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Questionnaires, Ratings and Scales (QRS)

Questionnaires, Ratings, and Scales (QRS) are a series of questions, tasks or assessments used in clinical research, and made available in the public domain or copyrighted. The QRS and ADQRS teams develop Controlled Terminology, SDTM (submission) and ADaM (analysis) standards for organizing and formatting data via QRS and ADQRS supplements.


 

What's New

QRS Name Short Name (--CAT) Domain Permission Version Release Date
WHO Disability Assessment Schedule 2.0 - 12 Item Interviewer-Administered WHODAS 2.0 – 12-ITEM INTERVIEWER QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 12 Item Proxy-Administered WHODAS 2.0 – 12-ITEM PROXY QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 12 Item Self-Administered WHODAS 2.0 – 12-ITEM SELF QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 12+24 Item Interviewer-Administered WHODAS 2.0 - 12+24- ITEM INTERVIEWER QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Interviewer-Administered WHODAS 2.0 – 36-ITEM INTERVIEWER QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Proxy-Administered WHODAS 2.0 – 36-ITEM PROXY QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Self-Administered WHODAS 2.0 – 36-ITEM SELF QS Granted
v 1.0 February 28, 2017

Questionnaires, Ratings, and Scales (QRS) are represented in SDTMIG 3.2 and earlier versions in the Questionnaires (QS) domain or in custom domains. Two draft domains have been proposed for ratings and scales other than questionnaires, the Functional Tests (FT) and Clinical Classifications (CC) findings domains. The FT domain is being readied for inclusion in SDTMIG v3.3.

The CC domain is not being readied for inclusion in SDTMIG 3.3. Instead, the Disease Response (RS) domain, originally intended for classifications of disease response, is being revised to include all clinical classifications. The revised RS domain will be renamed to Disease Response and Clinical Classifications and undergo public review in 2016Q1. A number of rating and scale supplements were prepared using the CC domain code. It is expected that they will be revised to use the RS domain code when SDTMIG 3.3 is published.

Submission using SDTMIG 3.2 and earlier versions should represent ratings and scales other than questionnaires in custom domains. The terminology in published FT supplements and the FT domain code can be used for such a custom domain. The terminology in published CC supplements, but with the RS domain code, can be used in the RS domain. In either case, the user should alert regulators of their use of the supplements in the Data Reviewers Guide.

 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 RS 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: Clinical classifications measures are 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). 

 

