Collection Assumptions

• --YN ("Yes/No") questions are used to provide a definite answer. The absence of a response is ambiguous as it can mean "no," "none," or that the response is missing.
• Variables with the question text "Were there any interventions?" (e.g., “Were there any concomitant medications?") support the cleaning of data and confirmation that entry of collected data is complete. TOBA-416 - Getting issue details... STATUS
• Values collected for these fields TOBA-586 - Getting issue details... STATUS will not be represented in subsequent tabulation datasets. 

• --REASND is used with tabulation variable --STAT. TOBA-419 - Getting issue details... STATUS  
• The value "NOT DONE" in --STAT indicates that the subject was not questioned about the intervention or that data were not collected TOBA-363 - Getting issue details... STATUS ; it does not mean that the subject had no interventions.

• When free-text interventions/treatments are recorded, the location may be included in the --TRT variable to facilitate coding (e.g., lung biopsy). Location may be collected when the implementer needs to identify the specific anatomical location of the intervention. This location information does not need to be removed from the verbatim --TRT when creating tabulation datasets.
• The non-standard variables --ATC1 through --ATC5 and --ATC1CD through --ATC5CD are used only when the intervention is coded using the World Health Organization's Anatomical Therapeutic Chemical (ATC) classification system (https://www.who.int/medicines/regulation/): 1 = the anatomical main group, 2 = the therapeutic main group, 3 = the therapeutic/pharmacological subgroup, 4 = chemical/therapeutic/pharmacological subgroup, 5 = chemical substance.
• Implementers may add MedDRA coding elements as NSVs to the Interventions domain if that dictionary is used for coding.

• Applicants may collect location data using a subset list of controlled terminology on the CRF.
• Applicants may prepopulate hidden variables TOBA-421 - Getting issue details... STATUS with values assigned within their operational database.

• --YN ("Yes/No") questions are used to provide a definite answer. The absence of a response is ambiguous as it can mean "no," "none," or that the response is missing.
• Variables with the question text "Were there any <events>?" (e.g., “Were there any adverse events?”) support the cleaning of data and confirmation that entry of collected data is complete. 
• These questions can be used on any CRF.
• Values collected for these fields will not be represented in subsequent tabulation datasets.

• Categories and subcategories are determined per protocol design and values are generally not entered via CRF.
• Implementers may:
  • Prepopulate and display category values to help individuals involved in data collection understand what data should be recorded on the CRF.
  • Prepopulate hidden variables with the values assigned within their operational database.
  • Populate values directly in the tabulation dataset during dataset creation.

• --REASND is used with tabulation variable --STAT. 
• The value "NOT DONE" in --STAT indicates that the subject was not questioned about the event or that data were not collected; it does not mean that the subject had no events. TOBA-422 - Getting issue details... STATUS

• --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] TOBA-424 - Getting issue details... STATUS [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. TOBA-425 - Getting issue details... STATUS

Horizontal (denormalized) and vertical data structures (normalized) TOBA-402 - Getting issue details... STATUS TOBA-403 - Getting issue details... STATUS

• 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). TOBA-403 - Getting issue details... STATUS
• 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 TOBA-426 - Getting issue details... STATUS 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 TOBA-427 - Getting issue details... STATUS 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. TOBA-428 - Getting issue details... STATUS  

• 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; TOBA-429 - Getting issue details... STATUS 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”.