CDISC creates supplements for four 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 and Disease Response: Clinical Classifications and Disease Response instruments or criteria are represented in the Disease Response and Clin Classification (RS) domain.
- 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 instruments 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.
- Disease Response: Named instruments or criteria whose output provides information about the pathological and/or clinical changes that result from treatment. The changes may include eradication of detectable disease, stabilization of disease, or disease progression. Disease response criteria are frequently, though not always, related to oncology. This information will be obtained from trained healthcare professionals and may include items such as size of tumors or other abnormalities and the method of obtaining the data (e.g., CT Scan, MRI). Data from these criteria or instruments may be represented in a combination of QRS and non-QRS domains. For example, for an oncology disease response instrument, the extent of disease response (e.g., partial response) would be represented in RS, whereas tumor data would be represented in TU and TR, and MRI information would be represented in PR.
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.
- Exempt from Copyright: The copyright holder has exempted the copyright; the instrument’s use is subject to the copyright holder’s terms of use policy.
- 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).
- In Development: The Supplement is currently being developed.
- Volunteer Resource Needed: We invite you contribute your expertise by volunteering to develop this supplement.
- Pending: CDISC has requested permission from the copyright holder.
- Denied: The copyright holder has denied permission to implement the QRS supplement; therefore, no supplement was developed.
- No response received: The copyright holder has not responded to our request; therefore, no supplement has been developed.
- Version: Each Supplement version has a unique number.
- Release Date: Date CDISC published the QRS supplement.
QRS Supplements
QRS Name | Short Name (--CAT) | SDTM Domain/ADaM Dataset | Permission | Version Release Date |
---|---|---|---|---|
10-Meter Walk/Run | 10-METER WALK/RUN | ADaM | Public Domain |
Version: 1.0
17 Feb 2022 |
10-Meter Walk/Run | 10-METER WALK/RUN | FT | Public Domain |
Version: 1.0
18 Jan 2022 |
12-Item Multiple Sclerosis Walking Scale |
MSWS-12 | QS | No Response Received | N/A |
4-Stair Ascend | 4-STAIR ASCEND | FT | Public Domain |
Version: 1.0
30 Sep 2024 |
4-Stair Ascend | 4-STAIR ASCEND | ADaM | Public Domain |
Version: 1.0
30 Sep 2024 |
4-Stair Descend | 4-STAIR DESCEND | FT | Public Domain |
Version: 1.0
30 Sep 2024 |
4-Stair Descend | 4-STAIR DESCEND | ADaM | Public Domain |
Version: 1.0
30 Sep 2024 |
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
Version: 2.0
29 Aug 2022 |
Acute Physiology and Chronic Health Evaluation II | APACHE II | ADaM | Public Domain |
Version: 1.0
28 Jun 2024 |
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: 1.0
22 May 2020 |
Airway Questionnaire | AQ20 | QS | Granted |
Version: 1.0
12 Feb 2014 |
AJCC TNM Staging System 7th Edition (AJCC V7) | AJCC V7 | RS | Granted |
Version: 1.0
28 Jun 2024 |
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 |
Amsterdam Stool Scale |
No Response Received | N/A |
||
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
Version: 2.0
28 Jun 2024 |
Asthma Control Questionnaire |
ACQ | QS | Denied | N/A |
Asthma Control Questionnaire |
ACQ | Denied | N/A |
|
Asthma Control Test |
ACT | QS | No Response Received | N/A |
Asthma Control Test |
ACT | No Response Received | N/A |
|
Asthma Daytime Symptom Diary | ADSD | QS | Granted |
