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Date: 2020-10-06

Review PeriodInstrument NameQRS DeveloperQC AssigneeQCCopy EditingFDA Review?QRS IR or PR
1-DevelopmentColumbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING)S. Kopko




1-DevelopmentFunctional Assessment Scale - NACC Version (FAS-NACC UDS v3.0)S. Kopko
2019-09-25 In Process

new copyright received for v3.0 CRF - CT Approved in PKG 41



1-DevelopmentPatient-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 - meeting in Jan. 2020 and on 6/23/20 to move forward


1-Development Change ControlBarnes Akathisia Rating Scale (BARS)S. Sudini




1-Development Change ControlBrief Psychiatric Rating Scale-Anchored (BPRS-A)S. KarraS. Kopko



1-Development Change ControlColumbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT)TBDTBD


Example update needed based on QRS Skipped Records concept.
1-Development Change ControlColumbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)TBDTBD

CSSR-S Baseline example change control from DBooth 2019-12-05.pdfExample update needed based on QRS Skipped Records concept.
1-Development Change ControlEuropean Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)TBDTBDupdate to include standardized numeric values from manual


1-Development Change ControlEuropean Quality of Life Five Dimension Three Level Scale (EQ-5D-3L)TBDTBDupdate to include standardized numeric values from manual


1-Development Change ControlExacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome v2.0 (Published supplement conversion to current WIKI template)S. KopkoD. Booth2020-01-08 Dana doing QC of final CT change control before updating WIKI supplement
Priority review request
1-Development Change ControlFunctional Assessment Questionnaire - NACC Version (FAQ-NACC UDS v2.0)S. SudiniS. KopkoBased on QRS CT team review, Dana doing QC of 2019-12-19 FAQ-NACC UDS v2.0 final CT


1-Development Change ControlPAIN Relief (PR) Change Control v1.2S. KopkoD. Booth



1-Development Change ControlTanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23

In Process
1-Development Change ControlTanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23

In Process
1-Development Change ControlUnified Parkinson's Disease Rating Scale (UPDRS)TBDTBDSection 4 QSTESTCD = UPD128 response table correction needed


2-Team reviewInternational Physical Activity Questionnaire (October 2002) Long Last 7 Days Self-Administered Format (IPAQ-LF SELF-ADMINISTERED VERSION)D. CoreyS. Kopko2020-02-26: Completed TR QC Checklist
2020-06-03:  Completed TR #2



3-Internal review Disability Rating Scale (DRS)F. AlipourS. Kopko

2020-09-30 Completed TR

Ready for IR




3-Internal review Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ)D. CoreyS. Kopko

2020-09-30 Completed TR

Ready for IR




3-Internal review Karnofsky Performance Scale (KPS SCALE)F. AlipourS. Kopko

2020-09-09 Completed TR

Ready for IR



In Process
3-Internal reviewKurtzke Functional Systems Scores (KFSS)F. AlipourS. Kopko

2020-07-15 TR completed

Ready for IR












4-Between IR and PRAJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko2019-04-18 Completed IR
JIRA Issues Done
2020-01-13 Completed
2020-05-27: Restored and updates to current QRS template


4-Between IR and PRChildren's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19S. KopkoD. Booth2019-04-18 Completed IR
No JIRA Issues
TBD for PRTBDNeeds current QRS Template Updates
4-Between IR and PRCovi Anxiety Scale (COVI)S. KopkoA Humphrey2019-06-28 Completed IR
No JIRA Issues
TBD for PR
Needs current QRS Template Updates
4-Between IR and PRDeployment Risk and Resilience Inventory-2 (DRRI-2)S. KopkoD. Booth2019-06-28 Completed IR
No JIRA Issues
TBD for PR
Needs current QRS Template Updates
4-Between IR and PRDisease Steps (DISEASE STEPS)S. KarraS. Kopko2019-04-18 Completed IR
JIRA issues approved
TBD for PR
Needs current QRS Template Updates
4-Between IR and PREuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0)S. KopkoJörg Sahlmann D. Booth2019-06-28 Completed IR
JIRA Issues Approved
Copy-editing and EORTC review will occur prior to FDA reviewTBDNeeds current QRS Template Updates
4-Between IR and PREuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0)S. KopkoJörg Sahlmann D. Booth2019-06-28 Completed IR
No JIRA Issues
Copy-editing and EORTC review will occur prior to FDA reviewTBDWait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30.
4-Between IR and PRGeriatric Depression Scale Short Form (GDS SHORT FORM)D. BoothS. Kopko2016-06-26 Completed TR
2019-10-04 Completed IR
JIRA Issues Open
TBD for PRNoNeeds current QRS Template Updates
4-Between IR and PRMini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko

2018-05-11 IR Completed
2019-05-23 1st PAR

review comments updated and Completed QC for PR 

2020-09-24 Updated to current template

TBD for FDA IRYes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
4-Between IR and PRMini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko

2018-05-11 IR Completed
2019-05-23 1st PAR review comments updated and Completed QC for PR 

2020-09-24 Updated to current template

TBD for FDA IRYes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
4-Between IR and PRPAIN Intensity (PI) Change Control v1.2S. KopkoK. Minkalis2019-07-31 Completed TR
2019-10-04 Completed IR
JIRA Issues Under review
TBD for PR2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.Needs current QRS Template Updates
4-Between IR and PRPsoriasis Area and Severity Index (PASI)D. CoreyD. Booth2019-10-04 Completed IR
No JIRA Issues

Completed for FDA IR

Dana revising for 2nd FDA IR

2020-06-29 FDA IR comments receivedNeeds current QRS Template Updates
4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)S. KopkoTBD2018-08-04 Completed IR
JIRA Issue under review
Needs current QRS Template Updates
2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
4-Between IR and PRSuicidal Ideation Questionnaire-JR (SIQ-JR)S. KopkoA. Palmer2018-08-04 Completed IR
JIRA Issues Done
Needs current QRS Template Updates
2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
4-Between IR and PRTransition Dyspnea Index (TDI)S. KarraS. Kopko2019-06-28 Completed IR
No JIRA Issues
TBD for PR
Needs current QRS Template Updates
4-Between IR and PRTrauma Symptom Checklist for Children (TSCC)D. BoothTBD2018-08-14 Completed IR
JIRA Issues Done
Needs current QRS Template Updates
2020-07-101 Updated PAR agreement signed-good to move forward








5-Public review Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. Kopko

2019-06-28 IR completed
No JIRA Issues

2020-09-23 updated to current template

Ready for copyediting for PR

5-Public review Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)D. CoreyD. Booth

2019-09-11 Completed TR
2019-10-04 Completed IR
JIRA issues approved

2020-08-18 updated to current template - ready for PR

 Ready for copyediting for PR

5-Public review Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)D. CoreyD. Booth

2019-09-11 Completed TR
2019-10-04 Completed IR
JIRA issues approved

2020-08-18 updated to current template - ready for PR

 Ready for copyediting for PR

5-Public review Baseline Dyspnea Index (BDI)S. KarraS. Kopko

2019-06-28 Completed IR
No JIRA Issues

2020-09-28 updated to current template - ready for PR

2020-01-13 Completed Batch 5



5-Public review Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)S. KopkoK. Minkalis

2019-06-28 Completed IR
No JIRA Issues
2020-09-05PR Checklist by Dana

2020-09-24 updated to current template - ready for PR

TBD and WORD doc needed for FDA IRPriority review request
5-Public review Eastern Cooperative Oncology Group Performance Status (ECOG)S. SudiniS. Kopko

2019-06-28 Completed IR
No JIRA Issues

2020-10-05 updated to current template - ready for PR

TBD for PR
Needs current QRS Template Updates
5-Public review Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)D. CoreyS. Kopko

2019-07-31 Completed TR

2020-09-08 Completed IR - 1 Issue Done - Ready for PR




5-Public review Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI templateS. KopkoD. Booth

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)

2020-08-15 QC Checklist completed

2020-09-08 Completed IR - 1 Issue Done - Ready for PR

TBD for FDA IRPriority review request
5-Public review KDIGO AKI Stage (KDIGO AKI)D. CoreyS. Kopko

2020-03-20: Completed TR
2020-07-08 Completed QC Checklist

2020-09-08 Completed IR - 1 Issue Done - Ready for PR




5-Public review Kurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth

2019-11-20 Completed TR

2020-09-08 Completed IR - 1 Issue Done - Ready for PR

Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request
5-Public review National Early Warning Score 2 (NEWS2)D. BoothS. Kopko

2019-04-22 Completed TR

2020-08-19 QC Checklist - Steve Copyright permission on OneDrive?

