Page History

Date: 20202021-0304-2309

1-DevelopmentEQ-5D-5L - update to include standardized numeric values from manual 1-Development

Review Period	Instrument Name	QRS Developer	QC Assignee	QC	Copy Editing	FDA Review?	QRS IR or PR
1-Development

EQ-5D-3L - update to include standardized numeric values from manual 1

Columbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING)

S. Kopko

1-Development

Functional Assessment Scale - NACC Version (FAS-NACC UDS v3.0)

S. Kopko

In Process: Draft CT in review with

	2019-09-25 In Process new copyright received for v3.0 CRF - CT Approved in PKG 41
1-Development	Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0 (PRO-CTCAE v1.0)	S. Kopko

NCI and FDA -

they re

meeting

on this

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. Zilber	S. Kopko	2021-03-25: QRS CT change control approved
1-Development Change Control	Brief Psychiatric Rating Scale-Anchored (BPRS-A)	TBD	S. Kopko
1-Development Change Control	Columbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT)	TBD	TBD	Example update needed based on QRS Skipped Records concept.
1-Development Change Control

PAIN Relief (PR) Change Control v1.2S. KopkoD. Booth

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

TBD

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

Example update needed based on QRS Skipped Records concept.

1-Development Change Control

Barnes Akathisia Rating Scale (BARS)S. Sudini

European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)	D. Erabelly	S. Kopko	update to include standardized numeric values from manual 2021-03-18 Q&A with SK
1-Development Change Control

Brief Psychiatric Rating Scale-Anchored (BPRS-A)

European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L)

D. Erabelly

S. Karra

S. 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

Disability Rating Scale (DRS)S. Karra 1-Development Change Control

Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome v2.0 (Published supplement conversion to current WIKI template)

S. Kopko

D. Booth

Priority review request

In Process 2019-11-26

2020-01-08 Dana doing QC of final CT change control before updating WIKI supplement		Priority review request
1-Development Change Control	Functional Assessment Questionnaire - NACC Version (FAQ-NACC UDS v2.0)	S. Sudini	S. Kopko	Based on QRS CT team review, Dana doing QC of 2019-12-19 FAQ-NACC UDS v2.0 final CT

S. Sudini


1-Development Change Control

Functional Assessment Questionnaire (FAQ)

PAIN Relief (PR) Change Control v1.2

S. Kopko

In Process -conversion to WIKI supplement and existing title needs to be renamed to Functional Activity Questionnaire (FAQ)

D. Booth
1-Development Change Control

Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template

Tanner Scale Boy Version

S.

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)

To be added to Copyediting Batch 4 and WORD doc needed for FDA IR

Kopko

CT change control from RP to RS approved 2020-04-23

In Process

Priority review request

1-Development Change Control

Karnofsky Performance Scale (KPS SCALE)

Tanner Scale Boy Version

S. Sudini

S. Kopko	CT change control from RP to RS approved 2020-04-23			In Process
1-Development Change Control

Kurtzke Functional Systems Scores (KFSS)S. Sudini 2-Team reviewGlucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES

Unified Parkinson's Disease Rating Scale (UPDRS)

F. Alipour

S. Kopko

Section 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. Corey

S. Kopko

2019-07-09 Completed TR QC 2019-07-31 Completed 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	S. Kopko	TR Completed 2021-04-13 IR Completed
3-Internal review

2-Team review

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

D. Corey

S. Kopko

2020-02-26: Completed TR QC Checklist
2020-06-03

-04

: Completed TR

completed

#2

2-Team review

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

KDIGO AKI Stage (KDIGO AKI

)

D. Corey

S. Kopko

2020-03-20: 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

2019-11-20 Completed TR

Priority review request2-Team reviewRockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0)

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	S. 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. Corey	S. Kopko

2020-03-20: Completed TR QC Checklist

2020-03-20: TR completed

Ready for IR 3-Internal review Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR

TR Completed 2021-04-13 IR Completed
7-Publication	Disability Rating Scale (DRS)	F. Alipour	S. Kopko	2020-09-30 Completed TR 2020-11-17 Completed IR 2021-02-11 Completed PR	2021-04-03 Publiished
7-Publication	Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ)	D. Corey	S. Kopko

D. Corey2019-05-23 1st PAR review comments updated and Completed QC for PR TBD2018-05-11 IR Completed - 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, PAR

