practical implementation of the model of community-engaged research. This model of approaching scientific questions is supported at NIH.
Five years from now weâ€™ll have a data set of populations with health disparities that went through your projectsâ€”children, teachers, farmworkers, etc. What are the possibilities to know what happened? I think the value of that is extremely high.We all have been talking for the last year about the pandemic of racism and how to deal with that. We know it's not going to be easy and it's going to take time. In the future, could this lay the foundation for additional investigation on those issues? This kind of approach and model may be helpful and informative for us for addressing the vexing chronic pandemics we have made painfully little-to-no progress in the last 30 yearsâ€”diabetes, moderate obesity, heart disease (particularly hypertension), uncontrolled asthmaâ€”which disproportionately affect populations with health disparities. Are there any efforts to integrate RADx-UP data with data collected by other NIH COVID-19 initiatives, such as the NC3C?
The ultimate goal of RADx-UP is to contribute to a database of RADx data. Beyond that, though, the consortium may be able to contribute to a larger data hub at NIH that would include de-identified data around COVID-19 from other projects, such as NC3, the NIH Post-Acute Sequelae of SARS-CoV-2 infection (PASC ) Initiative and the Say Yes COVID Test.
CDE REVIEW PROCESS & TIME LINEOverall, how will the NIH reviewing CDEs impact my project?
If your project is collecting all NIH RADx-UP Required CDEs with only modification of question wording, it will not impact your project. If you are excluding 1 or more questions, the justification for each exclusion must be submitted through the AOR to the Institutes and Center grants management office/ chief grant manager (IC CGMO) with a copy to the PO. The IC GMO/CGMO will make a determination of outcome and notify the PI through the Authorized Organization Representative (AOR) through the Notice of Grant Award with copies to the IC PO, the CDCC and the CDCC POs for additional tracking and NIH oversight. This may also trigger re-review by the responsible IRB.
Please describe the steps, timeline, and who will review the CDEs?
As part of the project integration into the RADx-UP Consortium, a report on each of the CDEs to be included in the project protocol has been submitted by the project PI though the EIT on the NIH RADx-UP CDE Tracking Form. The NIH RADx-UP CDE Tracking Form is reviewed by the NIH RADx-UP CDE Review Team (Review Team) and a recommendation is made as to whether the project research strategy and justification supports approval or denial of an exception request. The Review Team recommendation is reviewed by the Governance Committee (GC) co-chairs and their decision is conveyed to the Review Team for communication with the IC PO/CGMO to provide feedback and options to the project PI. It is rare to have an exception to collecting a CDE approved. Any exclusion of a CDE triggers the requirement to submit an official request for change of the Terms and Conditions of Award through the AOR to the IC GMO/CGMO with a copy to the PO. Once the CGMO makes a decision about the requested Change of the Terms and Conditions of Award, the CGMO notified the AOR through the Notice of Grant Award, the PO, and the CDCC POs. The CDCC POs archive that information in the Project file and notify the GC co-chairs and the Executive Committee co-chairs for NIH tracking. Please also see the OPERA approved slide addressing this process.
What is the timeline for decisions or requests for updates from the project?
Each project should carefully consider the decision to collect or not collect a required NIH RADx-UP Required CDE. Each project must report data collection plans to the CDCC as soon as possible. On the NIH side, this process has been evolving. It is now clear and established and you can expect a completed review with a recommendation to the IC PO/CGMO within 3 weeks of receipt of the CDCC NIH RADx-UP Tracking Form being submitted to the NIH RADx-UP CDE Review Team.
When will the POs be reaching out, or do PIs need to reach out to their PO?
The NIH RADx-UP CDE Review Team will notify the IC PO/CGMO of the GC recommendation and the IC PO will contact the PI.
Will requested changes be retroactive?
The NIH RADx-UP Executive Committee and Governance Committee expect that every project will comply with the requirement within the Terms and Conditions of Award to collect and share CDEs from the point of notification forward. Projects are not expected to collect data retrospectively.
What should the escalation process look like from NIH's side when POs and Grants Managers are unresponsive?
If an IC PO/GMO/CGMO is non-responsive to the PI, the PI can request assistance from the CDCC POs who will reach out to the NIH colleagues. However, the PI and AOR should try more than once to reach out to the IC PO/GMO/CGMO.
