In April 2020, CDISC released an Interim User Guide in response to the COVID-19 Global Pandemic. To expedite its release, we did not follow the CDISC Standards Development Process.
Version 1.0 of the COVID-19 Therapeutic Area User Guide (TAUG) was developed by taking content from the Interim User Guide through our Standards Development Process to further refine and enhance the document. COVID-19 TAUG v1.0 describes the most common biomedical concepts relevant to COVID-19 and the necessary metadata to represent such data consistently with SDTM, including:
- Guidance on the use of domains and variables
- Examples of SDTM datasets, with text describing the situational context and pointing out records of note
The COVID-19 TAUG v1.0 covers the following concepts:
- Risk Factors – Pre-existing medical conditions, personal protective equipment (PPE), travel, contacts, smoking, exposure to animals.
- Onset of Disease – Signs and symptoms, laboratory tests, virus identification, antibody testing, SARS-CoV-2 Viral load.
- Assisted ventilation and oxygen treatments, hospitalization, pulmonary function tests, respiratory imaging, vital signs and urine output.
- Vaccines, concomitant medications.
Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards and TAUGs specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
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.
TA Specifications show how to modify TAUG examples for various versions of the SDTM and SDTMIG . These specifications assist the FDA and the Japanese PMDA with testing to enable support of the standards and inclusion in their respective Technical Conformance Guides.1,2
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