| Review Period | Instrument Name | QRS Developer | QC Assignee | QC | Copy Editing | FDA Review? | QRS IR or PR |
| 1-Development | EQ-5D-3L - update to include standardized numeric values from manual | | | | | | |
| 1-Development | EQ-5D-5L - update to include standardized numeric values from manual | | | | | | |
| 1-Development | Columbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING) | S. Kopko | | | | | |
| 1-Development |
Hamilton Depression Rating Scale 17-Item (HAMD 17)
S. Kopko | Published supplement conversion to current WIKI template | Priority review request | | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0 (PRO-CTCAE v1.0) | S. Kopko | | | | | |
In ProcessExacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome| Change Control | PAIN Relief (PR) Change Control v1.2 | S. Kopko | D. Booth |
Published supplement conversion to current WIKI template | Priority review requestPatient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0 (PRO-CTCAE v1.0| Change Control | Barnes Akathisia Rating Scale (BARS) | S. |
Kopko| Sudini | | | | | |
| 1-Development Change Control |
PAIN Relief (PR) Change Control v1.2| Brief Psychiatric Rating Scale-Anchored (BPRS-A) | S. Karra | S. Kopko |
D. Booth| | | | |
| 1-Development Change Control |
Barnes Akathisia | Disability Rating Scale ( |
BARS Sudini| Karra | | | | | |
| 1-Development Change Control |
Brief Psychiatric Rating Scale-Anchored (BPRS-A)| Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome Published supplement conversion to current WIKI template | S. |
KarraS Kopko| 1-Development Change Control | Disability Rating Scale (DRS) | S. Karra | | | | | |
| | Priority review request | In Process 2019-11-26 |
| 1-Development Change Control | Functional Assessment Questionnaire - NACC Version (FAQ-NACC) | S. Sudini | S. Kopko | | | | In Process |
| 2019-09-25 new copyright received for v3.0 CRF |
| | | 1-Development Change Control | Functional Assessment Questionnaire (FAQ) | S. Sudini | S. Kopko | In Process | | | |
| 1-Development Change Control |
Karnofsky Performance Scale (KPS SCALE)| Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template | S. |
Sudini | | | Priority review request | In Process 2019-11-15 |
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| 1-Development Change Control |
Kurtzke Expanded Disability Status | Karnofsky Performance Scale ( |
EDSS KopkoIn ProcessPriority review request| | |
| 1-Development Change Control | Kurtzke Functional Systems Scores (KFSS) | S. Sudini | | | | | |
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| 2-Team review |
Functional Assessment of Chronic Illness Therapy-Fatigue 13-Item Scale Version 4 (FACIT-FATIGUE 13-ITEM V4) | S. Karra | D. Booth | Team QC completed in May except need new terminology for total score and author codes in suppquals (db action items to start, then sk to finish) | Checking TBD | 2019-05-29 Completed TR | 2-Team review | Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES) | D. Corey | S. Kopko | 2019-07-09 Completed TR QC | 2019-07-31 Completed Team Review | | Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES) | D. Corey | S. Kopko | 2019-07-09 Completed TR QC | | | 2019-07-31 Completed Team Review |
| 2-Team review | Kurtzke Expanded Disability Status Scale (EDSS) | S. Kopko | D. Booth | 2019-11-19 TBD | | Priority review request | 2019-11-20 TR Completed |
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| 3-Internal review | Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR) | D. Corey S. Kopko | D. Corey | 2019-05-23 1st PAR review comments updated and Completed QC for PR | | TBD | 2018-05-11 IR Completed - 2019-06-12 sent for 2nd PAR review, SK sent update message to PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR |
| 3-Internal review | Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR) | D. Corey S. Kopko | D. Corey | 2019-05-23 1st PAR review comments updated and Completed QC for PR | | TBD | IR Completed - 2019-06-12 sent for 2nd PAR review; SK sent update message to PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR |
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| 4-A IR Comment Resolution | Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS | S. Sudini | S. Kopko | Completed | | | IR completed 2019-06-28 |