What are some "good enough" reasons for CDEs to not be collected according to NIH procedures?
There are very few justifications for not collecting NIH RADx-UP Required CDEs that are acceptable. Only project research design could potentially merit exclusion of 1 or more NIH RADx-UP Required CDEs.
Will the CDE recommendations of the community partners be considered?
Community partner input is important and it is incumbent on the PIs/POs to discuss the significance of collection of CDEs with community partners and work with them to develop the appropriate approach to meeting this NIH requirement.
How will project compliance with Common Data Element requirements effect funding, especially going into Year 2?
Funding will vary by project and by situation, but if a project is non-compliant and does not make an effort to do the required data collection, that would impact future funding.
CHALLENGESSome projects have struggled to receive initial IRB approval. They are concerned about the initial delays with the CDE finalization and not being allowed any cost extensions. What would you say to these projects?
Project PIs should discuss this situation with the IC GMO/CGMO.t their information is safe, that the certificate of confidentiality protects them, and that this information will be used to benefit their communities in the long run.
How do we find out how to get on the Child Health Working group?
Project teams/community partners can get involved on the RADx-UP WGs via this form. Feedback and suggestions from the Child Health Working Group will inform the tier 2 Child Health/Pediatric Common Data Elements for the RADx-UP program, which will be recommended, but are optional.
Should we submit data if it isnâ€™t complete, i.e., if a participant didnâ€™t fully fill out a survey?
Yes. The CDCC does not expect complete data sets from every participant.
What is the NIH CDE Tracking Form? In order to help the CDCC prepare for collecting data from across the RADx-UP program, each team should complete the NIH CDE Tracking Form. Use this form to communicate which of the Common Data Elements you intend to collect.As a reminder, the NIH expects that all RADx-UP projects will collect the Tier 1 NIH Common Data Elements (CDEs). However, we recognize that the needs of your community, project, and science may mean that you cannot collect each and every one of the CDEs as written.The NIH CDE Tracking Form provides a dedicated process for identifying any CDEs you cannot capture, or variances in wording, or value sets that you are capturing in a different way. In addition, the form asks you to identify which NIH CDEs you do plan to collect. Each project must answer whether or not you will collect Social Security numbers from your participants (yes/no â€“ no explanation required). Learn more about the exception process and other details about the CDEs here.The RADx-UP CDCC is responsible for collecting and transmitting de-identified participant data to the NIH RADx Hub and will work 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 will be working to encourage research collaboratives to ask the required Common Data Elements related to COVID-19 questions across the consortium and beyond. How will RADx-UP ensure consistency in the data collected for participants in each projectâ€™s study especially given the diversity of populations that will be reached by the projects? The RADx-UP CDCC's Data Science and Biostatistics Core worked with NIH to prepare the initial recommended set of Common Data Elements (CDEs). The NIH CDEs were developed primarily from questions in the PhenX and NIH Disaster Research Response (DR2) COVID-19 data collection toolkits and align with the Centers for Disease Control and Prevention (CDC) required minimum data to be submitted with COVID-19 test information for each sample collected. Participant identifiers will be collected in a separate database and kept separate from the de-identified research data.To help standardize and integrate these data, with NIH leadership an initial set of NIH RADx-UP CDEâ€™s were developed to be collected by each research project. 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.Find the final required Common Data Elements on the RADx-UP Toolkit. If you have questions about how your project will implement the CDEs, please contact your CDCC Engagement Impact team as soon as possible. Are projects required to collect CDEs? One of the NIH priorities for RADx-UP is contributing data to the RADx Data Hub, a national resource of RADx-generated research data that can help researchers and public health officials better understand the impact of the pandemic, including the outcomes, protective/resiliency factors, disparities, and possible solutions. In order to ensure consistency in how RADx-UP projects collect data for our program and the RADx Data Hub and simplify the analysis of that data, the NIH defined a set of Common Data Elements (CDEs).The NIH RADx-UP Tier 1 CDEs