Questionnaires, Ratings and Scales (QRS)

The Functional Tests and Questionnaires web page is in the process of being revised to the new Questionnaires, Ratings and Scales (QRS) Web Page.  As part of this process the existing COP 017 SDTMIG Questionnaire Supplements document and all related reference documents are also being revised to use the Questionnaires, Ratings and Scales (QRS) concepts.  This revision will take place over the next few months, but in preparation of this we are providing current information on QRSs below.  Also the current table of all published QRSs and COP 017 reference documents are now part of this page.

The CDISC Questionnaires, Ratings and Scales(QRS) are represented in the Questionnaires (QS), Functional Tests (FT) and Clinical Classifications (CC) findings domains.  The FT and CC domains were included in the SDTMIG v3.3 Batch 1 & 2 public reviews and are being readied for inclusion in v3.3.  With the evolution of these CDISC domains, the new Questionnaires, Ratings and Scales reference is more widely understood. 

 

The CDISC community needs to take the following steps into consideration in implementing a QRS as a CDISC data standard.

  • CDISC COP 017 describes QRS standards development process.  The first step involves submitting a new QRS Standard Request Form.  When reviewed and approved by the QRS Sub-Team, the QRS Supplement is posted on this page.  Updated reference files for COP 017 can be downloaded here.
  • Sponsors may participate in and/or request the development of supplements and terminology through the CDISC SDTM QRS Sub-Team or the QRS Controlled Terminology Team.
  • The QRS Supplements are developed based on user demand and therapeutic area standards requirements. The QRS Standard Request Form needs to be provided to the CDISC SDTM QRS Sub-Team in order to track the request.  Sponsors need to always consult the CDISC Website Standards page to review the QRS Products terminology and supplements prior to modeling any data as a CDISC QRS standard.
  • QRSs may exist in the public domain or may be copyrighted.  If copyrighted, CDISC must obtain permission to implement the measure as a CDISC data standard.  If this permission is not obtained, it is not implemented.
  • All standard supplement development is coordinated with the CDISC SDTM QRS Sub-Team as the governing body.
    • The process involves drafting the controlled terminology and defining specific standardized values for Qualifier, Timing, and Result variables to populate the SDTM QS, FT or CC domains.
    • All –CAT, –TESTCD/--TEST controlled terminology is governed by QRS Controlled Terminology Team.
  • CDISC publishes standard Questionnaires, Ratings and Scales(QRS) products, which include SDTM Annotated CRFs and Supplements to the SDTMIG along with the related controlled terminology.
  • Domain definitions to review in order to determine the SDTM domain to represent a QRS.
  • Questionnaires: Questionnaires are named, stand-alone measures designed to provide an assessment of a concept.  Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis.  Questionnaires consist of defined questions with a defined set of potential answers.  Most often, questionnaires have as their primary purpose the generation of a quantitative statistic to assess a qualitative concept.
  • Functional Tests: Functional tests are named, stand-alone task-based evaluations, designed to provide an assessment of mobility, dexterity, and/or cognitive ability. A functional test is not a subjective assessment of how the subject generally performs a task. Rather it is an objective measurement of the performance of the task by the subject in a specific instance. Functional tests have documented methods for administration and analysis and require a subject to perform specific activities that are evaluated and recorded. Most often, functional tests are direct quantitative measurements.
  • Clinical Classifications: The Clinical Classifications domain is for named measures whose output is an ordinal or categorical score that serves as a surrogate for, or ranking of, disease status or other physiological or biological status. These measures are based on a trained health-care professional’s observation of a subject’s health condition or status with input from associated clinical records review. Clinical Classifications may be based solely on objective data from clinical records, or they may involve a clinical judgment or interpretation of the directly observable signs, behaviors, or other physical manifestations related to a condition or subject status. These physical manifestations may be findings that are typically represented in other SDTM domains such as labs, vital signs, or clinical events. Therefore, Clinical Classifications are often composite scores based on diverse inputs. This assessment method differs from a more traditional question-and-answer interview commonly seen in other Questionnaires, Ratings and Scales(QRS).

