CDISC develops SDTM (tabulation) and ADaM (analysis) QRS supplements that provide information on how to structure the data in a standard format for public domain and copyright-approved instruments. An instrument is a series of questions, tasks or assessments used in clinical research to provide a qualitative or quantitative assessment of a clinical concept or task-based observation. Controlled Terminology is also developed to be used with the supplements.

CDISC creates supplements for three types of instruments:
Questionnaires: Questionnaire instruments are stored in the Questionnaires (QS) domain and are named, standalone instruments designed to provide an assessment of a concept. Questionnaires often have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and usually document methods for administration and analysis. Questionnaires consist of defined questions with a defined set of potential answers. Most often, the primary purpose of questionnaires is to generate quantitative statistic to assess a qualitative concept.

Functional Tests: Functional Test instruments are stored in the Functional Tests (FT) domain and are named, standalone 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: Named instruments 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. Usually the instrument will be published in a professional journal or on a website.

Clinical Classifications are based on a trained healthcare 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 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 may be composite scores based on diverse inputs. This assessment method differs from a more traditional question-and-answer interview commonly seen in questionnaires.


How can I access the published supplements?

Accessing the Published Supplements

The QRS standards package is available on the QRS web page. The following is a description of the column headings in the QRS published supplements table and how to access the package.

  • QRS Name: Click on QRS Name to access the SDTMIG QRS Supplement, ADaMIG QRS Supplement, and/or an annotated CRF.
  • Short Name: (--CAT): SDTM Short Name used to identify the QRS instrument within the SDTMIG and in Controlled Terminology.
  • SDTM Domain / ADaM Dataset: Indicates the SDTM FINDINGS domain in which the SDTMIG supplement is represented. A designation of ADaM indicates an ADaMIG supplement exists for the instrument.
  • Permission: Indicates the CDISC permission status of the instrument.
    • Public Domain: The instrument is in the public domain; no permission is necessary.
    • Granted: The copyright holder has granted CDISC permission to develop a supplement. Controlled Terminology for --CAT, --TEST, --TESTCD can also be developed. Where applicable, the SDTMIG supplement includes response values in --ORRES and scored values in –STRESC/--STRESN. This means that meaningful examples of data from the instrument can be included in supplements. Sponsors still need to obtain copyright permission from the copyright holder to use the instrument in their clinical trials.
    • Author Permission Required: This permission level requires the user to obtain the CDISC QRS Supplements from the copyright holder.  A README file is provided that explains how to obtain the instrument and CDISC QRS supplement(s).
    • Denied: The copyright holder has denied permission to implement the QRS supplement. No supplement was developed.
    • No response received: The copyright holder has not responded to attempted contacts. No supplement was developed.
    • Pending: The QRS instrument’s copyright status is in review, but there is no resolution at this point in time.
  • ​Version: Each Supplement version has a unique number.
  • Release Date: Date CDISC published the QRS supplement.

QRS Supplements

Displaying 1 - 216 of 216
QRS Name Short Name (--CAT) SDTM Domain/ADaM Dataset Permission Version Release Date
12-Item Multiple Sclerosis Walking Scale
MSWS-12 QS No Response Received
N/A
6 Minute Walk Test SIX MINUTE WALK FT Public Domain
Version: 1.0
21 May 2014
Abnormal Involuntary Movement Scale AIMS RS Public Domain
Version: 1.0
22 May 2013

Version: 2.0
3 Apr 2021
Acute Physiology and Chronic Health Evaluation II APACHE II RS Public Domain
Version: 1.0
29 Jun 2016
ADHD Rating Scale-IV Home Version
ADHD-RS-IV HOME VERSION QS No Response Received
N/A
Age, treatment with systemic antibiotics, leukocyte count, serum albumin, and serum creatinine as a measure of renal function ATLAS RS Public Domain
Version: 1
19 May 2020
Airway Questionnaire AQ20 QS Granted
Version: 1.0
12 Feb 2014
Alcohol Use Disorders Identification Test - Consumption Questions AUDIT-C QS Public Domain
Version: 1.0
6 Nov 2014
Alcohol Use Disorders Identification Test - Self-Report Version AUDIT-SR QS Public Domain
Version: 1.0
19 Nov 2014
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) ADAS-COG QS Granted
Version: 1.0
26 Jan 2012
Alzheimer's Disease Cooperative Study-Activities of Daily Living - MCI ADCS-ADL MCI QS Granted
Version: 1.0
16 Aug 2013
Arizona Sexual Experiences Scale - Female ASEX-FEMALE QS Granted
Version: 1.0
1 Feb 2017
Arizona Sexual Experiences Scale - Male ASEX-MALE QS Granted
Version: 1.0
1 Feb 2017
ASSIGN Risk Score ASSIGN CVD 10-YEAR RISK RS Public Domain
Version: 1.0
14 Jul 2016
Asthma Control Questionnaire
ACQ QS Denied
N/A
Asthma Control Test
ACT QS No Response Received
N/A
Asthma Quality of Life Questionnaire
AQLQ QS Denied
N/A
Atherosclerotic Cardiovascular Disease 10-Year Risk Estimator ASCVD 10-YEAR RISK RS Public Domain
Version: 1.0
14 Jul 2016
Barnes Akathisia Rating Scale BARS QS Granted
Version: 1.0
15 May 2013
Baseline Dyspnea Index BDI QS Granted
Version: 1.0
1 Oct 2013
Bladder Control Scale BLCS QS Granted
Version: 1.0
18 Dec 2013