2020-09-08 Completed IR - 1 Issue Done - Ready for PR

Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request
5-Public review Patient Determined Disease Steps (PDDS)

Owner contacted CDISC with updated letter that removed the deference to Performance Scales (PS) due to potential copyright issues with that instrument
S. KopkoD. Corey

2020-06-10: Completed TR
2020-07-08 Completed QC Checklist

2020-09-08 Completed IR - 1 Issue Done - Ready for PR




5-Public review Rockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0)D. CoreyS. Kopko

2020-07-08 Completed QC Checklist from TR on 2020-03-18

2020-09-08 Completed IR - 1 Issue Done - Ready for PR



Ready for IR








6-Between PR and Publication4 Stair AscendD. CoreyS. Kopko2019-05-01 Completed PR
JIRA Issues Done
2019-08-28 Completed2020-01-31 Completed FDA final quick review
2020-06-24 Draft Updates based on 10 Meter Walk/Run presented to FDA - minor revisons and WORD file generatin for final quick review
FDA quick review issues reviewed at 2020-03-25 & 04-01 meetings
To be updated based on 2nd FDA IR on 10 Meter Walk/Run
Needs current QRS Template Updates
6-Between PR and Publication4 Stair Descend D. CoreyS. Kopko2019-05-01 Completed PR
JIRA Issues Done
2019-08-28 Completed2020-01-31 Completed FDA final quick review
2020-06-24 Draft Updates based on 10 Meter Walk/Run presented to FDA - minor revisons and WORD file generatin for final quick review
FDA quick review issues reviewed at 2020-03-25 & 04-01 meetings
To be updated based on 2nd FDA IR on 10 Meter Walk/Run
Needs current QRS Template Updates
6-Between PR and PublicationCombat Exposure Scale (CES)D. BoothS. Kopko2019-05-01 Completed PR
2019-05-31 Completed Publication QC
No JIRA Issues
TBD NoNeeds current QRS Template Updates
6-Between PR and PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. Booth2019-08-17 Completed PRTBD NoNeeds current QRS Template Updates
6-Between PR and PublicationDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. CoreyD. Booth

2019-05-29 Completed TR
2019-10-04 Completed IR
No JIRA Issues

2020-06-22 PR Completed - 
No Issues

Needs current QRS Template Updates before WORD file for publishing
Dana/Diane doing QC before Publication
6-Between PR and PublicationDiabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)D. CoreyD. Booth

2019-06-05 Completed TR
2019-10-04 Completed IR
JIRA issues approved

2020-06-22 PR Completed - 
No Issues

Needs current QRS Template Updates before WORD file for publishing
Dana/Diane doing QC before Publication
6-Between PR and PublicationDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. CoreyD. Booth

2016-06-26 Completed TR
2019-10-04 Completed IR
JIRA issues approved

2020-06-22 PR Completed - 
No Issues

Needs current QRS Template Updates before WORD file for publishing
Dana/Diane doing QC before Publication
6-Between PR and PublicationNon-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)D. BoothS. Kopko2019-05-01 Completed PR
Publication QC TBD
JIRA Issues Done
2020-01-13 Completed
2020-03-10 WORD/PDF Created

2020-04-09 Full Package in FDA COA review
2020-06-03 Received FDA IR comments

2020-08-26 comment resolution review with FDA

Needs current QRS Template Updates
6-Between PR and PublicationPaced Tapping (PACED TAPPING)D. CoreyS. Kopko2019-08-17 Completed PR
JIRA issues approved
TBD NoNeeds current QRS Template Updates
6-Between PR and PublicationPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(PQL01 - PQL18)
D. CoreyS. Kopko

