Versions Compared

Old Version 106

changes.mady.by.user Dana Booth

Saved on

compared with

New Version Current

changes.mady.by.user Steve Kopko

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Date: 20192021-1004-0209

1-DevelopmentEQ-5D-5L - update to include standardized numeric values from manual1-Development
Review PeriodInstrument NameQRS DeveloperQC AssigneeQCCopy EditingFDA Review?QRS IR or PR
1-Development
EQ-5D-3L - update to include standardized numeric values from manual
Columbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING)S. Kopko
     





1-Development
Hamilton Depression Rating
Functional Assessment Scale
17
-
Item (HAMD 17Priority review request
NACC Version (FAS-NACC UDS v3.0)S. Kopko
Published supplement conversion to current WIKI template

2019-09-25 In Process

new copyright received for v3.0 CRF - CT Approved in PKG 41


1-Development
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) -
Patient-Reported
OutcomeD. BoothPublished supplement conversion to current WIKI templatePriority review request1-DevelopmentPatient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0
Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0 (PRO-CTCAE v1.0)S. Kopko
     

  • NCI and FDA - meeting in Jan. 2020 and on 6/23/20 to move forward
  • NIH Draft CT review commeents resolved with S. Mitchell
1-Development Change ControlPAIN Relief (PR) Change Control v1.2S. KopkoIn Process    



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



1-Development Change ControlBrief Psychiatric Rating Scale-Anchored (BPRS-A)
S. Karra1-Development
TBDS. Kopko
  Priority review request 




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


Example update needed based on QRS Skipped Records concept.
 
1-Development Change Control
Functional Assessment Questionnaire - NACC Version (FAQ-NACC)S. SudiniS. Kopko

In Process

new copyright requested for v3.0 CRF

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

CSSR-S Baseline example change control from DBooth 2019-12-05.pdfExample update needed based on QRS Skipped Records concept.
 
1-Development Change Control
Functional Assessment Questionnaire (FAQ)
European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)D. Erabelly
S. Sudini
S. Kopko
In Process  
  • update to include standardized numeric values from manual
  • 2021-03-18 Q&A with SK
 



1-Development Change Control
Karnofsky Performance Scale (KPS SCALE)
European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L)D. ErabellyS.
Sudini    
Kopko
  • update to include standardized numeric values from manual
  • 2021-03-18 Q&A with SK
  • 2021-04-08 ready for TR
 



1-Development Change Control
Kurtzke Expanded Disability Status Scale (EDSS
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome v2.0 (Published supplement conversion to current WIKI template)S. Kopko
   Priority review request
D. Booth2020-01-08 Dana doing QC of final CT change control before updating WIKI supplement
Priority review request
 

1-Development Change Control
Kurtzke Functional Systems Scores (KFSS
Functional Assessment Questionnaire - NACC Version (FAQ-NACC UDS v2.0)S. Sudini
     2-Team reviewFunctional 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 TR2-Team reviewGlucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)D. CoreyS. Kopko2019-07-09 Completed TR QC2019-07-31 Completed Team Review3-Internal review Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)D. CoreyD. Booth2019-09-10 Completed TR QC

2019-09-11 Completed TR

2019-10-04 IR Completed

3-Internal review Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)D. CoreyD. Booth2019-09-10 Completed TR QC

2019-09-11 Completed TR

2019-10-04 IR Completed

3-Internal review Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. CoreyD. Booth2019-05-27 Completed TR QC  

2019-05-29 Completed TR

2019-10-04 IR Completed

3-Internal review Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)D. CoreyD. Booth2019-06-21 Completed TR QC  
2019-06-05 Completed TR

2019-10-04 IR Completed

3-Internal review Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. CoreyD. Booth2019-09-09 Completed TR QC  
2016-06-26: Completed TR

2019-10-04 IR Completed

3-Internal review Geriatric Depression Scale Short Form (GDS SHORT FORM)D. BoothS. Kopko2019-06-28 Completed IR QC TBD
2016-06-26: Completed TR

2019-10-04 IR Completed

3-Internal review 
PAIN Intensity (PI) Change Control v1.2S. KopkoK. Minkalis2019-07-09 Completed TR QCPriority review request

2019-07-31 Completed TRe

2019-10-04 IR Completed

3-Internal review 

Psoriasis Area and Severity Index (PASI)

D. CoreyD. Booth2019-08-20 Completed TR QC2019-10-04 IR Completed3-Internal review Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. Corey S. KopkoD. Corey2019-05-23 1st PAR review comments updated and Completed QC for PR  TBD

2018-05-11 IR Completed - 2019-06-12 sent for 2nd PAR review, next steps: copyediting & FDA IR

SK sent update message to PAR 2019-08-20.