Version: 1.0
27 Aug 2024 |
Asthma Nighttime Symptom Diary | ANSD | QS | Granted |
Version: 1.0
27 Aug 2024 |
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 | RS | Public Domain |
Version: 1.0
15 May 2013
Version: 2.0
29 Aug 2022 |
Baseline Dyspnea Index | BDI | RS | Granted |
Version: 1.0
1 Oct 2013
Version: 2.0
9 Dec 2021 |
Beck Depression Inventory II |
No Response Received | N/A |
||
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 |
Borg CR-10 Scale | BORG CR10 | QS | Granted |
Version: 1.0
1 Jun 2014 |
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 | RS | Public Domain |
Version: 1.0
29 Jan 2013
Version: 1.1
23 Jun 2014
Version: 1.2
28 Jul 2014
Version: 2.0
27 Feb 2023 |
Brief Symptom Inventory-18 |
BSI-18 | Denied | N/A |
|
Bristol Stool Form Scale |
BSFS | QS | No Response Received | 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 |
Changes in Sexual Functioning Questionnaire short-form – Female |
No Response Received | N/A |
||
Changes in Sexual Functioning Questionnaire short-form – Male |
No Response Received | N/A |
||
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 | Author Permission Required |
Version: 1.0
18 Feb 2015 |
Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION | QS | Author Permission Required |
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 Screening (C-SSRS SCREENING) | C-SSRS SCREENING | QS | Granted |
Version: 1.0
29 May 2023 |
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 |
Comfort Behavior Scale | COMFORT-B SCALE | RS | Granted |
Version: 1.0
28 Jun 2024 |
Controlled Oral Word Association Test | COWAT | FT | Public Domain |
Version: 1.0
21 Sep 2021 |
COPD Assessment Test |
COPD ASSESSMENT TEST | Denied | N/A |
|
Covi Anxiety Scale | COVI | RS | Public Domain |
Version: 1.0
29 Jun 2021 |
Craig Handicap Assessment and Reporting Technique - Short Form | CHART-SF | ADaM | Public Domain |
Version: 1.0
30 May 2023 |
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 |
Crohn's Disease Activity Index Version 1 | CDAI V1 | RS | Public Domain |
Version: 1.0
30 Nov 2021 |
Current Opioid Misuse Measure | COMM | QS | Granted |
Version: 1.0
7 Aug 2012 |
Deployment Risk and Resilience Inventory-2 | DRRI-2 | QS | Public Domain |
Version: 1.0
29 Jun 2021 |
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 |
Diabetes Treatment Satisfaction Questionnaire : DTSQ - Change |
(DTSQC) | Denied | N/A |
|
Diabetes Treatment Satisfaction Questionnaire: DTSQ - Status |
Denied | N/A |
||
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 | RS | Public Domain |
Version: 1.0
30 Oct 2013
Version: 2.0
24 Jun 2021 |
Duchenne Muscular Dystrophy 6-Minute Walk Test |
No Response Received | N/A |
||
Eastern Cooperative Oncology Group Performance Status | ECOG | RS | Public Domain |
Version: 1.0
26 Jun 2013
Version: 2.0
3 Apr 2021 |
Eastern Cooperative Oncology Group Performance Status | ECOG | ADaM | Public Domain |
Version: 1.0
27 Jul 2020
Version: 1.1
10 Mar 2021
Version: 1.2
23 Jan 2024 |
Egen Klassifikation Scale |
No Response Received | N/A |
||
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 2014
Version: 1.1
19 Jun 2014
Version: 1.2
28 Oct 2015
Version: 1.3
31 May 2022 |
European Quality of Life Five Dimension Three Level Scale | EQ-5D-3L | QS | Granted |
Version: 1.0
5 Mar 2014
Version: 1.1
19 Jun 2014
Version: 1.2
28 Oct 2015
Version: 1.3
31 May 2022 |
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 |
Fagerstrom Test for Cigarette Dependence | FTCD | QS | Granted |
Version: 1.0
14 Nov 2024 |
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 Activities Questionnaire | FAQ | RS | Granted |
Version: 1.0
19 Aug 2013
Version: 2.0
24 Jun 2021 |
Functional Assessment of Multiple Sclerosis | FAMS | QS | Granted |
