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Metadataspec

Num

Collection Variable Use

Implementation

1

--YN

--YN ("Yes/No") questions are used to provide a definite answer. The absence of a response is ambiguous as it can mean "no," "none," or that the response is missing.
Variables with the question text "Were there any interventions?" (e.g., “Were there any concomitant medications?") support the cleaning of data and confirmation that entry of collected data is complete.
Jira
showSummary false
server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key TOBA-416
Values collected for these fields
Jira
showSummary false
server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key TOBA-586
will not be represented in subsequent tabulation datasets.

2

--CAT, --SCAT

Categories and subcategories are determined per protocol design and values are generally not entered via CRF.
Jira
showSummary false
server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key TOBA-417
Implementers may:
- Prepopulate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF.
- Prepopulate hidden variables with the values assigned within their operational database.
- Populate values directly in the tabulation dataset during dataset creation.

3

Variables for date and time

The time an intervention started will be collected if there is a scientific or regulatory reason to collect this level of detail and the time can be realistically determined.
Collection variables for date
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showSummary false
server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key TOBA-418
(e.g., --DAT, --STDAT, --ENDAT) will be concatenated with collection variables for time (e.g., --TIM, --STTIM, --ENTIM) as applicable to populate tabulation variables for dates (e.g., --DTC, --STDTC, --ENDTC) using ISO 8601 format.

4

-- REASND

5

--SPID

--SPID may be populated by the implementer's data collection system.
If collected, --SPID it can be used as an identifier in a data query to communicate clearly to individuals involved in data collection the record in question.

6

Coding

When free-text interventions/treatments are recorded, the location may be included in the --TRT variable to facilitate coding (e.g., lung biopsy). Location may be collected when the implementer needs to identify the specific anatomical location of the intervention. This location information does not need to be removed from the verbatim --TRT when creating tabulation datasets.
The non-standard variables --ATC1 through --ATC5 and --ATC1CD through --ATC5CD are used only when the intervention is coded using the World Health Organization's Anatomical Therapeutic Chemical (ATC) classification system (https://www.who.int/medicines/regulation/): 1 = the anatomical main group, 2 = the therapeutic main group, 3 = the therapeutic/pharmacological subgroup, 4 = chemical/therapeutic/pharmacological subgroup, 5 = chemical substance.
Implementers may add MedDRA coding elements
Jira
showSummary false
server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key TOBA-420
as NSVs to the Interventions domain if that dictionary is used for coding.

7

Location (--LOC) and related variables (--LAT, --DIR, -- PORTOT)

Applicants may collect location data using a subset list of controlled terminology on the CRF.
Applicants may prepopulate hidden variables
Jira
showSummary false
server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key TOBA-421
with values assigned within their operational database.

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