CDASH FA specification

TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Observation Class

Domain

Data Collection Scenario

Implementation Options

Order Number

Collection Variable

Collection Variable Label

DRAFT Collection Definition

Question Text

Prompt

Data Type

Collection Core

Case Report Form Completion Instructions

Tabulation Target

Mapping Instructions

Controlled Terminology Codelist Name

Subset Controlled Terminology/CDASH Codelist Name

Implementation Notes

Findings About Events or Interventions

FA

N/A

1

STUDYID

Study Identifier

A unique identifier for a study.

What is the study identifier?

[Protocol/Study]

Char

HR

N/A

STUDYID

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.

Findings About Events or Interventions

FA

N/A

2

SITEID

Study Site Identifier

A unique identifier for a site within a study.

What is the site identifier?

Site (Identifier)

Char

HR

N/A

DM.SITEID

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site.

EDC: This should be pre-populated.

Findings About Events or Interventions

FA

N/A

3

SUBJID

Subject Identifier for the Study

A unique subject identifier within a site and a study.

What [is/was] the (study) [subject/participant] identifier?

[Subject/Participant] (Identifier)

Char

HR

Record the identifier for the subject.

DM.SUBJID

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.

Findings About Events or Interventions

FA

N/A

4

VISIT

Visit Name

The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.

What is the visit name?

[Visit]

Char

R/C

N/A

VISIT

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.

Findings About Events or Interventions

FA

N/A

5

VISDAT

Visit Date

Date the clinical encounter occurred (or started).

What [is/was] the date of the visit?

(Visit) Date

Char

R/C

Record the [date/start date] of the visit using this format (DD-MON-YYYY).

N/A

This field is not an tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the collection VISDAT/VISTIM components and populating the tabulation variable FADTC in ISO 8601 format.

N/A

The date the finding about measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the FA CRF using the Findings About Date (FADAT) field.

Findings About Events or Interventions

FA

N/A

6

FAOBJ

Findings About Object of the Observation

A description of the object or focal point of the findings observation that is represented by FATEST.

[Applicantsdt,-defined phrase]

[Applicant-defined phrase]

Char

HR

[Protocol-specific]

FAOBJ

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

The FAOBJ will usually be pre-printed or hidden, not solicited as an actual question. These FA domains are usually created by the applicant.

Findings About Events or Interventions

FA

N/A

7

FAYN

Findings About Collected

An indication of whether data was collected for the finding topic.

Has the subject had any [Findings topic(s)] (after/before [study specific time frame])?; [Was/Were] (there) any [Findings topic(s)] (reported) (after/before [study specific time frame])?; Were all eligibility criteria met?

Any [Finding Topic]

Char

O

Indicate if the there are findings. If Yes, include the appropriate details where indicated on the CRF.

N/A

Does not map to a tabulation variable.

(NY)

N/A

This is a field that can be used in any CRF to indicate whether there is data to record. Used primarily as a data cleaning field, it provides verification that all other fields on the CRF were deliberately left blank. FAPERF should be used to capture a response about whether planned measurements, tests, or observations were done.

Findings About Events or Interventions

FA

N/A

8

FAPERF

Findings About Performed

An indication of whether a planned measurement, series of measurements, test, observation or specimen was performed or collected.

[Were any/Was the] [FATEST/topic] ([measurement(s)/test(s)/examination(s)/specimen(s)/sample(s))] [performed/collected]?

([FATEST/ topic] ([Measurement (s)/Test(s)/Examination(s)/Specimen(s)/Sample(s)]) [Performed/Collected]?

Char

O

Indicate if the [FATESTs] was/were collected. If Yes, include the appropriate details where indicated on the CRF.

FASTAT

This field does not map directly to an tabulation variable. May be used to populate a value into the tabulation variable FASTAT. If the collection variable FAPERF="N", the value of the tabulation variable FASTAT is "OT DONE". If FAPERF="Y", FASTAT is null. A combination of tabulation variables (e.g., FACAT and FASCAT, FATPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable FATESTCD would be populated with FAALL and an appropriate test name (FATEST) provided.

(NY)

N/A

This field is used to capture a response to whether a planned measurement, test or observation was performed. A negative response can be collected as "N" and mapped to the tabulation FASTAT variable as "NOT DONE".