Version: 1.0
30 Oct 2013 |
Functional Assessment Questionnaire-NACC UDS V2.0 | FAQ-NACC UDS V2.0 | RS | Granted |
Version: 1.0
20 Aug 2013
Version: 2.0
29 Aug 2022 |
Functional Assessment Scale-NACC UDS V3.0 | FAS-NACC UDS V3.0 | RS | Granted |
Version: 1.0
27 Feb 2023 |
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 |
Generalized Anxiety Disorder 7-Item Version 2 | GAD-7 V2 | QS | Exempt from Copyright |
Version: 1.0
29 Aug 2022 |
Generalized Anxiety Disorder 7-Item Version 2 | GAD-7 V2 | ADaM | Exempt from Copyright |
Version: 1.0
29 Aug 2022 |
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
Version: 1.1
30 May 2023 |
Geriatric Depression Scale Short Form | GDS SHORT FORM | QS | Public Domain |
Version: 1.0
22 May 2013 |
Glasgow Coma Scale (GCS) The National Institute of Neurological Disorders and Stroke (NINDS) Version 1.0 | GCS NINDS V1.0 | RS | Public Domain |
Version: 1.0
31 Dec 2015
Version: 2.0
27 Feb 2023 |
Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes | GMSS VERSION TYPE 1 DIABETES | QS | Granted |
Version: v1.0
24 Jun 2021 |
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 |
Harvey-Bradshaw Index | HBI | RS | Public Domain |
Version: 1.0
29 May 2023 |
Hauser Ambulation Index | HAUSER AMBULATION INDEX | FT | Granted |
Version: 1.0
23 Apr 2014 |
Heinrich-Carpenter Quality of Life Scale |
No Response Received | N/A |
||
Hospital Anxiety and Depression Scale | HADS | QS | Granted |
Version: 1.0
13 Jun 2014
Version: 1.1
19 May 2020 |
Huntington's Disease Cognitive Assessment Battery |
HD-CAB | FT | Denied | N/A |
Hypoglycemic Confidence Scale | HCS | QS | Granted |
Version: 1.0
21 Sep 2021 |
Impact of Visual Impairment Scale | IVIS | QS | Granted |
Version: 1.0
18 Dec 2013 |
Independent Living Scales |
No Response Received | N/A |
||
Inflammatory Bowel Disease Questionnaire | IBDQ | QS | Author Permission Required |
Version: 1.0
27 Mar 2022 |
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 |
International Physical Activity Questionnaire (August 2002) Short Last 7 Days Self-Administered Format | IPAQ-SF SELF-ADMINISTERED VERSION | QS | Public Domain |
Version: 1.0
30 Nov 2021 |
International Physical Activity Questionnaire (August 2002) Short Last 7 Days Telephone Format | IPAQ-SF PHONE VERSION | QS | Public Domain |
Version: 1.0
30 Nov 2021 |
International Physical Activity Questionnaire (November 2002) Long Last 7 Days Telephone Format | IPAQ-LF PHONE VERSION | QS | Public Domain |
Version: 1.0
30 Nov 2021 |
International Physical Activity Questionnaire (October 2002) Long Last 7 Days Self-Administered Format | IPAQ-LF SELF-ADMINISTERED VERSION | QS | Public Domain |
Version: 1.0
30 Nov 2021 |
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 |
Kansas City Cardiomyopathy Questionnaire |
No Response Received | N/A |
||
Karnofsky Performance Scale | KPS SCALE | RS | Public Domain |
Version: 1.0
7 Aug 2012
Version: 2.0
3 Apr 2021 |
Kiddie-Sads-Lifetime |
No Response Received | N/A |
||
Kidney Disease: Improving Global Outcomes - KDIGO AKI Stage | KDIGO AKI | RS | Public Domain |
Version: 1.0
29 Jun 2021
Version: 1.1
21 Sep 2021 |
King's Stool Scale |
No Response Received | N/A |
||
Kurtzke Expanded Disability Status Scale | EDSS | RS | Public Domain |
Version: 2.0
21 Nov 2024 |
Kurtzke Expanded Disability Status Scale | EDSS | QS | Public Domain |
Version: 1.0
23 Oct 2013 |
Kurtzke Expanded Disability Status Scale | EDSS | ADaM | Public Domain |
Version: 1.0
27 Jul 2020
Version: 1.1
10 Mar 2021 |
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
Version: 2.1
17 Jul 2024 |
Life Events Checklist for DSM-5, Standard Version | LEC-5 STANDARD VERSION | QS | Public Domain |
Version: 1.0
10 Mar 2020 |
MATRICS Consensus Cognitive Battery (as the complete package of ten tests) |