| 4-A IR Comment Resolution | AJCC TNM Staging System 7th Edition (AJCC V7) | D. Booth | S. Kopko | Completed | Copyediting in Batch 4 | | IR completed 2019-04-18 |
| 4-A IR Comment Resolution | Asthma Daytime Symptom Diary V1.0 (ADSD V1.0 |
3-Internal review | Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) | D. Corey | D. Booth | 2019-09-10 Completed TR QC | 2019-09-11 Completed TR 2019-10-04 IR Completed | 3-Internal review | Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) | D. Corey | D. Booth | 2019-09-10 Completed TR QC | 2019-09-11 Completed TR 2019-10-04 IR Completed | | 3-Internal review | Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) | D. Corey | D. Booth | 2019-05-27 Completed TR QC | | | 2019-05-29 Completed TR 2019-10-04 IR Completed |
| 3-Internal review | Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS) | D. Corey | D. Booth | 2019-06-21 Completed TR QC | | | 2019-06-05 Completed TR2019-10-04 IR Completed |
3-Internal review | Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS| ) | D. Corey | D. Booth | 2019-09- |
09 20160626: 11 Completed TR
2019-10-04 IR Completed |
3-Internal review | | 4-A IR Comment Resolution | Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) | D. Corey |
Geriatric Depression Scale Short Form (GDS SHORT FORM)S. Kopko0628 IR TBD20160626: 11 Completed TR
2019-10-04 IR Completed |
3-Internal review
| | 4-A IR Comment Resolution | Baseline Dyspnea Index (BDI) | S. Karra |
PAIN Intensity (PI) Change Control v1.2D. Corey K. Minkalis | 2019-07-09 Completed TR QC | Priority review request | 2019-07-31 Completed TRe 2019-10-04 IR Completed | 3-Internal review | Psoriasis Area and Severity Index (PASI) | D. Corey | D. Booth | 2019-08-20 Completed TR QC | 2019-10-04 IR Completed | 3-Internal review | Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR) | | Completed | Copyediting in Batch 4 | | IR completed 2019-06-28 |
| 4-A IR Comment Resolution | Brief Psychiatric Rating Scale (BPRS) | S. Kopko | K. Minkalis | Completed | Copyediting and WORD doc needed for FDA IR | Priority review request | IR completed 2019-06-28 |
| 4-A IR Comment Resolution | Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19 |
Corey2019-05-23 1st PAR review comments updated and Completed QC for PR | | TBD | 2018-05-11 IR Completed - 2019-06-12 sent for 2nd PAR review, next steps: copyediting & FDA IR SK sent update message to PAR 2019-08-20. | 3-Internal review | Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR) | D. Corey S. Kopko | D. Corey | 2019-05-23 1st PAR review comments updated and Completed QC for PR | | TBD | | Booth | Completed | Copyediting needed for PR | TBD | IR completed 2019-04-18 |
| 4-A IR Comment Resolution | Covi Anxiety Scale (COVI) | S. Kopko | A Humphrey | Completed | | | IR completed 2019-06-28 |
2018-08-14 IR Completed - 2019-06-12 sent for 2nd PAR review, next steps: copyediting & FDA IR
SK sent update message to PAR 2019-08-20. |
| 4-A IR Comment Resolution |
Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS| Deployment Risk and Resilience Inventory-2 (DRRI-2) | S. |
SudiniS Kopko| Booth | Completed | | | IR completed 2019-06-28 |
| 4-A IR Comment Resolution |
AJCC TNM Staging System 7th Edition (AJCC V7)| Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) | D. Corey | D. Booth |
S. Kopko | Completed | Copyediting in Batch 4 | | | 2019-05-27 Completed TR QC | | | 2019-05-29 Completed TR
2019-10-04 IR Completed |
IR completed 2019-04-18 |
| 4-A IR Comment Resolution |
Baseline Dyspnea Index (BDI) | S. Karra | S. Kopko | Completed | Copyediting in Batch 4 | | | Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS) | D. Corey | D. Booth | 2019-06-21 Completed TR QC | | | 2019-06-05 Completed TR
2019-10-04 IR Completed |
IR completed 2019-06-28 |
| 4-A IR Comment Resolution |
Brief Psychiatric Rating Scale (BPRS) | S. Kopko | K. Minkalis | Completed | | Priority review request | | Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS) | D. Corey | D. Booth | 2019-09-09 Completed TR QC | | | 2016-06-26: Completed TR
2019-10-04 IR Completed |
IR completed 2019-06-28 |
| 4-A IR Comment Resolution |
Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19| Eastern Cooperative Oncology Group Performance Status (ECOG) | S. Sudini | S. Kopko |
