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Date: 20192021-1204-0209

Review PeriodInstrument NameQRS DeveloperQC AssigneeQCCopy EditingFDA Review?QRS IR or PR
1-Development
EQ-5D-3L - update to include standardized numeric values from manual      
Columbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING)S. Kopko




1-Development
EQ-5D-5L - update to include standardized numeric values from manual      1-DevelopmentColumbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING)S. Kopko     1-Development Change ControlPAIN Relief (PR) Change Control v1.2S. KopkoD. Booth    
Functional 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
     

  • 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 ControlBarnes Akathisia Rating Scale (BARS)S.
Sudini
Zilber
    
S. Kopko2021-03-25: QRS CT change control approved 
 



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




1-Development Change Control
Disability
Columbia-Suicide Severity Rating Scale
(DRS)S. Karra    
- Since Last Visit (C-SSRS SINCE LAST VISIT)TBDTBD


Example update needed based on QRS Skipped Records concept.
 
1-Development Change Control
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome Published supplement conversion to current WIKI templateS. KopkoD. Booth  Priority review request In Process 2019-11-26
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 ControlEuropean 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 ControlExacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome v2.0 (
1-Development Change ControlFunctional Assessment Questionnaire - NACC Version (FAQ-NACC)S. SudiniS. Kopko   In Process 2019-09-25 new copyright received for v3.0 CRF1-Development Change ControlFunctional Assessment Questionnaire (FAQ)S. SudiniS. KopkoIn Process   1-Development Change ControlHamilton Depression Rating Scale 17-Item (HAMD 17)
Published supplement conversion to current WIKI template)S. KopkoD. Booth
 2019
2020-
11-15 TBD 
01-08 Dana doing QC of final CT change control before updating WIKI supplement
Priority review request
In Process 2019-11-15

1-Development Change Control
Karnofsky Performance Scale (KPS SCALE)
Functional Assessment Questionnaire - NACC Version (FAQ-NACC UDS v2.0)S. Sudini
     
S. KopkoBased on QRS CT team review, Dana doing QC of 2019-12-19 FAQ-NACC UDS v2.0 final CT


1-Development Change Control
Kurtzke Functional Systems Scores (KFSS)
PAIN Relief (PR) Change Control v1.2S.
Sudini
Kopko
             2-Team reviewGlucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)D. CoreyS. Kopko2019-07-09 Completed TR QC  2019-07-31 Completed Team Review2-Team reviewKurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth2019-11-19 TBD Priority review request2019-11-20 TR Completed        3-Internal review Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. Corey S. KopkoD. Corey2019-05-23 1st PAR review comments updated and Completed QC for PR  TBD2018-05-11 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, 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. Corey2019-05-23 1st PAR review comments updated and Completed QC for PR TBDIR 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 ResolutionAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. Kopko

Completed - needs review by S. Sudini on comment resolutions

No JIRA Issues

  IR completed 2019-06-284-A IR Comment ResolutionAJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko

Completed

JIRA Issues Done

Copyediting in Batch 4 IR completed 2019-04-184-A IR Comment ResolutionAsthma Daytime Symptom Diary V1.0 (ADSD V1.0)D. CoreyD. Booth

2019-09-10 Completed TR QC

JIRA issues approved

  2019-09-11 Completed TR
2019-10-04 IR Completed4-A IR Comment ResolutionAsthma Nighttime Symptom Diary V1.0 (ANSD V1.0)D. CoreyD. Booth

2019-09-10 Completed TR QC

JIRA issues approved

  2019-09-11 Completed TR
2019-10-04 IR Completed4-A IR Comment ResolutionBaseline Dyspnea Index (BDI)S. KarraS. Kopko

Completed 

No JIRA Issues

Copyediting in Batch 4 IR completed 2019-06-284-A IR Comment ResolutionBrief Psychiatric Rating Scale (BPRS)S. KopkoK. Minkalis

Completed 

No JIRA Issues

 Copyediting and WORD doc needed for FDA IRPriority review requestIR completed 2019-06-284-A IR Comment Resolution
D. 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)F. AlipourS. 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 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
  • 2021-04-13 IR Completed



3-Internal review International Physical Activity Questionnaire (August 2002) Short Last 7 Days Self-Administered Format (IPAQ-SF SELF-ADMINISTERED VERSION)D. CoreyS. Kopko
  • 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
  • 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. BoothS. Kopko2019-04-18 Completed IR
JIRA Issues Done		2020-01-13 Completed
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. KopkoD. Booth
  • 2019-04-18 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)
Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19
S. KopkoD. Booth
  • 2019-06-28 Completed IR
    No JIRA Issues
DoneCopyediting needed for
  • 2021-04-09 Completed PR
TBD for PR
IR completed 2019-04-18


