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Table of Contentstoc

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Summary

This article is intended to provide details related to mapping of CRF data in XPT, CSV, and Excel transfer style exports - addressing variable setup in ClinSpark and reporting of those variables. In this article, “Base Fields” refer to variables that are fully or partially intrinsic to the ClinSpark application and not fully modifiable by site users.  “Custom Fields” refer to variables that are based on study design and therefore entirely modifiable by site users.

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The available settings for both aliases and the global setting are:

Setting Name

Description

Possible values

Default

dataWrap

The character to use to wrap data in text files (e.g. CSV files). Normally a quote " is used to wrap values to ensure that commas within text aren't incorrectly assumed to be a field delimiter.

Any value

"

delimiter

The delimiter to use when generating text files (e.g. a comma is used for CSV files).

Any value

,

includeUniqueRowId

Determines if the ROWID variable is included

true or false

false

includeUnlockedForms

Allows inclusion of data linked to unlocked forms

true or false

false

includeSiteId

Determines if the SITEID variable is included

true or false

false

USUBJIDSeparator

The separator to use between elements of the USUBJID variable

Any value

-

USUBJIDSubject

The subject number to use within USUBJID

See the section on USUBJID for details

randomizationScreening

A note on date and time formats

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It is possible to change the format of dates and times in transfer reports, but this needs to be done by Foundry Health engineering IQVIA support staff via request on the service desk and may incur a fee.

Randomized Subjects

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When generating the report, this option will narrow output to subjects that have obtained a randomization number. However, if subjects are also defined as part of the report input prior to generating, this setting will be ignored.

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Transfer Data Mapping (Base Fields)

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Protocol Name maps within every dataset under a “STUDYID” column header when reported via a Clinical Data CSV or Clinical Data Excel Transfer report.

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Variable Attributes

ClinSpark NAME

FIELD NAME

REQD

SAS VARIABLE NAME

DEFAULT REPRESENTATION

MAX LENGTH

DATA TYPE

EXPLA-NATION

ClinSpark Notes

SUGGESTED CODELIST

STUDYID

Study ID or Number

Yes

STUDYID

(none)

20

Text

The ID of the study.

Protocol name if defined, otherwise study name

(none)

SITEID

ClinSpark

The ‘Location OID’ associated with the Study Site.

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If the Transfer Report settings request inclusion of the SITEID variable, Site ID maps within every dataset under a “SITEID” column header when reported via a Clinical Data CSV or Clinical Data Excel Transfer report.

Variable Attributes

ClinSpark NAME

FIELD NAME

REQD

SAS VARIABLE NAME

DEFAULT REPRESENTATION

MAX LENGTH

DATA TYPE

EXPLANATION

ClinSpark Notes

SUGGESTED CODELIST

SITEID

Site ID

Yes

SITEID

(none)

N/A

Text

Study Site Identifier

(none)

(none)

DOMAIN

ClinSpark

Domains are established at the Item Group level and are used to define datasets.  CRF Items contained within an Item Group will report within that Item Group’s Domain.

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Each unique dataset manifests as an Excel Tab when reported via a Clinical Data Excel Transfer report

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Variable Attributes

ClinSpark NAME

FIELD NAME

REQD

SAS VARIABLE NAME

DEFAULT REPRESENTATION

MAX LENGTH

DATA TYPE

EXPLANATION

ClinSpark Notes

SUGGESTED CODELIST

DOMAIN

Domain Abbreviation

Yes

DOMAIN

(none)

(none)

Text

Dataset for data reporting

Domain abbreviation as defined at Item Group

(none)

USUBJID

ClinSpark

Subject IDs are a Concatenation of Study ID (established as part of Study Configuration), Site ID (the study site Location OID) and Subject Number (established as part of a Cohort Assignment), separated by a suitable separator.  This should uniquely identify a subject across all studies. 