Version: 1.1
9 May 2014
BODE Index BODE INDEX RS Public Domain
Version: 1.0
6 Jan 2016
Bowel Control Scale BWCS QS Granted
Version: 1.0
18 Dec 2013

Version: 1.1
9 May 2014
Brief Assessment of Cognition in Schizophrenia BACS FT Granted
Version: 1.0
1 Mar 2015
Brief Pain Inventory-Interference Scale BPI QS Granted
Version: 1.0
7 Aug 2012

Version: 1.1
30 Jun 2016
Brief Pain Inventory-Interference Scale Short Form BPI SHORT FORM QS Granted
Version: 1.0
7 Aug 2012

Version: 1.1
30 Jun 2016
Brief Psychiatric Rating Scale-Anchored BPRS-A QS Public Domain
Version: 1.0
29 Jan 2013

Version: 1.1
23 Jun 2014

Version: 1.2
28 Jul 2014
Brief Symptom Inventory-18
BSI-18 Denied
N/A
Brooke Upper Extremity Rating Scale BUERS RS Public Domain
Version: 1.0
6 Feb 2017
CDC Classification System for HIV-Infected Adults and Adolescents CDC HIV CLASSIFICATION FOR ADULTS AND ADOLESCENTS RS Public Domain
Version: 1.0
29 Jun 2016
Child Health Questionnaire CF87
CHQ-CF87 Denied
N/A
Child Health Questionnaire PF28
CHQ-PF28 Denied
N/A
Child Health Questionnaire Survey PF50
CHQ-PF50 Denied
N/A
Child-Pugh Classification CHILD-PUGH CLASSIFICATION RS Public Domain
Version: 1.0
6 Jan 2015
Chronic Respiratory Questionnaire - Self-Administered Standardized Format First Administration Version CRQ-SAS FIRST ADMINISTRATION VERSION QS Granted
Version: 1.0
18 Feb 2015
Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION QS Granted
Version: 1.0
18 Feb 2015
Clinical COPD Questionnaire (CCQ) 1 Week Version CCQ 1 WEEK VERSION QS Granted
Version: 1.0
1 Jul 2015
Clinical COPD Questionnaire (CCQ) 24 Hour Version CCQ 24 HOUR VERSION QS Granted
Version: 1.0
1 Jul 2015
Clinical Global Impression CGI QS Public Domain
Version: 1.0
7 Aug 2012

Version: 1.1
2 Apr 2013

Version: 1.2
15 Dec 2016

Version: 2.0
20 Mar 2019

Version: 2.1
11 Jul 2019
Clinical Global Impression CGI ADaM Public Domain
Version: 1.0
27 Jul 2020

Version: 1.1
10 Mar 2021
Columbia Suicide Severity Rating Scale - Baseline C-SSRS BASELINE QS Granted
Version: 1.0
7 Aug 2012

Version: 1.1
6 Feb 2013

Version: 1.2
3 Sep 2014
Columbia-Suicide Severity Rating Scale Already Enrolled Subjects C-SSRS ALREADY ENROLLED SUBJECTS QS Granted
Version: 1.0
13 Jun 2014
Columbia-Suicide Severity Rating Scale Baseline Screening C-SSRS BASELINE/SCREENING VERSION QS Granted
Version: 1.0
5 Nov 2014
Columbia-Suicide Severity Rating Scale Baseline/Screening Version Phase 1 Study C-SSRS BASELINE/SCREENING VERSION PHASE 1 STUDY QS Granted
Version: 1.0
4 Dec 2013

Version: 1.1
3 Sep 2014
Columbia-Suicide Severity Rating Scale Since Last Visit C-SSRS SINCE LAST VISIT QS Granted
Version: 1.0
6 Feb 2013

Version: 1.1
3 Sep 2014
Combat Exposure Scale CES QS Public Domain
Version: 1.0
8 Mar 2021
COPD Assessment Test
COPD ASSESSMENT TEST Denied
N/A
Craig Handicap Assessment and Reporting Technique - Short Form Interview Version CHART-SF INTERVIEW VERSION QS Public Domain
Version: 1.0
2 Jul 2014

Version: 1.1
6 Nov 2014
Craig Handicap Assessment and Reporting Technique - Short Form Paper Version CHART-SF PAPER VERSION QS Public Domain
Version: 1.0
6 Nov 2014
Current Opioid Misuse Measure COMM QS Granted
Version: 1.0
7 Aug 2012
Diabetes Distress Scale for Adults with Type 1 Diabetes T1-DDS QS Granted
Version: 1.0
8 Mar 2021
Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes PARENT-DDS QS Granted
Version: 1.0
8 Mar 2021
Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes PARTNER-DDS QS Granted
Version: 1.0
8 Mar 2021
Disability Assessment for Dementia DAD QS Granted
Version: 1.0
27 Jun 2013
Disability Rating Scale DRS RS Public Domain
Version: 1.0
21 Mar 2014