are required for all projects, with the exception that Social, Ethical, and Behavioral Implications (SEBI) projects that are not testing participants do not have to collect the testing and symptom CDEs. Tier 2 CDEs are recommended additions. If you have questions about the NIH CDEs, or are interested in learning more, select here to visit our CDE Questions with Dr. Kibbe series, which includes short podcasts as well as written key points.Projects are also expected to share data with the CDCC as a part of the RADx-UP program. We recognize that some projects may already have IRB approval with limited consent for sharing of data, and have begun collecting data. These projects will need to submit an amendment to their IRB, including an updated consent form.If you still have uncertainties about the expectations for data sharing or the NIH CDEs, reach out to your NIH program officer for more guidance. Can RADx-UP projects modify the CDE language? The NIH CDEs can be modified slightly, as long as the original intention of the question remains the same. The format of the answersshould not be modified as doing so would mean the data wouldnâ€™t map correctly and consistently across the program. If you have specific questions or concerns regarding the CDE questions and/or answers, please reach out to your EIT. Our project has already begun, or soon will begin, COVID-19 research in our community. How can we coordinate with the CDCC to best implement the NIH Common Data Elements? We understand that data collection may already be under way. Please work with your CDCC Engagement Impact Team to align your projectâ€™s data collection with recommended RADx-UP Common Data Elements that we will collect across all NIH RADx-UP projects to ensure your projectâ€™s contribution to the RADx Hub. Our project has developed a preliminary study questionnaire based on an existing toolkit. How can we harmonize our questions with the other RADx-UP projects? Find the final required Common Data Elements here. If you have questions about how your project will implement the CDEs, please contact your CDCC Engagement Impact team as soon as possible.Using the Common Data Elements, 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 submitted to the CDCC will be available to all consortium members (following approvals by relevant groups/committees within RADx-UP) and the CDCC will be working to encourage research collaboratives to ask COVID-19 questions across the consortium and beyond. If a projectâ€™s IRB application has already been approved before incorporating RADx-UPâ€™s data sharing language into their Informed Consent Form (ICF), will they need to amend their informed consent form and resubmit it to the IRB? Yes, projects will need to amend their informed consent form to incorporate the RADx-UP data sharing template language. Please be sure to review your Notice of Special Interest (NOSI) for the requirements specific to your project, track any changes to your informed consent language, and send a file showing those changes to your CDCC EIT for review and approval prior to IRB submission.
Will there be any constraints on what platforms we can use for our data collection? We donâ€™t anticipate constraints on your choice of data collection platform, but we recommend that your project use REDCap. We request that you follow the NIH Common Data Elements and other guidelines closely â€“ the wording of the CDE questions, response, and the number coding for each response (ex. Yes = 1, No = 0, Unknown = 999) needs to be consistent across all of the projects. The final CDEs and other guidelines (including the answer coding) are posted here. Please discuss any concerns and barriers with your CDCC Engagement Impact Team. Is there any guidance available on the suggested data infrastructure for projects that are not performing direct testing? It is still recommended that all projects use survey tools from PhenX and DR2, to the extent possible. This will help with collating data across projects. We also recommend that the projects use REDCap as their data capture system. Since many research data collection methods are guided by technology â€“ including access to the Internet â€“ how can the RADx-UP CDCC help projects characterize the variability of these issues and inform our operational choices? We recognize that not all projects have access to the Internet or advanced data collection systems, especially in remote communities. Please work with your CDCC Engagement Impact Team (EIT) to share information about your research teamâ€™s technology needs, and any concerns you have about technology access in the communities that you serve. The EITs will work with you to find a way to address these needs and help projects uncover solutions. Do all RADx-UP projects require the assembly of a Data and Safety Monitoring Board (DSMB)? Does the CDCC have resources available to assist with this? 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).
