Page History

...

Metadataspec

Num

Field or Variable

Guidance

1

--CAT, --SCAT

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.

2

--PERF, --STAT, --REASND

--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.

3

--SPID

--SPID may be populated by the applicant's data collection system. If collected, it can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question.
This field may be populated by the applicant's data collection system.

4

Variables for date and time

Time will be collected if there is a scientific or regulatory reason to collect this level of detail and the time can be realistically determined.
- Metadata tables generally include --DAT and --TIM will be added from the CDASH Model as appropriate.
Collection variables for date and time (e.g., --DAT, --TIM) will be used to collect the date or date and time that the test was performed, or the specimen was collected. The start and end dates and times (e.g., for specimen collection) will be collected as appropriate.
The date of collection of a test can be derived from the date of visit. In such cases, a separate date of observation field is not required to be present on the CRF.
Date and time variables will not be used to collect dates that are the result of a tests. Test results will be collected using --ORRES.

5

Horizontal (denormalized) and vertical data structures (normalized)

Jira

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.

6

Tests and original results

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.

7

Location variables (--LOC, --LAT, --DIR, --PORTOT)

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.

8

–ORRES, --RES, --DESC, and --RESOTH

9

Root variables

The Findings About Events and Intervention domains use the same root variables as the Findings domain, with the addition of the --OBJ variable.

...

Page tree