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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Paced Tapping (PACED TAPPING)

CDISC Reference

Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short NamePACED TAPPING
QRS Permission StatusApproved
TeamHuntington's Disease Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Version1.0
StatusDRAFT
Date2019-06-16
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical trials.
Known Issues
  • QRS Controlled Terminology Request: The PACED TAPPING CRF includes the following controlled terminology: “milliseconds squared and inverted milliseconds squared”. A NCI/EVS Controlled Terminology request was submitted in September 2018 to update the UNIT codelist with these new units. The units represented in the supplement example match the CRF units that are in the controlled terminology request. This controlled terminology update will be resolved before the supplement is published. The supplement will proceed through the CDISC standards review process.
    • The CDISC lab terminology team currently has a backlog of terminology requests. The PACED TAPPING UNIT requests have a request number of CDISC-3495. This request is expected to be published in either P38 (June 2019 release) or P39 (September 2019 release).


Revision History

DateVersion
2019-06-16
1.0 Draft

© 2019 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Paced Tapping (PACED TAPPING) functional test.

CDISC does not modify QRS instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this functional test is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Functional Tests (FT) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this functional test are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

2 Copyright Status

Stout Labs and Monash University own the copyright for the PACED TAPPING instrument and have granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. Hence, CDISC developed FTTESTCD and  FTTEST for each item based on the actual question text on the functional test. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (Paced Tapping Annotated CRF.pdf).

Note: CDISC controlled terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website (https://www.cdisc.org/standards/terminology).

CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges Stout Labs and Monash University for the approval to include the PACED TAPPING in the CDISC data standards.

References for Paced Tapping (PACED TAPPING):

  • Rowe KC, Paulsen JS, Langbehn DR, et al. Self-paced timing detects and tracks change in prodromal Huntington disease. Neuropsychology. 2010;24(4):435-442. doi:10.1037/a0018905
  • Stout JC, Paulsen JS, Queller S, et al. Neurocognitive signs in prodromal Huntington disease. Neuropsychology. 2011;25(1):1-14. doi:10.1037/a0020937

3 The FT Domain Model

3.1 Assumptions for the FT Domain Model

All assumptions and business rules described in the SDTMIG FT domain are applicable to this supplement. Additional assumptions specific to the PACED TAPPING are listed below.

The PACED TAPPING is a test where participants try to keep pace with a computer generated tapping tones using a computer mouse. The data shown here reflects the data points that the computer software can produce from the 4 trials and some summary variables. It uses repeated tones at a constant rate to measure psychomotor functioningThe subject tries to match paced tones from a computer and then self-paced tones once the computer-produced tones stop. A computer mouse is used for the tapping, and 4 trials are administered with the entire test lasting between 1 and 6 minutes

  1. The numerical value for all data points in the PACED TAPPING test is recorded in FTORRES, FTSTRESC, and FTSTRESN. Counts of trials and interlap intervals have no units, however other variables have units—usually milliseconds, milliseconds squared, and inverse of milliseconds QRSSUPP-165 - Getting issue details... STATUS —and are recorded in FTORRESU and FTSTRESU.

  2. Task start time, stop time, and duration are given as part of the data created by the computer software and are represented in the example as FTDTC, FTENDTC, and FTDUR.
  3. Terminology
    1. FTCAT, FTTESTCD, FTTEST, FTORRESU, and FTSTRESU values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the unit fields is provided in Section 4, SDTM Mapping Strategy. 

3.2 Example for the PACED TAPPING FT Domain Model

The PACED TAPPING example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for one subject collected at the baseline visit for the PACED TAPPING instrument. The example uses CDISC Controlled Terminology for FTTESTCD, FTTEST, and FTCAT. All original results are represented with preferred terminology in FTORRES. This result is then transformed into the standard numeric score in FTSTRESN and a character representation of the standard numeric score in FTSTRESC.

The table represents the questions from the PACED TAPPING form. A full test consists of summary variables and 4 full trials (FTREPNUM QRSSUPP-154 - Getting issue details... STATUS = 1 through 4). However, to save space, only the summary variables and 1 full trial (FTREPNUM = 1) are represented here.


Information for Reviewers

We are unable to make the example show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


 ft.xpt

ft.xpt

RowSTUDYIDDOMAINUSUBJIDFTSEQFTTESTCDFTTESTFTCATFTORRESFTORRESUFTSTRESCFTSTRESNFTSTRESUFTLOBXFLFTREPNUMVISITNUMFTDTCFTENDTCFTDUR
1STUDYXFT2324-P00011PTAP101PTAP1-Total Trials ExpectedPACED TAPPING4
44
Y
1

