| Num | Variable Population | Implementation |
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| 1 | 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.
| | 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.
- However, 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.
| | 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 |
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| 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 sponsorapplicant-defined and can be any alphanumeric strings the sponsor 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.
| | 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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