All Published QRS Supplements

QRS Name Short Name (--CAT) Domain Permission Version Release Date
6 Minute Walk Test SIX MINUTE WALK FT Public Domain
v 1.0 May 21, 2014
Abnormal Involuntary Movement Scale AIMS QS Public Domain
v 1.0 May 22, 2013
Acute Physiology and Chronic Health Evaluation II APACHE II RS Public Domain
v 1.0 June 29, 2016
Airway Questionnaire AQ20 QS Granted
v 1.0 February 12, 2014
Alcohol Use Disorders Identification Test – Consumption Questions AUDIT-C QS Public Domain
v 1.0 November 6, 2014
Alcohol Use Disorders Identification Test – Self-Report Version AUDIT-SR QS Public Domain
v 1.0 November 19, 2014
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) ADAS-COG QS Granted
v 1.0 January 26, 2012
Alzheimer's Disease Cooperative Study-Activities of Daily Living - MCI ADCS-ADL MCI QS Granted
v 1.0 August 16, 2013
Arizona Sexual Experiences Scale – Female ASEX-FEMALE QS Granted
v 1.0 February 1, 2017
Arizona Sexual Experiences Scale – Male ASEX-MALE QS Granted
v 1.0 February 1, 2017
ASSIGN Risk Score ASSIGN CVD 10-YEAR RISK RS Public Domain
v 1.0 July 14, 2016
Atherosclerotic Cardiovascular Disease 10-Year Risk Estimator ASCVD 10-YEAR ESTIMATOR RS Public Domain
v 1.0 July 14, 2016
Barnes Akathisia Rating Scale BARS QS Granted
v 1.0 May 15, 2013
Baseline Dyspnea Index BDI QS Granted
v 1.0 October 1, 2013
Bladder Control Scale BLCS QS Granted
v 1.0 December 18, 2013
v 1.1 May 9, 2014
BODE Index BODE INDEX RS Public Domain
v 1.0 January 6, 2016
Bowel Control Scale BWCS QS Granted
v 1.0 December 18, 2013
v 1.1 May 9, 2014
Brief Assessment of Cognition in Schizophrenia BACS FT Granted
v 1.0 March 1, 2015
Brief Pain Inventory-Interference Scale BPI QS Granted
v 1 August 7, 2012
v 1.1 June 30, 2016
Brief Pain Inventory-Interference Scale Short Form BPI SHORT FORM QS Granted
v 1 August 7, 2012
v 1.1 June 30, 2016
Brief Psychiatric Rating Scale-Anchored BPRS-A QS Public Domain
v 1.0 January 29, 2013
v 1.1 June 23, 2014
v 1.2 July 28, 2014
Brooke Upper Extremity Rating Scale BUERS RS Public Domain
v 1 February 6, 2017
CDC Classification System for HIV-Infected Adults and Adolescents CDC HIV CLASSIFICATION FOR ADULTS AND ADOLESCENTS RS Public Domain
v 1.0 June 29, 2016
Child-Pugh Classification CHILD-PUGH CLASSIFICATION RS Public Domain
v 1.0 January 6, 2015
Chronic Respiratory Questionnaire – Self-Administered Standardized Format First Administration Version CRQ-SAS FIRST ADMINISTRATION VERSION QS Granted
v 1.0 February 18, 2015
Chronic Respiratory Questionnaire – Self-Administered Standardized Format Follow-up Administration Version CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION QS Granted
v 1.0 February 18, 2015
Clinical COPD Questionnaire (CCQ) 1 Week Version CCQ 1 WEEK VERSION QS Granted
v 1.0 July 1, 2015
Clinical COPD Questionnaire (CCQ) 24 Hour Version CCQ 24 HOUR VERSION QS Granted
v 1.0 July 1, 2015
Clinical Global Impression CGI QS Public Domain
v 1.0 August 7, 2012
v 1.1 April 2, 2013
v 1.2 December 15, 2016
Columbia Suicide Severity Rating Scale - Baseline C-SSRS BASELINE QS Granted
v 1.0 August 7, 2012
v 1.1 February 6, 2013
v 1.2 September 3, 2014
Columbia-Suicide Severity Rating Scale Already Enrolled Subjects C-SSRS ALREADY ENROLLED SUBJECTS QS Granted
v 1.0 June 13, 2014
Columbia-Suicide Severity Rating Scale Baseline Screening C-SSRS BASELINE SCREENING VERSION QS Granted
v 1.0 November 5, 2014
