Page History

• Variables subject to controlled terminology will be populated with the controlled term, including term casing.
• Otherwise, text data will be represented in upper case (e.g., NEGATIVE).

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 a single checkbox indicates "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. 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.

--SEQ

• Values in --SEQ will uniquely identify a record for a given USUBJID or SPTOBID within a domain.
• Conventions for establishing and maintaining --SEQ values are applicant-defined. Values may or may not be sequential depending on data processes and sources.

• 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.

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