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Date: 20202021-0604-0309

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 Control
Columbia-Suicide Severity
Barnes Akathisia Rating Scale
Baseline
(
C-SSRS BASELINE
BARS)
TBDTBDExample update needed based on QRS Skipped Records concept.
S. ZilberS. Kopko2021-03-25: QRS CT change control approved 


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



1-Development Change ControlColumbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT)TBDTBD


Example update needed based on QRS Skipped Records concept.
1-Development Change Control
Barnes Akathisia
Columbia-Suicide Severity Rating Scale Baseline (
BARS
C-SSRS BASELINE)
S. Sudini1-Development Change ControlBrief Psychiatric Rating Scale-Anchored (BPRS-A)S. KarraS. Kopko    1-Development Change ControlDisability Rating Scale (DRS)S. Karra     
TBD
     
TBD

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
Three
Five Level Scale (EQ-5D-
3L
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
Five
Three Level Scale (EQ-5D-
5L
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.
Sudini
Kopko
S
D.
KopkoIn Process -conversion to WIKI supplement and existing title needs to be renamed to Functional Activity Questionnaire (FAQ)   
Booth



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

 2019-12-04 TBD by Dana

2019-12-04 Completed TR (revised with "QRS skipped Item" logic based on agreement with FDA at follow-up QRS Skipped Records meeting on 12/9)

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

In Process
1-Development Change Control
Karnofsky Performance Scale (KPS SCALE)
Tanner Scale Boy VersionS. Sudini
     
S. KopkoCT change control from RP to RS approved 2020-04-23

In Process
1-Development Change Control
Kurtzke Functional Systems Scores (KFSS)S. Sudini     1-Development Change ControlPAIN Relief (PR) Change Control v1.2S. KopkoD. Booth1-Development Change Control

Patient Determined Disease Steps (PDDS)

S. KopkoOwner contacted CDISC with an updated letter that removed the deference to Performance Scales (PS) due to potential copyright issues with that instrument - need to remove all references to PS in the supplement and annotated CRF1-Development Change ControlTanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23In Process1-Development Change ControlTanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23In Process1-Development Change ControlUnified Parkinson's Disease Rating Scale (UPDRS)TBDTBDSection 4 QSTESTCD = UPD128 response table correction needed        2-Team review
Unified 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
Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES
)D. CoreyS. Kopko

2019-07-31 Completed TR

 
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review 
2-Team review
International Physical Activity Questionnaire (
October
August 2002)
Long
Short Last 7 Days
Self-Administered
Telephone Format (IPAQ-
LF SELF-ADMINISTERED
SF PHONE VERSION)D. CoreyS. Kopko

2020-02-26: Completed TR QC Checklist

2020-03-04: TR completed

2-Team reviewKDIGO AKI Stage (KDIGO AKI)
  • TR Completed
  • 2021-04-13 IR Completed



7-PublicationDisability Rating Scale (DRS)F. Alipour
D. Corey
S. Kopko
  • 2020-
03
  • 09-
20:
  • 30 Completed TR
QC Checklist
  • 2020
-03-20: TR completed
Ready for IR2-Team reviewKurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth

2019-11-19 TBD by Dana

2019-11-20 Completed TR

 Priority review request2-Team reviewRockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0)
  • -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. Alipour
D. Corey
S. Kopko
  • 2020-
03
  • 09-
20:
  • 09 Completed TR
QC Checklist
  • 2020-
03-20 TR completedReady for IR
  • 11-17 Completed  IR
  • 2021-02-11 Completed PR


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


  • 2021-04-03 Publiished








4-Between IR and PRAJCC TNM Staging System 7th Edition (AJCC V7)D. Booth
        3-Internal review         4-A IR Comment ResolutionAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. Sudini
S. Kopko2019-
06
04-
28 IR completed

2019-12-04 updated to current template

No JIRA Issues

Ready for copyediting for PR Needs current QRS Template Updates4-A IR Comment ResolutionAsthma Daytime Symptom Diary V1.0 (ADSD V1.0)
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. Kopko
D. Corey
D. Booth
  • 2019-
09
  • 04-
11 Completed TR