2020-09-30 Completed TR 2020-11-17 Completed IR 2021-02-11 Completed PR			2021-04-03 Publiished
7-Publication	Karnofsky Performance Scale (KPS SCALE)	F. Alipour	S. Kopko	2020-09-09 Completed TR 2020-11-17 Completed IR 2021-02-11 Completed PR			2021-04-03 Publiished
7-Publication	Kurtzke Functional Systems Scores (KFSS)	F. Alipour	S. 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	AJCC TNM Staging System 7th Edition (AJCC V7)	D. Booth	S. Kopko	2019-04-18 Completed IR JIRA Issues Done	2020-01-13 Completed 2020-05-27: Restored and updates to current QRS template
5-Public review	Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19	S. Kopko	D. Booth	2019-04-18 Completed IR No JIRA Issues April PR		Yes
5-Public review	Covi Anxiety Scale (COVI)	S. Kopko	A 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	D. Booth	2019-06-28 Completed IR No JIRA Issues 2021-04-09 Completed PR	TBD for PR
5-Public review	Disease Steps (DISEASE STEPS)	S. Karra

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 TBDIR Completed - 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, PAR 4-A IR Comment ResolutionAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. Sudini

S. Kopko

2019-

05

04-

06

18 Completed

QC Checklist

IR completed 2019-06-28

2019-12-04 updated to current template

No JIRA Issues

IR JIRA issues approved 2021-04-09 Completed PR	TBD for PR
4-Between IR and PR	European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0)	S. Kopko	Jörg Sahlmann D. Booth	2019-06-28 Completed IR JIRA Issues Approved	Copy-editing and EORTC review will occur prior to FDA review	TBD April
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	Jörg Sahlmann

Ready for copyediting for PR 4-A IR Comment ResolutionAJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko

Completed

2019-04-18 IR completed

JIRA Issues Done

2020-01-13 Completed MaybeDana checking for text revisions4-A IR Comment ResolutionAsthma Daytime Symptom Diary V1.0 (ADSD V1.0)D. Corey

D. Booth

2019-

09

06-

10 Completed TR QC

28 Completed IR No JIRA Issues	Copy-editing and EORTC review will occur prior to FDA review	TBD April	.
4-Between IR and PR	Geriatric Depression Scale Short Form (GDS SHORT FORM)	D. Booth	S. Kopko	2016-06-26

2019-09-11

 Completed TR
2019-10-04 Completed IR

Completed

JIRA

issues approved TBD

Issues Open

TBD for PR

No

Needs current QRS Template Updates

4-

A

Between IR

Comment ResolutionAsthma Nighttime Symptom Diary V1.0 (ANSD V1.0

and PR

Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)

D. Corey

D

S.

Booth

Kopko

2019

2018-

09

05-

10

11 IR Completed

TR QC

2019-

09-11 Completed TR
2019-10-04 IR Completed

JIRA issues approved

TBD

05-23 1st PAR

review comments updated and Completed QC for PR

2020-09-24 Updated to current template

TBD for FDA IR

Yes

2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates

4-Between IR and PR

Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)

D. Corey

S. Kopko

2018-05-11 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

Yes

2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates

4-Between IR and PR

PAIN Intensity (PI) Change Control v1.2

4-A IR Comment ResolutionBaseline Dyspnea Index (BDI)S. KarraS. Kopko

Completed

IR completed 2019-06-28

No JIRA Issues

2020-01-13 Completed Ready for PR4-A IR Comment ResolutionBrief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)

S. Kopko

K. Minkalis

Completed

2019-07-31 Completed TR
2019-

06

10-

28

04 Completed IR

No

JIRA Issues Under review

TBD for PR

Checklist TBD by DanaTo be Added 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. KopkoD. Booth

Completed

2019-04-18 Completed IR

JIRA Issues Done

Copyediting needed for PRTBD

	2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.	Needs current QRS Template Updates
4-Between IR and PR	Psoriasis Area and Severity Index (PASI)	D. Corey	D. Booth	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

4-A IR Comment ResolutionCovi Anxiety Scale (COVI

)

S. Kopko

A Humphrey

Completed

2019-06-28 Completed IR

No JIRA Issues

TBD 4-A IR Comment ResolutionDeployment Risk and Resilience Inventory-2 (DRRI-2)S. KopkoD. Booth

Completed

2019-06-28 Completed IR

No JIRA Issues

TBD 4-A IR Comment ResolutionDiabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)D. CoreyD. Booth