3-Internal review Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. Corey S. KopkoD. Corey2019-05-23 1st PAR review comments updated and Completed QC for PR TBD

2018-08-14 IR Completed - 2019-06-12 sent for 2nd PAR review, next steps: copyediting & FDA IR

SK sent update message to PAR 2019-08-20.

4-A IR Comment ResolutionAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. KopkoCompleted  IR completed 2019-06-28
S. KopkoBased on QRS CT team review, Dana doing QC of 2019-12-19 FAQ-NACC UDS v2.0 final CT


1-Development Change ControlPAIN Relief (PR) Change Control v1.2S. KopkoD. Booth



1-Development Change ControlTanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23

In Process
1-Development Change ControlTanner Scale Boy VersionS. SudiniS. KopkoCT change control from RP to RS approved 2020-04-23

In Process
1-Development Change ControlUnified Parkinson's Disease Rating Scale (UPDRS)F. AlipourS. KopkoSection 4 QSTESTCD = UPD128 response table correction needed

In Process

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

2-Team review






3-Internal review 

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

D. CoreyS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)D. BoothS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review International Physical Activity Questionnaire (October 2002) Long Last 7 Days Self-Administered Format (IPAQ-LF SELF-ADMINISTERED VERSION)D. CoreyS. Kopko
  • 2020-02-26: Completed TR QC Checklist
  • 2020-06-03:  Completed TR #2
  • 2021-04-13 IR Completed



3-Internal review International Physical Activity Questionnaire (August 2002) Short Last 7 Days Self-Administered Format (IPAQ-SF SELF-ADMINISTERED VERSION)D. CoreyS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review International Physical Activity Questionnaire (November 2002) Long Last 7 Days Telephone Format (IPAQ-LF PHONE VERSION)D. CoreyS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



3-Internal review International Physical Activity Questionnaire (August 2002) Short Last 7 Days Telephone Format (IPAQ-SF PHONE VERSION)D. CoreyS. Kopko
  • TR Completed
  • 2021-04-13 IR Completed



7-PublicationDisability Rating Scale (DRS)F. AlipourS. Kopko
  • 2020-09-30 Completed TR
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationQuality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ)D. CoreyS. Kopko
  • 2020-09-30 Completed TR
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


  • 2021-04-03 Publiished
7-PublicationKarnofsky Performance Scale (KPS SCALE)F. AlipourS. Kopko
  • 2020-09-09 Completed TR
  • 2020-11-17 Completed  IR
  • 2021-02-11 Completed PR


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


  • 2021-04-03 Publiished








4-Between IR and PR
4-A IR Comment ResolutionIR completed
AJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko
CompletedCopyediting in Batch 4 
2019-04-18
4-A IR Comment ResolutionBaseline Dyspnea Index (BDI)
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 2019-02-19
S. KarraIR completed
S. Kopko
Completed Copyediting in Batch 4 
D. Booth
  • 2019-
06-284-A IR Comment Resolution
  • 04-18 Completed IR No JIRA Issues
  • April PR

Yes
5-Public review Covi Anxiety Scale (COVI
Brief Psychiatric Rating Scale (BPRSIR completed
)S. Kopko
K. MinkalisCompleted  Priority review request
A Humphrey
  • 2019-06-28
4-A IR Comment Resolution
  • Completed IR
    No JIRA Issues
  • 2021-04-09 Completed PR
  • 2021-04-09 Completed PR
TBD for PR

5-Public review Deployment Risk and Resilience Inventory-2 (DRRI-2)
Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19
S. KopkoD. Booth
  • 2019-06-28 Completed
Copyediting needed for PRTBD
  • IR
    No JIRA Issues
  • 2021
IR completed 2019
  • -04-
184-A IR Comment Resolution
  • 09 Completed PR
TBD for PR

