Resources
Key Resources
This PDF was issued as guidance for industry and FDA staff. It provides useful information such as reporting recommendations, statistical practices, and examples of calculations.
The RADx-rad DCC Data Core will provide viral standards and variant test panels for awardees. We will also provide benchmarking, usability and LIMS toolkits.
This checklist is intended to guide RADx-rad awardees on what HIPAA-defined identifiers need to be removed before submitting data to the repository. If you have questions about a specific field, please seek guidance from your organization’s IRB Chair and/or Privacy Officer.
An introduction to the study registration content and processes for RADx-rad Awardees. This page includes Includes presentations by NIH (Dr. Vivian Ota Wang, PhD, CGC, FACMG), 2. The RADx Institutional Certification Form and 3. Study Data Sharing and Submission Information documents. Please note that the two forms here: the Institutional Certification and Study Sharing Plan…
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For the most up-to-date templates, please visit: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas The link will direct you to the Diagnostic Templates (Molecular and Antigen), as well as the Serology/Antibody Templates.
This resource describes the minimum common data elements (CDEs) required for awardees collecting prospective human subjects data. A minimum set of CDEs has been released by NIH for the RADx program. All RADx-rad projects that prospectively collect human participants data are required to collect and use those CDEs in their studies. DCC understands the minimum…
A template for the Minimum CDE Waiver is provided here. It is recommended that a completed waiver request be submitted by the PI to the NIH Program Officer (PO) for approval with a copy to Dr. Kirk Roberts (kirk.roberts@uth.tmc.edu).
To ensure data collected at RADx-rad are compliant with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles, NIH recommends using Common Data Elements (CDEs) for data collection and data standardization. The consistent use of CDEs within the RADx program will greatly increase the interoperability and reusability of collected data, thus enabling efficient data integration and data…
The RADx Data Hub is the ultimate destination of RADx-rad data. It is managed by the NIH. The RADx-rad DCC will ensure that data submitted to the hub will comply with standards agreed upon by the RADx program at NIH. The DCC will work with awardees to apply Common Data Elements (CDEs), generate participant RADx-IDs…
Other Resources
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- Data Core Resources
- Data Sharing
- Data Tools
- Diagnostic Core Resources
- FAQs
- FDA templates
- Guidelines
- IRB
- Policy
- Tools
Starting place to learn about FDA Emergency Use Authorizations (EUAs)
Association for Molecular Pathology (AMP) resources for SARS-COV-2 testing
RADx-UP is a part of RADx, the overall National Institutes of Health (NIH) initiative to help speed innovation in the development and implementation of COVID-19 testing. One of the priorities for RADx is building the RADx Data Hub, a national resource of RADx-generated research data that can help researchers and public health officials better understand…
CLIA Guidelines for SARS-CoV-2 Test Result Reporting
Template language for Human Subjects Consents describing how the RADx-rad DCC Unique Study Participants ID will be created and used to maintain participant confidentiality
Up-to-date Diagnostic FAQs from the FDA
Guidance on Human Factors and Usability for medical device development
FDA Guidance for the use of AI and Machine Learning during the COVID-19 Pandemic
FDA guidelines for medical device makers during COVID-19
Up-to-date Variant guidance from the FDA
Up-to-date Variant guidance from the FDA
For the most up-to-date templates, please visit: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas The link will direct you to the Diagnostic Templates (Molecular and Antigen), as well as the Serology/Antibody Templates.
Up-to-date Diagnostic FAQs from CLIA
Guidance on laboratory reporting from HHS
Molecular diagnostic testing guidance from the IDSA
The Interactive Mapping Interface (IMI) is a web application that offloads the burden of finding common data elements (CDEs) for Radx project awardees. It provides an interactive user interface and CDE suggestion algorithm that can help researchers to quickly look up CDE candidates for their data dictionary. Awardees can share data dictionaries with their research…
Guidance on sample collection and handling from the CDC
This resource describes the minimum common data elements (CDEs) required for awardees collecting prospective human subjects data. A minimum set of CDEs has been released by NIH for the RADx program. All RADx-rad projects that prospectively collect human participants data are required to collect and use those CDEs in their studies. DCC understands the minimum…
The National Institutes Of Health (NIH) Common Data Element (CDE) Repository
This website provides access to COVID-19 related data collection tools (CRFs, DCFs, instruments, surveys, questionnaires) that are currently in use. We hope that investigators will consider choosing from these tools rather than developing new ones. The source of each instrument has been verified and contact information is provided in case additional information is needed.
“NIH is requesting public comment on the use of CDEs, particularly in the context of COVID-19 research, including opportunities for advancing research with CDEs, challenges to adopting CDEs, and guidance or tools that could facilitate use of CDEs. These comments will be used to inform NIH’s continuing development of guidance of CDE use for COVID-related…
Catalog of recommended measurement protocols Toolkit developed by scientific community via a consensus-based process Web-based resource, freely available for use
Up-to-date COVID-19 policy briefs from the FDA
If an awarded project has difficulty to collect all minimum CDEs and wants to request a modification to the minimum CDEs, please follow this process.
The RADx Data Hub YouTube channel is now live at this link: https://www.youtube.com/@NIHRADxDataHub
An introduction to the study registration content and processes for RADx-rad Awardees. This page includes Includes presentations by NIH (Dr. Vivian Ota Wang, PhD, CGC, FACMG), 2. The RADx Institutional Certification Form and 3. Study Data Sharing and Submission Information documents. Please note that the two forms here: the Institutional Certification and Study Sharing Plan…
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This document contains regulatory information for RADx-rad Awardees preparing an EUA submission.
Open access toolkit of news, publications and COVID-19 resources
Validated Usability tools and guidance from the US Government