Denied | N/A |
||
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 | Denied | N/A |
Mini International Neuropsychiatric Interview (MINI) |
MINI | No Response Received | N/A |
|
Minnesota Tobacco Withdrawal Scale-Revised | MTWS-R | QS | Public Domain |
Version: 1.0
20 Sep 2024 |
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 | Public Domain |
Version: 1.0
21 Aug 2013 |
Modified Van Assche Index | MVAI | RS | Public Domain |
Version: 1.0
29 May 2023 |
Montgomery-Asberg Depression Rating Scale |
MADRS | No Response Received | N/A |
|
Montreal Classification for Crohn's Disease | MONTREAL CROHN'S | RS | Exempt from Copyright |
Version: 1.0
28 Aug 2023 |
Montreal Cognitive Assessment |
MOCA | Denied | N/A |
|
MOS Sleep Scale-Revised |
No Response Received | 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 |
|
National Early Warning Score 2 | NEWS2 | ADaM | Granted |
Version: 1.0
30 Nov 2023 |
National Early Warning Score 2 | NEWS2 | RS | Granted |
Version: 1.0
30 Nov 2021 |
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 |
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 | NSCLC-SAQ V1.0 | QS | Granted |
Version: 1.0
21 Nov 2024 |
North Star Ambulatory Assessment | NSAA | RS | Granted |
Version: 1.0
8 Feb 2017 |
Observer Global Impression | OGI | QS | Public Domain |
Version: 1.0
20 Oct 2024 |
Ocular Comfort Index |
OCI | No Response Received | N/A |
|
One Touch Stockings of Cambridge |
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
Version: 2.0
29 Aug 2022 |
Pain Relief | PR | QS | Public Domain |
Version: 1.0
7 Aug 2012
Version: 1.1
26 Jan 2017
Version: 2.0
29 May 2023 |
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
Version: 1.1
24 Jun 2021 |
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 | Exempt from Copyright |
Version: 1.0
24 Sep 2014
Version: 1.1
2 Oct 2015
Version: 2.0
29 May 2023 |
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 |
Penn State Electronic Cigarette Dependence Index | PSECDI | QS | Exempt from Copyright |
Version: 1.0
14 Nov 2024 |
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 |
Quality of Life After Brain Injury - Short Version |
No Response Received | N/A |
||
Questionnaire on Smoking Urges-Brief | QSU-BRIEF | QS | Granted |
Version: 1.0
20 Sep 2024 |
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 |
Reason for Living Questionnaire |
No Response Received | N/A |
||
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | RECIST | RS | Exempt from Copyright |
Version: 1.0
31 Oct 2023 |
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 |
Rockport One Mile Walk Test | ROCKPORT ONE MILE WALK TEST V1.0 | FT | Public Domain |
Version: 1.0
21 Sep 2021 |
Roland-Morris Disability Questionnaire | RDQ | QS | Public Domain |
Version: 1.0
7 Aug 2012 |
Rotterdam CT Score | Pending | N/A |
||
Rutgeerts Score | RUTGEERTS SCORE | RS | Public Domain |
Version: 1.0
28 Aug 2023 |
Satisfaction With Life Scale | SWLS | QS | Public Domain |
Version: 1.0
23 Apr 2014 |
SCID for DSM-5 |
No Response Received | N/A |
||
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 | QS | Volunteer Resource Needed | N/A |
Short Form 36 Health Survey Acute, US Version 2.0 | SF36 v2.0 Acute | QS | In Development | N/A |
Short Form 36 Health Survey Standard, US Version 1.0 | SF36 v1.0 Standard | QS | Volunteer Resource Needed | N/A |
Short Form 36 Health Survey Standard, US Version 2.0 | SF36 v2.0 Standard | QS | In Development | 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 |
|
Simple Endoscopic Score for Crohn's Disease Version 1 | SES-CD V1 | RS | Public Domain |
Version: 1.0
21 Sep 2021 |
Sport Concussion Assessment Tool - 3rd Edition |
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 |
Stroop Color and Word Test |
Denied | N/A |
||