Columbia-Suicide Severity Rating Scale Baseline/Screening Version Phase 1 Study C-SSRS BASELINE/SCREENING VERSION PHASE 1 STUDY QS Granted
v 1.0 December 4, 2013
v 1.1 September 3, 2014
Columbia-Suicide Severity Rating Scale Since Last Visit C-SSRS SINCE LAST VISIT QS Granted
v 1.0 February 6, 2013
v 1.1 September 3, 2014
Craig Handicap Assessment and Reporting Technique – Short Form Interview Version CHART-SF INTERVIEW VERSION QS Public Domain
v 1.0 July 2, 2014
v 1.1 November 6, 2014
Craig Handicap Assessment and Reporting Technique – Short Form Paper Version CHART-SF PAPER VERSION QS Public Domain
v 1.0 November 6, 2014
Current Opioid Misuse Measure COMM QS Granted
v 1.0 August 7, 2012
Disability Assessment for Dementia DAD QS Granted
v 1.0 June 27, 2013
Disability Rating Scale DRS QS Public Domain
v 1.0 March 21, 2014
Disease Steps Disease Steps QS Public Domain
v 1.0 October 30, 2013
Eastern Cooperative Oncology Group Performance Status ECOG QS Public Domain
v 1.0 June 26, 2013
Epworth Sleepiness Scale ESS QS Granted
v 1.0 June 26, 2013
European Quality of Life Five Dimension Five Level Scale EQ-5D-5L QS Granted
v 1.0 March 5, 2013
v 1.1 June 19, 2014
v 1.2 October 28, 2015
European Quality of Life Five Dimension Three Level Scale EQ-5D-3L QS Granted
v 1.0 March 5, 2013
v 1.1 June 19, 2014
v 1.2 October 28, 2015
Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome EXACT QS Granted
v 1.0 December 17, 2015
Expanded Disability Rating Sale – Postacute Interview Caregiver Version EXPANDED DRS-PI CAREGIVER VERSION QS Public Domain
v 1.0 April 19, 2016
Expanded Disability Rating Sale – Postacute Interview Survivor Version EXPANDED DRS-PI SURVIVOR VERSION QS Public Domain
v 1 April 19, 2016
Expanded Prostate Cancer Index Composite for Clinical Practice EPIC-CP QS Granted
v 1.0 June 22, 2016
Extended Glasgow Outcome Scale GOSE QS Public Domain
v 1.0 May 30, 2014
Extrapyramidal Symptom Rating Scale- Abbreviated ESRSA RS Granted
v 1.0 January 12, 2015
v 2.0 January 6, 2016
Faces Pain Scale – Revised FPSR QS Granted
v 1.0 August 7, 2012
Fatigue Severity Scale FSS QS Granted
v 1.0 December 18, 2013
v 1.1 May 9, 2014
Framingham Heart Study Cardiovascular Disease 10-Year Risk Score FHS CVD 10-YEAR RISK RS Public Domain
v 1.0 July 14, 2016
Functional Assessment of Multiple Sclerosis FAMS QS Granted
v 1.0 October 30, 2013
Functional Assessment Questionnaire FAQ QS Granted
v 1.0 August 19, 2013
Functional Assessment Questionnaire - NACC Version FAQ-NACC QS Granted
v 1.0 August 20, 2013
General Clinical Global Impression GENERAL CLINICAL GLOBAL IMPRESSIONS QS Public Domain
v 1.0 August 7, 2012
Generalized Anxiety Disorder - 7 Item GAD-7 QS Public Domain
v 1.0 March 12, 2014
Geriatric Depression Scale GDS QS Public Domain
v 1.0 May 22, 2013
Geriatric Depression Scale Short Form GDS SHORT FORM QS Public Domain
v 1.0 May 22, 2013
Glasgow Coma Scale NINDS Version GCS NINDS VERSION RS Public Domain
v 1.0 December 31, 2015
Hamilton Anxiety Rating Scale HAM-A RS Public Domain
v 1.0 May 16, 2013
v 2.0 December 16, 2015
Hamilton Depression Rating Scale 17-Item HAMD 17 RS Public Domain
v 1.0 August 7, 2012
v 1.1 May 15, 2013
v 2.0 May 23, 2016
Hamilton Depression Rating Scale 21-Item HAMD 21 RS Public Domain
v 1.0 May 29, 2013
v 2.0 December 16, 2015
Hamilton Depression Rating Scale 24-Item HAMD 24 RS Public Domain
v 1.0 December 5, 2016
Hauser Ambulation Index Hauser Ambulation Index FT Granted
v 1.0 April 23, 2014