5-Public review Disease Steps (DISEASE STEPS
Covi Anxiety Scale (COVI
)S. KarraS. Kopko
A HumphreyCompleted   IR completed 2019-06-284-A IR Comment Resolution
  • 2019-04-18 Completed IR
    JIRA issues approved
  • 2021-04-09 Completed PR
TBD for PR

4-Between IR and PREuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0
Deployment Risk and Resilience Inventory-2 (DRRI-2
)S. Kopko
D
Jörg Sahlmann D. Booth
Completed   
IR completed
2019-06-28 Completed IR
JIRA Issues Approved		Copy-editing and EORTC review will occur prior to FDA reviewTBD April
4-
A
Between IR
Comment ResolutionEastern Cooperative Oncology Group Performance Status (ECOG)S. SudiniS. KopkoCompleted   IR completed 2019-06-284-A IR Comment ResolutionEuropean Organisation for
and PREuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire -
Core 30 Version 3
Palliative Care V1.0 (EORTC QLQ-C15-
C30 V3
PAL V1.0)S. KopkoJörg
Sahlmann D
Sahlmann D. Booth
Completed  Needs review with EORTCTBDIR completed 2019-06-28 After that, copy-
2019-06-28 Completed IR
No JIRA Issues		Copy-editing and EORTC review will occur prior to FDA reviewTBD April.
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 PRGeriatric Depression Scale Short Form (GDS SHORT FORM)D. BoothS. Kopko
Jörg Sahlmann D. BoothCompleted Needs review with EORTCTBDIR completed 2019-06-28
After that, copy-editing and EORTC review will occur prior to FDA review. Should wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30.
2016-06-26 Completed TR
2019-10-04 Completed IR
JIRA Issues Open		TBD for PRNoNeeds current QRS Template Updates
4-Between IR and PRMini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko

2018-05-11 IR Completed
2019-05-23 1st PAR

review comments updated and Completed QC for PR 

2020-09-24 Updated to current template

TBD for FDA IRYes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
4-Between IR and PRMini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko

2018-05-11 IR Completed
2019-05-23 1st PAR review comments updated and Completed QC for PR 

2020-09-24 Updated to current template

TBD for FDA IRYes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
4-A IR Comment ResolutionTransition Dyspnea Index (TDI)S. KarraS. KopkoCompleted   IR completed 2019-06-284-Between IR and PRDisease Steps (DISEASE STEPS)S. KarraS. KopkoCompletedCopyediting needed for PR IR completed 2019-04-184-Between IR and PRPEDSQL Instruments (18)D. CoreyTBDTBD for PRTBD Hold for Batch 3 or  4?4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)S. KopkoTBDTBD for PR  

2018-08-04 IR Completed  - 2019-06-12 sent for 2nd PAR review, next steps: copyediting for public review

SK sent update message to PAR 2019-08-20.
4-Between IR and PR
Suicidal Ideation Questionnaire-JR (SIQ-JR)
PAIN Intensity (PI) Change Control v1.2S. Kopko
A
K.
Palmer
Minkalis2019-07-31 Completed TR
  2018-08
2019-10-04
IR Completed  - 2019-06-12 sent for 2nd PAR review, next steps: copyediting for public review

SK sent update message to PAR 2019-08-20.

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
Trauma Symptom Checklist for Children (TSCC
Psoriasis Area and Severity Index (PASI)D. CoreyD. Booth
TBDCompleted   2018-08-14 IR Completed
2019-06-12 Requested PAR agreement update to include as a CDISC standard
  • 2019-10-04 Completed IR No JIRA Issues
  • CRF & Supplement being updaed


  • 2020-06-29 FDA IR comments received

5-Public review Suicidal Ideation Questionnaire (SIQ)S. KopkoTBD
  • 2018-08-04 Completed IR JIRA Issue under review
  • April PR


