Funded in partnership with the IMI DRAGON project, the TAUG-COVID-19 v2.0 provides enhanced content for imaging, covering concepts related to utilizing imaging for disease detection, diagnosis, and monitoring. Additionally, the TAUG-COVID-19 v2.0 is a comprehensive resource to implement CDISC standards for data collection to analysis with advice and examples for CDASH, SDTM, and the ADaM, including:
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Guidance on the use of domains and variables
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Sample annotated case report forms (aCRFs)
- Examples of SDTM datasets, with text describing the situational context and pointing out records of note
- Guidance on the use of ADaM
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
Guidance for Ongoing Studies Disrupted by the COVID-19 Pandemic
The Guidance addresses how to represent changes in current studies if the conduct is impacted by COVID-19.
Resources for Public Health Researchers
The zip file comprises an annotated case report form and a mapping spreadsheet to support public health researchers utilizing the Novel Coronavirus (nCoV) Acute Respiratory Infection Clinical Characterisation Data Tool. Developed by the World Health Organization (WHO) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), the Data tool is being used as the foundation for many COVID-19 research studies globally across numerous countries.
CDISC would like to express our profound gratitude to the task force participants for their involvement in the development of these resources.
Interim ADaM Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic (Published 2 Jun 2021)
The Interim ADaM Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic provides additional recommendations for sponsors dealing with studies disrupted by the COVID-19 pandemic as well as examples of commonly used ADaM structures, such as the Subject-Level Analysis Dataset (ADSL) and the Occurrence Data Structure (OCCDS). It is based on ADaMIG v1.2 and ADaM v2.1 and can serve as a companion piece to the SDTM guidance published in the Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic or used independently.
Vaccine Administration v1.0 (Published 22 Jun 2021)
Version 1.0 of the Vaccine Administration: Mapping Curation of Minimum Data Elements and Metadata provides public health implementers with direction on how to define and organize data elements by providing metadata that enables machine readability, data sharing, and semantic interoperability, with the added benefit of facilitating the flow of data for submission to global regulatory authorities.
Developed in partnership with the Global Information for Public Health Transformation (GIPHT), an initiative of the Learning Health Community, the mapping document is based on the eHealth Network Guidelines on proof of vaccination for medical purposes - basic interoperability elements v.1.1 and focuses on supporting the international travel use case. The mappings represent a minimum set of key data elements for electronically documenting vaccinations, are informed by the US CDC Endorsed Data Elements, the EU Digital Green Certificate and the WHO Interim Guidance for Developing a Smart Vaccine Certificate (SVC) and point to the following global standards: CDISC, HL7-FHIR, ISO Standards (8601 and 3166) and ICD 10/11, SNOMED, WHODrug and ATC Classifications.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.