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Date: 20202021-0704-09

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


1-Development Change ControlBrief Psychiatric Rating Scale-Anchored (BPRS-A)TBDS.
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 Control
Disability Rating Scale (DRS)
S. Karra     1-Development Change Control
European 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
   S. Karra



1-Development Change Control
Functional Assessment Questionnaire (FAQ)
PAIN Relief (PR) Change Control v1.2S. Kopko
In Process -conversion to WIKI supplement and existing title needs to be renamed to Functional Activity Questionnaire (FAQ) 
D. Booth



1-Development Change ControlTanner Scale Boy VersionS. SudiniS. Kopko
 
CT change control
to be presented to QRS CT team
from RP to RS approved 2020-04-23

In Process
1-Development Change Control
Karnofsky Performance Scale (KPS SCALE)S. Sudini     1-Development Change ControlPAIN Relief (PR) Change Control v1.2S. KopkoD. Booth    1-Development Change ControlTanner Scale Boy Version
Tanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23
  Unified Parkinson'


In Process
1-Development Change Control
Tanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23  In Process1-Development Change Control
Unified 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
Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES







3-Internal review 

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

D. CoreyS. Kopko
2019-07-31 Completed TR   2-Team review
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)D. Booth
Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template
S. Kopko
D. Booth 2019-12-04 TBD by Dana
2019-12-04 Completed TR (revised with "QRS skipped Item" logic based on agreement with FDA at follow-up QRS Skipped Records meeting on 12/9)
  • 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 
Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request 2-Team review
International Physical Activity Questionnaire (
October
August 2002)
Long
Short Last 7 Days Self-Administered Format (IPAQ-
LF
SF SELF-ADMINISTERED VERSION)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 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
2-Team reviewKurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth2019-11-20 Completed TR Priority review request2-Team reviewKurtzke Functional Systems Scores (KFSS
)F. AlipourS. Kopko
  • 2020-
07
  • 09-
08
  • 30 Completed TR
in process   3-Internal review 
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationQuality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ
KDIGO AKI Stage (KDIGO AKI
)D. CoreyS. Kopko
  • 2020-
03
  • 09-
20:
  • 30 Completed TR
  • 2020-
07-08 Completed QC Checklist  Ready for IR3-Internal 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
  • 11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationKarnofsky Performance Scale (KPS SCALE)F. AlipourS. Kopko
D. Corey
  • 2020-
06
  • 09-
10:
  • 09 Completed TR
  • 2020-
07-08 Completed QC Checklist  Ready for IR3-Internal review Rockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0)
  • 11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationKurtzke Functional Systems Scores (KFSS)F. Alipour
D. Corey4-Between IR and PRAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. Kopko2019-06-28 IR completed
2019-12-04 updated to current template
No JIRA IssuesReady for copyediting for PR Needs current QRS Template Updates
S. Kopko
  • 2020-07-
08 Completed QC Checklist  Ready for IR
  • 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
  4-Between IR and PRAsthma Daytime Symptom Diary V1.0 (ADSD V1.0)


5-Public review Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19S. Kopko
D. Corey
D. Booth
  • 2019-
09
  • 04-
11 Completed TR
2019-10-04 Completed IR
JIRA issues approved TBD Needs current QRS Template Updates
  • 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
4-Between IR and PRAsthma Nighttime Symptom Diary V1.0 (ANSD V1.0)D. CoreyD. Booth2019-09-11 Completed TR
2019-10-04 Completed IR
JIRA issues approved TBD Needs current QRS Template Updates4-Between IR and PRBaseline Dyspnea Index (BDI)S. KarraS. Kopko
  • 2019-06-28 Completed IR
    No JIRA Issues
2020
  • 2021-
01
  • 04-
13 Completed Batch 5
Needs current QRS Template Updates Needs current QRS Template Updates
  • 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 PR
Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0)S. Kopko
K
Jörg Sahlmann D.
Minkalis
Booth2019-06-28 Completed IR
No
JIRA Issues

PR Checklist TBD by DanaTBD Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request
ApprovedCopy-editing and EORTC review will occur prior to FDA reviewTBD April
 