2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review Suicidal Ideation Questionnaire-JR (SIQ-JR)S. KopkoA. Palmer
  • 2018-08-04 Completed IR
  • JIRA Issues Done
  • April PR
Needs current QRS Template Updates
2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review Transition Dyspnea Index (TDI)S. Karra
6-Between PR and Publication4 Stair AscendD. CoreyS. KopkoCompleted2019-08-28 Completed2019-09-06 FDA final quik reviewCompleted Public Review 2019-05-016-Between PR and Publication4 Stair Descend D. CoreyS. KopkoCompleted2019-08-28 Completed 2019-09-06 FDA final quik reviewCompleted Public Review 2019-05-016-Between PR and PublicationAge, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)D. CoreyK. KellyCompleted2019-07-23 Copyediting for Publication requested Completed Public Review 2019-05-016-Between PR and PublicationCombat Exposure Scale (CES)D. Booth
S. Kopko
  • 2019-
05-31 Completed Publication QC - need comment confirmationTBD Completed Public Review 2019-05-01
  • 06-28 Completed IR No JIRA Issues
  • Ready for PR - add to April?



5-Public review Trauma Symptom Checklist for Children (TSCC
6-Between PR and PublicationEmotion Recognition (EMOTION RECOGNITION
)D.
Corey
Booth
S
D.
KopkoCompleted Public Review 2019-05-012019-07-23 Copyediting for Publication requested Completed Public Review 2019-05-01
Corey
  • 2018-08-14 Completed IR JIRA Issues Done
  • April PR


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








7-PublicationAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. Kopko
  • 2019-06-28 IR completed
    No JIRA Issues
  • 2021-03-05 Completed PR
Completed
  • 2021-04-03 Publiished
5-Public review Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)D. CoreyD. Booth
  • 2019-09-11 Completed TR
  • 2019-10-04 Completed IR
    JIRA issues approved
  • 2021-03-05 Completed PR
 Completed
  • 2021-04-07 1st FDA Review

5-Public review Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)D. CoreyD. Booth
  • 2019-09-11 Completed TR
  • 2019-10-04 Completed IR
    JIRA issues approved
  • 2021-03-05 Completed PR
Completed
  • 2021-04-07 1st FDA Review

5-Public review Baseline Dyspnea Index (BDI)S. KarraS. Kopko
  • 2019-06-28 Completed IR No JIRA Issues
  • Ready for PR - add to April?




5-Public review Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)S. KopkoK. Minkalis
  • 2019-06-28 Completed IR No JIRA Issues
  • 2020-09-05 PR Checklist by Dana
  • 2021-02-03 FDA Responses reeived on Research Request
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review

PUB-341 to be sent in April


7-PublicationEastern Cooperative Oncology Group Performance Status (ECOG)S. SudiniS. Kopko
  • 2019-06-28 Completed IR
    No JIRA Issues
  • 2021-03-05 PR Completed


  • 2021-04-03 Publiished
5-Public review Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)D. CoreyS. Kopko
  • 2019-07-31 Completed TR
  • 2020-09-08 Completed IR - 1 Issue Done - Ready for PR
  • 2021-04-09 PR Completed



5-Public review Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI templateS. KopkoD. Booth
  • 2019-12-04 Completed TR (revised with "QRS skipped Item" logic based on agreement with FDA at follow-up QRS Skipped Records meeting on 12/9)
  • 2020-08-15 QC Checklist completed
  • 2020-09-08 Completed IR - 1 Issue Done
  • 2021-02-15 QRS Research Request
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review

5-Public review KDIGO AKI Stage (KDIGO AKI)D. CoreyS. Kopko
  • 2020-03-20: Completed TR
  • 2020-07-08 Completed QC Checklist
  • 2020-09-08 Completed IR - 1 Issue Done
  • 2021-04-09 PR Completed



5-Public review Kurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth
  • 2019-11-20 Completed TR
  • 2020-09-08 Completed IR - 1 Issue Done
  • PR after FDA review
  • 2021-03-03 Completed copyediting for FDA Review

5-Public review Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko

2018-05-11 IR Completed
2019-05-23 1st PAR

review comments updated and Completed QC for PR 

2020-09-24 Updated to current template

TBD for FDA IR

Dana checking with PAR for user manuals

Yes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. CoreyS. Kopko

2018-05-11 IR Completed
2019-05-23 1st PAR review comments updated and Completed QC for PR 

2020-09-24 Updated to current template

TBD for FDA IR

Dana checking with PAR for user manuals

Yes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates
5-Public review National Early Warning Score 2 (NEWS2)D. BoothS. Kopko
  • 2019-04-22 Completed TR
  • 2020-08-19 QC Checklist - Steve Copyright permission on OneDrive?
  • 2020-09-08 Completed IR - 1 Issue Done
  • April PR