Version: 2.0
3 Apr 2021
Disease Steps DISEASE STEPS QS Public Domain
Version: 1.0
30 Oct 2013
Eastern Cooperative Oncology Group Performance Status ECOG ADaM Public Domain
Version: 1.0
27 Jul 2020

Version: 1.1
10 Mar 2021
Eastern Cooperative Oncology Group Performance Status ECOG RS Public Domain
Version: 1.0
26 Jun 2013

Version: 2.0
3 Apr 2021
Emotion Recognition EMOTION RECOGNITION FT Granted
Version: 1
19 May 2020
Epworth Sleepiness Scale ESS QS Granted
Version: 1.0
26 Jun 2013

Version: 1.1
8 Mar 2021
European Quality of Life Five Dimension Five Level Scale EQ-5D-5L QS Granted
Version: 1.0
5 Mar 2013

Version: 1.1
19 Jun 2014

Version: 1.2
28 Oct 2015
European Quality of Life Five Dimension Three Level Scale EQ-5D-3L QS Granted
Version: 1.0
5 Mar 2013

Version: 1.1
19 Jun 2014

Version: 1.2
28 Oct 2015
Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome EXACT QS Granted
Version: 1.0
24 Mar 2016
Expanded Disability Rating Sale - Postacute Interview Caregiver Version EXPANDED DRS-PI CAREGIVER VERSION QS Public Domain
Version: 1.0
19 Apr 2016
Expanded Disability Rating Sale - Postacute Interview Survivor Version EXPANDED DRS-PI SURVIVOR VERSION QS Public Domain
Version: 1.0
19 Apr 2016
Expanded Prostate Cancer Index Composite for Clinical Practice EPIC-CP QS Granted
Version: 1.0
22 Jun 2016
Expanded Prostate Cancer Index Composite Short Form EPIC-26 QS Granted
Version: 1.0
22 Jun 2016
Extended Glasgow Outcome Scale GOSE QS Public Domain
Version: 1.0
30 May 2014
Extrapyramidal Symptom Rating Scale- Abbreviated ESRSA RS Granted
Version: 1.0
12 Jan 2015

Version: 2.0
6 Jan 2016
Faces Pain Scale - Revised FPSR QS Granted
Version: 1.0
7 Aug 2012
Fatigue Severity Scale FSS QS Granted
Version: 1.0
18 Dec 2013

Version: 1.1
9 May 2014
Framingham Heart Study Cardiovascular Disease 10-Year Risk Score FHS CVD 10-YEAR RISK RS Public Domain
Version: 1.0
14 Jul 2016
Functional Assessment of Multiple Sclerosis FAMS QS Granted
Version: 1.0
30 Oct 2013
Functional Assessment Questionnaire FAQ QS Granted
Version: 1.0
19 Aug 2013
Functional Assessment Questionnaire - NACC Version FAQ-NACC VERSION QS Granted
Version: 1.0
20 Aug 2013
General Clinical Global Impression GCGI QS Public Domain
Version: 1.0
7 Aug 2012
Generalized Anxiety Disorder - 7 Item GAD-7 QS Public Domain
Version: 1.0
12 Mar 2014
Geriatric Depression Scale GDS QS Public Domain
Version: 1.0
22 May 2013
Geriatric Depression Scale Short Form GDS SHORT FORM ADaM Public Domain
Version: 1.0
29 Jan 2021
Geriatric Depression Scale Short Form GDS SHORT FORM QS Public Domain
Version: 1.0
22 May 2013
Glasgow Coma Scale NINDS Version GCS NINDS VERSION RS Public Domain
Version: 1.0
31 Dec 2015
Haemophilia Quality of Life Questionnaire Adult Version
HAEM-A-QOL No Response Received
N/A
Haemophilia Quality of Life Questionnaire Children's Long Version Age Group I
HAEMO-QOL CHILDREN'S LONG VERSION AGE GROUP I No Response Received
N/A
Haemophilia Quality of Life Questionnaire Children's Long Version Age Group II
HAEMO-QOL CHILDREN'S LONG VERSION AGE GROUP II No Response Received
N/A
Haemophilia Quality of Life Questionnaire Children's Long Version Age Group III
HAEMO-QOL CHILDREN'S LONG VERSION AGE GROUP III No Response Received
N/A
Haemophilia Quality of Life Questionnaire Children's Short Version Age Group I
HAEMO-QOL CHILDREN'S SHORT VERSION AGE GROUP I No Response Received
N/A
Haemophilia Quality of Life Questionnaire Children's Short Version Age Group II/III
HAEMO-QOL CHILDREN'S SHORT VERSION AGE GROUP II/III No Response Received
N/A
Haemophilia Quality of Life Questionnaire Parent's Long Version Age Group I
HAEMO-QOL PARENT'S LONG VERSION AGE GROUP I No Response Received
N/A
Haemophilia Quality of Life Questionnaire Parent's Long Version Age Group II
HAEMO-QOL PARENT'S LONG VERSION AGE GROUP II No Response Received
N/A
Haemophilia Quality of Life Questionnaire Parent's Long Version Age Group III
HAEMO-QOL PARENT'S LONG VERSION AGE GROUP III No Response Received
N/A
Hamilton Anxiety Rating Scale HAM-A RS Public Domain
Version: 1
16 May 2013

