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The following are general conventions for variable population:

NumTabulation Variable UseImplementation
1Text Data Casing
  • 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).

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   
  • 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.

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

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

--CAT, --SCAT
  • Values for --CAT and/or--SCAT are known (identified) about the data before it is collected.
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. 

NumVariableGuidance

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.

1Original 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:

USUBJIDLBTESTCDLBTESTLBCATLBORRESLBSTATLBREASND
ABC-001LBALLLaboratory Test ResultsHEMATOLOGY
NOT DONE
ABC-001LBALLLaboratory Test ResultsURINALYSIS
NOT DONENo urine specimen present

Biological Significance 

Nonclinical Only:




For assessments of biological significance when the overall interpretation is a record in the domain, use the supplemental qualifier (SUPP--) record (with QNAM = --BIOSIG) linked to the record that contains the overall interpretation or a particular result. An example would be a QNAM value of LBBIOSIG in SUPPLB with a value of "Y", indicating that a lab result for albumin of 30 mg/mL was biologically significant.

It should be noted that biological significance is different from the concepts of normal and abnormal, which are generally submitted in --ORRES.

2Derived Records
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