2019-10-04 Completed IR

JIRA issues approved

 TBD Needs current QRS Template Updates4-A IR Comment ResolutionAsthma Nighttime Symptom Diary V1.0 (ANSD V1.0)D. CoreyD. Booth

2019-09-11 Completed TR

2019-10-04 Completed IR

JIRA issues approved

 TBD Needs current QRS Template Updates4-A IR Comment ResolutionBrief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION
  • 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. Kopko
K
D.
Minkalis
Booth
  • 2019-06-28 Completed IR
    No JIRA Issues

PR Checklist TBD by Dana

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

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

4-
A
Between IR
Comment Resolution
and PREuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0
Covi Anxiety Scale (COVI
)S. Kopko
A Humphrey
Jörg Sahlmann D. Booth2019-06-28 Completed IR
No
JIRA Issues
 TBD Needs current QRS Template Updates4-A IR Comment ResolutionDeployment Risk and Resilience Inventory-2 (DRRI-2
ApprovedCopy-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
 TBD 
Copy-editing and EORTC review will occur prior to FDA reviewTBD April.
Needs current QRS Template Updates
4-
A
Between IR
Comment ResolutionEastern Cooperative Oncology Group Performance Status (ECOG)
and PRGeriatric Depression Scale Short Form (GDS SHORT FORM)D. Booth
S. Sudini
S. Kopko2016-06-26 Completed TR
2019-
06
10-
28
04 Completed IR
No
JIRA Issues Open
 TBD
TBD for PR
 
NoNeeds current QRS Template Updates
4-
A
Between 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)
and PRMini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko
Jörg Sahlmann D. BoothTBD

2018-05-11 IR Completed
2019-

06-28 Completed IR

No JIRA Issues

Copy-editing and EORTC review will occur prior to FDA review

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-
A
Between IR
Comment ResolutionEuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL V1.0)
and PRMini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko
Jörg Sahlmann D. Booth

2018-05-11 IR Completed
2019-

06-28 Completed IR

No JIRA Issues

Copy-editing and EORTC review will occur prior to FDA review

TBD

Wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30.

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-
A
Between IR
Comment ResolutionGeriatric Depression Scale Short Form (GDS SHORT FORM)
and PRPAIN Intensity (PI) Change Control v1.2
D. Booth4-A IR Comment ResolutionPAIN Intensity (PI) Change Control v1.2S. Kopko
S. Kopko

2016-06-26 Completed TR

2019-10-04 Completed IR

JIRA Issues Open

 TBDNoNeeds current QRS Template Updates
K. Minkalis2019-07-31 Completed TR
2019-10-04 Completed IR
JIRA Issues Under review
 TBD
TBD for PR2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.Needs current QRS Template Updates
4-
A
Between IR
Comment Resolution
and PRPsoriasis Area and Severity
Transition Dyspnea
Index (
TDI
PASI)
S
D.
Karra
Corey
S
D.
Kopko
Booth
  • 2019-
06
  • 10-
28
  • 04 Completed IR
  • No JIRA Issues
 TBD Needs current QRS Template Updates        4-Between IR and PRAJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko
  • 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
2019-04-18
  • Completed IR
  • JIRA Issues Done
  • April PR
Needs current QRS Template Updates
2019-11-06 PAR completed 2nd Review and looks good.
2020
-01-13 Completed Needs restore and updates to current QRS template
-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review Transition Dyspnea Index (TDI
4-Between IR and PRDisease Steps (DISEASE STEPS
)S. KarraS. Kopko
  • 2019-
04
  • 06-
18
  • 28 Completed IR
  • No JIRA
issues approved

TBD

 Needs 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. Corey

S. Kopko

S. Kopko

2018-05-11 IR Completed

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

Needs current QRS Template UpdatesYes2019-06-12 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 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

S. Kopko

2018-05-11 IR Completed

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

Needs current QRS Template UpdatesYes2019-06-12 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 PRPsoriasis Area and Severity Index (PASI)D. CoreyD. Booth

