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Date: 20202021-04-1009

1-DevelopmentEQ-5D-5L - update to include standardized numeric values from manual      1-Development
Review PeriodInstrument NameQRS DeveloperQC AssigneeQCCopy EditingFDA Review?QRS IR or PR
1-Development
EQ-5D-3L - update to include standardized numeric values from manual      1-
Columbia-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
   
  • NIH Draft CT review commeents resolved with S. Mitchell



1-Development Change Control
Columbia-Suicide Severity
Barnes Akathisia Rating Scale
Baseline
(
C-SSRS BASELINE
BARS)
TBDTBD

Example update needed based on QRS Skipped Records concept.

S. ZilberS. Kopko2021-03-25: QRS CT change control approved 


1-Development Change ControlBrief Psychiatric Rating Scale-Anchored (BPRS-A)TBDS. 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 Control
PAIN Relief (PR) Change Control v1.2S. KopkoD. Booth   
Columbia-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 Control
Barnes Akathisia Rating Scale (BARS)S. Sudini     1-Development Change ControlBrief Psychiatric Rating Scale-Anchored (BPRS-A)S. KarraS. Kopko   
European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)D. ErabellyS. Kopko
  • update to include standardized numeric values from manual
  • 2021-03-18 Q&A with SK



1-Development Change ControlEuropean Quality of Life Five Dimension Three Level Scale (EQ-5D-3L)D. ErabellyS. Kopko
  • update to include standardized numeric values from manual
  • 2021-03-18 Q&A with SK
  • 2021-04-08 ready for TR
 



1-Development Change Control
Disability Rating Scale (DRS)S. Karra     1-Development Change ControlExacerbations of Chronic
Exacerbations 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 Control
Functional Assessment Questionnaire (FAQ)
Tanner Scale Boy VersionS. SudiniS. Kopko
In Process -conversion to WIKI supplement and existing title needs to be renamed to Functional Activity Questionnaire (FAQ)  
CT change control from RP to RS approved 2020-04-23

In Process
 
1-Development Change Control
Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template
Tanner Scale Boy VersionS.
Kopko
Sudini
D
S.
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)

Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request
KopkoCT change control from RP to RS approved 2020-04-23

In Process
1-Development Change Control
Karnofsky Performance
Unified Parkinson's Disease Rating Scale (
KPS SCALE
UPDRS)F. AlipourS.
Sudini     1-Development Change ControlKurtzke Functional Systems Scores (KFSS)S. Sudini             2-Team reviewGlucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)D. CoreyS. Kopko

2019-07-31 Completed TR

 
KopkoSection 4 QSTESTCD = UPD128 response table correction needed

In Process

Contacting Author & NINDS on represenitng "ON/OFF" periods

2-Team review






3-Internal review 

Crohn's Disease Activity Index Version 1 (CDAI V1)

D. CoreyS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)D. BoothS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review 
2-Team review
International Physical Activity Questionnaire (October 2002) Long Last 7 Days Self-Administered Format (IPAQ-LF SELF-ADMINISTERED VERSION)D. CoreyS. Kopko
  • 2020-02-26: Completed TR QC Checklist
  • 2020-06-03:  Completed TR #2
  • 2021-04
: TR completed2-Team review
  • -13 IR Completed



3-Internal review International Physical Activity Questionnaire (August 2002) Short Last 7 Days Self-Administered Format (IPAQ-SF SELF-ADMINISTERED VERSION
KDIGO AKI Stage (KDIGO AKI
)D. CoreyS. Kopko

2020-03-20: Completed TR QC Checklist

2020-03-20: TR completed

Ready for IR2-Team reviewKurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth

2019-11-19 TBD by Dana

2019-11-20 Completed TR

 Priority review request2-Team reviewRockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review International Physical Activity Questionnaire (November 2002) Long Last 7 Days Telephone Format (IPAQ-LF PHONE VERSION)D. CoreyS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review International Physical Activity Questionnaire (August 2002) Short Last 7 Days Telephone Format (IPAQ-SF PHONE VERSION)D. CoreyS. Kopko

2020-03-20: Completed TR QC Checklist

2020-03-20 TR completed

Ready for IR
  • TR Completed
  • 2021-04-13 IR Completed



7-PublicationDisability Rating Scale (DRS)F. AlipourS. Kopko
  • 2020-09-30 Completed TR
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationQuality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ)D. CoreyS. Kopko
  • 2020-09-30 Completed TR
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationKarnofsky Performance Scale (KPS SCALE)F. AlipourS. Kopko
  • 2020-09-09 Completed TR
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationKurtzke Functional Systems Scores (KFSS)F. AlipourS. Kopko
  • 2020-07-15 TR completed
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished








4-Between IR and PRAJCC TNM Staging System 7th Edition (AJCC V7)D. Booth
        3-Internal review Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. Corey S. KopkoD. Corey

2018-05-11 IR Completed

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

 TBD2019-06-12 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, PAR3-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. KopkoD. Corey

2019-06-12 IR Completed

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

 TBD2019-06-12 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 ResolutionAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. Sudini
S. Kopko2019-
06-28 IR completed

2019-12-04 updated to current template

No JIRA Issues

Ready for copyediting for PR 4-A IR Comment ResolutionAJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko2019-04-18
04-18 Completed IR
JIRA Issues Done		2020-01-13 Completed
 MaybeDana checking for text revisions
2020-05-27: Restored and updates to current QRS template

5-Public review Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19S. Kopko
4-A IR Comment ResolutionAsthma Daytime Symptom Diary V1.0 (ADSD V1.0)D. Corey
D. Booth
  • 2019-
09
  • 04-
11 Completed TR

2019-10-04 Completed IR

JIRA issues approved

 TBD 4-A IR Comment ResolutionAsthma Nighttime Symptom Diary V1.0 (ANSD V1.0)D. CoreyD. Booth

2019-09-11 Completed TR

2019-10-04 Completed IR

JIRA issues approved

 TBD 4-A IR Comment Resolution
  • 18 Completed IR No JIRA Issues
  • April PR

Yes
5-Public review Covi Anxiety Scale (COVI)S. KopkoA Humphrey
  • 2019-06-28 Completed IR
    No JIRA Issues
  • 2021-04-09 Completed PR
  • 2021-04-09 Completed PR
TBD for PR

5-Public review Deployment Risk and Resilience Inventory-2 (DRRI-2
Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION
)S. Kopko
K
D.
Minkalis
Booth
  • 2019-06-28 Completed IR
    No JIRA Issues

PR Checklist TBD by Dana

Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request4-A IR Comment ResolutionChildren's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19S. Kopko
  • 2021-04-09 Completed PR
TBD for PR

5-Public review Disease Steps (DISEASE STEPS)S. KarraS. Kopko
D. Booth
  • 2019-04-18 Completed IR
    JIRA
Issues DoneCopyediting needed for
  • issues approved
  • 2021-04-09 Completed PR
TBD for PR

4-
A
Between IR
Comment ResolutionCovi Anxiety Scale (COVI)S. KopkoA Humphrey

2019-06-28 Completed IR

No JIRA Issues

 TBD 4-A IR Comment Resolution
and PREuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0
Deployment Risk and Resilience Inventory-2 (DRRI-2
)S. Kopko
D
Jörg Sahlmann D. Booth2019-06-28 Completed IR
No
JIRA Issues Approved
 TBD 
Copy-editing and EORTC review will occur prior to FDA reviewTBD April
4-Between IR and PR
4-A IR Comment ResolutionEastern Cooperative Oncology Group Performance Status (ECOG)S. SudiniS. Kopko

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
Palliative Care V1.0 (EORTC QLQ-
C30 V3
C15-PAL V1.0)S. KopkoJörg
Sahlmann D
Sahlmann D. Booth2019-06-28 Completed IR
No JIRA Issues		Copy-editing and EORTC review will occur prior to FDA reviewTBD April.
4-
A
Between IR
Comment ResolutionEuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0)
and PRGeriatric Depression Scale Short Form (GDS SHORT FORM)D. BoothS. Kopko
Jörg Sahlmann D. Booth
2016-06-26 Completed TR
2019-
06
10-
28
04 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.
OpenTBD 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-A IR Comment ResolutionGeriatric Depression Scale Short Form (GDS SHORT FORM)D. BoothS. Kopko

2016-06-26 Completed TR

2019-10-04 Completed IR

JIRA Issues Open

 TBDNo4-A IR Comment ResolutionPAIN Intensity (PI) Change Control v1.2S. KopkoK. Minkalis

2019-07-31 Completed TR

2019-10-04 Completed IR

JIRA Issues Under review

 TBD2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.4-A IR Comment ResolutionPsoriasis Area and Severity Index (PASI)D. CoreyD. Booth

2019-10-04 Completed IR

No JIRA Issues

Copyediting Batch 4 and WORD doc needed for FDA IR Priority review request4-A IR Comment ResolutionTransition Dyspnea Index (TDI)S. KarraS. Kopko