2015-10-10T11:15:30

Error rendering macro 'jira'

null

2015-10-10T11:29:45PT14M15S
2STUDYXFT2324-P00012PTAP102PTAP1-Total Trials AdministeredPACED TAPPING4
44
Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
3STUDYXFT2324-P00013PTAP103PTAP1-Total Trials CompletedPACED TAPPING4
44
Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
4STUDYXFT2324-P00014PTAP104PTAP1-Total Interval Tone Admin AllPACED TAPPING44
4444
Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
5STUDYXFT2324-P00015PTAP105PTAP1-Total Interval Tone Trim AllPACED TAPPING44
4444
Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
6STUDYXFT2324-P00016PTAP105APTAP1-Minimum

Error rendering macro 'jira'

null

Interval Tone All
PACED TAPPING321msec321321msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
7STUDYXFT2324-P00017PTAP105BPTAP1-Maximum Interval Tone AllPACED TAPPING340msec340340msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
8STUDYXFT2324-P00018PTAP105CPTAP1-Mean Interval Tone AllPACED TAPPING331msec331331msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
9STUDYXFT2324-P00019PTAP105DPTAP1-Median Interval Tone AllPACED TAPPING330msec330330msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
10STUDYXFT2324-P000110PTAP105EPTAP1-Variance Interval Tone AllPACED TAPPING465ms2465465ms2Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
11STUDYXFT2324-P000111PTAP105FPTAP1-Deviation Interval Tone AllPACED TAPPING22msec2222msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
12STUDYXFT2324-P000112PTAP105GPTAP1-Reciprocal Interval Tone AllPACED TAPPING0.045451/ms0.045450.045451/msY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
13STUDYXFT2324-P000113PTAP105HPTAP1-Avg Sign Dev Interval Tone AllPACED TAPPING18msec1818msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
14STUDYXFT2324-P000114PTAP106PTAP1-Total Interval Self Admin AllPACED TAPPING124
124124
Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
15STUDYXFT2324-P000115PTAP107PTAP1-Total Interval Self Trim AllPACED TAPPING124
124124
Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
16STUDYXFT2324-P000116PTAP107APTAP1-Minimum Interval Self AllPACED TAPPING312msec312312msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
17STUDYXFT2324-P000117PTAP107BPTAP1-Maximum Interval Self AllPACED TAPPING342msec342342msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
18STUDYXFT2324-P000118PTAP107CPTAP1-Mean Interval Self AllPACED TAPPING320msec320320msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
19STUDYXFT2324-P000119PTAP107DPTAP1-Median Interval Self AllPACED TAPPING324msec324324msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
20STUDYXFT2324-P000120PTAP107EPTAP1-Variance Interval Self AllPACED TAPPING426ms2426426ms2Y
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
21STUDYXFT2324-P000121PTAP107FPTAP1-Deviation Interval Self AllPACED TAPPING154msec154154msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
22STUDYXFT2324-P000122PTAP107GPTAP1-Reciprocal Interval Self AllPACED TAPPING0.006491/ms0.006490.006491/msY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
23STUDYXFT2324-P000123PTAP107HPTAP1-Avg Sign Dev Interval Self AllPACED TAPPING21msec2121msecY
12015-10-10T11:15:302015-10-10T11:29:45PT14M15S
24STUDYXFT2324-P000124PTAP108PTAP1-Trials Expected in TrialPACED TAPPING1
11
Y112015-10-10T11:15:302015-10-10T11:29:45

Error rendering macro 'jira'

null

PT14M15S
25STUDYXFT2324-P000125PTAP109PTAP1-Trials Administered in TrialPACED TAPPING1
11
Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
26STUDYXFT2324-P000126PTAP110PTAP1-Trials Completed in TrialPACED TAPPING1
11
Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
27STUDYXFT2324-P000127PTAP111PTAP1-Num Intervals Expected Tone TrialPACED TAPPING11
1111
Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
28STUDYXFT2324-P000128PTAP112PTAP1-Num Intervals Trim Tone TrialPACED TAPPING11
1111
Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
29STUDYXFT2324-P000129PTAP112APTAP1-Minimum Interval Tone TrialPACED TAPPING348msec348348msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
30STUDYXFT2324-P000130PTAP112BPTAP1-Maximum Interval Tone TrialPACED TAPPING372msec372372msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
31STUDYXFT2324-P000131PTAP112CPTAP1-Mean Interval Tone TrialPACED TAPPING369msec369369msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
32STUDYXFT2324-P000132PTAP112DPTAP1-Median Interval Tone TrialPACED TAPPING354msec354354msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
33STUDYXFT2324-P000133PTAP112EPTAP1-Variance Interval Tone TrialPACED TAPPING360ms2360360ms2Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
34STUDYXFT2324-P000134PTAP112FPTAP1-Deviation Interval Tone TrialPACED TAPPING47msec4747msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
35STUDYXFT2324-P000135PTAP112GPTAP1-Reciprocal Interval Tone TrialPACED TAPPING0.021281/ms0.021280.021281/msY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
36STUDYXFT2324-P000136PTAP112HPTAP1-Avg Sign Dev Interval Tone TrialPACED TAPPING21msec2121msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
37STUDYXFT2324-P000137PTAP113PTAP1-Num Intervals Expected Self TrialPACED TAPPING31
3131
Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
38STUDYXFT2324-P000138PTAP114PTAP1-Num Intervals Trim Self TrialPACED TAPPING31
3131
Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
39STUDYXFT2324-P000139PTAP114APTAP1-Minimum Interval Self TrialPACED TAPPING286msec286286msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
40STUDYXFT2324-P000140PTAP114BPTAP1-Maximum Interval Self TrialPACED TAPPING378msec378378msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
41STUDYXFT2324-P000141PTAP114CPTAP1-Mean Interval Self TrialPACED TAPPING349msec349349msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
42STUDYXFT2324-P000142PTAP114DPTAP1-Median Interval Self TrialPACED TAPPING319msec319319msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
43STUDYXFT2324-P000143PTAP114EPTAP1-Variance Interval Self TrialPACED TAPPING486ms2486486ms2Y112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
44STUDYXFT2324-P000144PTAP114FPTAP1-Deviation Interval Self TrialPACED TAPPING74msec7474msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
45STUDYXFT2324-P000145PTAP114GPTAP1-Reciprocal Interval Self TrialPACED TAPPING0.013511/ms0.013510.013511/msY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S
46STUDYXFT2324-P000146PTAP114HPTAP1-Avg Sign Dev Interval Self TrialPACED TAPPING20msec2020msecY112015-10-10T11:15:302015-10-10T11:29:45PT14M15S

Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.


4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM FT domain. It also provides guidance on how the result variables QRSSUPP-166 - Getting issue details... STATUS (FTORRES, FTORRESU, FTSTRESC, FTSTRESN and FTSTRESU) should be populated.


FTTESTCD = "PTAP105A" FTTEST = "PTAP1-Minimum Interval Tone All" to FTTESTCD="PTAP105D" FTTEST = "PTAP1-Median Interval Tone All"

FTTESTCD = "PTAP105F" FTTEST = "PTAP1-Deviation Interval Tone All"

FTTESTCD = "PTAP105H" FTTEST = "PTAP1-Avg Sign Dev Interval Tone All"

FTTESTCD = "PTAP107A" FTTEST = "PTAP1-Minimum Interval Self All" to FTTESTCD="PTAP107D" FTTEST = "PTAP1-Median Interval Self All"

FTTESTCD = "PTAP107F" FTTEST = "PTAP1-Deviation Interval Self All"

FTTESTCD = "PTAP107H" FTTEST = "PTAP1-Avg Sign Dev Interval Self All"

FTTESTCD = "PTAP112A" FTTEST = "PTAP1-Minimum Interval Tone Trial" to FTTESTCD="PTAP112D" FTTEST = "PTAP1-Median Interval Tone Trial"

FTTESTCD = "PTAP112F" FTTEST = "PTAP1-Deviation Interval Tone Trial"

FTTESTCD = "PTAP112H" FTTEST = "PTAP1-Avg Sign Dev Interval Tone Trial"

FTTESTCD = "PTAP114A" FTTEST = "PTAP1-Minimum Interval Self Trial" to FTTESTCD="PTAP114D" FTTEST = "PTAP1-Median Interval Self Trial"

FTTESTCD = "PTAP114F" FTTEST = "PTAP1-Deviation Interval Self Trial"

FTTESTCD = "PTAP114H" FTTEST = "PTAP1-Avg Sign Dev Interval Self Trial"

FTORRESFTORRESUFTSTRESCFTSTRESNFTSTRESU
'numeric value'
msec'numeric value''numeric value'msec


FTTESTCD = "PTAP105E" FTTEST = "PTAP1-Variance Interval Tone All"

FTTESTCD = "PTAP107E" FTTEST = "PTAP1-Variance Interval Self All"

FTTESTCD = "PTAP112E" FTTEST = "PTAP1-Variance Interval Tone Trial"

FTTESTCD = "PTAP114E" FTTEST = "PTAP1-Variance Interval Self Trial"

FTORRESFTORRESUFTSTRESCFTSTRESNFTSTRESU
'numeric value'

ms2 QRSSUPP-153 - Getting issue details... STATUS

'numeric value''numeric value'ms2


FTTESTCD = "PTAP105G" FTTEST = "PTAP1-Reciprocal Interval Tone All"

FTTESTCD = "PTAP107G" FTTEST = "PTAP1-Reciprocal Interval Self All"

FTTESTCD = "PTAP112G" FTTEST = "PTAP1-Reciprocal Interval Tone Trial"

FTTESTCD = "PTAP114G" FTTEST = "PTAP1-Reciprocal Interval Self Trial"

FTORRESFTORRESUFTSTRESCFTSTRESNFTSTRESU
'numeric value'
1/ms'numeric value''numeric value'1/ms


End of Document

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