D. BoothCompleted | Copyediting needed for PR | TBD | 0418| 28 |
| 4-A IR Comment Resolution |
Covi Anxiety Scale (COVI| European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0) | S. Kopko |
A Humphrey| Jörg Sahlmann D. Booth | Completed |
| | Needs review with EORTC | TBD |
| IR completed 2019-06-28 After that, copy-editing and EORTC review will occur prior to FDA review. |
| 4-A IR Comment Resolution |
Deployment Risk and Resilience Inventory-2 (DRRI-2| European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0) | S. Kopko | Jörg Sahlmann D. Booth | Completed |
| | Needs review with EORTC | TBD |
| IR completed 2019-06-28
After that, copy-editing and EORTC review will occur prior to FDA review. Should wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30. |
| 4-A IR Comment Resolution |
Eastern Cooperative Oncology Group Performance Status (ECOG) | | Geriatric Depression Scale Short Form (GDS SHORT FORM) | D. Booth |
S. SudiniCompleted | 2019-06-28 Completed IR QC | |
| | TBD | 2016-06-26: Completed TR
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IR completed 0628| 04 IR Completed |
| 4-A IR Comment Resolution |
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0)| PAIN Intensity (PI) Change Control v1.2 | S. Kopko |
Jörg Sahlmann D BoothCompleted | Needs review with EORTC | TBD | | Minkalis | 2019-07-09 Completed TR QC | | 2019-10-22: CDER is currently re-considering its priorities for the standardization of pain instrument data. | 2019-07-31 Completed TR
2019-10-04 IR Completed |
IR completed 2019-06-28 After that, copy-editing and EORTC review will occur prior to FDA review. |
| 4-A IR Comment Resolution |
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0) | S. Kopko | Jörg Sahlmann D. Booth | Completed | Needs review with EORTC | TBD | | Psoriasis Area and Severity Index (PASI) | D. Corey | D. Booth | 2019-08-20 Completed TR QC | | | 2019-10-04 IR Completed |
IR completed 2019-06-28 After that, copy-editing and EORTC review will occur prior to FDA review. Should wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30. |
| 4-A IR Comment Resolution | Transition Dyspnea Index (TDI) | S. Karra | S. Kopko | Completed | | | IR completed 2019-06-28 |
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| 4-Between IR and PR | Disease Steps (DISEASE STEPS) | S. Karra | S. Kopko | Completed | Copyediting needed for PR | | IR completed 2019-04-18 |
| 4-Between IR and PR | PEDSQL Instruments (18) | D. Corey | TBD | TBD for PR | TBD | | Hold for Batch 3 or 4? |
| 4-Between IR and PR | Suicidal Ideation Questionnaire (SIQ) | S. Kopko | TBD | TBD for PR | | | 2018-08-04 IR Completed - 2019-06-12 sent for 2nd PAR review, |
next steps: copyediting for public review| SK sent update message to |
PAR | PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019- |
08| 11-20 Dana to draft new agreement based on reply from V. King, PAR |
| 4-Between IR and PR | Suicidal Ideation Questionnaire-JR (SIQ-JR) | S. Kopko | A. Palmer | Completed | | | 2018-08-04 IR Completed - 2019-06-12 sent for 2nd PAR review, |
next steps: copyediting for public review| SK sent update message to PAR |
2019-08-20.| 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR |
| 4-Between IR and PR | Trauma Symptom Checklist for Children (TSCC) | D. Booth | TBD | Completed | | | 2018-08-14 IR Completed
2019-06-12 Requested PAR agreement update to include as a CDISC standard |
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| 6-Between PR and Publication | 4 Stair Ascend | D. Corey | S. Kopko | Completed | 2019-08-28 Completed | 2019-09-06 FDA final |
quik | quick review | Completed Public Review 2019-05-01 |
| 6-Between PR and Publication | 4 Stair Descend | D. Corey | S. Kopko | Completed | 2019-08-28 Completed | 2019-09-06 FDA final |
quik | quick review | Completed Public Review 2019-05-01 |
| 6-Between PR and Publication | Age, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS) | D. Corey | K. Kelly | Completed |
2019-07-23 Copyediting for Publication requestedCopyediting completed
In Publication process | | Completed Public Review 2019-05-01 |
| 6-Between PR and Publication | Combat Exposure Scale (CES) | D. Booth | S. Kopko | 2019-05-31 Completed Publication QC - need comment confirmation | TBD | | Completed Public Review 2019-05-01 |
