| Num | Variable Population | Implementation |
|---|
| 21 | Text 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.
- The value for QLABEL should be the original domain variable label for all QNAM values.
| | 32 | "Yes", "No", 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.
| | 43 | --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. |
| | 54 | --GRPID | - The value of --GRPID is generally assigned during or after data collection at the discretion of the applicant.
| | 65 | --REFID | - Values for --REFID are sponsor-defined and can be any alphanumeric strings the sponsor chooses, consistent with their internal practices.
| | 76 | --CAT, --SCAT | - Values for --CAT and/or--SCAT are known (identified) about the data before it is collected.
| | 87 | --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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