- Created by Dana Booth, last modified on May 17, 2022
| Supplement Name | Priority? | Progress | Therapeutic Area | Comment |
| Adhesion Scale | Yes - 2017 | Need more information - Unable to find a QRS called 'Adhesion Scale'. Is this an FDA created scale? (??? Is this the FDA Adhesion Scoring System from Assessing Adhesion with Transdermal Delivery Systems andTopical Patches for ANDAs Draft Guidance for Industry???) | ||
| Columbia-Suicide Severity Rating Scale for Adults | Yes - 2017 | Need more information - There are many C-SSRS instruments for adults. An instrument specifically for Adults was not found. Rows 4 thru 8 show the Adult instruments we have already done. Are you interested in these? Or other versions? | ||
| Columbia-Suicide Severity Rating Scale - Already Enrolled Subjects (C-SSRS ALREADY ENROLLED SUBJECTS) | Done | FDA to Review Published Supplement? | ||
| Columbia-Suicide Severity Rating Scale - Baseline (C-SSRS BASELINE) | Done | FDA to Review Published Supplement? | ||
| Columbia-Suicide Severity Rating Scale - Baseline Screening (C-SSRS BASELINE SCREENING VERSION) | Done | FDA to Review Published Supplement? | ||
| Columbia-Suicide Severity Rating Scale - Baseline Screening Version Phase 1 Study (C-SSRS BASELINE SCREENING VERSION PHASE 1 STUDY) | Done | FDA to Review Published Supplement? | ||
| Columbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT) | Done | FDA to Review Published Supplement? | ||
| Diabetes scale (Specific name to be provided later) | Yes - 2017 | Need more information - need a specific name to search for. 2019-04-08: T1D QRS are now in early development at CDISC. | ||
| Irritation Scale | Yes - 2017 | Need more information - unable to find a QRS called 'Irritation Scale'. | ||
| Nasal symptom score | Yes - 2017 | Need more information - clarification needed. Is this the Total Nasal Symptom Score described at https://eprovide.mapi-trust.org/instruments/total-nasal-symptom-score ? | ||
| PROMIS Tools (Fatigue; Physical Functioning) | Yes - 2017 | Permission to be requested | C. Conley CHF TA request 2019-01-17 | |
| Sheehan Disability Scale (SDS) | Yes - 2017 | Done | FDA to Review Published Supplement? | |
| Young Mania Rating Scale (YMRS) | Yes - 2017 | Permission to be re-requested | ||
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Yes-2017 | Permission to be requested Also, are you interested in all three versions? Fyi, we have requested this before and not received permission. | ||
| St. George's Respiratory Questionnaire | Yes - 2016 and 2017 | Need more information - We are aware of three versions of the St. George's Respiratory Questionnaire (see rows 17-19) which we completed before 2016. Is there a another version you're interested in? | ||
| St. George's Questionnaire for COPD (SGRQ-C) | Done | COPD | FDA to Review Published Supplement? | |
| St. George's Respiratory Questionnaire Past 3 Months Version (SGRQ PAST 3 MONTHS VERSION) | Done | COPD | FDA to Review Published Supplement? | |
| St. George's Respiratory Questionnaire Past 4 Weeks Version (SGRQ PAST 4 WEEKS VERSION) | Done | COPD | FDA to Review Published Supplement? | |
| 36-Item Short Form (SF-36) | Yes - 2016 | In copyright discussions | 2019-04-08: These are still in discussion with Optum. Currently trying to reach copyright agreement terms. | |
| Ankylosing Spondylitis Quality of Life (ASQOL) Scale | Yes - 2016 | Permission to be requested | ||
| Assessment in Ankylosing Spondylitis (ASAS) Response Criteria, 20% improvement (ASAS20) | Yes - 2016 | Permission to be requested | ||
| British Isles Lupus Activity Group (BILAG) | Yes - 2016 | Need more information. Which version would you like? (https://eprovide.mapi-trust.org/instruments/british-isles-lupus-assessment-group-index) | ||
| Complete Spontaneous Bowel Movement (CSBM) | Yes - 2016 | Need more information - unable to find this questionnaire. Lori McLeod also tried to find an official version for us and was told to ask the FDA. | ||
| EXACT-PRO | Yes - 2016 | Done | FDA to Review Published Supplement? | |
