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Date: 20202021-1004-0609

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
  • NIH Draft CT review commeents resolved with S. Mitchell



1-Development Change ControlBarnes Akathisia Rating Scale (BARS)S.
Sudini
ZilberS. 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 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)
TBD
D. ErabellyS. Kopko
TBD
  • 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)
TBD
D. ErabellyS. Kopko
TBD
  • 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 (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)
TBD
F. AlipourS. Kopko
TBD
Section 4 QSTESTCD = UPD128 response table correction needed

In Process

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

2-Team review
International Physical Activity Questionnaire (October 2002) Long Last 7 Days Self-Administered Format (IPAQ-LF SELF-ADMINISTERED VERSION)







3-Internal review 

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

D.
D.
CoreyS. Kopko
2020-02-26: Completed TR QC Checklist
2020-06-03:  Completed TR #2
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review 
Disability Rating Scale (DRS)
Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)D. Booth
F. Alipour
S. Kopko
  • TR Completed
2020
  • 2021-
09
  • 04-
30
  • 13 IR Completed
TR

Ready for IR




3-Internal review 
Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ
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-
09
  • 06-
30
  • 03:  Completed TR
  • #2
  • 2021-04-13 IR Completed
Ready for IR



3-Internal review 
Karnofsky Performance Scale (KPS SCALE)
International Physical Activity Questionnaire (August 2002) Short Last 7 Days Self-Administered Format (IPAQ-SF SELF-ADMINISTERED VERSION)D. Corey
F. Alipour
S. Kopko

2020-09-09 Completed TR

Ready for IR

In Process
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal
reviewKurtzke Functional Systems Scores (KFSS)
review International Physical Activity Questionnaire (November 2002) Long Last 7 Days Telephone Format (IPAQ-LF PHONE VERSION)D. Corey
F. Alipour
S. Kopko

2020-07-15 TR completed

Ready for IR

4-Between IR and PRAJCC TNM Staging System 7th Edition (AJCC V7
  • 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.
Booth
CoreyS. Kopko
2019-04-18
  • TR Completed
IR
JIRA Issues Done2020-01
  • 2021-04-13 IR Completed
2020-05-27: Restored and updates to current QRS template4-Between IR and PRChildren's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19



7-PublicationDisability Rating Scale (DRS)F. AlipourS. Kopko
D. Booth2019-04-18 Completed IR
No JIRA IssuesTBD for PRTBDNeeds current QRS Template Updates4-Between IR and PRCovi Anxiety Scale (COVI)S. KopkoA Humphrey2019-06-28 Completed IR
No JIRA IssuesTBD for PRNeeds current QRS Template Updates4-Between IR and PRDeployment Risk and Resilience Inventory-2 (DRRI-2)S. KopkoD. Booth2019-06-28 Completed IR
No JIRA IssuesTBD for PRNeeds current QRS Template Updates4-Between IR and PRDisease Steps (DISEASE STEPS)S. KarraS. Kopko2019-04-18 Completed IR
JIRA issues approvedTBD for PRNeeds current QRS Template Updates4-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 ApprovedCopy-editing and EORTC review will occur prior to FDA reviewTBD
  • 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)S. KopkoD. Booth
  • 2019-06-28 Completed IR
    No JIRA Issues
  • 2021-04-09 Completed PR
TBD for PR

5-Public review Disease Steps (DISEASE STEPS)S. KarraS. Kopko
  • 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)S. KopkoJörg Sahlmann D. Booth2019-06-28 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. Booth2019-06-28 Completed IR
No JIRA Issues		Copy-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 PR
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0)
PAIN Intensity (PI) Change Control v1.2S. Kopko
Jörg Sahlmann D. Booth
K. Minkalis2019-07-31 Completed TR
2019-
06
10-
28
04 Completed IR
No JIRA IssuesCopy-editing and EORTC review will occur prior to FDA
JIRA Issues Under reviewTBD
Wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30.
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 PR
Geriatric Depression Scale Short Form (GDS SHORT FORM)
Psoriasis Area and Severity Index (PASI)D. CoreyD. Booth
S. Kopko2016-06-26 Completed TR
  • 2019-10-04 Completed IR