2019-05-27 Completed TR QC

2019-05-29 Completed TR
Completed 2019-10-04 IR

No JIRA Issues

TBD 4-A IR Comment ResolutionDiabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)D. CoreyD. Booth

2019-06-21 Completed TR QC

2019-06-05 Completed TR
2019-10-04 IR Completed

JIRA issues approved

TBD 4-A IR Comment ResolutionDiabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)D. CoreyD. Booth

2019-09-09 Completed TR QC

2016-06-26: Completed TR

2019-10-04 Completed IR

JIRA issues approved

TBD

TBD	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. Kopko	A. 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	S. 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. Booth	D. Corey	2018-08-14 Completed IR JIRA Issues Done April PR		2020-07-10 Updated PAR agreement signed-good to move forward

7-Publication	Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS

4-A IR Comment ResolutionEastern Cooperative Oncology Group Performance Status (ECOG)

S. Sudini

S. Kopko

Completed

2019-06-28

Completed

IR completed
No JIRA Issues

TBD 4-A IR Comment ResolutionEuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3

2021-03-05 Completed PR	Completed		2021-04-03 Publiished
5-Public review	Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)

S

D.

Kopko

Corey

Jörg Sahlmann D

D. Booth

2019-09-11 Completed TR
2019-

06

10-

28

04 Completed IR

No

JIRA

IssuesCopy-editing and EORTC review will occur prior to FDA reviewTBD4-A IR Comment Resolution

issues approved 2021-03-05 Completed PR	Completed	2021-04-07 1st FDA Review
5-Public review	Asthma Nighttime Symptom Diary V1.0 (ANSD

European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care V1.0 (EORTC QLQ-C15-PAL

V1.0)

S

D.

Kopko

Corey

Jörg Sahlmann

D. Booth

Completed

2019-09-11 Completed TR
2019-

06

10-

28

04 Completed IR

No

JIRA

IssuesCopy-editing and EORTC review will occur prior to FDA reviewTBDShould wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30.

issues approved 2021-03-05 Completed PR	Completed	2021-04-07 1st FDA Review
5-Public review	Baseline Dyspnea Index (BDI)	S. Karra

4-A IR Comment ResolutionGeriatric Depression Scale Short Form (GDS SHORT FORM)D. Booth

S. Kopko

2019-06-28 Completed

IR QC

2016-06-26 Completed TR
2019-10-04 IR Completed

JIRA Issues Open

TBDNo

IR No JIRA Issues Ready for PR - add to April?
5-Public review	Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)

4-A IR Comment ResolutionPAIN Intensity (PI) Change Control v1.2

S. Kopko

K. Minkalis

2019-

07

06-

09 Completed TR QC

2019-07-31 Completed TR
2019-10-04 Completed IR

JIRA Issues Under review

TBD2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.

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-Publication	Eastern Cooperative Oncology Group Performance Status (ECOG)	S. Sudini	S. Kopko

4-A IR Comment ResolutionPsoriasis Area and Severity Index (PASI)D. CoreyD. Booth

2019-08-20 Completed TR QC

2019-10-04 Completed IR

No JIRA Issues

Copyediting Batch 4 and WORD doc needed for FDA IR 4-A IR Comment ResolutionTransition Dyspnea Index (TDI)S. KarraS. KopkoCompleted

2019-06-28 Completed IR
No JIRA Issues

TBD 4-Between IR and PRDisease Steps (DISEASE STEPS)

2021-03-05 PR Completed			2021-04-03 Publiished
5-Public review	Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)	D. Corey

S. Karra

S. Kopko

2019-07-31 Completed TR

2019

2020-

04

09-

18

08 Completed IR

JIRA issues approved

TBD

- 1 Issue Done - Ready for PR
2021

IR completed 2019

-04-

18

09 PR Completed

4-Between IR and PR

Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3

PQL01 - PQL18)

D. CoreyS. Kopko

2018-10-01 Completed IR

No JIRA Issues

2020-02-21 CompletedReady for PR4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)S. KopkoTBD

2018-08-04 Completed IR Completed

Jira

server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	QRSSUPP-74

JIRA Issue under review

TBD for PR

TBD 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

Completed

2018-08-04 Completed IR

JIRA Issues Done

TBD 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

Completed

2018-08-14 Completed IR

JIRA Issues Done

TBD 2019-06-12 Requested PAR agreement update to include as a CDISC standard 6-Between PR and Publication4 Stair AscendD. CoreyS. Kopko

Completed

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 meeting6-Between PR and Publication