Version: 2
16 Dec 2015

Version: 2.1
19 May 2020
Hamilton Depression Rating Scale 17-Item HAMD 17 RS Public Domain
Version: 1.0
7 Aug 2012

Version: 1.1
15 May 2013

Version: 2.0
23 May 2016
Hamilton Depression Rating Scale 21-Item HAMD 21 RS Public Domain
Version: 1.0
29 May 2013

Version: 2.0
16 Dec 2015
Hamilton Depression Rating Scale 24-Item HAMD 24 RS Public Domain
Version: 1.0
5 Dec 2016
Hamilton Depression Rating Scale 6 - Clinician Version HAMD 6 CLINICIAN VERSION RS Granted
Version: 1.0
3 Aug 2016
Hamilton Depression Rating Scale 6 - Self-Report Version HAMD 6 SELF-REPORT VERSION QS Granted
Version: 1.0
17 Oct 2016
Hauser Ambulation Index HAUSER AMBULATION INDEX FT Granted
Version: 1.0
23 Apr 2014
Hospital Anxiety and Depression Scale HADS QS Granted
Version: 1.0
13 Jun 2014

Version: 1.1
19 May 2020
Impact of Visual Impairment Scale IVIS QS Granted
Version: 1.0
18 Dec 2013
Inflammatory Bowel Disease Questionnaire IBDQ QS Granted
Version: 1.0
3 Apr 2021
Influenza Intensity and Impact Questionnaire - Once Daily FLU-IIQ ONCE DAILY QS Author Permission Required
Version: 1.0
24 Sep 2014
Influenza Intensity and Impact Questionnaire - Twice Daily FLU-IIQ TWICE DAILY QS Author Permission Required
Version: 1.0
1 Oct 2014
Inventory of Depressive Symptomatology - Clinician-Rated IDS-C RS Granted
Version: 1.0
22 Dec 2016
Inventory of Depressive Symptomatology - Self-Report IDS-SR QS Granted
Version: 1.0
22 Dec 2016
JFK Coma Recovery Scale-Revised CRS-R RS Public Domain
Version: 1.0
15 Apr 2015

Version: 2.0
31 Dec 2015
Karnofsky Performance Scale KPS SCALE RS Public Domain
Version: 1.0
7 Aug 2012

Version: 2.0
3 Apr 2021
Kurtzke Expanded Disability Status Scale EDSS ADaM Public Domain
Version: 1.0
27 Jul 2020

Version: 1.1
10 Mar 2021
Kurtzke Expanded Disability Status Scale EDSS QS Public Domain
Version: 1.0
23 Oct 2013
Kurtzke Functional Systems Scores KFSS RS Public Domain
Version: 1.0
13 Nov 2013

Version: 1.1
19 Feb 2014

Version: 2.0
3 Apr 2021
Life Events Checklist for DSM-5, Standard Version LEC-5 STANDARD VERSION QS Public Domain
Version: 1.0
10 Mar 2020
Mayo-Portland Adaptability Inventory MPAI-4 QS Public Domain
Version: 1.0
30 Jun 2014
Menstrual Distress Questionnaire Form-T (Today)
MDQ-T No Response Received
N/A
Michigan Neuropathy Screening Instrument MNSI QS Public Domain
Version: 1.0
7 Aug 2012
Mini International Neuropsychiatric Interview (MINI)
MINI No Response Received
N/A
Model for End Stage Liver Disease MELD RS Public Domain
Version: 1.0
1 Apr 2015

Version: 2.0
6 Jan 2016
Modified Fatigue Impact Scale MFIS QS Granted
Version: 1.0
18 Dec 2013
Modified Hachinski Ischemic Scale NACC Version MHIS-NACC QS Granted
Version: 1.0
18 Sep 2013
Modified Medical Research Council Dyspnea Scale MMRC QS Public Domain
Version: 1.0
9 Oct 2013
Modified Rankin Scale MRS QS Granted
Version: 1.0
21 Aug 2013
Montgomery-Asberg Depression Rating Scale
MADRS No Response Received
N/A
Montreal Cognitive Assessment
MOCA Denied
N/A
Movement Disorder Society Version of the Unified Parkinson's Disease Rating Scale MDS-UPDRS QS Granted
Version: 1.0
9 Aug 2012
MS Quality of Life - 54 MSQOL-54 QS Granted
Version: 1.0
15 Jan 2014

Version: 1.1
9 May 2014
Multiple Sclerosis Impact Scale version 1
MSIS-29v1 No Response Received
N/A
Multiple Sclerosis Impact Scale version 2
MSIS-29v2 No Response Received
N/A
Negative Symptoms Assessment-16 NSA-16 RS Granted
Version: 1.0
1 Apr 2015