2019-10-04 Completed IR

No JIRA Issues

Copyediting Batch 4 and WORD doc needed for FDA IR

Yes

Dana sent for FDA IR 2020-05-05

4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)S. KopkoTBD

2018-08-04 Completed IR

Jira
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-74
JIRA Issue under review

TBD for PR

 TBD

Needs current QRS Template Updates

 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

2018-08-04 Completed IR

JIRA Issues Done

 TBD

Needs current QRS Template Updates

 2019-06-12 sent for 2nd PAR review, SK sent update message to PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR4-Between IR and PRTrauma Symptom Checklist for Children (TSCC)D. BoothTBD

2018-08-14 Completed IR

JIRA Issues Done

 TBD

Needs current QRS Template Updates

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

2019-06-28 Completed IR

No JIRA Issues

2020-01-13 Completed Batch 5Ready for PR after Batch 85-Public ReviewDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. CoreyD. Booth

2019-05-29 Completed TR

2019-10-04 Completed IR

No JIRA Issues

2020-01-13 Completed Batch 6May PR5-Public ReviewDiabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)D. CoreyD. Booth

2019-06-05 Completed TR

2019-10-04 Completed IR

JIRA issues approved

2020-01-13 Completed Batch 6May PR
5-Public ReviewDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. CoreyD. Booth

2016-06-26 Completed TR

2019-10-04 Completed IR

JIRA issues approved

2020-01-13 Completed Batch 6May PR
5-Public Review

Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3

PQL01 - PQL18)

D. CoreyS. Kopko

2018-10-01 Completed IR

No JIRA Issues

2020-01-22 Completed Batch 8June PR6-Between PR and Publication4 Stair AscendD. CoreyS. Kopko

2019-05-01 Completed PR

JIRA Issues Done

2019-08-28 Completed2020-01-31 Completed FDA final quick reviewFDA quick review issues to be reviewed at 2020-03-25 & 04-01 meetings - CRF NOT DONE questions in CDISC review6-Between PR and Publication4 Stair Descend D. CoreyS. Kopko

2019-05-01 Completed PR

JIRA Issues Done

2019-08-28 Completed2020-01-31 Completed FDA final quick reviewFDA quick review issues to be reviewed at 2020-03-25 & 04-01 meetings - CRF NOT DONE questions in CDISC review6-Between PR and PublicationCombat Exposure Scale (CES)D. BoothS. Kopko

2019-05-31 Completed Publication QC

2019-05-01 Completed PR

No JIRA Issues

TBD NoNeeds current QRS Template Updates6-Between PR and PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. Booth

2019-08-17 Completed PR

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

TBD

 No

Needs current QRS Template Updates
  • 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

Publication QC TBD

  • JIRA Issues Done
2020
  • 2021-01-
13 Completed2020-03-10 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
  • 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 Updates6-Between PR and PublicationRAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT
2021-03-08 Published
7-PublicationPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(PEDSQL01 - PEDSQL18)		D.
Booth
CoreyS. Kopko
2019
  • 2018-
08
  • 10-
17
  • 01 Completed
PR
  • IR
    No JIRA
Issues OpenTBD NoNeeds current QRS Template Updates6-Between PR and PublicationRising From Floor
  • 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
D. Corey
S. Kopko
  • 2019-
05
  • 08-
01
  • 17 Completed PR

2019-05-13 Completed Publication QC

  • JIRA Issues Done
2019-08-28
Completed
2020-01-31 Completed FDA final quick review
 No2021-03-08 Published
FDA quick review issues to be reviewed at 2020-03-25 & 04-01 meetings - CRF NOT DONE questions in CDISC review
6-Between PR
and PublicationSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)
and PublicationRising From FloorD.
Booth
CoreyS. Kopko2019-05-01 Completed PR
Publication QC TBD
2019-05-13 Completed Publication QC
JIRA Issues Done		2019-08-28 Completed2020-01-
13
31 Completed FDA final quick review
2020-
03
06-24 Draft Updates based on 10
WORD/PDF Created
Meter Walk/Run presented to FDA - minor revisions and WORD file 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
2020-04-09 Full Package in FDA COA review
6-Between PR and Publication
Ten Meter Walk/Run
Symptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D.
Corey
Booth
D
S.
Booth
Kopko
  • 2019-05-01 Completed PR

