Date: 2020-03-23
| 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 | Functional Assessment Scale - NACC Version (FAS-NACC UDS v3.0) | S. Kopko | In Process: 2019-09-25 new copyright received for v3.0 CRF - CT Approved in PKG 41 | ||||
| 1-Development | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0 (PRO-CTCAE v1.0) | S. Kopko | Draft CT in review with NCI and FDA - they re meeting on this in Jan. 2020 | ||||
| 1-Development Change Control | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) | TBD | TBD | Example update needed based on QRS Skipped Records concept. | |||
| 1-Development Change Control | Columbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT) | TBD | TBD | Example update needed based on QRS Skipped Records concept. | |||
| 1-Development Change Control | PAIN Relief (PR) Change Control v1.2 | S. Kopko | D. Booth | ||||
| 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 | ||||
| 1-Development Change Control | Disability Rating Scale (DRS) | S. Karra | |||||
| 1-Development Change Control | Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome v2.0 (Published supplement conversion to current WIKI template) | S. Kopko | D. Booth | Priority review request | In Process 2019-11-26 2020-01-08 Dana doing QC of final CT change control before updating WIKI supplement | ||
| 1-Development Change Control | Functional Assessment Questionnaire - NACC Version (FAQ-NACC UDS v2.0) | S. Sudini | S. Kopko | Based on QRS CT team review, Dana doing QC of 2019-12-19 FAQ-NACC UDS v2.0 final CT | |||
| 1-Development Change Control | Functional Assessment Questionnaire (FAQ) | S. Sudini | S. Kopko | In Process -conversion to WIKI supplement and existing title needs to be renamed to Functional Activity Questionnaire (FAQ) | |||
| 1-Development Change Control | Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template | S. Kopko | D. Booth | 2019-12-04 TBD by Dana 2019-12-04 Completed TR (revised with "QRS skipped Item" logic based on agreement with FDA at follow-up QRS Skipped Records meeting on 12/9) | To be added to Copyediting Batch 4 and WORD doc needed for FDA IR | Priority review request | |
| 1-Development Change Control | Karnofsky Performance Scale (KPS SCALE) | S. Sudini | |||||
| 1-Development Change Control | Kurtzke Functional Systems Scores (KFSS) | S. Sudini | |||||
| 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 | ||
| 2-Team review | International Physical Activity Questionnaire (October 2002) Long Last 7 Days Self-Administered Format (IPAQ-LF SELF-ADMINISTERED VERSION) | D. Corey | S. Kopko | 2020-02-26: Completed TR QC Checklist 2020-03-04: TR completed | |||
| 2-Team review | KDIGO AKI Stage (KDIGO AKI) | D. Corey | S. Kopko | 2020-03-20: Completed TR QC Checklist 2020-03-20: TR completed | Ready for IR | ||
| 2-Team review | Kurtzke Expanded Disability Status Scale (EDSS) | S. Kopko | D. Booth | 2019-11-19 TBD 2019-11-20 Completed TR | Priority review request | ||
| 2-Team review | Rockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0) | D. Corey | S. Kopko | 2020-03-20: Completed TR QC Checklist 2020-03-20: TR completed | Ready for IR | ||
| 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 | |
| 4-A IR Comment Resolution | Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS | S. Sudini | S. Kopko | 2019-05-06 Completed QC Checklist IR completed 2019-06-28 2019-12-04 updated to current template No JIRA Issues | Ready for copyediting for PR | ||
| 4-A IR Comment Resolution | AJCC TNM Staging System 7th Edition (AJCC V7) | D. Booth | S. Kopko | Completed 2019-04-18 IR completed JIRA Issues Done | 2020-01-13 Completed | Maybe | Dana checking for text revisions |
| 4-A IR Comment Resolution | Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) | D. Corey | D. Booth | 2019-09-10 Completed TR QC 2019-09-11 Completed TR JIRA issues approved | TBD | ||
| 4-A IR Comment Resolution | Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) | D. Corey | D. Booth | 2019-09-10 Completed TR QC 2019-09-11 Completed TR JIRA issues approved | TBD | ||
| 4-A IR Comment Resolution | Baseline Dyspnea Index (BDI) | S. Karra | S. Kopko | Completed IR completed 2019-06-28 No JIRA Issues | 2020-01-13 Completed | Ready for PR | |
| 4-A IR Comment Resolution | Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION) | S. Kopko | K. Minkalis | Completed 2019-06-28 Completed IR No JIRA Issues PR Checklist TBD by Dana | To be Added to Copyediting Batch 4 and WORD doc needed for FDA IR | Priority review request | |
| 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 2019-04-18 Completed IR JIRA Issues Done | Copyediting needed for PR | TBD | |
| 4-A IR Comment Resolution | Covi Anxiety Scale (COVI) | S. Kopko | A Humphrey | Completed 2019-06-28 Completed IR No JIRA Issues | TBD | ||
| 4-A IR Comment Resolution | Deployment Risk and Resilience Inventory-2 (DRRI-2) | S. Kopko | D. Booth | Completed 2019-06-28 Completed IR No JIRA Issues | TBD | ||
| 4-A IR Comment Resolution | 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 No JIRA Issues | TBD | ||
| 4-A IR Comment Resolution | 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 JIRA issues approved | TBD | ||
| 4-A IR Comment Resolution | 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 Completed IR JIRA issues approved | TBD | ||
| 4-A IR Comment Resolution | Eastern Cooperative Oncology Group Performance Status (ECOG) | S. Sudini | S. Kopko | Completed 2019-06-28 Completed IR No JIRA Issues | TBD | ||