 

QRS Name

Short Name

(--CAT)

Domain

Permission

Version

Release Date

6 Minute Walk Test (SIX MINUTE WALK)

SIX MINUTE WALK

FT

Public Domain

v1.0

May 21, 2014

Abnormal Involuntary Movement Scale (AIMS)

AIMS

QS

Public Domain

v1.0

May 22, 2013

Airway Questionnaire (AQ20)

AQ20

QS

Granted

v1.0

February 12, 2014

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

ADAS-COG

QS

Granted

v1.0

January 26, 2012

Alzheimer's Disease Cooperative Study-Activities of Daily Living - MCI (ADCS-ADL MCI)

ADCS-ADL MCI

QS

Granted

v1.0

August 15, 2013

Alcohol Use Disorders Identification Test – Consumption Questions (AUDIT-C)

AUDIT-C

QS

Public Domain

v1.0

November 6, 2014

Alcohol Use Disorders Identification Test – Self-Report Version (AUDIT-SR)

AUDIT-SR

QS

Public Domain

v1.0

November 19, 2014

Brief Assessment of Cognition in Schizophrenia (BACS)

BACS

FT

Granted

V1.0

March 1, 2015

Barnes Akathisia Rating Scale (BARS)

BARS

QS

Public Domain

v1.0

May 15, 2013

Baseline Dyspnea Index (BDI)

BDI

QS

Granted

v1.0

October 1, 2013

Bladder Control Scale (BLCS)

BLCS

QS

Granted

v1.0

v1.1

December 18, 2013

May 9, 2014

Bowel Control Scale (BWCS)

BWCS

QS

Granted

v1.0

 v1.1

December 18, 2013

May 9, 2014

Brief Pain Inventory-Interference Scale - Short Form (BPI-I)

BPI SHORT FORM

QS

Granted

v1.0

August 7, 2012

Brief Pain Inventory-Interference Scale (BPI-I)

BPI

QS

Granted

v1.0

August 7, 2012

Brief Psychiatric Rating Scale-Anchored (BPRS-A)

BPRS-A

QS

Public Domain

V1.0

v1.1

v1.2

January 29, 2013

June 12, 2014

July 28, 2014

Chronic Respiratory Questionnaire – Self-Administered Standardized Format First Administration Version (CRQ-SAS FIRST ADMINISTRATION VERSION)

CRQ-SAS FIRST ADMINISTRATION VERSION

QS

Granted

v1.0

February 18, 2015

Chronic Respiratory Questionnaire – Self-Administered Standardized Format Follow-up Administration Version (CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION

CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION

QS

Granted

v1.0

February 18, 2015

Clinical Global Impression (CGI)

CGI

QS

Public Domain

v1.0

v1.1

August 7, 2012

April 2, 2013

Columbia Suicide Severity Rating Scale - Baseline (CSSRS-BSL)

C-SSRS BASELINE

QS

Granted

v1.0

v1.1

v1.2

August 7, 2012

February 06, 2013

September 3, 2014

Columbia-Suicide Severity Rating Scale Already Enrolled Subjects (C-SSRS ALREADY ENROLLED SUBJECTS)

C-SSRS ALREADY ENROLLED SUBJECTS

QS

Granted

v1.0

June 13, 2014

Columbia-Suicide Severity Rating Scale Baseline Screening (C-SSRS BASELINE SCREENING VERSION)

C-SSRS BASELINE SCREENING VERSION

QS

Granted

v1.0

November 5, 2014

Columbia-Suicide Severity Rating Scale Baseline/Screening Version Phase 1 Study

(C-SSRS BASELINE/SCREENING VERSION PHASE 1 STUDY)

C-SSRS BASELINE/SCREENING VERSION PHASE 1 STUDY

QS

Granted

v1.0

v1.1

December 4, 2013

September 3, 2014

Columbia-Suicide Severity Rating Scale Since Last Visit (C-SSRS SINCE LAST VISIT)

C-SSRS SINCE LAST VISIT

QS

Granted

v1.0

v1.1

February 06, 2013

September 3, 2014

Craig Handicap Assessment and Reporting Technique – Short Form Interview Version (CHART-SF INTERVIEW VERSION)