Findings About Events or Interventions

FA

N/A

9

FADAT

Findings About Assessment Date

The date when the findings about assessment was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).

What was the date the findings about assessment was performed?

Date

Char

R/C

Record date of measurements using this format (DD-MON-YYYY).

FADTC

This field does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable FADTC in ISO 8601 format.

N/A

The date the FA measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the FA CRF using the Date of Collection (FADAT) field.

Findings About Events or Interventions

FA

N/A

10

FATIM

Findings About Assessment Time

The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).

What was the time of the findings about assessment?

Time

Char

R/C

Record time of measurement (as complete as possible).

FADTC

This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable VSDTC in ISO 8601 format.

N/A

Collect time if it is relevant for the analysis.

Findings About Events or Interventions

FA

N/A

11

FATEST

Findings About Test Name

Descriptive name for the test being performed.

What [is/was] the name (of the [measurement/test/examination])?

[Measurement/Test/Examination/] (Name)

Char

HR

Record the name of the FATEST if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.

FATEST; FATESTCD

Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable FATESTCD may be determined from the value collected in FATEST.

N/A

Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Test" can be included in the column heading.

Findings About Events or Interventions

FA

N/A

12

FATSTDTL

Findings About Test Detail

A further description of FATESTCD and FATEST.

What [is/was] the [measurement/test/examination] detail name?

[Measurement/Test/Examination] Detail (Name)

Char

O

Record the detail of the [FATEST], if not pre-printed on the CRF.

FATSTDTL

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

It is recommended that the test detail name be pre-printed on the CRF. If the form is laid out as a grid, then words such as "Test," "Test Name" can be included in the column heading.

Findings About Events or Interventions

FA

N/A

13

FACAT

Category for Findings About

A grouping of topic-variable values based on user-defined characteristics.

What [is/was] the [type/category/name] (of the [measurement/test/examination/specimen/sample])?

[Category/Category Value]; NULL

Char

O

Record the FA category, if not pre-printed on the CRF.

FACAT

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included in the column heading.

Findings About Events or Interventions

FA

N/A

14

FASCAT

Subcategory for Findings About

A sub-division of the FACAT values based on user-defined characteristics.

What [is/was] the [type/subcategory/name] (of the [measurement/test/examination/specimen/sample])?

[FA Subcategory/FA Subcategory Value]; NULL

Char

O

Record the FA subcategory, if not pre-printed on the CRF.

FASCAT

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included in the column heading. FASCAT can only be used if there is an FACAT, and it must be a subcategorization of FACAT.

Findings About Events or Interventions

FA

N/A

15

FAPOS

Findings About Position of Subject

The position of the subject during a measurement or examination.

In what position was the subject during the [measurement/ test/examination/specimen collection/sample collection]?; What was the position of the subject (during the [measurement/test/examination/specimen collection/sample collection])?

Position

Char

O

Record the position of the subject during the FA test.

FAPOS

Maps directly to the tabulation variable listed in the Tabulation Target column.

(POSITION)

N/A

Findings About Events or Interventions

FA

N/A

16

FAORRES

FA Result or Finding in Original Units

Result of the measurement or finding as originally received or collected.

What [is/was] the [result/amount/(subject's) characteristic] (of the [measurement/test/examination/question/assessment])?

([Result/Amount] of) [value from FATEST]

Char

HR

Record the FATEST result.

FAORRES

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Both quantitative results and interpretive findings or summaries may be recorded here.

Findings About Events or Interventions

FA

N/A

17

FAORRESU

FA Original Units

The unit of the result as originally received or collected.

What [is/was] the unit (of the [measurement/test/examination])?

Unit

Char

R/C

Select the unit of measure associated with the test, or record if not pre-printed on the CRF.

FAORRESU

Maps directly to the tabulation variable listed in the Tabulation Target column.

(UNIT)

N/A

Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.

Findings About Events or Interventions

FA

N/A

18

FAORNRLO

FA Normal Range Lower Limit- Orig Unit

The lower end of normal range or reference range for continuous results stored in FAORRES.

What [is/was] the lower limit of the reference range (for the [measurement/test/examination])?

Normal Range Lower Limit

Char

O

Record the lower limit of the reference range of the FA test.

FAORNRLO

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

--ORNRLO should be populated only for continuous findings. The tabulation variable --STNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment, or could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.