2019-06-28 Completed IR

No JIRA Issues

 TBD         4-Between IR and PRDisease Steps (DISEASE STEPS)S. KarraS. Kopko

2019-04-18 Completed IR

JIRA issues approved

TBD 
4-Between IR and PR
Suicidal Ideation Questionnaire (SIQ
Psoriasis Area and Severity Index (PASI)
S
D.
Kopko
Corey
TBD
D. Booth
2018
  • 2019-
08
  • 10-04 Completed IR
Jira
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-74
  • No JIRA Issues
  • CRF & Supplement being updaed


  • 2020-06-29 FDA IR comments received

5-Public review Suicidal Ideation Questionnaire (SIQ)S. KopkoTBD
  • 2018-08-04 Completed IR JIRA Issue under review
TBD for
  • April PR
 TBD 


2019-11-06
-12 sent for 2nd PAR review, SK sent update message to PAR 2019-08-20 received reply
PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review Suicidal Ideation Questionnaire-JR (SIQ-JR)S. KopkoA. Palmer
  • 2018-08-04 Completed IR
  • JIRA Issues Done
  • April PR
Needs current QRS Template Updates
2019-11-06
that
PAR completed 2nd Review
completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR
and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review Transition Dyspnea Index (TDI)S. KarraS. Kopko
  • 2019-06-28 Completed IR No JIRA Issues
  • Ready for PR - add to April?



5-Public review Trauma Symptom Checklist for Children (TSCC)D. BoothD. Corey
  • 2018-08-14 Completed IR JIRA Issues Done
  • April PR


  • 2020-07-10 Updated PAR agreement signed-good to move forward








7-PublicationAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. Kopko
  • 2019-06-28 IR completed
    No JIRA Issues
  • 2021-03-05 Completed PR
Completed
  • 2021-04-03 Publiished
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
  • 2021-03-05 Completed PR
 Completed
  • 2021-04-07 1st FDA Review

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
  • 2021-03-05 Completed PR
Completed
  • 2021-04-07 1st FDA Review

5-Public review Baseline Dyspnea Index (BDI)S. KarraS. Kopko
  • 2019-06-28 Completed IR No JIRA Issues
  • Ready for PR - add to April?




5-Public review Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)S. KopkoK. Minkalis
  • 2019-06-28 Completed IR No JIRA Issues
  • 2020-09-05 PR Checklist by Dana
  • 2021-02-03 FDA Responses reeived on Research Request
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review

PUB-341 to be sent in April


7-PublicationEastern Cooperative Oncology Group Performance Status (ECOG)S. SudiniS. Kopko
  • 2019-06-28 Completed IR
    No JIRA Issues
  • 2021-03-05 PR Completed


  • 2021-04-03 Publiished
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
  • 2021-04-09 PR Completed



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
  • 2021-02-15 QRS Research Request
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review

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
  • 2021-04-09 PR Completed



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
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review

5-Public review Mini-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 IR

Dana checking with PAR for user manuals

Yes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review Mini-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 IR

Dana checking with PAR for user manuals

Yes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
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
  • April PR

TBD April with PR
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
  • 2021-04-09 PR Completed



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
  • April PR











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 revisions and WORD file generation 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 revisions and WORD file generation 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
7-PublicationCombat Exposure Scale (CES)D. BoothS. Kopko
  • 2019-05-01 Completed PR
  • 2019-05-31 Completed Publication QC No JIRA Issues
Completed No2021-03-08 Published
7-PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. Booth2019-08-17 Completed PRCompleted No2021-03-08 Published
7-PublicationDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. CoreyD. Booth

2019-05-29 Completed TR
2019-10-04

4-Between IR and PRSuicidal Ideation Questionnaire-JR (SIQ-JR)S. KopkoA. Palmer

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, PAR4-Between IR and PRTrauma Symptom Checklist for Children (TSCC)D. BoothTBD

2018-08-14 Completed IR

JIRA Issues Done

 TBD  2019-06-12 Requested PAR agreement update to include as a CDISC standard        5-Public ReviewBaseline Dyspnea Index (BDI)S. KarraS. Kopko

2019-06-28 Completed IR

No JIRA Issues

2020-01-13 Completed Batch 5Ready for PR after Batch 85-Public ReviewDiabetes 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

2020-01-13 Completed Batch 6April PR5-Public ReviewDiabetes 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

2020-01-13 Completed Batch 6April PR5-Public ReviewDiabetes 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