Version: 2.0
25 May 2016
Neuropathic Pain Scale NPS QS Granted
Version: 1.0
13 Jun 2014
Neuropsychiatric Inventory NPI QS Granted
Version: 1.0
13 Sep 2013
Nine-Hole Peg Test NHPT FT Granted
Version: 1.0
2 Apr 2014
North Star Ambulatory Assessment NSAA RS Granted
Version: 1.0
8 Feb 2017
Ocular Comfort Index
OCI No Response Received
N/A
Oswestry Disability Index Version 2.1a ODI V2.1A QS Granted
Version: 1.0
24 Mar 2016
Overactive Bladder OAB-Q QS Granted
Version: 1.0
20 Nov 2014
Overactive Bladder Questionnaire Short Form OAB-Q SHORT FORM QS Granted
Version: 1.0
20 Nov 2014
Paced Auditory Serial Addition Test PASAT FT Granted
Version: 1.0
9 Apr 2014
Paced Tapping PACED TAPPING FT Granted
Version: 1.0
8 Mar 2021
Pain Intensity PI QS Public Domain
Version: 1.0
7 Aug 2012

Version: 1.1
26 Jan 2017
Pain Relief PR QS Public Domain
Version: 1.0
7 Aug 2012

Version: 1.1
26 Jan 2017
Parkinson's Disease Quality of Life Scale
PDQUALIF No Response Received
N/A
Patient Determined Disease Steps PDDS QS Public Domain
Version: 1.0
23 Oct 2013
Patient Global Impression PGI ADaM Public Domain
Version: 1.0
27 Jul 2020

Version: 1.1
10 Mar 2021
Patient Global Impression PGI QS Public Domain
Version: 1.0
20 Mar 2019

Version: 1.1
11 Jul 2019
Patient Health Questionnaire - 15 PHQ-15 QS Public Domain
Version: 1.0
21 Oct 2015
Patient Health Questionnaire - 9 PHQ-9 QS Public Domain
Version: 1.0
24 Sep 2014

Version: 1.1
2 Oct 2015
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Child PEDSQL NEUROMUSCULAR MODULE ACUTE V3 CHILD QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Child Parent Report PEDSQL NEUROMUSCULAR MODULE ACUTE V3 CHILD PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Teen PEDSQL NEUROMUSCULAR MODULE ACUTE V3 TEEN QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Teen Parent Report PEDSQL NEUROMUSCULAR MODULE ACUTE V3 TEEN PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Toddler Parent Report PEDSQL NEUROMUSCULAR MODULE ACUTE V3 TODDLER PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Young Adult PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG ADULT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Young Adult Parent Report PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG ADULT PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Young Child PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG CHILD QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Acute Version 3 Young Child Parent Report PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG CHILD PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Child PEDSQL NEUROMUSCULAR MODULE V3 CHILD QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Child Parent Report PEDSQL NEUROMUSCULAR MODULE V3 CHILD PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Teen PEDSQL NEUROMUSCULAR MODULE V3 TEEN QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Teen Parent Report PEDSQL NEUROMUSCULAR MODULE V3 TEEN PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Toddler Parent Report PEDSQL NEUROMUSCULAR MODULE V3 TODDLER PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Young Adult PEDSQL NEUROMUSCULAR MODULE V3 YOUNG ADULT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Young Adult Parent Report PEDSQL NEUROMUSCULAR MODULE V3 YOUNG ADULT PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Young Child PEDSQL NEUROMUSCULAR MODULE V3 YOUNG CHILD QS Granted
Version: 1.0
18 Nov 2020
Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 Young Child Parent Report PEDSQL NEUROMUSCULAR MODULE V3 YOUNG CHILD PARENT REPORT QS Granted
Version: 1.0
18 Nov 2020
Pittsburgh Sleep Quality Index
PSQI No Response Received
N/A
Positive and Negative Syndrome Scale PANSS RS Granted
Version: 1.0
24 Feb 2016
PTSD Checklist for DSM-5 PCL-5 QS Public Domain
Version: 1.0
10 Mar 2020
Quick Inventory of Depressive Symptomatology - Clinician-Rated QIDS-C RS Granted
Version: 1.0
22 Dec 2016
Quick Inventory of Depressive Symptomatology - Self-Report QIDS-SR QS Granted
Version: 1.0
22 Dec 2016
RAND 36-Item Health Survey 1.0 RAND-36 V1.0 QS Granted
Version: 1.0
15 Jan 2014
RAND Social Support Survey Instrument RAND SOCIAL SUPPORT SURVEY INSTRUMENT QS Granted
Version: 1.0
8 Mar 2021
Revised Fibromyalgia Impact Questionnaire FIQR QS Granted
Version: 1.0
13 Jun 2014
Rey Auditory Verbal Learning Test AVLT-REY FT Public Domain
Version: 1.0
14 Sep 2015
Rivermead Post-Concussion Symptoms Questionnaire RPQ QS Public Domain
Version: 1.0
5 Nov 2014
Roland-Morris Disability Questionnaire RDQ QS Public Domain
Version: 1.0
7 Aug 2012
Satisfaction With Life Scale SWLS QS Public Domain
Version: 1.0
23 Apr 2014
Screener and Opioid Assessment for Patients with Pain SOAPP-R QS Granted
Version: 1.0
7 Aug 2012
Sexual Functioning Questionnaire short-form – Female
CSFQ-14 FEMALE No Response Received
N/A
Sexual Functioning Questionnaire short-form – Male
CSFQ-14 MALE No Response Received
N/A
Sheehan Disability Scale SDS QS Granted
Version: 1.0
12 Sep 2013