5-Public review	Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template	S. Kopko	D. 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	PUB-341 to be sent in April
5-Public review	KDIGO AKI Stage (KDIGO AKI)	D. Corey	S. 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. Kopko	D. 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	PUB-341 to be sent in April
5-Public review	Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR)	D. Corey	S. 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	Yes	2019-11-06 PAR completed 2nd Review and looks good. 2020-07-101 Updated PAR agreement signed-good to move forward Needs current QRS Template Updates
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. Corey	S. 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	Yes	2019-11-06 PAR completed 2nd Review and looks good. 2020-07-101 Updated PAR agreement signed-good to move forward Needs current QRS Template Updates
5-Public review	National Early Warning Score 2 (NEWS2)	D. Booth	S. 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. Kopko	D. 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)

4 Stair Descend 2019

D. Corey

S. Kopko

Completed

2020-

05

07-

01 Completed PR

JIRA Issues Done

2019-08-28 Completed

08 Completed QC Checklist from TR on 2020-03-18
2020-

01

09-

31 Completed FDA final quick review

08 Completed IR - 1 Issue Done
April PR

FDA quick review issues to be reviewed at 2020-03-25 meeting



6-Between PR and Publication

Age, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)

4 Stair Ascend

D. Corey

K

S.

Kelly

Kopko

Completed

2019-05-01 Completed PR

No

JIRA Issues Done

2020

2019-

01-21 Completed6-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 No

08-28 Completed

2020-01-31 Completed FDA final quick review
2020-

03-20 WORD/PDFs requested

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 Publication

Emotion Recognition (EMOTION RECOGNITION)

4 Stair Descend

D. Corey

S. Kopko

2019-05-01 Completed

Public Review

PR

No

JIRA Issues Done

2019-08-28 Completed

2020-01-

21

31 Completed FDA final quick review
2020-

03-20 WORD/PDFs requested

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-Publication	Combat Exposure Scale (CES)	D. Booth	S. Kopko	2019-05-01 Completed PR 2019-05-31 Completed Publication QC No JIRA Issues	Completed	No	2021-03-08 Published
7-Publication	Epworth

6-Between PR and PublicationEpworth

Sleepiness Scale (ESS)

S. Kopko

D. Booth

Completed

2019-08-17 Completed PR

jira

Completed

server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	QRSSUPP-162

JIRA Issue under reviewCompleted 6-Between PR and PublicationHamilton Anxiety Rating Scale (HAM-A)S. KopkoL. McLeod

Completed Public Review 2019-05-01

No JIRA Issues

Copyediting completed
In Publication process Completed PR 2019-05-016-Between PR and PublicationHospital Anxiety and Depression Scale (HADS)S. KopkoK. Minkalis

2019-05-31 Completed Publication QC

No JIRA Issues

Copyediting completed
In Publication process Completed PR 2019-05-016-Between PR and PublicationLife Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION)D. BoothL. McLeod

2019-05-30 Completed Publication QC

JIRA Issues Done

Batch 5 Copyediting for PublicationFDA quick review neededCompleted PR 2019-05-016-Between PR and Publication

No	2021-03-08 Published
7-Publication	Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)	D. Corey	D. 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-Publication	Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS)	D. Corey	D. 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-Publication	Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS)	D. Corey	D. 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 Publication	Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)	D. Booth	S. 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-Publication	Paced Tapping (PACED TAPPING)	D. Corey	S. Kopko	2019-08-17 Completed PR JIRA issues approved	Completed	No	2021-03-08 Published
7-Publication	Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 (PEDSQL01 - PEDSQL18)	D. Corey	S. Kopko	2018-10-01 Completed IR No JIRA Issue2020- 2020-09-17 Completed PR 1 JIRA Issue Done	Completed		2020-12-10 Published
7-Publication	RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)	D. Booth	S. Kopko	2019-08-17 Completed PR JIRA Issues Done	Completed	No	2021-03-08 Published
6-Between PR and Publication	Rising From Floor	D. Corey	S. Kopko	2019-05-01 Completed PR 2019-05-13 Completed Publication QC JIRA Issues Done	2019-08-28 Completed	2020-01-31 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 Publication	Symptoms of Major Depressive Disorder Scale v1.0 (SMDDS

Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ

V1.0)

D. Booth

S. Kopko

2019-05

-01 Completed PR

Publication QC TBD

JIRA Issues Done

2020-01-13 Completed Batch 3 Copyediting for Publishing - WORD file in Review

-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 Publication

Paced Tapping (PACED TAPPING)

10-Meter Walk/Run

D. Corey

S

D.