2018-10-01 Completed IR
No JIRA Issue2020-

2020-09-17 Completed PR

1 JIRA Issue Done

2020-01-22 Completed Batch 8
Dana/Diane doing QC before Publication
6-Between PR and PublicationRAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)D. BoothS. Kopko2019-08-17 Completed PR
JIRA Issues Open
TBD NoNeeds current QRS Template Updates
6-Between PR and PublicationRising From FloorD. CoreyS. Kopko2019-05-01 Completed PR
2019-05-13 Completed Publication QC
JIRA Issues Done
2019-08-28 Completed2020-01-31 Completed FDA final quick review
2020-06-24 Draft Updates based on 10 Meter Walk/Run presented to FDA - minor revisons and WORD file generatin for final quick review
FDA quick review issues reviewed at 2020-03-25 & 04-01 meetings
To be updated based on 2nd FDA IR on 10 Meter Walk/Run
Needs current QRS Template Updates
6-Between PR and PublicationSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. BoothS. Kopko2019-05-01 Completed PR
Publication QC TBD
JIRA Issues Done
2020-01-13 Completed
2020-03-10 WORD/PDF Created

2020-04-09 Full Package in FDA COA review
2020-06-03 Received FDA IR comments

2020-08-26 comment resolution review with FDA

Needs current QRS Template Updates
6-Between PR and Publication10-Meter Walk/RunD. CoreyD. Booth2019-05-01 Completed PR
2019-05-12 Publication QC Completed
JIRA Issues Done

2019-08-28 Completed

2020-08-

2020-01-31 Completed FDA final quick review
2020-03-25 & 04-01 meetings-FDA quick review issues reviewed  & revisions needed
2020-06-24 Draft Updates presented to FDA

2020-08-10 WORD file generated and send for FDA final quick review


6-Between PR and PublicationVeterans Administration Lung Study Group (VALG)D. BoothS. Kopko2019-05-01 Completed PR
2019-05-13 Publication QC Completed-need comment confirmation
JIRA Issues Done
TBD NoNeeds current QRS Template Updates
7-PublicationAge, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)D. CoreyK. Kellly2019-05-01 Completed PR
No JIRA Issues
2020-01-21 Completed
2020-05-21 WORD/PDF Revised for publishing

5/27/2020
7-PublicationClinical Global Impressions (CGI)S. KopkoD. Booth
Completed 2019-04-11
3/20/2019
7-PublicationEmotion Recognition (EMOTION RECOGNITION)D. CoreyS. Kopko2019-05-01 Completed PR
No JIRA Issues
2020-01-21 Completed
2020-05-19 WORD/PDF Revised for publishing

5/22/2020
7-PublicationHamilton Anxiety Rating Scale (HAM-A)S. KopkoL. McLeod2019-05-01 Completed PR
No JIRA Issues
2020-01-21 Completed
2020-05-21 WORD/PDF Revised for publishing

5/22/2020
7-PublicationHospital Anxiety and Depression Scale (HADS)S. KopkoK. Minkalis

2019-05-01 Completeed

2019-05-30
Completed Publication QC
No JIRA Issues

2020-01-21 Completed
2020-05-21 WORD/PDF Revised for publishing

5/22/2020
7-PublicationLife Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION)D. BoothL. McLeod2019-05-01 Completed PR
2019-05-30 Completed Publication QC
JIRA Issues Done
2020-02-21 Completed
2020-03-12 WORD/PDF created
No3/31/2020
7-PublicationPatient Global Impressions (PGI)S. KopkoD. Booth
Completed 2019-04-11
3/20/2019
7-PublicationPTSD Checklist for DSM-5 (PCL-5)D. BoothS. Kopko2019-05-01 Completed PR
2019-05-30 Completed Publication QC
JIRA Issues Done
2020-02-21 Completed
2020-03-12 WORD/PDF created
No3/31/2020
1-DevelopmentControlled Oral Word Association Test (COWAT)D. CoreyHOLD



9 QRS General IssuesDermatology Life Quality Index (DLQI)D. BoothHOLD



1-DevelopmentFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)D. BoothHOLD

2019-06-12: Early draft supplement sent for FDA review.
1-DevelopmentFunctional Assessment of Cancer Therapy-Lung Version 4 (FACT-L V4)D. BoothHOLD



1-DevelopmentFunctional Assessment of Chronic Illness Therapy-Dyspnea (Dyspnoea) 10 Item Short Form (FACIT-DYSPNEA SF)D. BoothHOLD



1-DevelopmentFunctional Assessment of Chronic Illness Therapy-Fatigue 13-Item Scale Version 4 (FACIT-FATIGUE 13-ITEM V4)S. KarraD. BoothTeam 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 TBD2019-05-29 Completed TR
9 QRS General IssuesUnified Huntington's Disease Rating Scale '99 (UHDRS 1999)D. CoreyHOLD


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