  • No JIRA Issues
OpenTBD for PRNoNeeds current QRS Template Updates4-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 IRYes
  • 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
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 IR
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
Yes

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 PR
5-Public review Transition Dyspnea Index (TDI)S. Karra
PAIN Intensity (PI) Change Control v1.2
S. Kopko
K. Minkalis
  • 2019-
07-31 Completed TR
2019-10-04
  • 06-28 Completed IR

  • No JIRA Issues
Under reviewTBD for PR2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.Needs current QRS Template Updates4-Between IR and PR
  • Ready for PR - add to April?



5-Public review Trauma Symptom Checklist for Children (TSCC
Psoriasis Area and Severity Index (PASI
)D.
Corey
BoothD.
Booth
Corey
2019
  • 2018-
10
  • 08-
04
  • 14 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
  • Done
  • April PR


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








7-PublicationAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. Sudini
4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)2018
S. Kopko
TBD
  • 2019-
08
  • 06-
04 Completed
  • 28 IR completed
JIRA Issue under reviewNeeds current QRS Template Updates2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates4-Between IR and PRSuicidal Ideation Questionnaire-JR (SIQ-JR)S. KopkoA. Palmer
  • 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
2018-08
  • -04 Completed IR
    JIRA
Issues DoneNeeds current QRS Template Updates2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates4-Between IR and PRTransition Dyspnea Index (TDI)S. KarraS. Kopko2019-06-28 Completed IR
No JIRA IssuesTBD for PRNeeds current QRS Template Updates4-Between IR and PRTrauma Symptom Checklist for Children (TSCC)D. BoothTBD2018-08-14 Completed IR
JIRA Issues DoneNeeds current QRS Template Updates2020-07-101 Updated PAR agreement signed-good to move forward
  • 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. Karra
5-Public review Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. Sudini
S. Kopko
  • 2019-06-28
IR completed
No Ready for copyediting for PR
  • Completed IR No JIRA Issues

2020-09-23 updated to current template

  • Ready for PR - add to April?




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
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. Corey
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 PR5-Public review Baseline Dyspnea Index (BDI)S. Karra
S. Kopko
  • 2019-
06
  • 07-
28
  • 31 Completed
IR
  • TR
No JIRA Issues
  • 2020-09-
28 updated to current template - ready
  • 08 Completed IR - 1 Issue Done - Ready for PR
2020
  • 2021-
01
  • 04-
13
  • 09 PR Completed
Batch 5



5-Public review 
Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)
Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI templateS. Kopko
K
D.
Minkalis
Booth
  • 2019-
06
  • 12-
28 Completed IR
No JIRA Issues
2020-09-05PR Checklist by Dana
  • 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-
24 updated to current template - ready for PRTBD and WORD doc needed for FDA IR
  • 08 Completed IR - 1 Issue Done
  • 2021-02-15 QRS Research Request
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review
Priority review request

5-Public review 
Eastern Cooperative Oncology Group Performance Status (ECOG)
KDIGO AKI Stage (KDIGO AKI)D. Corey
S. Sudini
S. Kopko
2019
  • 2020-
06
  • 03-
28
  • 20: Completed
IR
No JIRA Issues
  • TR
  • 2020-07-08 Completed QC Checklist
  • 2020-
10-05 updated to current template - ready for PRTBD for PRNeeds current QRS Template Updates
  • 09-08 Completed IR - 1 Issue Done
  • 2021-04-09 PR Completed



5-Public review 
Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)D. CoreyS. Kopko
Kurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth
  • 2019-11-20
2019-07-31
  • Completed TR
  • 2020-09-08 Completed IR - 1 Issue Done
- Ready for PR
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review

5-Public review 
Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template
Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko
D. Booth

2018-05-11 IR Completed
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)