| Hamilton Rating Scale for Depression, 17-item (HAMD-17) | Yes - 2016 | Done | FDA to Review Published Supplement? | |
| International Prostate Symptom Scale (IPSS) | Yes - 2016 | Permission to be requested | ||
| Montgomery Asberg Depression Rating Scale (MADRS) | Yes - 2016 | Permission to be requested Fyi, we have requested this before and not received permission. | ||
| Myelofibrosis Symptom Assessment Form (MFSAF). Especially the “splenomegaly and associated mechanical symptoms” sub-scale/domain | Yes - 2016 | Need more information - Which version are you interested in? (https://eprovide.mapi-trust.org/instruments/myelofibrosis-symptom-assessment-form) | 2019-05-24 update: fyi, C-Path is also extremely interested in the MFSAF instrument. T. Griffey has been working with CDISC to try and obtain permission from Mayo, but the last we heard (in Feb 2019) was that Mayo lawyers were reviewing the copyright agreement. There has been no response to inquiries since then. | |
| Spontaneous Bowel Movement (SBM) | Yes - 2016 | Need more information - unable to find this questionnaire. Lori McLeod also tried to find an official version for us and was told to ask the FDA. | ||
| The SELENA-SLEDAI: The Systemic Lupus Erythematosus (SLE) Disease Activity Index (SLEDAI), as modified in the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) trial | Yes - 2016 | Terminology in progress | sponsor - Eanna Kiely | 2019-04-08: Need to follow-up w/E. Kiely on development status. |
| 4-Stair Ascend | Yes | Public review | Neurology | FDA Internal Review completed 2018-11-16 FDA Quick Review TBD |
| 4-Stair Descend | Yes | Public review | Neurology | FDA Internal Review completed 2018-11-16 FDA Quick Review TBD |
| 9-Hole Peg Test | Yes | Done | Neurology | FDA to Review Published Supplement? |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (Severe Impairment) (DCS-ADL-SEVERE) | Yes | Terminology done | Neurology | |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (Standard)(ADCS-ADL) | Yes | Terminology done | Neurology | |
| Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change | Yes | Terminology previously done, but should it be removed? Does the generic CGI cover this? | Neurology | |
| Bayley III Scales of Infant and Toddler Development (BSID-III) | Yes | Permission requested. | Neurology | 2019-04-08: CDISC copyright agreement began revisions after this had been requested. Will re-request. |
| Brief Fatigue Inventory (BFI) | Yes | Permission to be requested | Oncology | |
| Brief Psychiatric Rating Scale (BPRS) | Yes | Supplement in progress | Psychiatry | TBD |
| Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS) | Yes | Permission to be requested | Rheumatology | |
| Bristol Stool Scale (BSS) | Yes | 2019-04-08: No response received after numerous requests. | Gastroenterology | |
| Children's Depression Rating Scale - Revised (CDRS-R) | Yes | Internal review | Psychiatry | TBD |
| Clinical Global Impressions - generic version (CGI generic) | Yes | In preparation for publication | Psychiatry | C. Conley request 2019-01-30 FDA Quick Review Completed 2019-03-14 |
| Clinical Opiate Withdrawal Scale (COWS) | Yes | Terminology done | Pharmacology/Toxicology | |
| Clinician-Administered PTSD Scale (CAPS) for DSM-5 with DSM-IV | Yes | Terminology in progress | Psychiatry | |
| Columbia Suicide Severity Rating Scale: Children's Since Last Visit (C-SSRS CHILDREN'S SINCE LAST VISIT) | Yes | checking into this - I believe we may already have permission for this one. | Psychiatry | |
| Disease Activity Score 28 (DAS-28) | Yes | progress unknown - checking into this 2019-04-08: There are questions on if and how to develop this score. Information has been received for review. | Rheumatology | |
| EORTC QLQ-C30 | Yes | Terminology done | Oncology | TBD |
| Functional Assessment of Cancer Therapy - Breast Cancer, Version 4 (FACT-B v4) | Yes | Terminology done | Oncology | |
| Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C) | Yes | Terminology done | Oncology | |
| Functional Assessment of Cancer Therapy - General (FACT-G) | Yes | Terminology done | Oncology | |
