COVID-19 (Coronavirus) CDISC CDASH CRF & SDTM Mapping Resources
| Author | Éanna Kiely |
|---|---|
| Published | 2020-03-31 11:09 |
| Tags | CDASH, SDTM, Mapping, COVID-19, Coronavirus, Series |
| Introduction | |
|---|---|
| Part 1 | HPSC COVID-19 Case Form 3.2 |
| Part 2 | ISARIC COVID-19 CRF |
| Part 3 | WHO/2019-nCoV/SurveillanceCRF/2020.2 |
| Part 4 | Comparison of all mapped CRFs |
Introduction
In this series of blogs we will be mapping publicly available COVID-19 (Coronavirus) Case Report Forms to CDISC CDASH and SDTM.
SDTM is the required data standard for submitting patient level data to the US FDA and Japanese PMDA as a part of a regulatory submission. SDTM can also be used for sharing data between researchers.
CDASH is the recommended data standard for collecting clinical trial data and has wide use within the (bio)pharmaceutical industry and is gaining adoption in an academic/hospital research setting.
How to use this Resource
Part 1 in the series is intended for researchers that are new to CDISC, CRF design and mapping. It takes a short, but complete CRF, and explains the process of mapping a CRF to CDASH and SDTM, and the documents used.
The subsequent CRFs mappings are larger, including entire studies, and intended for use by researchers that are more experienced in CDISC. They contain open mapping questions or considerations and should be used as a guide for creating a CDISC mapping strategy.
Other CDISC COVID-19 Resources
CDISC has organized a task force to rapidly develop standards for COVID-19. This group is expected to resolve some of these open mappings questions in the CDISC Interim User Guide for COVID-19 which is scheduled for release on the 11th of May 2020.
Publicly Available COVID-19 CRFs
| Region / Country | Responsible Body | CRF(s) | Comment | Mapping Status |
|---|---|---|---|---|
| International | ISARIC | WHO/ISARIC | ISARIC partnered with the WHO to create a CRF. This is currently in use in a Clinical Characterisation Protocol (CCP). |
Ongoing |
| International | WHO | WHO/2019-nCoV/SurveillanceGuidance/2020.6 | Less detail than WHO/ISARIC but includes data files in excel. WHO has a licence on the CRF. |
|
| Europe | ECDC | Links to WHO/2019-nCoV/SurveillanceGuidance/2020.6 | ||
| US | CDC | COVID-19 Case Report Form | The CDC provides a very detailed laboratory assessment form | |
| Germany | Robert Koch Institute (RKI) | Request Form for Passenger Contact Tracing | I could only find the one example for flight passengers in English. The rest of the material available in German looks very useful |
|
| Europe/Germany | German Center for Infection Research (DZIF) and others | LEOSS Patient Registry | An active patient registry. | A request for the CRF and metadata has been sent |
| Ireland | Health Protection Surveillance Centre (HPSC) | COVID-19 Case Form 3.2 | A short CRF that covers most of the data types collected. More detailed adult and child/infant COVID-19 CRFs are available. |
Ongoing |
| Australia | New South Wales Government Health | Novel coronavirus case questionnaire | Detailed also includes flight information. |
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