5-Public review Disease Steps (DISEASE STEPS
4-A IR Comment ResolutionCovi Anxiety Scale (COVI
)S. KarraS. Kopko
A Humphrey

Completed 

No JIRA Issues

  IR completed 2019-06-284-A IR Comment Resolution
  • 2019-04-18 Completed IR
    JIRA issues approved
  • 2021-04-09 Completed PR
TBD for PR

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
Deployment Risk and Resilience Inventory-2 (DRRI-2
)S. Kopko
D
Jörg Sahlmann D. Booth
Completed IR completed

No JIRA Issues

  
2019-06-28
4-A IR Comment ResolutionDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. CoreyD. Booth

2019-05-27 Completed TR QC

No JIRA Issues

  2019-05-29 Completed TR
2019-10-04 IR Completed4-A IR Comment ResolutionDiabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)D. Corey
Completed IR
JIRA Issues Approved		Copy-editing and EORTC review will occur prior to FDA reviewTBD April
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-
21
28 Completed
TR QC
IR
No JIRA
issues approved  2019-06-05 Completed TR
2019-10-04 IR Completed
IssuesCopy-editing and EORTC review will occur prior to FDA reviewTBD April.
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. Booth
  • 2019-10-04 Completed IR 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
  • April PR


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
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 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 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 Completed IR
No JIRA Issues

2020-06-22 PR Completed - 
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)D. CoreyD. Booth

2019-06-05 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. CoreyD. Booth

2016-06-26 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
6-Between PR and PublicationNon-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)D. BoothS. Kopko
  • 2019-05-01 Completed PR
    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

7-PublicationPaced Tapping (PACED TAPPING)D. CoreyS. Kopko
  • 2019-08-17 Completed PR JIRA issues approved
Completed No2021-03-08 Published
7-PublicationPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(PEDSQL01 - PEDSQL18
4-A IR Comment ResolutionDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. CoreyD. Booth

2019-09-09 Completed TR QC

JIRA issues approved

  2016-06-26: Completed TR
2019-10-04 IR Completed4-A IR Comment ResolutionEastern Cooperative Oncology Group Performance Status (ECOG)S. SudiniS. Kopko

Completed 

No JIRA Issues

  IR completed 2019-06-284-A IR Comment ResolutionEuropean 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. Booth

Completed 

No JIRA Issues

 Needs review with EORTCTBDIR completed 2019-06-28 After that, copy-editing and EORTC review will occur prior to FDA review.4-A 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)S. KopkoJörg Sahlmann D. Booth

Completed 

No JIRA Issues

Needs review with EORTCTBDIR 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 ResolutionGeriatric Depression Scale Short Form (GDS SHORT FORM)D. BoothS. Kopko

2019-06-28 Completed IR QC

JIRA Issues Open

 TBD2016-06-26: Completed TR
2019-10-04 IR Completed4-A IR Comment ResolutionPAIN Intensity (PI) Change Control v1.2S. KopkoK. Minkalis

2019-07-09 Completed TR QC

JIRA Issues Under review

 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 Completed4-A IR Comment ResolutionPsoriasis Area and Severity Index (PASI)D. CoreyD. Booth

2019-08-20 Completed TR QC

No JIRA Issues

  2019-10-04 IR Completed4-A IR Comment ResolutionTransition Dyspnea Index (TDI)S. KarraS. Kopko

Completed 

No JIRA Issues

  IR completed 2019-06-28        4-Between IR and PRDisease Steps (DISEASE STEPS)S. KarraS. Kopko

Completed

JIRA issues approved

Copyediting needed for PR IR completed 2019-04-184-Between IR and PRPEDSQL Instruments (18)D. CoreyTBDTBD for PRTBD Hold for Batch 3 or  4?4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)S. KopkoTBD

TBD for PR

JIRA Issues Under review

  2018-08-04 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, PAR4-Between IR and PRSuicidal Ideation Questionnaire-JR (SIQ-JR)S. KopkoA. Palmer

Completed

JIRA Issues Done

  2018-08-04 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, PAR4-Between IR and PRTrauma Symptom Checklist for Children (TSCC)D. BoothTBD

Completed 

JIRA Issues Done

  2018-08-14 IR Completed
2019-06-12 Requested PAR agreement update to include as a CDISC standard        6-Between PR and Publication4 Stair AscendD. CoreyS. Kopko

Completed

JIRA Issues Done

2019-08-28 Completed2019-09-06 FDA final quick reviewCompleted Public Review 2019-05-016-Between PR and Publication4 Stair Descend D. CoreyS. Kopko