4-Between IR and PR
Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19
European 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-
04
06-
18
28 Completed IR
No JIRA Issues
TBD for PR
Copy-editing and EORTC review will occur prior to FDA reviewTBD April
Needs current QRS Template Updates
.
4-Between IR and PR
Covi Anxiety
Geriatric Depression Scale Short Form (
COVI)
GDS SHORT FORM)D. BoothS. Kopko
A Humphrey
2016-06-26 Completed TR
2019-
06
10-
28
04 Completed IR
No
JIRA Issues OpenTBD for PR
 
NoNeeds current QRS Template Updates
4-Between IR and PR
Deployment Risk and Resilience Inventory-2 (DRRI-2)S. KopkoD. Booth2019-06-28 Completed IR
No JIRA IssuesTBD for PR 
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 IRYes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS
Needs current QRS
Template Updates
4-Between IR and PR
Disease Steps (DISEASE STEPS)
Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. Corey
S. Karra
S. Kopko
2019

2018-

04

05-

18  

11 IR Completed

IR
JIRA issues approvedTBD for PR


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
Eastern Cooperative Oncology Group Performance Status (ECOG)
PAIN Intensity (PI) Change Control v1.2S.
Sudini
Kopko
S. Kopko
K. Minkalis2019-07-31 Completed TR
2019-
06
10-
28
04 Completed IR
No
JIRA Issues Under reviewTBD for PR
 
2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.Needs current QRS Template Updates
4-Between IR and PR
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0)S. Kopko
Psoriasis Area and Severity Index (PASI)D. CoreyD.
Jörg Sahlmann D.
Booth
  • 2019-
06
  • 10-
28
  • 04 Completed IR

  • No JIRA Issues
ApprovedCopy-editing and EORTC review will occur prior to FDA reviewTBDNeeds current QRS Template Updates
  • 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
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 IssuesCopy-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
  • Done
TBD for
  • April PR
No
Needs 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 

TBD for PRYes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101

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
Needs current QRS Template Updates








7-PublicationAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. Sudini
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. Corey
S. Kopko
2018
  • 2019-
05-11 IR Completed
2019-05-23 1st PAR review comments updated and Completed QC for PR TBD for PRYes2019-11-06 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 PR
  • 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
PAIN Intensity (PI) Change Control v1.2S. KopkoK. Minkalis2019-07-31
  • Completed TR
  • 2019-10-04 Completed IR
    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 Updates
  • 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
4-Between IR and PRPsoriasis Area and Severity Index (PASI)D. CoreyD. Booth2019-10-04 Completed IR
No JIRA IssuesCompleted for FDA IR2020-06-29 FDA IR comments receivedNeeds current QRS Template Updates4-Between IR and PRSuicidal Ideation Questionnaire (SIQ
)S. Kopko
TBD
K. Minkalis
2018
  • 2019-
08
  • 06-
04
  • 28 Completed
IR
JIRA Issue under reviewNeeds 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
  • 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
4-Between IR and PRSuicidal Ideation Questionnaire-JR (SIQ-JR)S. KopkoA. Palmer2018-08-04 Completed IR
JIRA Issues DoneNeeds 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 Updates4-Between IR and PRTransition Dyspnea Index (TDI)S. Karra
S. Kopko
  • 2019-
06-28 Completed IR
No JIRA IssuesTBD for PR Needs current QRS Template Updates4-Between IR and PR
  • 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. Kopko
Trauma Symptom Checklist for Children (TSCC)2018
D. Booth
TBD
  • 2019-
08
  • 12-
14 Completed IR
JIRA Issues DoneNeeds current QRS Template Updates 2020-07-101 Updated PAR agreement signed-good to move forward
  • 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
5-Public ReviewDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS
)D. Corey
D
S.
Booth
Kopko
2019
  • 2020-
05
  • 03-
29
  • 20: Completed TR
2019
  • 2020-
10
  • 07-
04
  • 08 Completed
IR
No JIRA Issues
  • QC Checklist
  • 2020-
01
  • 09-
13 Completed Batch 6 2020-06-22 PR Completed
Issue Resolution in Process
Needs current QRS Template Updates5-Public ReviewDiabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)
  • 08 Completed IR - 1 Issue Done
  • 2021-04-09 PR Completed



