ISARIC COVID-19 CRF CDISC CDASH and SDTM Mapping (draft)
| Author | Éanna Kiely |
|---|---|
| Published | 2020-03-31 11:09 |
| Tags | CDASH, SDTM, Mapping, COVID-19, Coronavirus, ISARIC, WHO |
| 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 |
ISARIC COVID-19 CRF and Clinical Characterisation Protocol (CCP)
ISARIC created a COVID-19 CRF (Case Report Form) with the WHO. The CRF is being used in an active Clinical Characterisation Protocol (CCP). More information on the CRF and study can be found on the ISARIC COVID-19 resources.
Introduction
In this blog we will map the ISARIC COVID-19 CRF to CDASH and SDTM. ISARIC provided me with a copy of the REDCap eCRF metadata this will be used as the source for the mapping.
This blog is intended for intermediate CDISC CDASH and SDTM users. Researchers that are new to CDASH and SDTM and are interested in learning about mapping should start with the HSE HSPC COVID-19 Case Form mapping.
Open Mapping Questions
This mapping proposes to use the draft SDTM domains ER (Environmental and Social Factors) and SI (Site Summary) that are under construction and not used in a published (or draft) SDTMIG. The CRF mappings may change at some point in the future based on the outcomes of the CDISC Interim User Guide for COVID-19 .
ISARIC COVID-19 CRF 1.4 2020-02-24 and Metadata 2020-03-27 Review
We will be reviewing nCoV CASE RECORD FORM Version 1.3 24 Feb 2020 and metadata file ISARICnCoV_DataDictionary_2020-03-27.
The metadata file ISARICnCoV_DataDictionary_2020-03-27 contains 321 unique variables and 14 forms. However it is already mapped into CDASHIG 2.X format using correct CDISC SDTM Controlled Terminology. This reduces the amount of conversion work that we have to do.
| # | Form Name | Variable Count | CDISC Domains |
|---|---|---|---|
| 1 | participant_identification_number_pin | 1 | |
| 2 | data_platform_terms_of_submission | 9 | |
| 3 | inclusion_criteria | 11 | |
| 4 | demographics | 25 | |
| 5 | comorbidities | 19 | |
| 6 | onset_and_admission | 22 | |
| 7 | admission_signs_and_symptoms | 44 | |
| 8 | infectious_respiratory_disease_diagnosis | 14 | |
| 9 | infectious_respiratory_disease_pathogen_testing | 8 | |
| 10 | daily_form | 100 | |
| 11 | complications | 28 | |
| 12 | treatment | 27 | |
| 13 | outcome | 12 | |
| 14 | core_additional_information | 1 | |
| 321 |
ISARIC COVID-19 CRF Mapping
PARTICIPANT IDENTIFICATION #:
According to the CRF GENERAL GUIDANCE the PARTICIPANT IDENTIFICATION #: is
Participant Identification Numbers consist of a 3 digit site code and a 4 digit participant number.
However in the metadata it is mapped to subjid. We could direct this as a question to understand how SITEID is captured.
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