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Metadataspec
NumVariable PopulationImplementation
1Text strings greater than 200 characters

When text strings greater than 200 characters are collected, the following conventions for general observation class variables and SUPP-- datasets will be adhered to:

  • The first 200 characters of text should be stored in the parent domain variable and each additional 200 characters of text should be stored in a record in the SUPP-- dataset.
    • When splitting a text string into several SUPP-- records, the text should be split between words to improve readability.
    • The value of the first QNAM representing text over 200 characters will be the original domain variable name without any numeric suffix. 
    • The values for subsequent QNAMs will be sequential variable names, formed by appending a 1-digit integer, beginning with 1, to the original domain variable name. In cases where the standard domain variable name is already 8 characters in length, applicants will replace the last character with a digit when creating values for QNAM.
      • e.g., For Other Action Taken in Adverse Events (AEACNOTH), values for QNAM for the SUPPAE records would have the values AEACNOT1, AEACNOT2, and so on. 
        Jira
        showSummaryfalse
        serverIssue Tracker (JIRA)
        serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
        keyTOBA-627
    • The value for QLABEL should be the original domain variable label for all QNAM values.
2"Yes/No" values
  • For variables where the response is "Yes" or "No", both "Y" and "N" will be populated for responses. This eliminates confusion regarding whether a blank response indicates "N" or is a missing value.
  • Some variables are collected or derived in a manner that allows only 1 response (e.g., a single checkbox for "Yes"). In situations such as these, where it is unambiguous to populate only the response of interest, it is permissible to populate only 1 value ("Y" or "N") and leave the alternate value blank. 
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-628
3

--FOCID

  • Variable --FOCID is populated when a specific part of a subject or specimen is identified as a study-specific point of interest (e.g., injection site, biopsy site, treated site, region of the body).
  • When used, the variable serves as a cross-domain identifier for the study-specific focus of interest; any records relating to the same focus would have the same FOCID value.
4

--SEQ, --RECID

Variables --SEQ and --RECID are populated to explicitly identify domain records in different ways. Differences in variable population are described below.

--SEQ--RECID
Values uniquelyidentify records for subjects within a domain.Values uniquely identify records within a domain.

The relationship between records and values is not one-to-one.

  • Values may change between versions of datasets.
  • When a record is deleted, the value for the record may be reused to identify another record.

There is a one-to-one relationship between records and values.

  • Values for records do not change between versions of datasets even when content is modified. 
  • When a record is deleted, the value for the record will not be reused to identify another record.
Variable is numeric with numeric values.Variable is character with numeric, character, or alphanumeric values.
Conventions for establishing and maintaining values are applicant-defined. Values may or may not be sequential depending on data processes and sources.



5--GRPID

The value of --GRPID is generally assigned during or after data collection at the discretion of the applicant.

6

--REFID

Values for --REFID are applicant-defined and can be any alphanumeric strings the applicant chooses, consistent with their internal practices.

7--CAT, --SCAT
  • Values for --CAT and/or--SCAT are known (identified) about the data before it is collected.
  • Variable --SCAT will be populated only when there is a value in variable --CAT.
  • Values for --CAT and --SCAT will not be the domain name or dictionary classification represented in --DECOD and --BODSYS.
8--STAT
  • In general observation class domains, --STAT will be populated with "NOT DONE" when data are not collected for the topic of the observation.

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