How to Populate Records and Variables

The following are general conventions for variable population:

Num	Tabulation Variable Use	Implementation
1	Text Data Casing	Variables subject to controlled terminology will be populated with the exact value for the controlled term, including term casing. Otherwise, text data will be represented in upper case (e.g., NEGATIVE).
2	"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.
	--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.
3	--REFID	Values for --REFID are sponsor-defined and can be any alphanumeric strings the sponsor chooses, consistent with their internal practices.
4	--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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DErived records

Assumptions in this section are appliable to Interventions, Events, and Findings class domains and will be used with domain-specific assumptions as appropriate.

General assumptions for the population of values in tabulation variables are provided in this section. Assumptions in this section will be followed and complement more detailed assumptions provided in Domain Specifications.

The following assumptions will be implemented for Findings class domains.

Num

Variable

Guidance

Result Precision

For numeric non-derived data, --ORRES will represent results to precision collected. Precision will not be artificially changed due to computer storage considerations.
For numeric derived data, --ORRES and --STRESC will represent the correct number of significant figures based upon the calculation used to derive the value. Trailing zeroes will be retained when significant.

Standardized Units

Applicants may standardize units within a study for a given test per scientific and regulatory requirements. Standardization of units is recommended when data for the same test are collected via different sources using different units. In such cases, --ORRESU will represent the collected unit and --STRESU will represent the standardized unit.

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Original and Standardized Results (--ORRES, --ORRESU, --STRESC, --STRESU, --STRESN)

The following is applicable to results that are not collected via QRS instruments. Please refer to QS domain assumptions for expected variable population.

--ORRES will be populated with the result of the measurement or finding as originally collected or received, using controlled terminology when applicable.
- When applicable, the unit associated the value of --ORRES will be populated in --ORRESU, using controlled terminology.
Values will be populated in --STRESC when --ORRES is populated. The value of --STRESC will be:
- Derived by the conversion of numeric values in --ORRES to numeric values with standard units. Standard units will be represented in --STRESU using controlled terminology.
  - Numeric --ORRES values with characters attached (e.g., a greater than (>) or less than (<) sign) will be converted to standard units and the value of --STRESC will maintain the attached character (e.g., >10,000, <1).
- The assigned of the value of --ORRES.
  - For nonclinical studies, in the Macroscopic and Microscopic Findings (MA/MI) domains, --ORRES may contain a finding with multiple concatenated modifiers. In this case, --STRESC would represent only the finding without the modifiers.
Numeric values represented in --STRESC will be assigned to --STRESN. If --STRESC is a character value, then, --STRESN will be null.
- Numeric values with attached characters (e.g., >10,000, <1) are considered to be character results and will not be populated in --STRESN.

Tests Not Done

When an entire examination (e.g., Laboratory Test Results (LB)), a group of tests (e.g., hematology or urinalysis), or an individual test (e.g., glucose) is not done for a USUBJID, POOLID, or SPTOBID and this information is explicitly captured with or without the reason for not collecting the information, record(s) can be created in the dataset to represent these data.

In such cases, applicants may include:

Individual records for each test not done for each subject or pool; or
One record for each subject or pool for a group of tests that were not done. In such cases:
- The paired values of --TESTCD and --TEST will represent a general description of testing in scope for the domain and will be used for all groupings of not done tests within the domain.
  - --TESTCD will be the domain code concatenated with the word "ALL".
  - --TEST will be the domain description per controlled terminology.
- --CAT will represent the group of tests not done.
- --ORRES will be null.
- --STAT will be "NOT DONE".
- --REASND will be the reason the group of tests was not done, if collected.

For example, if a group of hematology or urinalysis tests represented in the LB domain are not done for a subject, then:

USUBJID	LBTESTCD	LBTEST	LBCAT	LBORRES	LBSTAT	LBREASND
ABC-001	LBALL	Laboratory Test Results	HEMATOLOGY		NOT DONE
ABC-001	LBALL	Laboratory Test Results	URINALYSIS		NOT DONE	No urine specimen present

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Derived Records

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How to Populate Records and Variables