CHART-SF INTERVIEW VERSION

QS

Public Domain

v1.0

v1.1

July 2, 2014

November 6, 2014

Craig Handicap Assessment and Reporting Technique – Short Form Paper Version (CHART-SF PAPER VERSION)

CHART-SF PAPER VERSION

QS

Public Domain

V1.0

November 6, 2014

Current Opioid Misuse Measure (COMM)

COMM

QS

Granted

v1.0

August 7, 2012

Disability Assessment for Dementia (DAD)

DAD

QS

Granted

v1.0

June 27, 2013

Disability Rating Scale (DRS)

DRS

QS

Public Domain

v1.0

March 21, 2014

Disease Steps

Disease Steps

QS

Public Domain

v1.0

October 30, 2013

Eastern Cooperative Oncology Group Performance Status (ECOG)

ECOG

QS

Public Domain

v1.0

June 27, 2013

Epworth Sleepiness Scale (ESS)

ESS

QS

Granted

v1.0

June 26, 2013

European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)

EQ-5D-5L

QS

Granted

V1.0

v1.1

March 5, 2013

June 19, 2014

European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L)

EQ-5D-3L

QS

Granted

V1.0

v1.1

March 5, 2013

June 19, 2014

Extended Glasgow Outcome Scale (GOSE)

GOSE

QS

Public Domain

v1.0

May 30, 2014

Extrapyramidal Symptom Rating Scale- Abbreviated (ESRSA)

ESRSA

CC

Public Domain

v1.0

January 12, 2015

Faces Pain Scale – Revised (FPS-R)

FPSR

QS

Granted

v1.0

August 7, 2012

Fatigue Severity Scale (FSS)

FSS

QS

Granted

v1.0

v1.1

December 18, 2013

May 9, 2014

Functional Assessment of Multiple Sclerosis (FAMS)

FAMS

QS

Granted

v1.0

October 30, 2013

Functional Assessment Questionnaire (FAQ)

FAQ

QS

Granted

v1.0

August 19, 2013

Functional Assessment Questionnaire (FAQ-NACC)

FAQ-NACC

QS

Granted

v1.0

August 20, 2013

General Clinical Global Impression

GENERAL CLINICAL GLOBAL IMPRESSIONS

QS

Public Domain

v1.0

August 7, 2012

Generalized Anxiety Disorder (GAD-7)

GAD-7

QS

Public Domain

v1.0

March 12, 2014

Pain Intensity

PAIN INTENSITY

QS

Public Domain

v1.0

August 7, 2012

Pain Relief

PAIN RELIEF

QS

Public Domain

v1.0

August 7, 2012

Geriatric Depression Scale (GDS)

GDS

QS

Public Domain

v1.0

May 22, 2013

Geriatric Depression Scale Short Form (GDS SHORT FORM)

GDS SHORT FORM

QS

Public Domain

v1.0

May 22, 2013

Hamilton Anxiety Rating Scale (HAM-A)

HAM-A

QS

Public Domain

v1.0

May 16, 2013

Hamilton Depression Rating Scale 17-Item (HAMD 17)

HAMD 17

QS

Public Domain

v1.0

v1.1

August 7,2012

May 15, 2013

Hamilton Depression Rating Scale 21-Item (HAMD 21)

HAMD 21

QS

Public Domain

v1.0

May 29, 2013

Hauser Ambulation Index

Hauser Ambulation Index

FT

Granted

v1.0

April 23, 2014

Hospital Anxiety and Depression Scale (HADS)

HADS

QS

Granted

v1.0

June 13, 2014

Impact of Visual Impairment Scale (IVIS)

IVIS

QS

Granted

v1.0

December 18, 2013

JFK Coma Recovery Scale–Revised (CRS-R)

CRS-R

CC

Public Domain

V1.0

April 15, 2015

Karnofsky Performance Scale (KPS SCALE)

KPS SCALE

QS

Public Domain

v1.0

August 7, 2012

Kurtzke Expanded Disability Status Scale (EDSS)

