News
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Protected: RADx-rad Master Template
There is no excerpt because this is a protected post.
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FDA templates for EUA Submissions
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.
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Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
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.
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Minimum CDE Waiver Template
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).
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Protected: Data Submission to RADx-rad DCC
There is no excerpt because this is a protected post.
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Minimum CDEs Required by NIH
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…
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RADx-rad Study Registration: Institutional Certification and Study Sharing and Submission Registration documents (NIH)
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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HIPAA “Safe Harbor” Checklist From for RADx-rad
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.
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Diagnostic Core Resources
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.
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Data flow for RADx-rad awardees
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…