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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.
  • The value for QLABEL should be the original domain variable label for all QNAM values.

• For variables where the response is "Yes" or "No", both "Y" and "N" will be   Variables where the response is "Yes" or "No" ("Y" or "N") should normally be populated for both "Y" and "N" responses.
  • This eliminates confusion regarding whether a blank response indicates "N" or is a missing value.
• However, some variables are collected or derived in a manner that allows only 1 response , such as when (e.g., a single checkbox indicates for "Yes"). In situations such as these, where it is unambiguous to populate only the only the response of interest, it is permissible to populate only 1 value ("Y" or "N") and leave the alternate value blank. An example of when it would be acceptable to use only a value of "Y" would be for Last Observation Before Exposure Flag (--LOBXFL) variables, where "N" is not necessary to indicate that a value is not the last observation before exposure. 

--FOCIDOften,

• 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

The following examples demonstrate records from various domains that tie to study-specific foci (i.e., injection site 1 and injection site 2) as identified in the protocol. In each case, the FOCID variable is populated identically across domains for the same focus. Note that, in this example, many variables have been omitted due to space considerations.

• .

--SEQ, --RECID

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

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

--REFID

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

• 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.

• In general observation class domains, --STAT will be populated with "NOT DONE" when data are not collected for the topic of the observation.