Version: 1.1
14 Oct 2013
Short Form 36 Health Survey Acute, US Version 1.0
SF36 v1.0 Acute No Response Received
N/A
Short Form 36 Health Survey Acute, US Version 2.0
SF36 v2.0 Acute No Response Received
N/A
Short Form 36 Health Survey Standard, US Version 1.0
SF36 v1.0 Standard No Response Received
N/A
Short Form 36 Health Survey Standard, US Version 2.0
SF36 v2.0 Standard No Response Received
N/A
Short Opiate Withdrawal Scale
SOWS SHORT No Response Received
N/A
Short-Form McGill Pain Questionnaire - 2 SHORT-FORM MPQ-2 QS Granted
Version: 1.1
30 Jun 2016

Version: 1.0
7 Aug 2012
Shortness of Breath with Daily Activities Questionnaire
SOBDA No Response Received
N/A
St. George's Respiratory Questionnaire - Past 3 Months Version SGRQ PAST 3 MONTHS VERSION QS Granted
Version: 1.0
9 Sep 2015
St. George's Respiratory Questionnaire - Past 4 Weeks Version SGRQ PAST 4 WEEKS VERSION QS Granted
Version: 1.0
9 Sep 2015
St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients SGRQ-C QS Granted
Version: 1.0
19 Feb 2014
Structured Clinical Interview for DSM Disorders
SCID No Response Received
N/A
Symbol Digit Modalities Test
SDMT FT Denied
N/A

N/A
Symptom Impact Questionnaire SIQR QS Granted
Version: 1.0
11 Mar 2015
Timed 25-Foot Walk T25FW FT Granted
Version: 1.0
26 Mar 2014
Timed Up and Go TUG FT Public Domain
Version: 1.0
21 May 2014
Trail Making Test TMT FT Author Permission Required
Version: 1.0
17 Dec 2015
Transition Dyspnea Index TDI QS Granted
Version: 1.0
9 Oct 2013
Unified Parkinson's Disease Rating Scale UPDRS QS Granted
Version: 1.0
9 Aug 2012

Version: 1.1
12 Jun 2014
Urgency Perception Scale UPS QS Granted
Version: 1.0
3 Dec 2014
Vignos Lower Extremity Rating Scale VLERS RS Public Domain
Version: 1.0
6 Feb 2017
Visual Functioning Questionnaire - 25 Interviewer Administered VFQ-25 INTERVIEWER ADMINISTERED QS Public Domain
Version: 1.0
14 Nov 2013

Version: 1.1
9 May 2014
Visual Functioning Questionnaire - 25 Self Administered VFQ-25 SELF ADMINISTERED QS Public Domain
Version: 1.0
14 Nov 2013

Version: 1.1
9 May 2014
West Haven Hepatic Encephalopathy Grade WEST HAVEN HEPATIC ENCEPHALOPATHY GRADE RS Public Domain
Version: 1.0
6 Jan 2016
Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Likert Scale Format
WOMAC LK 3.1 INDEX No Response Received
N/A
Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Numerical Rating Scale Format
WOMAC NRS 3.1 INDEX No Response Received
N/A
Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format
WOMAC VA 3.1 INDEX No Response Received
N/A
WHO Clinical Staging of HIV AIDS for Adults and Adolescents WHO HIV STAGING FOR ADULTS AND ADOLESCENTS RS Granted
Version: 1.0
29 Jun 2016
WHO Clinical Staging of HIV/AIDS for Children WHO HIV STAGING FOR CHILDREN RS Granted
Version: 1.0
29 Jun 2016
WHO Disability Assessment Schedule 2.0 - 12 Item Interviewer-Administered WHODAS 2.0 - 12-ITEM INTERVIEWER QS Granted
Version: 1.0
28 Feb 2017
WHO Disability Assessment Schedule 2.0 - 12 Item Proxy-Administered WHODAS 2.0 - 12-ITEM PROXY QS Granted
Version: 1.0
28 Feb 2017
WHO Disability Assessment Schedule 2.0 - 12 Item Self-Administered WHODAS 2.0 - 12-ITEM SELF QS Granted
Version: 1.0
28 Feb 2017
WHO Disability Assessment Schedule 2.0 - 12+24 Item Interviewer-Administered WHODAS 2.0 - 12 + 24-ITEM INTERVIEWER QS Granted
Version: 1.0
28 Feb 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Interviewer-Administered WHODAS 2.0 - 36-ITEM INTERVIEWER QS Granted
Version: 1.0
28 Feb 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Proxy-Administered WHODAS 2.0 - 36-ITEM PROXY QS Granted
Version: 1.0
28 Feb 2017
WHO Disability Assessment Schedule 2.0 - 36 Item Self-Administered WHODAS 2.0 - 36-ITEM SELF QS Granted
Version: 1.0
28 Feb 2017
Work Limitations Questionnaire
WLQ Denied
N/A
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem WPAI-SHP QS Public Domain
Version: 1.0
7 Aug 2012

Version: 1.1
29 Sep 2015
Young Mania Rating Scale
YMRS No Response Received
N/A

New QRS Supplements

No new QRS records found.

What is included in a QRS Supplement?

QRS supplements to the SDTMIG include instrument-specific Controlled Terminology and an SDTM example illustrating the use, applicable supplemental qualifiers and item-level mapping instructions for the results. Assumptions for implementing the instrument in SDTM are also included.