2019-05-12 Publication QC Completed

  • JIRA Issues Done
2019
  • 2021-
08
  • 01-
28
  • 25 2nd Copyediting Completed
  • 2020-
01-31 Completed FDA final quick reviewFDA quick review issues to be reviewed at 2020-03-25 & 04-01 meetings - CRF NOT DONE questions in CDISC review
  • 04-09 Full Package in FDA COA review
  • 2020-06-03 Received FDA IR comments
  • 2020-08-26 comment resolution review with FDA
  • 2921-02-12 2nd FDA Review Request

6-Between PR and Publication
Veterans Administration Lung Study Group (VALG)
10-Meter Walk/RunD.
Booth
Corey
S
D.
Kopko
Booth
  • 2019-05-01 Completed
PR

2019-05-13 Publication QC Completed-need comment confirmation

JIRA Issues Done

TBD NoNeeds current QRS Template Updates        7-PublicationClinical Global Impressions (CGI)S. KopkoD. Booth Completed 2019-04-11 2019-03-207-PublicationPatient Global Impressions (PGI)S. KopkoD. Booth Completed 2019-04-11 2019-03-207-PublicationLife Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION
  • 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

6-Between PR and PublicationVeterans Administration Lung Study Group (VALG)D. Booth
L
S.
McLeod
Kopko
  • 2019-05-01 Completed
PR
  • PR JIRA Issues Done
  • 2019-05-
30 Completed Publication QC

JIRA Issues Done

2020-02-21 Completed

2020-03-12 WORD/PDF created

No2020-03-31
  • 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. Kellly
7-PublicationPTSD Checklist for DSM-5 (PCL-5)D. BoothS. Kopko
2019-05-01 Completed PR

2019-05-30 Completed Publication QC

No JIRA Issues
Done
2020-
02
01-21 Completed
2020-
03
05-
12
21 WORD/PDF
createdNo
Revised for publishing
5/27/2020
7-PublicationClinical Global Impressions (CGI)S. KopkoD. Booth
Completed 2019-04-11
3/20/2019
2020-03-31
7-Publication
Age, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS
Emotion Recognition (EMOTION RECOGNITION)D. Corey
K
S.
Kellly
Kopko2019-05-01 Completed PR
No JIRA Issues		2020-01-21 Completed
2020-
03-20 WORD/PDFs requested2020-
05-
21
19 WORD/PDF Revised for publishing
2020-05-27

5/22/2020
7-Publication
Emotion Recognition (EMOTION RECOGNITION
Hamilton Anxiety Rating Scale (HAM-A)
D
S.
Corey
Kopko
S
L.
Kopko
McLeod2019-05-01 Completed PR
No JIRA Issues		2020-01-21 Completed
2020
-03
-
20 WORD/PDFs requested2020-
05-
19
21 WORD/PDF Revised for publishing
2020-05-22

5/22/2020
7-Publication
Hamilton
Hospital Anxiety
Rating
and Depression Scale (
HAM-A
HADS)S. Kopko
L
K.
McLeod
Minkalis

2019-05-01

Completed PR

Completeed

2019-05-30
Completed Publication QC
No JIRA Issues

2020-01-21 Completed
2020-03-20 WORD/PDFs requested

2020-05-21 WORD/PDF Revised for publishing
2020-05-22

5/22/2020
7-Publication
Hospital Anxiety and Depression Scale (HADS)S. Kopko
Life Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION)D. BoothL. McLeod
K. Minkalis
2019-05-01 Completed PR
2019-05-
31
30 Completed Publication QC
No
JIRA Issues Done2020-
01
02-21 Completed
2020-03-
20
12 WORD/
PDFs requested

2020-05-21 WORD/PDF Revised for publishing

PDF createdNo3/31/2020
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
5-Public review 
2020-05-22        QRS General Issues

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

TBDTBD

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

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

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


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




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




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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