General Guidance

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, AEACNOT3, 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 populated for responses. This eliminates confusion regarding whether a blank response indicates "N" or is a missing value.
• 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, only 1 value will be populated ("Y" or "N") and the alternate value will be blank. 

Product Impact on Individual Health only:

Interventions (e.g., concomitant medications) and events (e.g., medical history) can be collected as responses to a prespecified list of treatments or terms. In such cases:

• --PRESP represents when topic variable values, specific interventions (--TRT), or events (–TERM) were prespecified at the time of data collection. Values will be "Y" (for "Yes") or a null value.
• --OCCUR represents whether prespecified interventions or events occurred or did not occur. Values will be populated for prespecified interventions and events only. Possible values are "Y" and "N" (for "Yes" and "No"). When an intervention or event is not prespecified, the value of --OCCUR will be null. 
• --STAT and --REASND can be used to provide information about prespecified interventions and events for which there is no response (e.g., investigator forgot to ask). In such cases the value of --STAT will be "NOT DONE" and the value of --REASND will be the reason when collected.

The following table shows the population of --PRESP, --OCCUR, --STAT, and --REASND for different data collection scenarios.

• 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.

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.

If supplemental free text is collected for a result via CRF, then refer to Section 2.8.7.4, Free Text from Case Report Forms (CRFs). For responses collected via QRS instruments, refer to Section 2.8.7.2, Questionnaires, Ratings, and Scales.   

For all other results:

• --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 with 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.

--REASPF will represent the reason a test was performed, if collected.

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:

Nonclinical:

• When there is a need to derive results based on collected values in --ORRES (e.g., means or ratios based on collected values), a new record for the derived result will be created in the dataset. In such cases, --DRVFL will be populated with "Y" in the derived record. --GRPID may be used to explicitly define the relationship between a derived record and the records from which it was derived. This practice would be especially important in the case of multiple derived records in a domain for the same subject (e.g., 2 baseline averages). 
  • For example, a mean systolic blood pressure derived from collected systolic blood pressure would be represented in the following way:

Product Impact on Individual Health:

• Derived records will only be created for QRS domains as applicable. Refer to Section 2.8.7.2, Questionnaires, Ratings, and Scales (QRS).
• Otherwise, records for derived results will not be created. When needed such results will be derived as part of analysis.

• When appropriate, dates that are collected results will be represented as results in variable --ORRES. 
• Dates will be represented in --ORRES in ISO 8601 format. 
• Prior to representing a date as a result, confirm the date is actually a finding for an observation and not the timing of an observation.