TBD April with PR
5-Public review Patient Determined Disease Steps (PDDS)

Owner contacted CDISC with updated letter that removed the deference to Performance Scales (PS) due to potential copyright issues with that instrument		S. KopkoD. Corey
  • 2020-06-10: Completed TR
  • 2020-07-08 Completed QC Checklist
  • 2020-09-08 Completed IR - 1 Issue Done
  • 2021-04-09 PR Completed



5-Public review Rockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0)D. CoreyS. Kopko
  • 2020-07-08 Completed QC Checklist from TR on 2020-03-18
  • 2020-09-08 Completed IR - 1 Issue Done
  • April PR











6-Between PR and Publication4 Stair AscendD. CoreyS. Kopko2019-05-01 Completed PR
JIRA Issues Done		2019-08-28 Completed2020-01-31 Completed FDA final quick review
2020-06-24 Draft Updates based on 10 Meter Walk/Run presented to FDA - minor revisions and WORD file generation for final quick review		FDA quick review issues reviewed at 2020-03-25 & 04-01 meetings
To be updated based on 2nd FDA IR on 10 Meter Walk/Run
Needs current QRS Template Updates
6-Between PR and Publication4 Stair Descend D. CoreyS. Kopko2019-05-01 Completed PR
JIRA Issues Done		2019-08-28 Completed2020-01-31 Completed FDA final quick review
2020-06-24 Draft Updates based on 10 Meter Walk/Run presented to FDA - minor revisions and WORD file generation for final quick review		FDA quick review issues reviewed at 2020-03-25 & 04-01 meetings
To be updated based on 2nd FDA IR on 10 Meter Walk/Run
Needs current QRS Template Updates
7-PublicationCombat Exposure Scale (CES)D. BoothS. Kopko
  • 2019-05-01 Completed PR
  • 2019-05-31 Completed Publication QC No JIRA Issues
Completed No2021-03-08 Published
7-PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. Booth2019-08-17 Completed PRCompleted No2021-03-08 Published
7-PublicationDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. CoreyD. Booth

2019-05-29 Completed TR
2019-10-04 Completed IR
No JIRA Issues

2020-06-22 PR Completed - 
No Issues

2020-09-24 Updated to current template

Completed
2021-03-08 Published
7-PublicationDiabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)D. CoreyD. Booth

2019-06-05 Completed TR
2019-10-04 Completed IR
JIRA issues approved

2020-06-22 PR Completed - 
No Issues

2020-09-22 Updated to current template

Completed
2021-03-08 Published
7-PublicationDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. CoreyD. Booth

2016-06-26 Completed TR
2019-10-04 Completed IR
JIRA issues approved

2020-06-22 PR Completed - 
No Issues

2020-09-22 Updated to current template

Completed
2021-03-08 Published
6-Between PR and PublicationNon-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)D. BoothS. Kopko
  • 2019-05-01 Completed PR
    JIRA Issues Done
  • 2021-01-25 2nd Copyediting Completed
  • 2020-04-09 Full Package in FDA COA review
  • 2020-06-03 Received FDA IR comments
  • 2020-08-26 comment resolution review with FDA
  • 2921-02-12 2nd FDA Review Request

7-PublicationPaced Tapping (PACED TAPPING)D. CoreyS. Kopko
  • 2019-08-17 Completed PR JIRA issues approved
Completed No2021-03-08 Published
7-PublicationPediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(PEDSQL01 - PEDSQL18)		D. CoreyS. Kopko
  • 2018-10-01 Completed IR
    No JIRA 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. BoothS. Kopko
  • 2019-08-17 Completed PR JIRA Issues Done
Completed No2021-03-08 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 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 PublicationSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. BoothS. Kopko
  • 2019-05-01 Completed PR
    JIRA Issues Done
  • 2021-01-25 2nd Copyediting Completed
  • 2020-04-09 Full Package in FDA COA review
  • 2020-06-03 Received FDA IR comments
  • 2020-08-26 comment resolution review with FDA
  • 2921-02-12 2nd FDA Review Request

