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Date: 20202021-0704-1309

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




1-Development Change ControlTanner Scale Boy VersionS. SudiniS. KopkoCT 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)
Tanner Scale Boy VersionS. Sudini
1-Development Change ControlPAIN Relief (PR) Change Control v1.2
S. Kopko
D. Booth1-Development Change ControlTanner Scale Boy VersionS. SudiniS. Kopko1-Development Change Control
CT change control from RP to RS approved 2020-04-23

In Process
1-Development Change Control
Tanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23In Process
Unified Parkinson's Disease Rating Scale (UPDRS)
TBD
F. AlipourS. Kopko
TBD
Section 4 QSTESTCD = UPD128 response table correction needed
2


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 TR2-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)Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request
  • 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-
2-Team reviewInternational 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
2-Team reviewKurtzke Expanded Disability Status Scale (EDSS)
  • 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
D. Booth2019-11-20 Completed TRPriority review request2-Team reviewKurtzke Functional Systems Scores (KFSS)
  • 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. Corey
F. Alipour
S. Kopko
2020-07-08 TR in process
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review 
KDIGO AKI Stage (KDIGO AKI
International Physical Activity Questionnaire (August 2002) Short Last 7 Days Telephone Format (IPAQ-SF PHONE VERSION)D. CoreyS. Kopko
  • TR Completed
2020
  • 2021-
03
  • 04-
20:
  • 13 IR Completed
TR
2020-07-08 Completed QC ChecklistReady 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



7-PublicationDisability Rating Scale (DRS)F. AlipourS. Kopko
D. Corey
  • 2020-
06
  • 09-
10:
  • 30 Completed TR
  • 2020
-07-08 Completed QC ChecklistReady for IR
  • -11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationQuality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ
3-Internal review Rockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0
)D. CoreyS. Kopko
  • 2020-
07
  • 09-
08
  • 30 Completed
QC Checklist
  • TR
  • 2020-11-17 Completed 
Ready for
  • IR
4-Between IR and PRAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RS
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationKarnofsky Performance Scale (KPS SCALE)F. Alipour
S. Sudini
S. Kopko
2019-06-28 IR completed
2019-12-04 updated to current template
No JIRA IssuesReady for copyediting for PR
  • 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
Needs current QRS Template Updates








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 TBDNeeds 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 TBDNeeds 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
  • 09 Completed
Batch 5
Needs current QRS Template UpdatesNeeds current QRS Template Updates4-Between IR and PRBrief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION
  • PR
TBD for PR

5-Public review Disease Steps (DISEASE STEPS)S.
Kopko
Karra
K
S.
Minkalis
Kopko
  • 2019-
06
  • 04-
28
  • 18 Completed IR
No
  • JIRA
Issues
PR Checklist TBD by DanaTBD Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request
  • issues approved
  • 2021-04-09 Completed PR
TBD for PR

4-Between IR and PR
Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19S. Kopko
European 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
D
. Booth2019-
04
06-
18
28 Completed IR
No
JIRA Issues
TBD for PR
ApprovedCopy-editing and EORTC review will occur prior to FDA reviewTBD April
Needs current QRS Template Updates

4-Between IR and PR
Covi Anxiety Scale (COVI)
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0)S. Kopko
A Humphrey
Jörg Sahlmann D. Booth2019-06-28 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
Deployment Risk and Resilience Inventory-2 (DRRI-2)2019
Geriatric Depression Scale Short Form (GDS SHORT FORM)D. BoothS. Kopko
D. Booth
2016-06-
28 Completed
26 Completed TR
2019-10-04 Completed IR
No
JIRA Issues OpenTBD for PRNoNeeds current QRS Template Updates
4-Between IR and PR
Disease Steps (DISEASE STEPS)
Mini-Mental State Examination (MMSE) Functional Test (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
Needs current
QRS Template Updates
4-Between IR and PR
Eastern Cooperative Oncology Group Performance Status (ECOG)
Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. Corey
S. Sudini
S. Kopko

2018-05-11 IR Completed
2019-

06-28 Completed IR
No JIRA IssuesTBD 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 reviewTBDJörg Sahlmann

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 PR
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0)S. Kopko
Psoriasis Area and Severity Index (PASI)D. Corey
D. Booth
  • 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.
  • 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
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 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 

TBD for PRYes

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. Kopko2018-05-11 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 PRPAIN Intensity (PI) Change Control v1.2S. KopkoK. Minkalis
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
2019-07-31
  • 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 Updates4-Between IR and PR
  • 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
Psoriasis Area and Severity Index (PASI
)D. CoreyD. Booth
  • 2019-09-11 Completed TR
  • 2019-10-04 Completed IR
No JIRA IssuesCompleted for FDA IR2020-06-29 FDA IR comments receivedNeeds current QRS Template Updates
  • JIRA issues approved
  • 2021-03-05 Completed PR
Completed
  • 2021-04-07 1st FDA Review

5-Public review Baseline Dyspnea Index (BDI)S. Karra
4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)
S. Kopko
TBD2018
  • 2019-
08
  • 06-
04
  • 28 Completed
IR
JIRA Issue under review
  • IR No JIRA Issues
  • Ready for PR - add to April?




5-Public review Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION
Needs 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. Kopko
A
K.
Palmer
Minkalis
2018
  • 2019-
08
  • 06-
04
  • 28 Completed
IR
  • IR No 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 Updates
  • 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. Sudini
4-Between IR and PRTransition Dyspnea Index (TDI)S. Karra
S. Kopko
  • 2019-06-28 Completed IR
    No JIRA Issues
TBD 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
  • 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. Kopko
5-Public ReviewDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. Corey
D. Booth
  • 2019-
05
  • 12-
29
  • 04 Completed TR

2019-10-04 Completed IR
No JIRA Issues2020-01-13 Completed Batch 62020-06-22 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
  • (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. Corey
D
S.
Booth
Kopko
2019
  • 2020-
06
  • 03-
05
  • 20: Completed TR
2019
  • 2020-
10
  • 07-
04 Completed IR
JIRA issues approved
  • 08 Completed QC Checklist
  • 2020-
01
  • 09-
13 Completed Batch 62020-06-22 PR Completed
Issue Resolution in Process
Needs current QRS Template Updates
  • 08 Completed IR - 1 Issue Done
  • 2021-04-09 PR Completed



5-Public review Kurtzke Expanded Disability Status Scale (EDSS)S. Kopko
5-Public ReviewDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. Corey
D. Booth
2016
  • 2019-
06
  • 11-
26
  • 20 Completed TR
2019
  • 2020-
10
  • 09-
04
  • 08 Completed IR

JIRA issues approved2020-01-13 Completed Batch 62020-06-22 PR Completed
Issue Resolution in Process
Needs current QRS Template Updates
  • - 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
5-Public ReviewPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(PQL01 - PQL18
)D. CoreyS. Kopko

2018-

10

05-

01 Completed IR
No JIRA Issues2020-01-22 Completed Batch 8

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
July PR
6-Between PR and Publication4 Stair
Ascend
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-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 No
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
Needs 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 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

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
6-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
  • 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
  • FDA IR comments
  • 2020-08-26 comment resolution review with FDA
FDA IR comments resolution in processNeeds current QRS Template Updates
  • 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
  • PR 
    JIRA Issues Done
2019
  • 2020-08-
28 Completed
  • 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
- 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. 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. BoothHOLD
1-DevelopmentFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)D. BoothHOLD2019-06-12: 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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