Completed

JIRA Issues Done

2019-08-28 Completed2019-09-06 FDA final quick reviewCompleted Public Review 2019-05-016-Between PR and PublicationAge, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)D. CoreyK. Kelly

Completed

No JIRA Issues

Copyediting completed
In Publication process Completed Public Review 2019-05-016-Between PR and PublicationCombat Exposure Scale (CES)D. BoothS. Kopko

2019-05-31 Completed Publication QC - need comment confirmation

JIRA Issues Done

TBD Completed Public Review 2019-05-016-Between PR and PublicationEmotion Recognition (EMOTION RECOGNITION
)D. CoreyS. Kopko
Completed Public Review 2019-05
  • 2018-10-01 Completed IR
    No JIRA
IssuesCopyediting completed
In Publication process Completed Public Review 2019-05-016-Between PR and Publication
  • 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. Booth
Epworth Sleepiness Scale (ESS)

Completed

JIRA Issues Under review
S. Kopko
D. Booth
  • 2019-08-17 Completed PR JIRA Issues Done
Completed
 
 No
2019
2021-03-08
-17 Public Review completed
Published
6-Between PR and Publication
Hamilton Anxiety Rating Scale (HAM-A)Completed Public Review
Rising From FloorD. CoreyS. Kopko
L. McLeod
2019-05-01 Completed PR
2019-05-
01
13 Completed Publication QC
No
JIRA Issues
Copyediting completed
In Publication process Completed PR 2019-05-01Completed PR
Done2019-08-28 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 Publication
Hospital Anxiety and Depression Scale (HADS)S. KopkoK. Minkalis

2019-05-31 Completed Publication QC

No JIRA Issues

Copyediting completed
In Publication process 
Symptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. BoothS. Kopko
  • 2019-05-01
6-Between PR and PublicationLife Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION)D. BoothL. McLeod

2019-05-30 Completed Publication QC

JIRA Issues Done

Batch 5 Copyediting for PublicationFDA quick review needed
  • Completed PR
    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
Completed PR 2019-05-01

6-Between PR and Publication
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)
10-Meter Walk/RunD.
Booth
Corey
S
D.
Kopko
Booth
  • 2019-05
-30 Completed Publication QC

JIRA Issues Done

Batch 3 Copyediting completed 2109-09-24 
  • -01 Completed PR 
    JIRA Issues Done
  • 2020-08-07 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 review
Completed PR 2019-05-01

6-Between PR and Publication
Paced Tapping (PACED TAPPING
Veterans Administration Lung Study Group (VALG)D.
Corey
BoothS. Kopko
  • 2019-05-01 Completed

JIRA issues approved

Completed 2019-08-17 Public Review completed6-Between PR and PublicationPTSD Checklist for DSM-5 (PCL-5)D. BoothS. Kopko

2019-05-30 Completed Publication QC

JIRA Issues Done

Batch 5 Copyediting for PublicationFDA quick review neededCompleted PR 2019-05-016-Between PR and PublicationRAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)D. BoothS. Kopko

Completed

JIRA Issues Open

Completed 2019-08-17 Public Review completed6-Between PR and Publication
  • PR JIRA Issues Done
  • 2019-05-13 Publication QC Completed-need comment confirmation
  • Needs CDISC CRF by Dana
TBD No
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)
Rising From Floor
D. CoreyS. Kopko2019-05-
13 Completed Publication QC
01 Completed PR
No JIRA Issues
Done2019-08-28 Completed2019-09-06 FDA final quick reviewCompleted PR 2019-05-01
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
6-Between PR and PublicationSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. BoothS. Kopko

2019-05-30 Completed Publication QC need comment confirmation

JIRA Issues Done

Batch 3 Copyediting completed 2109-09-24 Completed PR 2019-05-016-Between PR and PublicationTen Meter Walk/RunD. CoreyD. Booth

Publication QC Completed 2019-05-12

JIRA Issues Done

2019-08-28 Completed2019-09-06 FDA final quick reviewCompleted PR 2019-05-016-Between PR and PublicationVeterans Administration Lung Study Group (VALG)D. BoothS. Kopko

Publication QC Completed 2019-05-13 need comment confirmation

JIRA Issues Done

TBD Completed PR 2019-05-01        7-PublicationClinical Global Impressions (CGI
)S. KopkoD. Booth
 

Completed 2019-04-11
 

3/20/2019
7-Publication
Patient Global Impressions (PGI)S. Kopko
PTSD Checklist for DSM-5 (PCL-5)D. Booth
 
S. Kopko
Completed
2019-
04
05-
11 3/20/2019        QRS General Issues
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 
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
(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
  



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