QRS supplements to the ADaMIG describe how to structure the questionnaire analysis dataset based on data structures described in the ADaMIG. Included in ADaMIG supplements are sample analysis descriptions, scoring for the statistical analysis plan, data checks, and examples of analysis dataset metadata, analysis variable metadata, and value-level metadata. Also included is an example of the final analysis dataset to be used for analysis and regulatory submission.

Are there QRS-like instruments for which the collected data would not be stored in the FT, QS, or RS domains?

Yes, the following are examples of QRS-like instruments represented in other domains:

  • Microscopic Findings (MI) domain: If the data is based on microscopic data, those types of scoring instruments would be represented in the MI domain (see the Prostate Cancer TAUG – Gleason Score example).
  • Findings About Events or Interventions (FA) domain: Sponsor-defined general single-Item assessment concepts. There are no published CDISC QRS Supplements for the evaluation of sponsor-defined general single-item assessments as they are not considered standard QRS instruments, but assess symptoms or other disease related items like overall quality of life, etc. These assessments may be evaluated using sponsor-defined general codelist scales, visual analog scales (VAS) or numeric rating scales (NRS). VAS and NRS Scales use various methods for describing the anchor points and may have descriptor anchors (e.g., beginning, middle and end) for various gradations or numbers). There may be examples of these assessments in the literature, but they are not considered CDISC QRS standard instruments, due to the extreme variability in the methods of capturing these types of assessments. These assessments may be in the public domain or may be copyrighted. Sponsors are responsible for the appropriate usage of any copyrighted assessments.
    • General single-Item assessments are represented in the Finding About (FA) domain as they relate to a finding about a disease condition as an event. This concept meets one of the following criteria on when to use the FA domain:
    • Data or observations that have different timing from an associated event or intervention as a whole.
    • An observation about an Event or Intervention which requires more than one variable for its representation, particularly when the observation may be represented with findings class variables (e.g., units, method).
    • More information on the use of the FA domain can be found in the SDTMIG.

 

I don't see any domains other than QS in the SDTMIG -- what do I do?
QRS supplements are represented in SDTMIG v3.2 and earlier versions in the Questionnaires (QS) domain or in custom domains. The Functional Tests (FT) and the Disease Response and Clin Classification (RS) findings domains for ratings and scales other than questionnaires will be included SDTMIG v3.3. The RS domain, originally intended for classifications of disease response, was renamed to Disease Response and Clin Classification and revised to include all clinical classifications. Submissions using SDTMIG v3.2 and earlier versions should represent ratings and scales other than questionnaires in custom domains that mirror the FT and RS domains. The terminology in published FT and RS supplements as well as the FT and RS domain codes can be used for such custom domains. The user should alert regulators of their use of the supplements in the Data Reviewers Guide.
What are the different ADaM data structures that could be used for QRS supplements?
  • ADaM Basic Data Structure (BDS): An analysis dataset that contains one or more records per subject, per analysis parameter, per analysis time point. The parameters are mapped from –TEST and –TESTCD, and additional parameters are created as needed for derived scores.
  • ADAM Other may also be used when the analysis has special needs that are not met by the BDS structure.
Where can I find QRS Controlled Terminology?

CDISC Controlled Terminology is maintained and distributed as part of the National Cancer Institute (NCI) Thesaurus and available in Excel, text, odm.xml, pdf, html and OWL/RDF formats. QRS SDTM terminology is included in the SDTM terminology download.

  • Here’s an example using the Excel format of CDISC Controlled Terminology to find categories:
  • In the SDTM CT spreadsheet, locate the category of the instrument in the following codelists: Category of Clinical Classification, Category of Functional Test, or Category of Questionnaire.
  • Next, search for the instrument’s –TESTCD and –TEST codelists by using category’s CDISC Synonym(s) value in searching all CDISC Submission Values. The instrument’s “test code” and “test name” codelists will be provided.
  • Here’s an example using the Excel format of CDISC Controlled Terminology to find terminology for The Satisfaction With Life Scale:
    • Go to the top of the spreadsheet and search for ‘Satisfaction With Life’.  
    • This brings you to the instrument’s entry in the Category of Questionnaire (QSCAT) codelist.  
    • The cells in this row starting at the far left:
      • EVS and Codelist C-codes for NCI reference use.
      • Codelist Name for the name of the codelist (“Category of Questionnaire”).
      • CDISC Submission Value which is the value of QSCAT for the instrument (SWLS).
      • CDISC Synonym(s) value used to locate the –TESTCD and –TEST codelists (SWLS01).
      • CDISC definition for this instrument.  
    • If you now search for SWLS01, you will find the –TESTCD and –TEST codelists (SWLS01TC and SWLS01TN) for The Satisfaction With Life Scale.
  • The QRS Terminology Naming Rules are in the QRS Implementation Documents panel on this page.
How does CDISC handle copyrighted instruments?

CDISC must obtain permission to create a QRS supplement for copyrighted instruments. If this permission is not obtained, the supplement is not created.