What is the process for data transfer to the CDCC? At the time of data transfer, the project team will download the CSV file with the data from their database in REDCap. This file will then be uploaded by a designated project team member into the secure RADx-UP CDCC data portal. The CDCC 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, or if the institution has federated credentials through In Common, their access will be granted via that method.The Duke CDCC is programming 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 upload, additional checks will be performed and then the file will be incorporated into the database.We will be granting projects access to the RADx-UP CDCC data portal on a rolling basis. What type of data support will CDCC provide? Data Core provides technical support by standardizing data representation, data harmonization, security and privacy, and data exchange. Please reference the Toolkit page (orientation toolkit tab) for a brief overview of data support. If you have a specific question regarding data, or would like to speak with a data core representative, please submit your request through your EIT. If we work with organizations that give us private patient data for which we are precluded from sharing outside the research team, or we have data that is governed by Medicare data use agreements, how will the RADx-UP data transfer reflect these limitations? The RADx-UP data use agreement anticipates several scenarios by which identifiable data may be prohibited from sharing, and we will work with each project to reflect your requirements. Please discuss any concerns and barriers with your CDCC Engagement Impact Team.
RADx-UP projects are working with many underserved populations who have many concerns about the information we will collect, how we will share it, and how a participantâ€™s identity could be exposed and exploited. How will the RADx-UP CDCC help us protect this data and assure participants? The RADx-UP CDCC's Data Science and Biostatistics Core is committed to working closely with each project to address these concerns, facilitate your research, and safeguard and protect your participant data. See specific questions within this FAQ about the RADx-UP approach to personal identifiers, data sharing and transfer, and more.We look forward to learning about your experience working across underserved populations and about how you have successfully engaged these communities and mitigated these concerns. Please engage with us, through your EIT, and the other projects through the RADx-UP Community of Practice so that together we can all explore the many challenges, opportunities, and solutions for conducting research with all the communities that we collectively serve. What personal identifiers we should be collecting as part of our RADx-UP data? Participant identifiers are one component of the NIH Common Data Elements (CDEs). Your ability to collect personal identifiers will depend on any data sovereignty agreements and your data sharing policies, as well as other factors about the populations your project works with. Final CDEs have been shared with RADx-UP projects both directly and archived in the RADx-UP Toolkit. In the meantime, please discuss any questions or concerns with your CDCC Engagement Impact Team.One purpose for collecting personal identifiers is to make sure that RADx-UP projects can recontact study subjects and that study subject data can be matched with externally available large data sets, such as those held by CMS. This is particularly important for future vaccine research. Another is so that we have the ability to de-duplicate (so each participant will only be counted 1 time when data sets are aligned and combined) RADx-UP data with data available through the NIH RADx Hub, a national resource of RADx COVID-19 research data. For projects conducting longitudinal surveys, how often will we need to share our data with CDCC? The CDCC will provide guidance on this. Periodic data sharing may be as frequent as weekly. Will RADx-UP establish a publications and data use committee with participation across project awardees? The RADx-UP CDCC Data Stewardship Committee, as well as the RADx-UP Steering Committee, will provide guidance on our collection and use of data. Both committees will include RADx-UP project team representatives. What guidance on data sharing can you give projects that are conducting COVID-19 testing for which some participants have declined, or have not yet agreed, to participate in research? The CDCC has provided guidance to inform your projectâ€™s data sharing, data use, and informed consent language. This can be found here on the Toolkit page under the Data Toolkit tab. Should the primary grant recipient maintain control of all study data to ensure the highest data quality and data security? Please follow the data sharing agreement in your supplement project and detailed further in the parent award. The CDCC is aware that data sharing agreements may vary by site. Please consult with your CDCC Engagement Impact Team for additional guidance. We know that RADx-UP projects are expected to maintain control of all study data. May two or more RADx-UP projects partner to host study data on a shared REDCap server (or another database)? Please follow the data sharing agreement in your parent grant and supplement project. The CDCC is aware that data sharing agreements may vary by project. Please consult with your CDCC Engagement Impact Team for additional guidance. How are you and your Data Stewardship Committee addressing Tribal data sovereignty? We fully recognize the importance of data sovereignty and the considerations involved in collaborating with tribal nations. A Data Stewardship Committee, comprised of Native and non-Native investigators and including the Director and Assistant Director of the NIH Tribal Health Research Office (THRO) will advise the CDCC on data sovereignty and sharing issues and advise on best practices has been established and has been meeting with the CDCC. 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. We want to make sure that we are inclusive of those considerations as well. How do we handle participants that only want to share Personal Health Information (PHI) with the project team and not the CDCC? Study teams may collect identifiable participant information and not share it with the CDCC. The CDCC would then need to go through the project teams to recontact participants for future studies or for linkages to external data sets. For more information about the research benefits of collecting personal identifiers, read here.