Findings About Events or Interventions

FA

N/A

19

FAORNRHI

FA Normal Range Upper Limit- Orig Unit

The upper end of normal range or reference range for continuous results stored in FAORRES.

What [is/was] the upper limit of the reference range (for the [measurement/test/examination])?

Normal Range Upper Limit

Char

O

Record the upper limit of the reference range of the FA test.

FAORNRHI

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

--ORNRHI should be populated only for continuous findings. The tabulation variable --STNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment, or could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.

Findings About Events or Interventions

FA

N/A

20

FANRIND

Findings About Reference Range Indicator

An indication or description about how the value compares to the normal range or reference range.

How [did/do] the reported values compare within the [reference/normal/expected] range?

Comparison to [Reference/Expected/Normal] Range

Char

O

Record where the test results were categorized within the respective reference range (e.g. HIGH, LOW, ABNORMAL).

FANRIND

Maps directly to the tabulation variable listed in the Tabulation Target column.

(NRIND)

N/A

Reference ranges may be defined by FAORNRLO, FAORNRHI, FASTNRC or other objective criteria. Reference Range Indicator may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.

Findings About Events or Interventions

FA

N/A

21

FASTAT

Findings About Completion Status

This variable is used to indicate that data are not available, by having the site recording the value as "Not Done".

Was the [--TEST ] not [completed/answered/done/assessed/evaluated ]?; Indicate if the([--TEST] was) not [answered/assessed/done/evaluated/performed].

Not Done

Char

O

Indicate if the [FATEST] measurement was not done.

FASTAT

Maps directly to the tabulation variable listed in the Tabulation Target column.

(ND)

N/A

Used only when the response value is collected as NOT DONE or NULL in lieu of or in addition to the collection FAPERF field. Typically a checkbox which indicates the test was NOT DONE. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank.

Findings About Events or Interventions

FA

N/A

22

FAREASND

Findings About Reason Not Performed

An explanation of why data are not available.

Was the [is/was] the reason that the [Findings topic/data/information/applicant-defined phrase] was not [collected/answered/done/assessed/evaluated]?

Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available]

Char

O

Provide the reason why an FA test was not collected.

FAREASND

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Applicant-defined controlled terminology may be used. The reason the data are not available may be chosen from applicant defined codelist (e.g., broken equipment, subject refused, etc.) or entered as free text. When --REASND is used, --STAT should also be populated in the tabulation dataset.

Findings About Events or Interventions

FA

N/A

23

FASPEC

Findings About Specimen Type

The type of specimen used for a measurement.

What [is/was] the specimen type?

Specimen Type

Char

O

Record the specimen material type.

FASPEC

Maps directly to the tabulation variable listed in the Tabulation Target column.

(SPECTYPE)

N/A

The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.

Findings About Events or Interventions

FA

N/A

24

FASPCCND

Findings About Specimen Condition

Description of the condition of the specimen.

What [is/was] the condition of the specimen?

Specimen Condition

Char

O

Record the condition of the specimen.

FASPCCND

Maps directly to the tabulation variable listed in the Tabulation Target column.

(SPECCOND)

N/A

May be collected using free or standardized text. Results may be affected by whether conditions for specimen were properly met. When local processing is used, applicants may not routinely collect specimen condition.

Findings About Events or Interventions

FA

N/A

25

FALOC

Location of the Finding About

The anatomical location of the subject, relevant to the collection of the measurement.

What [is/was] the anatomical location (of the [measurement/test/examination]) or What [is/was] the anatomical location where the [measurement/specimen] was taken/collected)?

Anatomical Location

Char

O

Record or select location on body where the measurement was performed, if not pre-printed on CRF.

FALOC

Maps directly to the tabulation variable listed in the Tabulation Target column.

(LOC)

N/A

Collected or pre-printed when the applicant needs to identify the specific anatomical location (e.g., ARM for blood pressure). Applicants may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.

Findings About Events or Interventions

FA

N/A

26

FALAT

Laterality of Location of Finding About

Qualifier for anatomical location, further detailing the side of the body.

What [is/was] the side (of the anatomical location of the [measurement/test/examination])?

Side

Char

O

Record the side of the anatomical location of the [FATEST] measurement.

FALAT

Maps directly to the tabulation variable listed in the Tabulation Target column.

(LAT)

N/A

May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.

Findings About Events or Interventions

FA

N/A

27

FADIR

Findings About Directionality

Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.