2020-01-13 Completed Batch 6April PR5-Public Review

Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3

PQL01 - PQL18)

D. CoreyS. Kopko2018-10-01

Completed IR
No JIRA Issues

2020-

01

06-22 PR Completed

Batch 8May PR6-Between PR and Publication4 Stair AscendD. CoreyS. Kopko

2019-05-01 Completed PR

JIRA Issues Done

2019-08-28 Completed2020-01-31 Completed FDA final quick reviewFDA quick review issues to be reviewed at 2020-03-25 meeting6-Between PR and Publication

- 
No Issues

2020-09-24 Updated to current template

Completed
2021-03-08 Published
7-PublicationDiabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)
4 Stair Descend 
D. Corey
S
D.
Kopko
Booth

2019-06-05

-01 Completed PR

JIRA Issues Done

2019-08-28 Completed2020-01-31 Completed FDA final quick reviewFDA quick review issues to be reviewed at 2020-03-25 meeting6-Between PR and PublicationAge, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS

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

2020-06-22 PR Completed - 
No Issues

2020-09-22 Updated to current template

Completed
2021-03-08 Published
7-PublicationDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. Corey
K. Kelly
D. Booth

2016-06-26 Completed TR
2019-

05

10-

01 Completed PR

04 Completed IR
JIRA issues approved

2020-06-22 PR Completed - 
No

JIRA

Issues

2020-

01-21

09-22 Updated to current template

Completed
2020

2021-03-
20 WORD/PDFs requested 
08 Published
6-Between PR and Publication
Combat Exposure Scale (CES
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)D. BoothS. Kopko
  • 2019-05-
31 Completed Publication QC2019-05-
  • 01 Completed PR
No
  • JIRA Issues
TBD No6-Between PR and Publication
  • Done
  • 2021-01-25 2nd Copyediting Completed
  • 2020-04-09 Full Package in FDA COA review
  • 2020-06-03 Received FDA IR comments
  • 2020-08-26 comment resolution review with FDA
  • 2921-02-12 2nd FDA Review Request

7-PublicationPaced Tapping (PACED TAPPING
Emotion Recognition (EMOTION RECOGNITION
)D. CoreyS. Kopko
  • 2019-
05
  • 08-
01
  • 17 Completed PR
No
  • JIRA
Issues

2020-01-21 Completed

  • issues approved
Completed No2021
2020
-03-
20 WORD/PDFs requested 6-Between PR and PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. Booth

2019-08-17 Completed PR

Jira
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-162
JIRA Issue under review

TBD 6-Between PR and PublicationHamilton Anxiety Rating Scale (HAM-A)S. KopkoL. McLeod

2019-05-01 Completed PR

No JIRA Issues

2020-01-21 Completed

2020-03-20 WORD/PDFs requested

08 Published
7-PublicationPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(PEDSQL01 - PEDSQL18)		D. CoreyS. Kopko
  • 2018-10-01 Completed IR
    No JIRA Issue2020-
  • 2020-09-17 Completed PR 1 JIRA Issue Done
Completed
2020-12-10 Published
7-PublicationRAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)D. BoothS. Kopko
  • 2019-08-17 Completed PR JIRA Issues Done
Completed No2021-03-08 Published
 
6-Between PR and Publication
Rising From FloorD. Corey
Hospital Anxiety and Depression Scale (HADS)
S. Kopko
K. Minkalis
2019-05-01 Completed PR
2019-05-
31
13 Completed Publication QC
No
JIRA Issues Done2019-08-28 Completed2020-01-
21
31 Completed FDA final quick review
2020-06-24 Draft Updates based on 10 Meter Walk/Run presented to FDA - minor revisions and WORD file generation for final quick review		FDA quick review issues reviewed at 2020-03
-20 WORD/PDFs requested 
-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 Publication
Life Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION
Symptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. Booth
L
S.
McLeod
Kopko
  • 2019-05-01 Completed PR

2019-05-30 Completed Publication QC

JIRA Issues Done

2020-02-21 Completed

2020-03-12 WORD/PDF created

NoReady for Publication

  • JIRA Issues Done
  • 2021-01-25 2nd Copyediting Completed
  • 2020-04-09 Full Package in FDA COA review
  • 2020-06-03 Received FDA IR comments
  • 2020-08-26 comment resolution review with FDA
  • 2921-02-12 2nd FDA Review Request

6-Between PR and Publication
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)
10-Meter Walk/RunD. CoreyD. Booth
S. Kopko
  • 2019-05-01 Completed
PRPublication QC TBD
  • PR 
    JIRA Issues Done
  • 2020-
01-13 Completed