Kopko

Completed

JIRA issues approved

Completed 2019-08-17 Public Review completed6-Between PR and PublicationPTSD Checklist for DSM-5 (PCL-5)D. BoothS. Kopko

2019-05-30 Completed Publication QC

JIRA Issues Done

Batch 5 Copyediting for PublicationFDA quick review needed

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

Completed PR 2019-05-01


6-Between PR and Publication

RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT

Veterans Administration Lung Study Group (VALG)

D. Booth

S. Kopko

Completed

JIRA Issues Open

Completed 2019-08-17 Public Review completed6-Between PR and Publication

2019-05-01 Completed PR JIRA Issues Done 2019-05-13 Publication QC Completed-need comment confirmation Needs CDISC CRF by Dana	TBD	No
7-Publication	Age, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)

Rising From Floor

D. Corey

S

K.

Kopko

Kellly

2019-05-

13 Completed Publication QC

01 Completed PR
No JIRA Issues

Done

2019

2020-

08

01-

28

21 Completed

2019-09-06 FDA final quick reviewCompleted PR 2019-05-01

2020-05-21 WORD/PDF Revised for publishing		5/27/2020
7-Publication	Clinical Global Impressions (CGI)	S. Kopko	D. Booth	Completed 2019-04-11	3/20/2019
7-Publication	Emotion Recognition (EMOTION RECOGNITION)	D. Corey

6-Between PR and PublicationSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0)D. Booth

S. Kopko

2019-05-01 Completed PR

Publication QC TBD

No JIRA Issues

Done

2020-01-

13 Completed Batch 3 Copyediting for Publishing - WORD file in Review

21 Completed 2020-05-19 WORD/PDF Revised for publishing		5/22/2020
7-Publication	Hamilton Anxiety Rating Scale (HAM-A)	S. Kopko	L. McLeod	2019-05-01 Completed PR No JIRA Issues	2020-01-21 Completed 2020-05-21 WORD/PDF Revised for publishing		5/22/2020
7-Publication	Hospital Anxiety and Depression Scale (HADS)	S. Kopko	K. 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-Publication	Life Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION)	D. Booth	L. McLeod	2019-05-01 Completed PR 2019-05-30 Completed Publication QC JIRA Issues Done	2020-02-21 Completed 2020-03-12 WORD/PDF created	No	3/31/2020

6-Between PR and PublicationTen Meter Walk/RunD. CoreyD. Booth

Publication QC Completed 2019-05-12

JIRA Issues Done

2019-08-28 Completed2019-09-06 FDA final quick reviewCompleted PR 2019-05-016-Between PR and PublicationVeterans Administration Lung Study Group (VALG)D. BoothS. Kopko

Publication QC Completed 2019-05-13 need comment confirmation

JIRA Issues Done

TBD Completed PR 2019-05-01 7-PublicationClinical Global Impressions (CGI)S. KopkoD. Booth Completed 2019-04-11 3/20/2019


7-Publication	Patient Global Impressions (PGI)	S. Kopko	D. Booth

Completed 2019-04-11

3/20/2019

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

7-Publication	PTSD Checklist for DSM-5 (PCL-5)	D. Booth	S. Kopko	2019-05-01 Completed PR 2019-05-30 Completed Publication QC JIRA Issues Done	2020-02-21 Completed 2020-03-12 WORD/PDF created	No	3/31/2020
5-Public review

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. Kopko	April PR
9 QRS General Issues	Dermatology Life Quality

Index (DLQI)D. BoothHOLD QRS General IssuesFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4QRS General Issues

Index (DLQI)

D. Booth

HOLD

2019-06-12: Early draft supplement sent for FDA review.


1-Development

Functional Assessment of Cancer Therapy-Lung Version 4 (FACT-L V4)

D. Booth

HOLD

QRS General IssuesQRS General Issues


1-Development	Functional Assessment of Chronic Illness Therapy-Dyspnea (Dyspnoea) 10 Item Short Form (FACIT-DYSPNEA SF)	D. Booth	HOLD


1-Development

Functional Assessment of Chronic Illness Therapy-Fatigue 13-Item Scale Version 4 (FACIT-FATIGUE 13-ITEM V4)

S. Karra

D. Booth

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 TBD	2019-05-29 Completed TR
9 QRS General Issues	Unified Huntington's Disease Rating Scale '99 (UHDRS 1999)	D. Corey	HOLD

xx

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