| Functional Assessment of Cancer Therapy - Hepatobiliary Cancer (FACT-HEP) | Yes | Terminology done | Oncology | |
| Functional Assessment of Cancer Therapy - Leukemia Version 4 (FACT-LEU V4) | Yes | Terminology done | Oncology | |
| Functional Assessment of Cancer Therapy - Lymphoma Version 4 (FACT-LYM V4) | Yes | Terminology done | Oncology | |
| Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI) | Yes | Terminology done | Oncology | |
| Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) | Yes | Terminology done | Oncology | |
| Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) | Yes | Terminology done | Rheumatology | |
| Global Dystonia Rating Scale (GDRS) | Yes | Permission to be requested | Neurology | |
| International Index of Erectile Function (IIEF) | Yes | Terminology done | Reproductive/urological | |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Yes | Permission to be requested | Heart Failure | C. Conley HF TA request 2019-01-30 |
| Kurtzke Expanded Disability Status Scale (EDSS) | Yes | Done | Neurology | FDA to Review Published Supplement? |
| MINI Mini-Mental State Exam (MMSE) | Yes | Supplement undergoing PAR review | Neurology | PAR copyright agreement expires in June 2020 - TBD |
| MINI Mini-Mental State Exam (MMSE-II) | Yes | Supplement undergoing PAR review | Neurology | PAR copyright agreement expires in June 2020 - TBD |
| NCCN/FACT-Bladder Symptom Index (18-item) Version 2 (NCCN FACT-FBLSI-18 V2) | Yes | Terminology done | Oncology | |
| NCCN/FACT-Kidney Symptom Index (19-item) Version 2 (NCCN FACT-FKSI-19 V2) | Yes | Terminology done | Oncology | |
| NCCN/FACT-Ovarian Symptom Index (18-item) Version 2 (NCCN FACT-FOSI-18 V2) | Yes | Terminology done | Oncology | |
| NCCN/FACT-Prostate Symptom Index (17-item) Version 2 (NCCN FACT-FPSI-17 V2) | Yes | Terminology done | Oncology | |
| Neurological Outcome Scale for Traumatic Brain Injury (NOS-TBI) | Yes | Terminology in progress - may need to re-request copyright permission | Neurology | |
| North Star Ambulatory Assessment (NSAA) | Yes | Done | Neurology | FDA to Review Published Supplement? |
| Patient Global Impressions - generic version (PGI generic) | Yes | In preparation for publication | Urology | FDA Quick Review Completed 2019-03-14 |
| Psoriasis Area and Severity Index (PASI) | Yes | Terminology done | Dermatology/Dental | C. Conley PSORIASIS TA request 2019-01-17 |
| Quality of Life in Neurological Disorders (Neuro-QoL) | Yes | Permission to be requested | Neurology | |
| Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) | Yes | Done | Psychiatry | FDA to Review Published Supplement? |
| Sheehan Disability Inventory (SDI) | Yes | Need more information - Is this the same as the Sheehan Disability Scale? CDISC completed a supplement for the Sheehan Disability Scale back in 2013. If this is the scale of interest, we may need to update it. | Psychiatry | |
| Simpson Angus Scale (SAS) | Yes | Need more information - would you like the original version or the modified version? | Psychiatry | |
| Subjective Opiate Withdrawal Scale (SOWS) | Yes | Terminology done | Neurology / Addiciton? | |
| Symbol Digit Substitution Test (SDST) | Yes | Permission to be requested | Psychiatry | |
| Rising From Floor | Yes | Public review | Neurology | FDA Internal Review completed 2018-11-16 FDA Quick Review TBD |
| UCSD Performance-Based Skills Assessment (UPSA) | Yes | Permission to be requested | Psychiatry | |
| Visual Analog Scales (VAS) | Yes | The QRS Subteam does not plan on developing VAS scales. See Notes column for further details. If this request is for Pain Intensity, the SDS QRS supplement needs updating (to remove Amazon reference) and ADQRS supplement is in progress. 2022-05-17. db: Pain Intensity was specifically removed from the FDA priority list | Pain | The SDS QRS Subteam views each of the different VAS questions as separate QS type instruments based on a specific topic, unless questions can be grouped together under a specific concept/name of an instrument. SDS extended leadership team has also reviewed this topic and was in agreement with SDS QRS Subteam. |