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The specific subject number used is configured through transfer report settings, the available options are:

Setting Value

Description

randomizationNumber

The subject’s Randomization Number

leadInNumber

The subject’s LeadIn Number

screeningNumber

The subject’s Screening Number

randomizationScreening

If a subject has a Randomization Number it will be used, otherwise their Screening Number will be used

randomizationLeadInScreening

If a subject has a Randomization Number it will be used, otherwise if they have a LeadIn Number it will be used, otherwise their Screening Number will be used

leadInScreening

If a subject has a LeadIn Number it will be used, otherwise their Screening Number will be used

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Clinical Data XPT

Subject IDs map within every dataset under a “USUBJID” variable when reported via a Clinical Data XPT Transfer report.

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Subject IDs map within every dataset under a “USUBJID” column header when reported via a Clinical Data CSV or Clinical Data Excel Transfer report.

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Variable Attributes

ClinSpark NAME

FIELD NAME

REQD

SAS VARIABLE NAME

DEFAULT REPRESENTATION

MAX LENGTH

DATA TYPE

EXPLANATION

ClinSpark Notes

SUGGESTED CODELIST

USUBJID

Subject ID or Number

Cond.

USUBJID

Concatenation of STUDYID and Subject Number

20

Text

The ID of the subject after randomization.

ClinSpark randomization number

(none)

[domain]GRPID

ClinSpark

Group IDs are used to ‘bind’ together data collected within a unique Form, even when that data spans multiple records or multiple domains.  For example, an “Adverse Event / Concomitant Medication” Form may contain AE Domain data as well as CM Domain data, with that data associated across datasets by way of shared AEGRPID and CMGRPID variables.

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Visit Numbers map within every dataset under a “VISITNUM” column header when reported via a Clinical Data CSV or Clinical Data Excel Transfer report.

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Variable Attributes

ClinSpark NAME

FIELD NAME

REQD

SAS VARIABLE NAME

DEFAULT REPRESENTATION

MAX LENGTH

DATA TYPE

EXPLANATION

ClinSpark Notes

SUGGESTED CODELIST

VISITNUM

Visit ID or Number

NO

VISITNUM

(none)

20

Text

The ID or Number of the visit

Study Event Visit #

(none)

VISIT

ClinSpark

Visits (or ‘Study Events’) describe study days (i.e. Day 1, Day 2, Day 3) or categories of activities (i.e. AE / CM Details).  Scheduled Study Events are used to organize activities that are scheduled to be collected on a particular day.  Unscheduled Study Events provide a container for ad-hoc activities that were not initially scheduled to be collected during a particular visit or at a particular time point.  Common Study Events provide a container for a sub-set of unscheduled activities (like AEs and Con Meds) so as to quickly differentiate these important activities from other unscheduled activities.

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Visits map within every dataset under a “VISIT” column header when reported via a Clinical Data CSV or Clinical Data Excel Transfer report.

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Variable Attributes

ClinSpark NAME

FIELD NAME

REQD

SAS VARIABLE NAME

DEFAULT REPRESENTATION

MAX LENGTH

DATA TYPE

EXPLANATION

ClinSpark Note

SUGGESTED CODELIST

VISIT

Visit Name

YES

VISIT

(none)

40

Text

The name of the visit.

Study Event Name

(none)

[domain]DTC

ClinSpark

DTC variables capture the Collection Time for data fields contained within the same Form.  This is intended to represent the date/time at which a data collector performs an activity.  For more information on how Collection Time is captured, refer to the Collection Time Knowledge Base Article.

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For more information regarding Repeating Item Groups, please refer to the the following Knowledge Base Articles:

Repeating Item Groups Knowledge Base Article

Default Item Groupings Knowledge Base ArticleGroups

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Clinical Data XPT

Item Group repeat numbers map within every dataset under a “[domain]REPEAT” variable when reported via a Clinical Data XPT Transfer report.