Rights of Copyright Holders

  • CDISC recognizes the copyright of all instrument copyright holders. All instrument owners maintain full copyright status when granting permission to CDISC to develop QRS supplements for the instrument.  A QRS supplement does not, in any way, affect copyright holder licensing fees or procedures.

Creating QRS Supplements

  • Granting CDISC the right to create supplements to represent an instrument in CDISC QRS domains is not a license for CDISC standards users to use the instrument without complying with the copyright holders licensing requirements.
  • No part of a copyrighted instrument or accompanying guidelines may be reproduced, distributed, or transmitted in any form, or by any means, including photocopying, recording, or other electronic or mechanical methods without the permission of the copyright holder and payment of applicable fees.
What do I do if the instrument I'm interested in using doesn't have a QRS supplement?

You can request a QRS supplement be developed by completing the QRS Supplement Request Form located in the QRS Implementation Documents green box on this page.

Please note, if a copyrighted instrument does not have a supplement, CDISC may not have received permission to develop it. These instruments have Permission values of either “Denied” or “No response received”.  

How does the FDA Clinical Outcome Assessment (COA) program relate to QRS supplements?
The FDA discusses the need for outcome measures that are defined as part of the Drug Development Tools Qualification Program for Clinical Outcome Assessment (COA) instruments. CDISC QRS Supplements assist in structuring COA data so that it is collected and reported in a standardized format.
What are the different types of FDA COAs?
COAs include the following types of analytical instruments:
  • Clinician-reported outcome (ClinRO)
  • Observer-reported outcome (ObsRO)
  • Patient-reported outcome (PRO)
  • Performance outcome (PerfO)
This table illustrates how the CDISC QRS supplements correlate with the FDA COA program.
FDA COA
CDISC SDTM QRS Supplements ClinRO ObsRO PRO PerfO
Questionaires X X       X
Functional tests X
Clinical Classifications X X

How does CDISC develop QRS Supplements?

QRS supplements are developed following the CDISC Standards Development Process defined in COP-001 and further described in the QRS Addendum. The related QRS development process documents include:

  1. QRS Standard Request Form
  2. QRS Public Domain Copyright Verification Document
  3. CDISC Copyright Letter
  4. QRS Supplement Template ​(Based on appropriate domains, such as QS, FT, and RS)
  5. QRS Terminology Spreadsheet Example
  6. QRS Naming Rules
  7. QRS Supplement QC Checklist v2

 
QRS supplements are developed on the CDISC Wiki. Once developed and released, each QRS supplement can be downloaded freely from the QRS webpage to implement for data submissions.
Where permitted by the copyright holder, the supplement is accompanied by a CRF annotated with SDTMIG submission values. In addition, a supplement to the ADaMIG may be included to provide the documentation to prepare the QRS supplement analysis dataset.

How can I get involved in developing CDISC QRS supplements?
CDISC relies on the subject matter expertise of volunteers to create our data standards. We invite you to join this effort. For information on volunteering at CDISC, please visit our Volunteer page.
How can I access the published supplements?

Accessing the Published Supplements

The QRS standards package is available on the QRS web page. The following is a description of the column headings in the QRS published supplements table and how to access the package.

  • QRS Name: Click on QRS Name to access the SDTMIG QRS Supplement, ADaMIG QRS Supplement, and/or an annotated CRF.
  • Short Name: (--CAT): SDTM Short Name used to identify the QRS instrument within the SDTMIG and in Controlled Terminology.
  • SDTM Domain / ADaM Dataset: Indicates the SDTM FINDINGS domain in which the SDTMIG supplement is represented. A designation of ADaM indicates an ADaMIG supplement exists for the instrument.
  • Permission: Indicates the CDISC permission status of the instrument.
    • Public Domain: The instrument is in the public domain; no permission is necessary.
    • Granted: The copyright holder has granted CDISC permission to develop a supplement. Controlled Terminology for --CAT, --TEST, --TESTCD can also be developed. Where applicable, the SDTMIG supplement includes response values in --ORRES and scored values in –STRESC/--STRESN. This means that meaningful examples of data from the instrument can be included in supplements. Sponsors still need to obtain copyright permission from the copyright holder to use the instrument in their clinical trials.
    • Author Permission Required: This permission level requires the user to obtain the CDISC QRS Supplements from the copyright holder.  A README file is provided that explains how to obtain the instrument and CDISC QRS supplement(s).
    • Denied: The copyright holder has denied permission to implement the QRS supplement. No supplement was developed.
    • No response received: The copyright holder has not responded to attempted contacts. No supplement was developed.
    • Pending: The QRS instrument’s copyright status is in review, but there is no resolution at this point in time.
  • ​Version: Each Supplement version has a unique number.
  • Release Date: Date CDISC published the QRS supplement.


Through the ePROVIDE platform and the PROQOLID, PROLABELS and PROINSIGHT databases, Mapi Research Trust creates vital links among those at every level of Patient-Centered Outcomes studies. 
Visit https://eprovide.mapi-trust.org/ for more information.

CDISC and Mapi Research Trust work together to ensure copyrighted instruments are available to CDISC to create QRS supplements by leveraging PROQOLID™, Mapi Research Trust’s comprehensive online database designed to assist academic researchers, physicians, students, pharmaceutical companies, health authorities, and international organizations in the search and evaluation of COAs.


QRS Public Reviews