| 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 2019-06-28 Completed IR No JIRA Issues | Copy-editing and EORTC review will occur prior to FDA review | TBD | |
| 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 2019-06-28 Completed IR | Copy-editing and EORTC review will occur prior to FDA review | TBD | Should wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30. |
| 4-A IR Comment Resolution | Geriatric Depression Scale Short Form (GDS SHORT FORM) | D. Booth | S. Kopko | 2019-06-28 Completed IR QC 2016-06-26 Completed TR JIRA Issues Open | TBD | No | |
| 4-A IR Comment Resolution | PAIN Intensity (PI) Change Control v1.2 | S. Kopko | K. Minkalis | 2019-07-09 Completed TR QC 2019-07-31 Completed TR JIRA Issues Under review | TBD | 2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data. | |
| 4-A IR Comment Resolution | Psoriasis Area and Severity Index (PASI) | D. Corey | D. Booth | 2019-08-20 Completed TR QC 2019-10-04 Completed IR No JIRA Issues | Copyediting Batch 4 and WORD doc needed for FDA IR | ||
| 4-A IR Comment Resolution | Transition Dyspnea Index (TDI) | S. Karra | S. Kopko | Completed 2019-06-28 Completed IR No JIRA Issues | TBD | ||
| 4-Between IR and PR | Disease Steps (DISEASE STEPS) | S. Karra | S. Kopko | Completed 2019-04-18 Completed IR JIRA issues approved | TBD | IR completed 2019-04-18 | |
| 4-Between IR and PR | Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 PQL01 - PQL18) | D. Corey | S. Kopko | 2018-10-01 Completed IR No JIRA Issues | 2020-02-21 Completed | Ready for PR | |
| 4-Between IR and PR | Suicidal Ideation Questionnaire (SIQ) | S. Kopko | TBD | 2018-08-04 Completed IR Completed QRSSUPP-74 - Getting issue details... STATUS JIRA Issue under review TBD for PR | TBD | 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 | |
| 4-Between IR and PR | Suicidal Ideation Questionnaire-JR (SIQ-JR) | S. Kopko | A. Palmer | Completed 2018-08-04 Completed IR JIRA Issues Done | TBD | 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 | |
| 4-Between IR and PR | Trauma Symptom Checklist for Children (TSCC) | D. Booth | TBD | Completed 2018-08-14 Completed IR JIRA Issues Done | TBD | 2019-06-12 Requested PAR agreement update to include as a CDISC standard | |
| 6-Between PR and Publication | 4 Stair Ascend | D. Corey | S. Kopko | Completed 2019-05-01 Completed PR JIRA Issues Done | 2019-08-28 Completed | 2020-01-31 Completed FDA final quick review | FDA quick review issues to be reviewed at 2020-03-25 meeting |
| 6-Between PR and Publication | 4 Stair Descend | D. Corey | S. Kopko | Completed 2019-05-01 Completed PR JIRA Issues Done | 2019-08-28 Completed | 2020-01-31 Completed FDA final quick review | FDA quick review issues to be reviewed at 2020-03-25 meeting |
| 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 2019-05-01 Completed PR No JIRA Issues | 2020-01-21 Completed 2020-03-20 WORD/PDFs requested | ||
| 6-Between PR and Publication | Combat Exposure Scale (CES) | D. Booth | S. Kopko | 2019-05-31 Completed Publication QC 2019-05-01 Completed PR No JIRA Issues | TBD | No | |
| 6-Between PR and Publication | Emotion Recognition (EMOTION RECOGNITION) | D. Corey | S. Kopko | 2019-05-01 Completed Public Review No JIRA Issues | 2020-01-21 Completed 2020-03-20 WORD/PDFs requested | ||
| 6-Between PR and Publication | Epworth Sleepiness Scale (ESS) | S. Kopko | D. Booth | Completed 2019-08-17 Completed PR QRSSUPP-162 - Getting issue details... STATUS JIRA Issue under review | Completed | ||
| 6-Between PR and Publication | Hamilton Anxiety Rating Scale (HAM-A) | S. Kopko | L. McLeod | Completed Public Review 2019-05-01 No JIRA Issues | Copyediting 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 No JIRA Issues | Copyediting 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 JIRA Issues Done | 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 | 2019-05-01 Completed PR Publication QC TBD JIRA Issues Done | 2020-01-13 Completed Batch 3 Copyediting for Publishing - WORD file in Review | ||
| 6-Between PR and Publication | Paced Tapping (PACED TAPPING) | D. Corey | S. Kopko | Completed JIRA issues approved | 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 JIRA Issues Done | 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 JIRA Issues Open | 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 JIRA Issues Done | 2019-08-28 Completed | 2019-09-06 FDA final 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 | 2019-05-01 Completed PR Publication QC TBD JIRA Issues Done | 2020-01-13 Completed Batch 3 Copyediting for Publishing - WORD file in Review | ||
| 6-Between PR and Publication | Ten Meter Walk/Run | D. Corey | D. Booth | Publication QC Completed 2019-05-12 JIRA Issues Done | 2019-08-28 Completed | 2019-09-06 FDA final 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 JIRA Issues Done | TBD | Completed PR 2019-05-01 | |
| 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 | ||
| QRS General Issues | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) | TBD | TBD | Change control needed: Example update needed base on QRS Skipped Records concept. CSSR-S Baseline example change control from DBooth 2019-12-05.pdf | |||
| QRS General Issues | Columbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT) | TBD | TBD | Example update needed base on QRS Skipped Records concept. | |||
| 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 | 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 |
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