HSPC COVID-19 Case Form CDISC CDASH and SDTM Mapping (draft)
| Author | Éanna Kiely |
|---|---|
| Published | 2020-03-26 08:23 |
| Last Update | 2020-03-31 11:09 |
| Tags | CDASH, SDTM, Mapping, COVID-19, Coronavirus, HPSC, ER, Environmental and Social Factors |
| 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
This blog is intended for researchers that are setting up COVID-19 (Coronavirus) clinical trials and have limited experience in CDISC CDASH and SDTM to help guide their mapping strategy.
CDISC can also be used as a standard format for sharing data outside of clinical trials.
Mapping COVID-19 CRFs to CDASH
A COVID-19 (Coronavirus) clinical trial may have case report forms (CRFs) that are designed for a healthcare setting and may not follow the typical CDASH Best Practices Recommendations for designing CRFs and collecting data.
In this example we will map the Irish Health Service Executive (HSE) Health Protection Surveillance Centre (HPSC) COVID-19 Case Form 3.2 March 2020 (2020-03-20) to CDASH.
We are choosing the HSPC COVID-19 Case Form since it captures most of the types of data that other forms have and is published and versioned.
A list of other COVID-19 CRFs is available on the introductory page.
COVID-19 CASE FORM V3.2 March 2020 Review
We start by briefly reviewing the CRF to see what domains the data will be mapped to. This gives us an overview of the complexity and time need for the mapping.
This CRF is separated into 8 sections and has an overall identifier. We will review each section in more detail for individuals new to CDISC CDASH CRF creation and SDTM data reporting mapping.
| # | Section | CDISC Domains | Questions (Fields) |
|---|---|---|---|
| 1 | CIDR Event ID | --REFID, SUPP-- | |
| 2 | Patient Details | DM, SC | |
| 3 | Clinical Details | MH, HO, ER | |
| 4 | Underlying Clinical Conditions Details | MH, VS, RP, SU | |
| 5 | Occupational Healthcare Exposure Status | SC, ER | |
| 6 | Patient Outcome | RS, DD | |
| 7 | Epidemiological Details | ER | |
| 8 | Interviewer Details | SI | |
| 9 | Additional Details / Notes | CO |
CIDR Event ID
The CRF starts with a Computerised Infectious Disease Reporting (CIDR) Event ID. This will be mapped to the Reference ID (--REFID) variable in SDTM for all domains except the Demographics (DM) domain.
| Variable Name | Variable Label | Type | Description |
|---|---|---|---|
| --REFID | Reference ID | Char | Optional internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image. |
In DM it will be mapped to a Supplemental Qualifier variable in the Supplemental Demographics Domain (SUPPDM) due to identifier variable restrictions (DM assumption 8.a) in the DM domain.
The --REFID variable will be used to link all of the records together in SDTM. We will see an example of this in the next section on Patient Details.
Patient Details
In Patient Details we are collecting information about the patient that CDISC splits into 2 separate domains. Sex and Date of Birth are mapped to the Demographics (DM) domain while the name, address, contact details and occupation are mapped to the Subject Characteristics (SC) domain.
These are split in CDISC since clinical trials do not usually collect patient identifying data. All data is anonymized to ensure the patients privacy according to GCP. If this data is needed in a trial for a (bio)pharmaceutical sponsor please have your Regulatory Affairs Specialist review this section of the CRF. In an investigator led trial there may be less stringent data protection requirements.
CDASHIG 2.1 CRF Metadata
We will use the CRF Metadata table from CDASH Implementation Guide (IG) 2.1. This is a useful specification for creating CRFs. Below are the Subject Characteristics (SC) and Demographics (DM) Example 1 CRF Metadata.
| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre- Populated Value | Query Display | List Style | Hidden |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SCPERF | 1 | Were subject characteristics collected? | Subject Characteristics Collected | Indicate if subject characteristics information was collected. If Yes, record theappropriate details. | Text | SCSTAT | If SCPERF = "Y", NOT SUBMITTED. If SCPERF ="N", SCSTAT where SCTESTCD = "SCALL". | (NY) | Yes; No | ||||
| EDLEVEL_SCORRES | 2 | What is the subject's education level? | Education Level | Indicate the subject's education level. | Text | SCORRES; SCTEST; SCTESTCD | SCORRES WHERE SCTESTCD = "EDLEVEL" | Did not complete Secondary School or Less than High School; Some Secondary School or High School Education; High School or Secondary School Degree Complete; Associate’s or TechnicalDegree Complete; College or Baccalaureate Degree Complete; Doctoral or Postgraduate Education | prompt | radio | |||
| JOBCLAS_SCORRES | 3 | What is the subject’semployment status? | Employment Status | Indicate the subject's employment status. | Text | SCORRES; SCTEST; SCTESTCD | SCORRES WHERE SCTESTCD = "JOBCLAS" | (EMPSTAT) | Full-time; Part-time; Not employed | prompt | radio | ||
| MARISTAT_SCORRES | 4 | What is the subject's maritalstatus? | Marital Status | Indicate the subject's marital status. | Text | SCORRES; SCTEST; SCTESTCD | SCORRES WHERE SCTESTCD = "MARISTAT" | (MARISTAT) | Never Married; Married; Legally Divorced; Divorced; Widowed | prompt | radio |
We are adding columns on the left for our section, source CRF label and variable. We will not be using source CRF variable in this example. We are changing the Query Display column to Display.
In order to map the Surname and Forename variables we open the CDISC SDTM Controlled Terminology. We choose the latest version
https://www.cdisc.org/standards/terminology
https://www.cancer.gov/research/resources/terminology/cdisc
https://evs.nci.nih.gov/ftp1/CDISC/SDTM/SDTM Terminology.xls
| Section | Source CRF Label | Source CRF Variable | CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Display | List Style | Hidden |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CIDR Event ID | CIDR Event ID | MUL_REFID | 1 | Computerised Infectious Disease Reporting Event Identifier | CIDR Event ID | <COMPLETED BY CONTENT EXPERT> | <COMPLETED BY CONTENT EXPERT> | SCREFID, MHREFID | prompt | |||||||
| Patient Details | Surname | LASTNAME_SCORRES | 2 | What is the patient's surname? | Surname | SCORRES; SCTEST; SCTESTCD | ||||||||||
| Patient Details | Forename | FRSTNAME_SCORRES | 3 | What is the patient's forename? | Forename | SCORRES; SCTEST; SCTESTCD | ||||||||||
| Patient Details | Sex | SEX | ||||||||||||||
| Patient Details | Date of Birth | BRTHDAT | ||||||||||||||
| Patient Details | Address | |||||||||||||||
| Patient Details | Country | |||||||||||||||
| Patient Details | EirCode | |||||||||||||||
| Patient Details | Phone No. | |||||||||||||||
| Patient Details | HSE Area | |||||||||||||||
| Patient Details | Occupation | EMPJOB_SCORRES | What is the patient's occupation? | Occupation |
Clinical Details
In clinical details we are capturing the medical history of the disease under study.
Epidemiological Details
Interviewer Details
Additional Details / Notes
Underlying Clinical Conditions Details
Occupational Healthcare Exposure Status
Patient Outcome
CDISC Technical Details
| Standard | Version | Comment |
|---|---|---|
| SDTM | 1.4 | Latest version accepted by the FDA |
| SDTMIG | 3.2 | Latest version accepted by the FDA |
| CT | 2019-12-20 | Latest version |
| CDASHIG | 2.1 | Latest version |
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