The Interim User Guide for COVID-19 describes the most common biomedical concepts relevant to COVID-19, and the necessary metadata to represent such data consistently with Terminology, CDASH, and SDTM. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
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 theNovel 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.
Vaccination Administration v1.0 (Published 22 Jun 2021)
Version 1.0 of the Vaccination 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.