How can RADx-UP projects, especially those who were required to document IRB approvals prior to the completion of the NIH Common Data Elements (CDEs), reconcile and harmonize the data that we collect with the CDEs and other requirements the CDCC may create? We anticipate that most projects will have selected questions that closely correspond to the NIH CDEs, and the CDCC will work with projects to assist in any needed harmonization. Please contact your CDCC Engagement Impact Team to discuss how your project can best utilize the posted NIH CDEs. There may be a need to amend project protocols with the IRB as the project evolves.
In Brief: The CDCC Testing Core 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 RADx-UP project, the Testing Core maintains a robust FAQ page. However, please communicate questions or needs through the project EIT. Watch this short video about the testing core.What is the purpose of the project review by the CDCC Testing Core?NIH charged the CDCC Testing Core team to provide 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. An important objective of the RADx-UP Testing Core is to help ensure planned testing strategies align with FDA authorized tests as well as with the goals and objectives of each projectâ€™s protocol for success.What is the COVID-19 Testing Plan Review?Early on, the CDCC Testing Core 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 Review Report,â€ which serves as a guidance and informational document.The COVID-19 Testing Core uses the COVID-19 Testing Review Report to communicate:
any concerns related to proposed testing strategies
potential testing strategies, for project team consideration, to better align with the projectâ€™s protocol goals and objectives
potential options for testing and procurement assistance
questions that need to be addressed by the project
specific guidance on regulatory topics
After project launch, the Testing Core will continue to monitor projects to assist with continued study success.Why does the Testing Core require so much information from RADx-UP projects?The NIH has appointed the RADx-UP CDCC Testing Core to review test protocols for operational feasibility, scientific integrity, and clinical applicability. Often, the Testing Core must ask many questions to provide scientific and technical assistance to Projects to ensure COVID-19 testing technology, sample collection, vendor selection, and implementation methodology is appropriate to achieve individual project and community goals. Testing plans that donâ€™t include FDA EUA testing assays (required by NIH) can lead to delays in that review process. The CDCC intake survey was redesigned to ask many Testing Core questions up front.Has the RADx-UP Coordination and Data Collection Center assembled a Testing Advisory Board? The RADx-UP CDCC has established a Testing Core with scientific and technical expertise to address any testing questions.How will the RADx-UP CDCC advise on COVID-19 testing technology and selection? The CDCC has partnered with Arizona State University to showcase their online repository of existing and emerging COVID-19 testing technologies, and this directory is available through our website. The CDCC can advise 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. If you have urgent or specific questions about your project, reach out to your CDCC Engagement Impact Team (EIT).Who should I contact if I am uncertain about my COVID-19 specimen collection or testing method? Your CDCC Engagement Impact Team should be your first point of contact for your specific uncertainties.How will RADx-UP coordinate with RADx TECH and RADx-ATP? The NIH is working with the RADx-UP CDCC to support the structures necessary to establish productive collaboration among the RADx programs (RADx-UP, RADx Tech, and RADx-ATP). We want to ensure that all RADx-UP projects have the resources you need to fulfill the goals of your projects. If partnering with RADx Tech or RADx-ATP is the best approach for your project, we 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 so that you can understand how new, FDA authorized technologies are appropriately matched to your project needs and goals. RADx TECH and RADx-ATP companies are NIH-supported companies. Our website lists the RADx TECH and RADx-ATP companies with FDA EUA COVID-19 assays for preferred matching to NIH-awarded projects. Bring your particular project's needs to your CDCC Engagement Impact Team to start this conversation.How do you plan to coordinate testing across RADx-UP projects to ensure consistency, and will the same test be given to all participants? RADx-UP projects will use the testing and collection methods that fit best with each projectâ€™s settings and goals. However, despite the differences, test results will be coded similarly to enable us to present and communicate the data consistently for the whole RADx-UP program.Will the Social, Ethical, and Behavioral Implications (SEBI) projects also be able to take advantage of diagnostic technologies being developed or tested as part of the larger project?Please discuss this with your NIH Program Officer. You can also reach out to your CDCC Engagement Impact Team if