| Ten Meter Walk/Run | Maybe | public review | Neurology | FDA Internal Review completed 2018-11-16 FDA Quick review TBD |
| AJCC TNM Cancer Staging battery | Maybe | Internal review | Oncology | |
| Beck Hopelessness Scale (BHS) | Maybe | progress unknown - checking into this | Psychiatry | |
| Beck Scale for Suicide Ideation (BSSI) | Maybe | progress unknown - checking into this | Psychiatry | |
| Clinical Global Impression (CGI-Anxiety) | Maybe | Public domain | Psychiatry, BP? | Will use of generic CGI |
| Clinical Global Impression Scale-Bipolar (CGI-BP) | Maybe | Public domain | Psychiatry, BP | |
| Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5) | Maybe | Permission to be requested | PTSD | |
| Columbia Suicide Severity Rating Scale: Children's Baseline (C-SSRS CHILDREN'S BASELINE) | Maybe | checking into this - I believe we may already have permission for this one. | Psychiatry | |
| Columbia Suicide Severity Rating Scale: Children's Baseline Screening (C-SSRS CHILDREN'S BASELINE SCREENING) | Maybe | checking into this - I believe we may already have permission for this one. | Psychiatry | |
| Columbia Suicide Severity Rating Scale: Lifetime/Recent (C-SSRS LIFETIME/RECENT) | Maybe | checking into this - I believe we may already have permission for this one. | Psychiatry | |
| Columbia Suicide Severity Rating Scale: Screening (C-SSRS SCREENING) | Maybe | checking into this - I believe we may already have permission for this one. | Psychiatry | |
| Crohn's Disease Activity Index (CDAI) | Maybe | progress unknown - checking into this | Gastroenterology/Inborn Errors | |
| Health Assessment Questionnaire - Disability Index, WITH VAS (HAQ-DI WITH VAS) | Maybe | Supplement in progress | Neurology | |
| Health Assessment Questionnaire - Disability Index, WITHOUT VAS (HAQ-DI WITHOUT VAS) | Maybe | Supplement in progress | Neurology | |
| Pediatric Outcome Data Collection Instrument (PODCI)(parent-reported for adolescents ages 11-18) | Maybe | Terminology done | Neurology | |
| Pediatric Outcome Data Collection Instrument (PODCI)(parent-reported for children ages 2-10) | Maybe | Terminology done | Neurology | |
| Pediatric Outcome Data Collection Instrument (PODCI)(self-reported for adolescents ages 11-18) | Maybe | Terminology done | Neurology | |
| PedsQL 3.0 Neuromuscular Module | Maybe | Ready for public review | Neurology | |
| Performance of Upper Limb Scale Version 1.2 (PULv1.2) | Maybe | Terminology done | Neurology | |
| Performance of Upper Limb Scale Version 2.0 (PULv2.0) | Maybe | Terminology done | Neurology | |
| Physician Global Assessment of Disease Activity (PhysGA) | Maybe | progress unknown - checking into this (GCI Genric supplement states PGA type instruments should use the CGI Generic approach??) | Multiple | C. Conley PSORIASIS TA request 2019-01-17 (place at bottom of list) |
| Positive and Negative Syndrome Scale Excited Component (PANSSEC) | Maybe | Need more information - Is this the same as PANSS? If so, we've already done this. | Psychiatry | |
| Suicidal Ideation Qustionnaire (SIQ) | Maybe | Supplement undergoing PAR review | Psychiatry | PAR copyright agreement expires in June 2020 |
| Tanner Staging Form - Boy (TANNER SCALE BOY VERSION) | Maybe | Done - moved to reproductive domain | Adolescent Development | No RP based supplement yet |
| Tanner Staging Form - Girl (TANNER SCALE GIRL VERSION) | Maybe | Done - moved to reproductive domain | Adolescent Development | No RP based supplement yet |
| Treatment Satisfaction Questionnaire for Medication (14-item) Version 1.4 (TSQM V1.4) | Maybe | progress unknown - checking into this | Multiple | |
| Verbal Learning and Recall Test (VLRT) | Maybe | checking into this - we have the Rey's AVLT already. This may have been a duplicate in our list. | Psychiatry and GAD | |
| Dermatology Life Quality Index (DLQI) | No longer, per FDA | Terminology done; supplement in progress | Dermatology/Dental | C. Conley PSORIASIS TA request not priority 2019-01-30 |
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