| 6-Between PR and Publication | Emotion Recognition (EMOTION RECOGNITION) | D. Corey | S. Kopko | Completed Public Review 2019-05-01 |
2019-07-23 Copyediting for Publication requestedCopyediting completed
In Publication process | | Completed Public Review 2019-05-01 |
| 6-Between PR and Publication | Epworth Sleepiness Scale (ESS) | S. Kopko | D. Booth | Completed | Completed | | 2019-08-17 Public Review completed |
| 6-Between PR and Publication | Hamilton Anxiety Rating Scale (HAM-A) | S. Kopko | L. McLeod | Completed Public Review 2019-05-01 |
2019-07-23 Copyediting for Publication requestedCopyediting completed
In Publication process | | Completed PR 2019-05-01 |
| 6-Between PR and Publication | Hospital Anxiety and Depression Scale (HADS) | S. Kopko | K. Minkalis | 2019-05-31 Completed Publication QC |
2019-07-23 Copyediting for Publication requestedCopyediting completed
In Publication process | | Completed PR 2019-05-01 |
| 6-Between PR and Publication | Life Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION) | D. Booth | L. McLeod | 2019-05-30 Completed Publication QC | Batch 5 Copyediting for Publication | FDA quick review needed | Completed PR 2019-05-01 |
| 6-Between PR and Publication | Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0) | D. Booth | S. Kopko | 2019-05-30 Completed Publication QC | Batch 3 Copyediting |
for Publication| completed 2109-09-24 | | Completed PR 2019-05-01 |
| 6-Between PR and Publication | Paced Tapping (PACED TAPPING) | D. Corey | S. Kopko | Completed | Completed | | 2019-08-17 Public Review completed |
| 6-Between PR and Publication | PTSD Checklist for DSM-5 (PCL-5) | D. Booth | S. Kopko | 2019-05-30 Completed Publication QC | Batch 5 Copyediting for Publication | FDA quick review needed | Completed PR 2019-05-01 |
| 6-Between PR and Publication | RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT) | D. Booth | S. Kopko | Completed | Completed | | 2019-08-17 Public Review completed |
| 6-Between PR and Publication | Rising From Floor | D. Corey | S. Kopko | 2019-05-13 Completed Publication QC | 2019-08-28 Completed | 2019-09-06 FDA final |
quik | quick review | Completed PR 2019-05-01 |
| 6-Between PR and Publication | Symptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0) | D. Booth | S. Kopko | 2019-05-30 Completed Publication QC need comment confirmation | Batch 3 Copyediting |
for Publication| completed 2109-09-24 | | Completed PR 2019-05-01 |
| 6-Between PR and Publication | Ten Meter Walk/Run | D. Corey | D. Booth | Publication QC Completed 2019-05-12 | 2019-08-28 Completed | 2019-09-06 FDA final |
quik | quick review | Completed PR 2019-05-01 |
| 6-Between PR and Publication | Veterans Administration Lung Study Group (VALG) | D. Booth | S. Kopko | Publication QC Completed 2019-05-13 need comment confirmation | TBD | | Completed PR 2019-05 |
-01D. Booth | HOLD | | | | | | -01 |
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| 7-Publication | Clinical Global Impressions (CGI) | S. Kopko | D. Booth | | Completed 2019-04-11 | | 3/20/2019 |
| 7-Publication | Patient Global Impressions (PGI) | S. Kopko | D. Booth | | Completed 2019-04-11 | | 3/20/2019 |
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| QRS General Issues | Controlled Oral Word Association Test (COWAT) | D. Corey | HOLD | | | | |
| QRS General Issues | Dermatology Life Quality Index (DLQI) | D. Booth | HOLD | | | | |
| QRS General Issues | Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4) | D. Booth | HOLD | | | 2019-06-12: Early draft supplement sent for FDA review. | |
| QRS General Issues | Functional Assessment of Cancer Therapy-Lung Version 4 (FACT-L V4) | D. Booth | HOLD | | | | |
| QRS General Issues | Functional Assessment of Chronic Illness Therapy-Dyspnea (Dyspnoea) 10 Item Short |
Form (FACIT-DYSPNEA SF)| Form (FACIT-DYSPNEA SF) | D. Booth | HOLD | | | | |
| QRS General Issues | Functional Assessment of Chronic Illness Therapy-Fatigue 13-Item Scale Version 4 (FACIT-FATIGUE 13-ITEM V4) | S. Karra | D. Booth | Team QC completed in May except need new terminology for total score and author codes in suppquals (db action items to start, then sk to finish) | | Checking TBD | 2019-05-29 Completed TR |
| QRS General Issues | Unified Huntington's Disease Rating Scale '99 (UHDRS 1999) | D. Corey | HOLD | | | | xx |