What [is/was] the directionality (of the anatomical location of the [measurement/test/examination])?

Directionality

Char

O

Record the directionality.

FADIR

Maps directly to the tabulation variable listed in the Tabulation Target column.

(DIR)

N/A

May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.

Findings About Events or Interventions

FA

N/A

28

FAPORTOT

FA Location Portion or Totality

Qualifier for anatomical location, further detailing the distribution (i.e.,arrangement of, apportioning of).

What [is/was] the portion or totality (of the anatomical location of the [measurement/test/examination])?

Portion or Totality

Char

O

Indicate the portion or totality anatomical location.

FAPORTOT

Maps directly to the tabulation variable listed in the Tabulation Target column.

(PORTOT)

N/A

Collected when the applicant needs to identify the specific portionality for the anatomical locations of the location of the FATEST. Applicants may collect the data using a subset list of controlled terminology on the CRF.

Findings About Events or Interventions

FA

N/A

29

FAMETHOD

Findings About Method

Method of the test or examination.

What was the method (used for the [measurement/test/examination])?

Method

Char

O

Record the method used for the measurement, test, or examination.

FAMETHOD

Maps directly to the tabulation variable listed in the Tabulation Target column.

(METHOD)

N/A

Findings About Events or Interventions

FA

N/A

30

FALEAD

Findings About Lead

The lead or leads identified to capture the measurement for a test from an instrument.

What [is/was] the lead (used to measure [measurement/test/examination])?

Lead

Char

O

Record the lead used for measurement.

FALEAD

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Findings About Events or Interventions

FA

N/A

31

FAFAST

Findings About Fasting Status

An indication that the subject has abstained from food/water for the specified amount of time.

[Is/Was] the subject fasting (prior to the [test being performed/sample being collected])?

Fasting

Char

O

Record whether the subject was fasting prior to the test being performed.

FAFAST

Maps directly to the tabulation variable listed in the Tabulation Target column.

(NY)

N/A

Results may be affected by whether the subject was fasting. This may not be relevant for all tests.

Findings About Events or Interventions

FA

N/A

32

FAEVAL

Findings About Evaluator

The role of the person providing the evaluation.

Who provided the (applicant-defined phrase) information?; Who was the evaluator?

[Evaluator/Reporter]

Char

O

Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, VENDOR).

FAEVAL

Maps directly to the tabulation variable listed in the Tabulation Target column.

(EVAL)

N/A

Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed, or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.

Findings About Events or Interventions

FA

N/A

33

FAEVALID

Findings About Evaluator Identifier

An identifier used to distinguish multiple evaluators with the same role recorded in FAEVAL.

What [is/was] the identifier of the [evaluator name/reporter name] (providing the-applicant-defined phrase-information)?

[Evaluator/Reporter] Identifier

Char

O

Record the unique identifier assigned to the person making the evaluation.

FAEVALID

Maps directly to the tabulation variable listed in the Tabulation Target column.

(MEDEVAL)

N/A

This variable is used in conjunction with FAEVAL to provide an additional level of detail.

Findings About Events or Interventions

FA

N/A

34

FACLSIG

Findings About Clinical Significance

An indication whether the test results were clinically significant.

[Is/Was] the ([measurement/test/examination]) result clinically significant?

([Measurement/Test/Examination/])/Clinically Significant

Char

O

Record whether the [FATEST] result was clinically significant.

SUPPFA.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPFA dataset as the value of SUPPFA.QVAL when SUPPFA.QNAM = "CLSIG" and SUPPFA.QLABEL = "Clinical Significance".

(NY)

N/A

Metadata Checks Findings

Metadata Check User Macros FAQ

For variable N/A / N/A / FATSTDTL, FATSTDTL is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FAPOS, FAPOS is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FAORNRLO, FAORNRLO is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FAORNRHI, FAORNRHI is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FANRIND, FANRIND is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FASPEC, FASPEC is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FASPCCND, FASPCCND is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FADIR, FADIR is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FAPORTOT, FAPORTOT is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FAMETHOD, FAMETHOD is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FALEAD, FALEAD is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FAFAST, FAFAST is a not a recognized tabulation variable in Tabulation Target
For variable N/A / N/A / FAEVALID, FAEVALID is a not a recognized tabulation variable in Tabulation Target

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CDASH FA specification