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• --PERF defines - variables to record whether an assessment has been performed/collected. --REASND is used to collect a reason why an assessment was not done.
• --PERF has the Question Text "[Were any/Was the] [--TEST/ topic]

•  [measurement(s)/test(s) /examinations (s)/specimen(s) /sample(s) ] [performed/collected]?" are intended to assist in the cleaning of data and in confirming that

• entry of collected data is complete.
• --PERF may be used at the page, panel, or question level.
• --PERF may be used during the creation of tabulaton datasets to derive a value into the SDTM variable --STAT. The implementer can use a combination of --CAT, --SCAT, with the --TESTCD= "--ALL" and --TEST= "<Name of the CRF module>" to represent what tests were not performed.

• Implementers must decide how to model each test not performed (e.g., to denote that all tests were not performed using TESTCD = "–ALL").
• --STAT has the Question Text "Was the [--TEST] not [completed/answered/done/assessed/evaluated]?; Indicate if (the [--TEST] was) not [answered/assessed/done/evaluated/performed]." This is intended to be used to collect a simple "NOT DONE" check box at the page, panel, or question level.
• --REASND is used with SDTM variable --STAT only. The value NOT DONE in --STAT indicates that

• a question was not asked or a test was not done, or a test was attempted but did not generate a result.

Horizontal (denormalized) and vertical data structures (normalized)

• In metadata specifications, many of the Findings class domains are presented in a normalized structure (1 record for each test) similar to a tabulation dataset, even though many data management systems hold the data in a denormalized structure (1 variable for each test).
• When implementing collection standards in a denormalized structure, create variable names for the Findings --TEST and/or --TESTCD values. To do this:
  • Define the denormalized variable names using available CDISC Controlled Terminology for --TESTCD; or
  • When a system allows more than 8-character variable names, the

• • value of variable --TESTCD

• • can be concatenated with the tabulation variable name separated by an underscore (e.g., DIABP_VSORRES, DIABP_VSLOC). 
• In the horizontal (denormalized) setting, collection variables such as --PERF, --LOC , and --STAT can be collected once for the whole horizontal record and applied to all of the observations on that record, or collected per test using collection variables, such as <--TESTCD>_--PERF. When tabulation datasets are created, any variables collected for the entire horizontal record will be mapped to each vertical record per tabulation guidance.
• In the horizontal (denormalized) setting, an identifier

• can be used to identify all --TESTCD for the same collection record. This supports mapping of data collected in a horizontal setting to tabulation datasets and creation of RELRECs.

• The value in --TEST will be 40 characters or less.
• The corresponding codelist value for the short test name, 8 characters or less, will be populated in the tabulation variable --TESTCD.
• Variable --TESTCD should be used to create a variable name and --TEST be used as the Prompt on the CRF.
• Both --TESTCD and --TEST are recommended for use in the operational database.
• Variable --ORRES is used to collect test results or findings in the original units

• as received or collected in character format. 
• If results are modified for coding, the --

• MODIFY variable contains the modified text.
• Variables --ORNRLO and --ORNRHI and --NRIND are used when normal or reference ranges are collected for results. 
• Standardization of the original results and/or normal/reference ranges will be performed during the creation of tabulation datasets.   

• Location variables are used to collect the location of the test.
• Applicants may collect location data using a subset list of controlled terminology on the CRF.
• Applicants may prepopulate hidden variables with values assigned

• within their operational database. 

• Variables --ORRES, --RES, --DESC, and --RESOTH are used to collect results. It is recommended that: 
  • --ORRES is used when the result is collected using a single question. The result will map directly to the tabulation variable --ORRES.
  • --RES and

• • --DESC are used when a pair of questions are asked to collect the result; a question to collect the result with a follow-up question for a description of the result

• • . For example, the question “Is the <condition> [absent/present]?" with a follow-up question “What is the finding that was observed?" where --RES is used to collect whether the finding is normal/abnormal or absent/present and --DESC is used to collect the description of the finding. 
  • --RES and --RESOTH are used when a question is asked that allows the selection of a prespecified finding, with a follow-up question to ask about the pre-specified response "OTHER". For example, the question "What is the result?" with a set of prespecified responses, including the choice “OTHER” with the follow-up question “Specify, Other”.