5-Public review Kurtzke Expanded Disability Status Scale (EDSS)S. Kopko
D. Corey
D. Booth
  • 2019-
06
  • 11-
05
  • 20 Completed TR
2019
  • 2020-
10
  • 09-
04
  • 08 Completed IR

JIRA issues approved2020-01-13 Completed Batch 6 2020-06-22 PR Completed
Issue Resolution in Process
Needs current QRS Template Updates5-Public ReviewDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS
  • - 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. Corey
D
S.
Booth
Kopko
2016

2018-

06

05-

26

11 IR Completed

TR


2019-

10-04 Completed IR
JIRA issues approved2020-01-13 Completed Batch 6 2020-06-22 PR Completed
Issue Resolution in Process

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
ReviewPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(PQL01 - PQL18
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-

10

05-

01

11 IR Completed

IR


No JIRA Issues2020-01-22 Completed Batch 8 July PR

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 Publication4 Stair AscendD. CoreyS. Kopko2019-05-01 Completed PR
JIRA Issues 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 revisons and WORD file generatin 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 Updates6-Between PR and Publication4 Stair Descend D. CoreyS. Kopko2019-05-01 Completed PR
JIRA Issues 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 revisons and WORD file generatin 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 Updates6-Between PR and PublicationCombat Exposure Scale (CES)D. BoothS. Kopko2019-05-01 Completed PR
2019-05-31 Completed Publication QC
No JIRA IssuesTBD NoNeeds current QRS Template Updates6-Between PR and PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. Booth2019-08-17 Completed PRTBD NoNeeds current QRS Template Updates
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
  • 2020-04-09 Full Package in FDA COA review
  • 2020-06-03
-10 WORD/PDF Created
  • 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
2020-04-09 Full Package in FDA COA review
2020-06-03 Received FdA IR commentsFDA IR comments resolution in processNeeds current QRS Template Updates6-Between PR and PublicationPaced Tapping (PACED TAPPING
)D. CoreyS. Kopko
2019
  • 2018-
08
  • 10-
17
  • 01 Completed
PR
  • IR
    No JIRA
issues approvedTBD NoNeeds current QRS Template Updates
  • Issue2020-
  • 2020-09-17 Completed PR 1 JIRA Issue Done
Completed
2020-12-10 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
  • PR
    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
  • FDA IR comments
FDA IR comments resolution in processNeeds current QRS Template Updates
  • 2020-08-26 comment resolution review with FDA
  • 2921-02-12 2nd FDA Review Request

6-Between PR and Publication
Ten
10-Meter Walk/RunD. CoreyD. Booth
  • 2019-05-01 Completed
PR
2019-05-12 Publication QC Completed
JIRA Issues Done
  • PR 
    JIRA Issues Done
  • 2020-08-07 completed 2nd copyediting and WORD file
  • 2021-02-17 completed 3rd copyediting and WORD file
2019-08-28 Completed
  • 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
- minor revisons and WORD file generatin for
  • 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
  • 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. Kopko
D. Booth Completed 2019-04-11 3/20/20197-PublicationPTSD Checklist for DSM-5 (PCL-5)
D. Booth
S. Kopko2019-05-01 Completed PR
2019-05-30 Completed Publication QC
JIRA Issues Done
2020-02-21 Completed
2020-03-12 WORD/PDF createdNo3/31/2020

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
5-Public review 
9 QRS General IssuesColumbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT)TBDTBD   Example update needed base on QRS Skipped Records concept.9 QRS General IssuesColumbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)TBDTBD  CSSR-S Baseline example change control from DBooth 2019-12-05.pdfChange control needed: Example update needed base on QRS Skipped Records concept.9 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    9 QRS General IssuesFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V49 QRS General Issues
(DLQI)D. BoothHOLD
  2019-06-12: Early draft supplement sent for FDA review. 




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




9 QRS 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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