Hospital Anxiety and Depression Scale HADS QS Granted
v 1.0 June 13, 2014
Impact of Visual Impairment Scale IVIS QS Granted
v 1.0 December 18, 2013
Influenza Intensity and Impact Questionnaire - Once Daily FLU-IIQ ONCE DAILY QS Author Permission Required
v 1.0 September 24, 2014
Influenza Intensity and Impact Questionnaire - Twice Daily FLU-IIQ TWICE DAILY QS Author Permission Required
v 1.0 October 1, 2014
Inventory of Depressive Symptomatology - Clinician-Rated IDS-C RS Granted
v 1 December 22, 2016
Inventory of Depressive Symptomatology - Self-Report IDS-SR QS Granted
v 1 December 22, 2016
JFK Coma Recovery Scale–Revised CRS-R RS Public Domain
v 1.0 April 15, 2015
v 2.0 December 31, 2015
Karnofsky Performance Scale KPS SCALE QS Public Domain
v 1.0 August 7, 2012
Kurtzke Expanded Disability Status Scale EDSS QS Public Domain
v 1.0 October 23, 2013
Kurtzke Functional Systems Scores KFSS QS Public Domain
v 1.0 November 13, 2013
v 1.1 February 19, 2014
Mayo-Portland Adaptability Inventory MPAI-4 QS Public Domain
v 1.0 June 30, 2014
Michigan Neuropathy Screening Instrument MNSI QS Public Domain
v 1.0 August 7, 2012
Model for End Stage Liver Disease MELD RS Public Domain
v 1.0 April 1, 2015
v 2.0 January 6, 2016
Modified Fatigue Impact Scale MFIS QS Granted
v 1.0 December 18, 2013
Modified Hachinski Ischemic Scale NACC Version MHIS-NACC QS Granted
v 1.0 September 18, 2013
Modified Medical Research Council Dyspnea Scale MMRC QS Public Domain
v 1.0 October 9, 2013
Modified Rankin Scale MRS QS Granted
v 1.0 August 21, 2013
Movement Disorder Society Version of the Unified Parkinson's Disease Rating Scale MDS-UPDRS QS Granted
v 1.0 August 9, 2012
MS Quality of Life - 54 MSQOL-54 QS Granted
v 1.0 January 15, 2014
v 1.1 May 9, 2014
Negative Symptoms Assessment-16 NSA-16 RS Granted
v 1.0 April 1, 2015
v 2.0 May 25, 2016
Neuropathic Pain Scale NPS QS Granted
v 1.0 June 13, 2014
Neuropsychiatric Inventory NPI QS Granted
v 1.0 September 13, 2013
Nine-Hole Peg Test NHPT FT Granted
v 1.0 April 2, 2014
North Star Ambulatory Assessment NSAA RS Granted
v 1.0 February 8, 2017
Overactive Bladder OAB-Q QS Granted
v 1.0 November 20, 2014
Overactive Bladder Questionnaire Short Form OAB-Q SHORT FORM QS Granted
v 1.0 November 20, 2014
Paced Auditory Serial Addition Test PASAT FT Granted
v 1.0 April 9, 2014
Pain Intensity PI QS Public Domain
v 1.0 August 7, 2012
v 1.1 January 26, 2017
Pain Relief PR QS Public Domain
v 1.0 August 7, 2012
v 1.1 January 26, 2017
Patient Determined Disease Steps PDDS QS Public Domain
v 1.0 October 23, 2013
Patient Health Questionnaire – 15 PHQ-15 QS Public Domain
v 1.0 October 21, 2015
Patient Health Questionnaire – 9 PHQ-9 QS Public Domain
v 1.0 September 24, 2014
v 1.1 October 2, 2015
Positive and Negative Syndrome Scale PANSS RS Granted
v 1.0 February 24, 2016
Quick Inventory of Depressive Symptomatology - Clinician-Rated QIDS-C RS Granted
v 1 December 22, 2016
Quick Inventory of Depressive Symptomatology - Self-Report QIDS-SR QS Granted
v 1 December 22, 2016
RAND 36-Item Health Survey 1.0 RAND-36 V1.0 QS Granted
v 1.0 January 15, 2014
Revised Fibromyalgia Impact Questionnaire FIQR QS Granted
v 1.0 June 13, 2014
Rey Auditory Verbal Learning Test AVLT-REY FT Public Domain
v 1.0 September 14, 2015
Rivermead Post-Concussion Symptoms Questionnaire RPQ QS Public Domain
v 1.0 November 5, 2014
Roland-Morris Disability Questionnaire RDQ QS Public Domain
v 1.0 August 7, 2012