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Variable naming is as follows:

Data Type

Variable Name

text

TEXT

integer

INT

float

FLOAT

date

DATE

time

TIME

datetime

DATETIME

string

STRING

boolean

BOOLEAN

partial date

PARTDAT

partial time

PARTTIM

partial datetime

PARTDTTM

duration datetime

DURDTTM

interval datetime

INTDTTM

incomplete datetime

INCDTTM

incomplete date

INCDATE

incomplete time

INCTIME

Clinical Data CSV and Excel

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Variable naming is as follows:

Data Type

Variable Name

text

TEXT

integer

INT

float

FLOAT

date

DATE

time

TIME

datetime

DATETIME

string

STRING

boolean

BOOLEAN

partial date

PARTDAT

partial time

PARTTIM

partial datetime

PARTDTTM

duration datetime

DURDTTM

interval datetime

INTDTTM

incomplete datetime

INCDTTM

incomplete date

INCDATE

incomplete time

INCTIME

General Notes about Data Mapping

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The following table describes variables found in the LAB_DATA dataset:

Variable Name

Description

Additional Details / Controlled Terms

STUDYID

Study Identifier

Unique identifier for a study.

DOMAIN

Domain Abbreviation

Two-character abbreviation for the domain

USUBJID

Unique Subject Identifier

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

LBGRPID

Group ID

Used to tie together a block of related records in a single domain for a subject.

EPOCH

Epoch

Stage of study (i.e. Screening, Lead-In, Treatment)

COHORT

Cohort

-

VISITNUM

Visit Number

  1. Clinical encounter number.

  2. Numeric version of VISIT, used for sorting.

VISIT

Visit Name

  1. Protocol-defined description of clinical encounter

  2. May be used in addition to VISITNUM and/or VISITDY

LBDTC

Date/Time of Specimen Collection

-

LBTPT

Planned Time Point Name

  1. Text Description of time when specimen should be taken.

  2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See LBTPTNUM and LBTPTREF. Examples: Start, 5 min post.

LBNAM

Vendor Name

The name or identifier of the laboratory that performed the test. This is defined in the ClinSpark interface via study site Central Lab ID.

ACCSNNUM

Accession ID or Number

The ID of the kit used at a subject visit.

LBDTM

Actual Collection Date and Time

The local date and time of actual specimen collection at the site.

LBDTN

Actual Collection Date and Time

The local date and time of actual specimen collection at the site.

ITEMNM

Item Name

Name of item containing lab service code(s)

BATTRNAM

Battery Name

The name of battery or panel to which the test belongs.

BATTRID

Battery ID

The ID of the battery or panel to which the test belongs. If a Battery ID does not exist, use the Test ID from the next level.

LBTEST

Lab Test Name

The name of the test performed as defined by the data provider.

RPTRESC

Reported Text Result

Reported text result by laboratory.

RPTRESN

Reported Numeric Result

Reported numeric result by laboratory.

RPTNRLO

Reported Reference Range Low

Reported lower limit of reference range by laboratory.

RPTNRHI

Reported Reference Range High

Reported upper limit of reference range by laboratory.

RPTRANC

Reported Reference Range

Reported lower and upper limit of reference range by laboratory.

RPTU

Reported Units

Reported result units by laboratory.

ALRTFL

Alert Flag

The alert flags generated by the laboratory reference ranges applied and tied to the reported result. There are 12 alert flags:
LP - Low Panic
LT - Low Telephone
LN - Low Normal
N - Normal
HN - High Normal
HT - High Telephone
HP - High Panic
AB - Abnormal
P - Prolonged
PP - Prolonged Panic
BL - Borderline
and blank when not used.

REVDTC

Date/Time of Review

Review restricted to applicable laboratory reviewer

REVSIG

Significance

Significance assigned by applicable reviewer. There are two options:
CS - Clinically Significant
NCS - Not Clinically Significant

REVRPT

Repeat

Repeat status assigned by applicable reviewer. There are two options:
Y - Yes
N - No

DELTFL

Delta Flag

The delta flag generated by the reference ranges applied and tied to the reported result. There are three delta flags:
D+ for an increase in value
D- for a decrease in value
and blank for no flag.

FILCRDTC

File Creation Date and Time

The local date and time the data file was created at the central laboratory. This includes a Universal Time Offset plus/minus hours and minutes.

TSTSTAT

Test Status

This indicates what the status of the test is. There are three test statuses:
Done
Not Performed
Cancelled