EDSS

QS

Public Domain

v1.0

October 23, 2013

Kurtzke Functional Systems Scores (KFSS)

KFSS

QS

Public Domain

v1.0

v1.1

November 13, 2013

February 19, 2014

Mayo-Portland Adaptability Inventory (MPAI-4)

MPAI-4

QS

Public Domain

v1.0

June 30, 2014

Short-FormMcGill Pain Questionnaire - 2 (SHORT-FORM MPQ 2)

SHORT-FORM MPQ-2

QS

Granted

v1.0

August 7, 2012

Michigan Neuropathy Screening Instrument (MNSI)

MNSI

QS

Public Domain

v1.0

August 7, 2012

Model for End Stage Liver Disease (MELD)

MELD

CC

Public Domain

V1.0

April 1, 2015

Modified Fatigue Impact Scale (MFIS)

MFIS

QS

Granted

v1.0

December 18, 2013

Modified Hachinski Ischemic Scale NACC Version (MHIS-NACC)

MHIS-NACC

QS

Granted

v1.0

September 18, 2013

Modified Medical Research Council Dyspnea Scale (MMRC)

MMRC

QS

Public Domain

v1.0

October 9, 2013

Modified Rankin Scale (MRS)

MRS

QS

Granted

v1.0

August 21, 2013

Movement Disorder Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

MDS-UPDRS

QS

Granted

v1.0

December 18, 2012

MS Quality of Life - 54 (MSQOL-54)

MSQOL-54

QS

Granted

v1.0

v1.1

January 15, 2014

May 9, 2014

Negative Symptoms Assessment-16 (NSA-16)

NSA-16

CC

Granted

V1.0

April 1, 2015

Neuropathic Pain Scale (NPS)

NPS

QS

Granted

v1.0

June 13, 2014

Neuropsychiatric Inventory (NPI)

NPI

QS

Granted

v1.0

September 13, 2013

Nine-Hole Peg Test (NHPT)

NHPT

FT

Granted

v1.0

April 2, 2014

Overactive Bladder (OAB-Q)

OAB-Q

QS

Granted

V1.0

November 20, 2014

Overactive Bladder Questionnaire Short Form (OAB-Q SHORT FORM)

OAB-Q SHORT FORM

QS

Granted

V1.0

November 20, 2014

Paced Auditory Serial Addition Test (PASAT)

PASAT

FT

Granted

v1.0

April 2, 2014

Patient Health Questionnaire – 9 (PHQ-9)

PHQ-9

QS

Granted

V1.0

September 24, 2014

Patient Determined Disease Steps (PDDS)

PDDS

QS

Public Domain

v1.0

October 23, 2013

RAND 36-Item Health Survey 1.0 (RAND-36 V1.0)

RAND-36 V1.0

QS

Granted

v1.0

January 15, 2014

Revised Fibromyalgia Impact Questionnaire (FIQR)

FIQR

QS

Granted

v1.0

June 13, 2014

Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

RPQ

QS

Public Domain

v1.0

November 5, 2014

Roland-Morris Disability Questionnaire (RDQ)

RDQ

QS

Public Domain

v1.0

August 7, 2012

Satisfaction With Life Scale (SWLS)

SWLS

QS

Public Domain

v1.0

April 23, 2014

Screener and Opioid Assessment for Patients with Pain (SOAPP-R)

SOAPP-R

QS

Granted

v1.0

August 7, 2012

Sheehan Disability Scale (SDS)

SDS

QS

Granted

v1.0

v1.1

September 12. 2013

October 14, 2013

St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C)

SGRQ-C

QS

Granted

v1.0

February 19, 2014

Symbol Digit Modalities Test (SDMT)

SDMT

FT

Not Granted

V1.0

V1.1

October 1, 2014

November 19, 2014

Symptom Impact Questionnaire (SIQR)

SIQR

QS

Granted

V1.0

March 11, 2015

Timed 25-Foot Walk (T25FW)

T25FW

FT

Granted

v1.0

March 26, 2014

Timed Up and Go (TUG)

TUG

FT

Public Domain

v1.0

May 21, 2014

Transition Dyspnea Index (TDI)