Satisfaction With Life Scale SWLS QS Public Domain
v 1.0 April 23, 2014
Screener and Opioid Assessment for Patients with Pain SOAPP-R QS Granted
v 1.0 August 7, 2012
Sheehan Disability Scale SDS QS Granted
v 1.0 September 12, 2013
v 1.1 October 14, 2013
Short-Form McGill Pain Questionnaire - 2 SHORT-FORM MPQ-2 QS Granted
v 1.0 August 7, 2012
v 1.1 June 30, 2016
St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients SGRQ-C QS Granted
v 1.0 February 19, 2014
St. George’s Respiratory Questionnaire - Past 3 Months Version SGRQ PAST 3 MONTHS VERSION QS Granted
v 1.0 September 9, 2015
St. George’s Respiratory Questionnaire - Past 4 Weeks Version SGRQ PAST 4 WEEKS VERSION QS Granted
v 1.0 September 9, 2015
Symbol Digit Modalities Test SDMT FT Not Granted
v 1.0 October 1, 2014
v 1.1 November 19, 2014
Symptom Impact Questionnaire SIQR QS Granted
v 1.0 March 11, 2015
The Expanded Prostate Cancer Index Composite Short Form EPIC-26 QS Granted
v v1.0 June 22, 2016
The Hamilton Depression Rating Scale 6 - Clinician Version HAMD 6 CLINICIAN VERSION RS Granted
v 1.0 August 3, 2016
The Hamilton Depression Rating Scale 6 – Self-Report Version HAMD 6 SELF-REPORT VERSION QS Granted
v 1.0 October 17, 2016
The Oswestry Disability Index Version 2.1a ODI V2.1A QS Granted
v 1.0 March 24, 2016
Timed 25-Foot Walk T25FW FT Granted
v 1.0 March 26, 2014
Timed Up and Go TUG FT Public Domain
v 1.0 May 21, 2014
Trail Making Test TMT FT Granted
v 1.0 December 17, 2015
Transition Dyspnea Index TDI QS Granted
v 1.0 October 9, 2013
Unified Parkinson's Disease Rating Scale MDS-UPDRS QS Granted
v 1.0 August 9, 2012
v 1.1 June 12, 2014
Urgency Perception Scale UPS QS Granted
v 1.0 December 3, 2014
Vignos Lower Extremity Rating Scale VLERS RS Public Domain
v 1 February 6, 2017
Visual Functioning Questionnaire - 25 Interviewer Administered VFQ-25 INTERVIEWER ADMINISTERED QS Public Domain
v 1.0 November 14, 2013
v 1.1 May 9, 2014
Visual Functioning Questionnaire - 25 Self Administered VFQ-25 SELF ADMINISTERED QS Public Domain
v 1.0 November 14, 2013
v 1.1 May 9, 2014
West Haven Hepatic Encephalopathy Grade WEST HAVEN HEPATIC ENCEPHALOPATHY GRADE RS Public Domain
v 1.0 January 6, 2016
WHO Clinical Staging of HIV AIDS for Adults and Adolescents WHO HIV STAGING FOR ADULTS AND ADOLESCENTS RS Granted
v v1.0 June 29, 2016
WHO Clinical Staging of HIV/AIDS for Children WHO HIV STAGING FOR CHILDREN RS Granted
v v1.0 June 29, 2016
WHO Disability Assessment Schedule 2.0 - 12 Item Interviewer-Administered WHODAS 2.0 – 12-ITEM INTERVIEWER QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 12 Item Proxy-Administered WHODAS 2.0 – 12-ITEM PROXY QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 12 Item Self-Administered WHODAS 2.0 – 12-ITEM SELF QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 12+24 Item Interviewer-Administered WHODAS 2.0 - 12+24- ITEM INTERVIEWER QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Interviewer-Administered WHODAS 2.0 – 36-ITEM INTERVIEWER QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Proxy-Administered WHODAS 2.0 – 36-ITEM PROXY QS Granted
v 1.0 February 28, 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Self-Administered WHODAS 2.0 – 36-ITEM SELF QS Granted
v 1.0 February 28, 2017
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem WPAI-SHP QS Public Domain
v 1.0 August 7, 2012
v 1.1 September 29, 2015

 

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.