6-Between PR and Publication10-Meter Walk/RunD. CoreyD. Booth
  • 2019-05-01 Completed PR 
    JIRA Issues Done
  • 2020-08-07 completed 2nd copyediting and WORD file
  • 2021-02-17 completed 3rd copyediting and WORD file
  • 2020-01-31 Completed FDA final quick review
  • 2020-03-25 & 04-01 meetings-FDA quick review issues reviewed  & revisions needed
  • 2020-06-24 Draft Updates presented to FDA
  • 2020-08-10 WORD file generated and send for 2nd FDA final quick review
  • 2021-02-17 WORD file generated and send for 3rd FDA final quick review

6-Between PR and PublicationVeterans Administration Lung Study Group (VALG
6-Between PR and PublicationEpworth Sleepiness Scale (ESS)S. KopkoD. BoothCompletedCompleted2019-08-17 Public Review completed6-Between PR and PublicationHamilton Anxiety Rating Scale (HAM-A)S. KopkoL. McLeodCompleted Public Review 2019-05-012019-07-23 Copyediting for Publication requested Completed PR 2019-05-016-Between PR and PublicationHospital Anxiety and Depression Scale (HADS)S. KopkoK. Minkalis2019-05-31 Completed Publication QC2019-07-23 Copyediting for Publication requested Completed PR 2019-05-016-Between PR and PublicationLife Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION)D. BoothL. McLeod2019-05-30 Completed Publication QCBatch 5 Copyediting for PublicationFDA quick review neededCompleted PR 2019-05-016-Between PR and PublicationNon-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)D. BoothS. Kopko2019-05-30 Completed Publication QCBatch 3 Copyediting for Publication Completed PR 2019-05-016-Between PR and Publication

Paced Tapping (PACED TAPPING)

D. CoreyS. KopkoCompletedCompleted2019-08-17 Public Review completed6-Between PR and PublicationPTSD Checklist for DSM-5 (PCL-5Completed PR
)D. BoothS. Kopko
  • 2019-05-
30 Completed Publication QCBatch 5 Copyediting for PublicationFDA quick review needed
  • 01 Completed PR JIRA Issues Done
  • 2019-05-
016-Between PR and Publication
  • 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
RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT
)D.
Booth
Corey
S
K.
Kopko
Kellly2019-05-01 Completed PR
No JIRA Issues		2020-01-21 Completed
2019
2020-
08-17 Public Review completed6-Between PR and PublicationRising From Floor
05-21 WORD/PDF Revised for publishing
5/27/2020
7-PublicationClinical Global Impressions (CGI)
D. Corey
S. Kopko
2019-05-13 Completed Publication QC2019-08-28 Completed 2019-09-06 FDA final quik reviewCompleted PR 2019-05-01
D. Booth
Completed 2019-04-11
3/20/2019
7-PublicationEmotion Recognition (EMOTION RECOGNITION)D. Corey
6-Between PR and PublicationSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. Booth
S. Kopko2019-05-
30 Completed Publication QC need comment confirmationBatch 3 Copyediting for Publication Completed PR 2019-05-01
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
6-Between PR and PublicationTen Meter Walk/RunD. CoreyD. BoothPublication QC Completed 2019-05-122019-08-28 Completed 2019-09-06 FDA final quik reviewCompleted PR 2019-05-016-Between PR and PublicationVeterans Administration Lung Study Group (VALG)D. BoothS. KopkoPublication QC Completed 2019-05-13 need comment confirmationTBD Completed PR 2019-05-017-PublicationClinical Global Impressions (CGI)S. KopkoD. Booth Completed 2019-04-11 3/20/2019
7-PublicationPatient Global Impressions (PGI)S. KopkoD. Booth
 

Completed 2019-04-11
 

3/20/2019
QRS General IssuesControlled Oral Word Association Test (COWAT
7-PublicationPTSD Checklist for DSM-5 (PCL-5)D.
Corey
Booth
HOLD    QRS General IssuesDermatology Life Quality Index (DLQI)D. BoothHOLD    QRS General IssuesFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)D. BoothHOLD  2019-06-12: Early draft supplement sent for FDA review. QRS General Issues
S. 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 Controlled Oral Word Association Test (COWAT)D. CoreyS. KopkoApril PR


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



1-DevelopmentFunctional 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)
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. Booth
HOLD     
Team 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
 



xx