2020-03-10 WORD/PDF Created

  • 08-07 completed 2nd copyediting and WORD file
  • 2021-02-17 completed 3rd copyediting and WORD file
  • 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 2nd FDA final quick review
  • 2021-02-17 WORD file generated and send for 3rd FDA final quick
2020-03-13 in FDA COA
  • review

6-Between PR and Publication
Paced Tapping (PACED TAPPING
Veterans Administration Lung Study Group (VALG)D.
Corey
BoothS. Kopko
  • 2019-05-01 Completed PR JIRA Issues Done
  • 2019-
08
  • 05-
17 Completed PRJIRA issues approved
  • 13 Publication QC Completed-need comment confirmation
  • Needs CDISC CRF by Dana
TBD
 
 No
6

7-
Between PR and PublicationPTSD Checklist for DSM-5 (PCL-5
PublicationAge, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)D.
Booth
Corey
S
K.
Kopko
Kellly2019-05-01 Completed PR

2019-05-30 Completed Publication QC

No JIRA Issues
Done
2020-
02
01-21 Completed
2020-
03
05-
12
21 WORD/PDF
createdNoReady for Publication6-Between PR and PublicationRAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)
Revised for publishing
5/27/2020
7-PublicationClinical Global Impressions (CGI)S. Kopko
D. Booth
S. Kopko

Completed 2019-
08
04-
17 Completed PR

JIRA Issues Open

TBD 6-Between PR and PublicationRising From Floor
11
3/20/2019
7-PublicationEmotion Recognition (EMOTION RECOGNITION)D. CoreyS. Kopko2019-05-01 Completed PR

2019-05-13 Completed Publication QC

No JIRA Issues
Done
2019
2020-
08
01-
28
21 Completed
2020-
01-31 Completed FDA final quick reviewFDA quick review issues to be reviewed at 2020-03-25 meeting
05-19 WORD/PDF Revised for publishing
5/22/2020
7-PublicationHamilton Anxiety Rating Scale (HAM-A)S. KopkoL. McLeod
6-Between PR and PublicationSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. BoothS. Kopko
2019-05-01 Completed PR

Publication QC TBD

No JIRA Issues
Done
2020-01-
13
21 Completed
2020-
03
05-
10
21 WORD/PDF
Created2020-03-13 in FDA COA review6-Between PR and PublicationTen Meter Walk/RunD. Corey
Revised for publishing
5/22/2020
7-PublicationHospital Anxiety and Depression Scale (HADS)S. KopkoK. Minkalis
D. Booth

2019-05-01

Completed PR

Completeed

2019-05-

12 Publication

30
Completed Publication QC

Completed


No JIRA Issues

Done

2019
2020-
08
01-
28
21 Completed
2020-
01-31 Completed FDA final quick reviewFDA quick review issues to be reviewed at 2020-03-25 meeting
05-21 WORD/PDF Revised for publishing
5/22/2020
7-PublicationLife Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION
6-Between PR and PublicationVeterans Administration Lung Study Group (VALG
)D. Booth
S
L.
Kopko
McLeod2019-05-01 Completed PR
2019-05-
13 Publication QC Completed-need comment confirmation
30 Completed Publication QC
JIRA Issues Done
TBD 
2020-02-21 Completed
2020-03-12 WORD/PDF created		No3/31/2020
        7-PublicationClinical Global Impressions (CGI)S. KopkoD. Booth Completed 2019-04-11 3/20/2019
7-PublicationPatient Global Impressions (PGI)S. KopkoD. Booth
 

Completed 2019-04-11
 

3/20/2019
        QRS General Issues

Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)

TBDTBD

Change control needed: Example update needed base on QRS Skipped Records concept.

CSSR-S Baseline example change control from DBooth 2019-12-05.pdf

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
5-Public review 
QRS General IssuesColumbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT)TBDTBDExample update needed base on QRS Skipped Records concept.QRS General Issues
Controlled Oral Word Association Test (COWAT)D. Corey
HOLD    
S. KopkoApril PR


9 QRS General IssuesDermatology Life Quality
Index (DLQI)D. BoothHOLD    QRS General IssuesFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4QRS General Issues
Index (DLQI)D. BoothHOLD
  2019-06-12: Early draft supplement sent for FDA review. 




1-Development
Functional Assessment of Cancer Therapy-Lung Version 4 (FACT-L V4)D. BoothHOLD
    QRS General IssuesQRS General Issues




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




1-Development
Functional 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
   



xx