Review Period | Instrument Name | QRS Developer | QC Assignee | QC | Copy Editing | FDA Review? | QRS IR or PR |
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 |
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1-Development | Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome | D. Booth |
| Published supplement conversion to current WIKI template |
| Priority review request |
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1-Development | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0 (PRO-CTCAE v1.0) | S. Kopko | | | | | |
1-Development Change Control | PAIN Relief (PR) Change Control v1.2 | S. Kopko | In Process | | | | |
1-Development Change Control | Barnes Akathisia Rating Scale (BARS) | S. Sudini | | | | | |
1-Development Change Control | Brief Psychiatric Rating Scale-Anchored (BPRS-A) | S. Karra | S. Kopko | | | Priority review request | |
1-Development Change Control | Disability Rating Scale (DRS) | S. Karra | | | | | |
1-Development Change Control | Functional Assessment Questionnaire - NACC Version (FAQ-NACC) | S. Sudini | S. Kopko | In Process new copyright requested 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) | S. Sudini | | | | | |
1-Development Change Control | Kurtzke Expanded Disability Status Scale (EDSS) | S. Kopko | | | | Priority 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 |
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| 2019-07-31 Completed Team Review |
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3-Internal review | Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) | D. Corey | D. Booth | 2019-09-10 Completed TR QC |
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| 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 |
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| 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- | 09 | 09 |
Jira request Jira |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | PUB-97 |
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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- | 09 | 09 | Jira request Jira |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | PUB-97 |
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3-Internal review | Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER | 3-Internal review | Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS) | D. Corey | D. Booth | TBD | | | 2016-06-26: Completed TR2019- | 09 | 09 |
3-Internal review | Geriatric Depression Scale | Jira request Jira |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | PUB-97 |
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3-Internal review | Geriatric Depression Scale Short Form (GDS SHORT FORM) | D. Booth | S. Kopko | 2019-06-28 Completed IR QC | | TBD | 2016-06-26: Completed TR 2019-0910-09 04 IR Jira request Jira |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | PUB-97 |
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| Completed |
3-Internal review
| PAIN Intensity (PI) Change Control v1.2 | S. Kopko | K. Minkalis | 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 |
| Priority review request | Team ReviewTRe 2019-10-04 IR Completed |
3-Internal review | PAIN Intensity (PI) Change Control v1.2 | S. Kopko | Psoriasis Area and Severity Index (PASI) | D. Corey | D. BoothK. Minkalis | 2019-0708-09 20 Completed TR QC | Priority review request |
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| 2019-0710-31 Completed TRe 2019-09-09 IR Jira request Jira |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | PUB-97 |
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| Psoriasis Area and Severity Index (PASI)04 IR 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, 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 | 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. |
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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 | Baseline Dyspnea Index (BDI) | S. Karra | S. Kopko | 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 | | 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 | S. Kopko | D. 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 |
4-A IR Comment Resolution | Deployment Risk and Resilience Inventory-2 (DRRI-2) | S. Kopko | D. Booth | Completed | | | IR completed 2019-06-28 |
4-A IR Comment Resolution | Eastern Cooperative Oncology Group Performance Status (ECOG) | S. Sudini | S. Kopko | Completed | | | IR completed 2019-06-28 |
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) | 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. |
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 | 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 2019-08-20. |
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. |
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 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 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 requested | | 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 requested | | 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 requested | | 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 requested | | 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 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 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 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 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 2019-05-01 |
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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) | D. Booth | HOLD | | | | |
QRS General Issues | Unified Huntington's Disease Rating Scale '99 (UHDRS 1999) | D. Corey | HOLD | | |
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