Structured Clinical Interview for DSM Disorders |
SCID | No Response Received | N/A |
|
Structured Clinical Interview for DSM Disorders (with psychotic) Summary Sheet |
No Response Received | N/A |
||
Structured Clinical Interview for DSM Disorders Research Version (SCID-RV) |
No Response Received | N/A |
||
Suicidal Ideation Questionnaire | SIQ | QS | Author Permission Required |
Version: 1.0
3 Mar 2022 |
Suicidal Ideation Questionnaire-JR | SIQ-JR | QS | Author Permission Required |
Version: 1.0
3 Mar 2022 |
Symbol Digit Modalities Test |
SDMT | FT | Denied | N/AN/A |
Symptom Impact Questionnaire | SIQR | QS | Granted |
Version: 1.0
11 Mar 2015 |
Symptoms of Major Depressive Disorder Scale Version 1.0 | SMDDS V1.0 | QS | Granted |
Version: 1.0
21 Nov 2024 |
Tanner Scale Boy | TANNER SCALE BOY | RS | Public Domain |
Version: 1.0
17 Feb 2022 |
Tanner Scale Girl | TANNER SCALE GIRL | RS | Public Domain |
Version: 1.0
17 Feb 2022 |
Test of Adaptive Behavior In Schizophrenia |
No Response Received | N/A |
||
Timed 25-Foot Walk | T25FW | FT | Granted |
Version: 1.0
26 Mar 2014
Version: 2.0
29 Aug 2022 |
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 | RS | Granted |
Version: 1.0
9 Oct 2013
Version: 2.0
21 Sep 2021 |
Trauma Symptom Checklist for Children | TSCC | QS | Author Permission Required |
Version: 1.0
3 Mar 2022 |
Traumatic Brain Injury–Quality of Life | Pending | N/A |
||
UCSD Performance-Based Skills Assessment |
No Response Received | N/A |
||
Unified Parkinson's Disease Rating Scale | UPDRS | RS | Granted |
Version: 1.0
9 Aug 2012
Version: 1.1
12 Jun 2014
Version: 2.0
29 Aug 2022 |
Urgency Perception Scale | UPS | QS | Granted |
Version: 1.0
3 Dec 2014 |
Veterans Administration Lung Study Group | VALG | RS | Public Domain |
Version: 1.0
29 Aug 2022 |
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 |
Wechsler Adult Intelligence Scale (WAIS-III/WAIS-IV) - Digit Span |
Denied | N/A |
||
Wechsler Adult Intelligence Scale (WAIS-III/WAIS-IV) - Letter-Number Sequencing Subtest |
Denied | N/A |
||
Wechsler Adult Intelligence Scale (WAIS-III/WAIS-IV) - Processing Speed |
Denied | N/A |
||
Wechsler Memory Scale ® 3rd Ed.: Letter-Number Span (WMS®-III) |
Denied | N/A |
||
Wechsler Memory Scale® 3rd Ed.: Spatial Span (WMS®-III) |
Denied | N/A |
||
Wechsler Test of Adult Reading (WTAR) |
Denied | N/A |
||
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 Specific Health Problems Questionnaire Version 2.0 | WPAI-SHP V2.0 | QS | Exempt from Copyright |
Version: 1.0
7 Aug 2012
Version: 1.1
29 Sep 2015
Version: 2.0
27 Feb 2023 |
Young Mania Rating Scale |
YMRS | No Response Received | N/A |
New QRS Supplements
Short Name (--CAT) | SDTM Domain/ADaM Dataset | Permission | Version Release Date | |
---|---|---|---|---|
4-Stair Ascend | 4-STAIR ASCEND | FT | Public Domain |
Version: 1.0
30 Sep 2024 |
4-Stair Ascend | 4-STAIR ASCEND | ADaM | Public Domain |
Version: 1.0
30 Sep 2024 |
4-Stair Descend | 4-STAIR DESCEND | FT | Public Domain |
Version: 1.0
30 Sep 2024 |
4-Stair Descend | 4-STAIR DESCEND | ADaM | Public Domain |
Version: 1.0
30 Sep 2024 |
Fagerstrom Test for Cigarette Dependence | FTCD | QS | Granted |
Version: 1.0
14 Nov 2024 |
Kurtzke Expanded Disability Status Scale | EDSS | RS | Public Domain |
Version: 2.0
21 Nov 2024 |
Minnesota Tobacco Withdrawal Scale-Revised | MTWS-R | QS | Public Domain |
Version: 1.0
20 Sep 2024 |
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 | NSCLC-SAQ V1.0 | QS | Granted |
Version: 1.0
21 Nov 2024 |
Observer Global Impression | OGI | QS | Public Domain |
Version: 1.0
20 Oct 2024 |
Penn State Electronic Cigarette Dependence Index | PSECDI | QS | Exempt from Copyright |
Version: 1.0
14 Nov 2024 |
Questionnaire on Smoking Urges-Brief | QSU-BRIEF | QS | Granted |