TDI

QS

Granted

v1.0

October 9, 2013

Unified Parkinson's Disease Rating Scale UPDRS

UPDRS

QS

Granted

v1.0

v1.1

August 9, 2012

June 12, 2014

Urgency Perception Scale (UPS)

UPS

QS

Granted

v1.0

December 3, 2014

Visual Functioning Questionnaire - 25 (VFQ-25 INTERVIEWER ADMINISTERED)

VFQ-25 INTERVIEWER ADMINISTERED

QS

Public Domain

v1.0

v1.1

November 14, 2013

May 9, 2014

Visual Functioning Questionnaire - 25 (VFQ-25 SELF ADMINISTERED)

VFQ-25 SELF ADMINISTERED

QS

Public Domain

v1.0

v1.1

November 14, 2013

May 9, 2014

Work Productivity and Activity Impairment Questionnaire  - Specific Health Problem (WPAI-SH)

WPAI-SHP

QS

Public Domain

v1.0

August 7, 2012

 

CDISC QRS Copyright and Public Domain Process:

  • QRSs are either in the public domain or have copyright requirements.  Public Domain QRSs are available without requiring any further permission for use.  Copyright QRSs require that CDISC obtain permission from copyright holders before implementing them in the CDISC QRS data standard.  That permission only relates to creation of the CDISC QRS data standard, not the use of the QRS in clinical studies.
  • Please note that all QRS copyright owners maintain full copyright status when granting permission to implement in the CDISC QRS data standard.  CDISC emphasizes that having a copyright QRS available in the CDISC standard data format will not in any way affect the licensing fee requirements or procedure requirements in using the QRS in clinical trials.  If the QRS is used in clinical trials, all of the procedures and licensing requirements required by the copyright holder must be followed.  Some copyright owners have requested to provide the CDISC QRS data documentation from their web sites and they will distribute it to clients upon granting copyright permission.  Clients selecting these QRS measures from the CDISC web site will be directed to the copyright owner’s web site.
  • CDISC standards for QRS include controlled terminology for test codes, test names, standard timing values, standard results for database values and an annotated CRF with the SDTM domain variable names.  The released QRS documentation is maintained on the CDISC QRS web page.
  • Please reference CDISC COP 017 CDISC SDTMIG Questionnaires, Ratings and Scales (QRS) Supplements(http://www.cdisc.org/bylaws-and-policies) for details on implementing CDISC standard QRS.

 

QRS Terminology:

  • To see the list of QRSs which have controlled terminology defined please access www.cdisc.org/terminology.  Click on CDISC Controlled Terminology and then click on CDISC QRS Directory to view the current released information.
  • The QRS Terminology Naming Rules for --CAT, --TEST, and --TESTCD can be downloaded from the QRS Implementation Documents box on this page.

 

Column Descriptions

  • QRS Name: Describes name of QRS.  Documentation includes the QRS Supplement to the Study Data Tabulation Model Implementation Guide (SDTMIG) and may include annotated CRFs where permitted.
  • Short Name (--CAT): Short Name used to identify the QRS within the SDTMIG domain table.
  • Domain: Indicates the SDTM FINDINGS domain in which the instrument is represented.
  • Permission:This indicates if CDISC has received permission from the copyright holder to directly reference or display the QRS content.  Possible values:
    • Public Domain: The QRS is in the public domain, so no permission is necessary.
    • Granted: The copyright holder has granted CDISC permission to publish controlled terminology for --CAT, --TEST, --TESTCD, and, where applicable, for response values in --ORRES, and for scored values in --STRES. This means that meaningful examples of data from the instrument can be included in user guides.  Sponsors still need to obtain copyright permission from the copyright holder to use the instrument in their clinical trials.
    • Not Granted: The copyright holder has not granted permission to implement the QRS as a CDISC data standard. This means that the instrument may not be available in the CDISC SDTM QRS data standard based on terminology requirements. 
  • Version: This refers to the CDISC version of the QRS. Each CDISC version of the instrument will be listed separately with a unique version number.
  • Release Date: Date CDISC published the QRS standard documentation.