you have specific questions about diagnostic technologies.Is there a resource for reviewing the approval status of vetted COVID-19 monitoring tests (swabs, serology, other)?A list of FDA Emergency Use Approved COVID-19 tests can be found here Arizona State University also hosts "Testing Commons", a reliable resource for COVID-19 tests and their regulatory status, platform, and type of specimen collected. visit Testing Commons here. The CDCC can advise on the availability of testing methods and the appropriate technology matched with your target population. Your CDCC Engagement Impact Team is the best point of contact for specific questions and guidance.Will CDCC follow the progress of project teams?Yes,both CDCC Data Core and Testing Core request project teams submit study data and share related information through online surveys at periodic intervals. This monitoring process will help CDCC to identify any difficulties project teams may be having so they can be addressed in real time. Please connect with your EIT for specific information about this process or if you have any needs the CDCC might assist with.How soon will COVID-19 tests approved by the FDA be included in the distribution and uptake pipeline across RADx-UP projects? The RADx-UP CDCC has created a resource of FDA authorized home collect and Point of Care (POC) COVID-19 testing technologies housed here. These FDA EUA listings will be updated regularly to assure the most recent information on approved or authorized testing is available. Your CDCC Engagement Impact Team is the best point of contact for specific questions and guidance.Do RADx-UP projects have to use FDA Emergency Use Authorization (EUA) COVID-19 assays?Except in rare instance. Test methods must have an FDA emergency use authorization (EUA). Read more here.Some point-of-care tests are bound by government contracts that make it impossible for RADx-UP projects to purchase them. Is the RADx-UP CDCC able to help with this? Shortages are a concern. The RADx-UP Testing Core is creating solutions to help projects meet their needs. Please contact your CDCC Engagement Impact Team to discuss your specific needs.Is the RADx-UP CDCC able to help projects reduce the overall cost of COVID-19 testing and laboratory fees, such as helping to negotiate a discount from a testing vendor? The RADx-UP Testing Core recognizes there is a lot of variability in supply chains and pricing and so is working with vendors and manufacturers to negotiate the best deals. Connect with your CDCC Engagement Impact Team so that we can better understand your needs.Can RADx-UP recommend a database containing COVID-19 testing data across the country, including date of test, test result, and demographics of the person tested, including location? On this website the CDC provides COVID-19 case surveillance data in two ways: an 11 data element public use dataset of the line-listed dataset of all COVID-19 cases shared with CDC, and a 31 data element restricted access dataset of the line-listed dataset of all COVID-19 cases shared with CDC. A restricted access, detailed version of the line-listed dataset of all COVID-19 cases shared with CDC is available for public use. The restricted access dataset includes 31 data elements, including state of residence and county of residence, with data suppression to ensure protection of individualsâ€™ privacy. This dataset may be most suitable for researchers and others withspecific analytic questions.For more information on the restricted access dataset including the data elements, registration information, and data use restrictions, please select here. For questions, please contact ASK SRRG.What is the importance of continued COVID-19 testing? The overlap of vaccination coverage with declining rates of infection is leading many to question the importance of continued COVID-19 testing. These are the reasons testing is still an important tool in our toolbox as we work our way out of the pandemic.
Vaccine efficacy against symptomatic disease in trials and real-world data ranges from 60%-100% depending on the vaccine, population, virus strain, and severity of disease, so testing is necessary for vaccinated people in whom the vaccine was not effective.
Vaccine deliberation contributes to lower vaccine covferage resulting in continued testing needs among unvaccinated people.
Children are some 25% of the U.S. population and will not be vaccinated soon, so they and people around them will continue to have testing needs.
The duration of protection against COVID-19 infection or vaccination is not fully elucidated and reinfections are possible, supporting continued need for testing.
NIH has dedicated resources for vaccine and testing initiatives, as both will be important tools until the pandemic is over.
Please let us know your community's testing-and-vaccine questions and how you're helping people understand how testing can best help them. We'll continue to gatherand share your recommendations and resourcesHow can we guarantee that the testing sites we identify for free tests are indeed free? You can find a list of free testing sites by state here on the Department of Health & Human Services website.