Version: 1.0
20 Sep 2024 |
Symptoms of Major Depressive Disorder Scale Version 1.0 | SMDDS V1.0 | QS | Granted |
Version: 1.0
21 Nov 2024 |
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.
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 (e.g., GHAS, RHI), those types of scoring instruments would be represented in the MI domain. This is because they are assessments predicated on biospecimen collection, done by a pathologist in a lab of tissue on a slide, not by a clinician of the person as a whole. They may be part of a QRS Clinical Classification as input from the lab, but are not Clinical Classification instruments in and of themselves.
- 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.
- 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.
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.
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.
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”.
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 |
As the SUPPQUAL domain standard evolved, a new variable naming rule was implemented that required the first two characters of SUPPQUAL QNAM variable to include the two-character domain abbreviation. The initial QRS SUPPQUAL QNAM variable names implementation did not follow this new naming rule.
The proposal describes renaming of the QRS instrument anchor variable names with updated definitions. This proposal was approved, and the new anchor names were added to the NSV Registry. The QRS sub-team and the SDS team agreed with the following steps regarding QRS supplements moving on 2021-05-10.
- A SDTMIG Known Issue describes this issue to guide how users need to handle the QRS anchor information going forward. QRS Anchor Variable Supplemental Qualifiers Renamed
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:
- QRS Standard Request Form
- QRS Public Domain Copyright Verification Document
- CDISC Copyright Letter
- QRS Supplement Template (Based on appropriate domains, such as QS, FT, and RS)
- QRS Terminology Spreadsheet Example
- QRS Naming Rules
- 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.
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.
- Exempt from Copyright: The copyright holder has exempted the copyright; the instrument’s use is subject to the copyright holder’s terms of use policy.
- Version: Each Supplement version has a unique number.
- Release Date: Date CDISC published the QRS supplement.
The QRS subteam implemented supplemental qualifier (suppqual) variables (also referred to as non-standard variables (NSV)) in QRS supplements based on the need to represent information on QRS CRFs that did not fit the QRS domains standard variables. CDISC created the Non-Standard Variable (NSV) Registry team to organize all CDISC suppqual variables as NSVs and created the NSV Registry to store the NSVs for users’ reference in developing CDISC standards. All QRS suppqual variables were reviewed to meet the current NSV naming rules. Based on this review many existing old QRS NSVs were updated to meet the new NSV naming rules. Due to limited resources, older QRS supplements could not be updated, but any future supplements will use the updated NSVs. Until this happens, it is recommended that users reference the “QRS NSV Registry FT QS RS Summary Final 2023-06-26” spreadsheet located on the QRS webpage under the QRS Resources tab. This spreadsheet contains the list of existing QRS suppqual variables along with the new suppqual (NSV) name included in the NSV Registry. The new suppqual QNAMs and QLABELs are in column C and D. When using a QRS supplement that includes QRS suppqual variables, users need to reference the spreadsheet and use the current NSV Registry variables.
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