05-23 1st PAR

review comments updated and Completed QC for PR 

2020-08-15 QC Checklist completed

2020-09-

08 Completed IR - 1 Issue Done - Ready for PR

24 Updated to current template

TBD for FDA IR

Priority review request

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 
KDIGO AKI Stage (KDIGO AKI
Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko
2020

2018-

03

05-

20:

11 IR Completed

TR


2020

2019-

07-08 Completed QC Checklist

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

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 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 PRAdd to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request
  • 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
- Ready for PR
  • 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
- Ready for
  • April 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
revisions and WORD file
generatin
generation for final quick reviewFDA 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
revisions and WORD file
generatin
generation for final quick reviewFDA 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
7-
Between PR and
PublicationCombat Exposure Scale (CES)D. BoothS. Kopko
  • 2019-05-01 Completed PR
  • 2019-05-31 Completed Publication QC

  • No JIRA Issues
TBD
Completed No
Needs current QRS Template Updates
2021-03-08 Published
7-
6-Between PR and
PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. Booth2019-08-17 Completed PR
TBD
Completed No
Needs current QRS Template Updates6-Between PR and
2021-03-08 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

Needs current QRS Template Updates before WORD file for publishingDana/Diane doing QC before Publication

2020-09-24 Updated to current template

Completed
2021-03-08 Published
7-
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 publishingDana/Diane doing QC before Publication

2020-09-22 Updated to current template

Completed
2021-03-08 Published
7-
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

2020-09-22 Updated to current template

Completed
2021-03-08 Published
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. Kopko
  • 2019-05-01 Completed PR
Publication QC TBD
  • JIRA Issues Done
2020
  • 2021-01-
13
  • 25 2nd Copyediting Completed
  • 2020-
03-10 WORD/PDF Created2020-
  • 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
  • 2921-02-12 2nd FDA Review Request

7-
6-Between PR and
PublicationPaced Tapping (PACED TAPPING)D. CoreyS. Kopko
  • 2019-08-17 Completed PR

  • JIRA issues approved
TBD
Completed No
Needs current QRS Template Updates
2021-03-08 Published
7-
6-Between PR and
PublicationPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(
PQL01
PEDSQL01 -
PQL18
PEDSQL18)D. CoreyS. Kopko
  • 2018-10-01 Completed IR
    No JIRA Issue2020-
  • 2020-09-17 Completed
PR
  • PR 1 JIRA Issue Done
Completed
2020-
01-22 Completed Batch 8Dana/Diane doing QC before Publication
12-10 Published
7-
6-Between PR and
PublicationRAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)D. BoothS. Kopko
  • 2019-08-17 Completed PR

  • JIRA Issues
Open
  • Done
TBD
Completed No
Needs current QRS Template Updates
2021-03-08 Published
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
revisions and WORD file
generatin
generation for final quick reviewFDA 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. Kopko
  • 2019-05-01 Completed PR
Publication QC TBD
  • JIRA Issues Done
2020
  • 2021-01-
13 Completed
2020-03-10 WORD/PDF Created
  • 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
Needs current QRS Template Updates
  • 2921-02-12 2nd FDA Review Request

6-Between PR and Publication10-Meter Walk/RunD. CoreyD. Booth
  • 2019-05-01 Completed
PR
2019-05-12 Publication QC Completed
  • PR 
    JIRA Issues Done
2019
  • 2020-08-
28 Completed2020-08-
  • 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

6-Between PR and PublicationVeterans Administration Lung Study Group (VALG)D. BoothS. Kopko
  • 2019-05-01
Completed PR
  • Completed PR JIRA Issues Done
  • 2019-05-13 Publication QC Completed-need comment confirmation
JIRA Issues Done
  • Needs CDISC CRF by Dana
TBD No
Needs 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
5-
Development
Public review Controlled Oral Word Association Test (COWAT)D. Corey
HOLD
S. KopkoApril PR


9 QRS General IssuesDermatology Life Quality Index (DLQI
)D. BoothHOLD1-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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