Page History

Date: 20202021-1004-0509

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

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	Barnes Akathisia Rating Scale (BARS)	S.

Sudini

Zilber	S. Kopko	2021-03-25: QRS CT change control approved
1-Development Change Control	Brief Psychiatric Rating Scale-Anchored (BPRS-A)

S. Karra

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	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)	TBD	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	European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)

TBD

D. Erabelly

S. Kopko

TBD

	update to include standardized numeric values from manual 2021-03-18 Q&A with SK
1-Development Change Control	European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L)

TBD

D. Erabelly

S. 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 Control	Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome v2.0 (Published supplement conversion to current WIKI template)	S. Kopko	D. Booth	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
1-Development Change Control	PAIN Relief (PR) Change Control v1.2	S. Kopko	D. Booth
1-Development Change Control	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	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	Unified Parkinson's Disease Rating Scale (UPDRS)

TBD

F. Alipour

S. Kopko

TBD

Section 4 QSTESTCD = UPD128 response table correction needed

In Process

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

2-Team review

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


3-Internal review	Crohn's Disease Activity Index Version 1 (CDAI V1)	D.

D.

Corey

S. Kopko

2020-02-26: Completed TR QC Checklist
2020-06-03: Completed TR #2

TR Completed 2021-04-13 IR Completed
3-Internal review

Disability Rating Scale (DRS)

Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)

D. Booth

F. Alipour

S. Kopko

TR Completed

2020

2021-

09

04-

30

13 IR Completed

TR

Ready for IR


3-Internal review

Functional Assessment Questionnaire (FAQ)

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

D. Corey

S. Karra

S. Kopko

2020-

07-15 QC Checklist & TR completed

02-26: Completed TR QC Checklist
2020-06-03: Completed TR #2
2021-04-13 IR Completed

IR until 2020-09-08


3-Internal review

Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES

International Physical Activity Questionnaire (August 2002) Short Last 7 Days Self-Administered Format (IPAQ-SF SELF-ADMINISTERED VERSION)

D. Corey

S. Kopko

2019-07-31

TR Completed

TR

IR until 2020

2021-

09

04-

08

13 IR Completed
3-Internal review

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

International Physical Activity Questionnaire (November 2002) Long Last 7 Days Telephone Format (IPAQ-LF PHONE VERSION)

D. Corey

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

Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review requestIR until 2020-09-08

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

3-Internal review Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ

)

D. Corey

S. Kopko

TR Completed

2020

2021-

09

04-

30

13 IR Completed

TR

Ready for IR

3-Internal review Karnofsky Performance Scale (KPS SCALE


7-Publication	Disability Rating Scale (DRS)	F. Alipour	S. Kopko	2020-09-

09

30 Completed TR

Ready for IR

In Process3-Internal review KDIGO AKI Stage (KDIGO AKI

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	2020-

03

09-

20:

30 Completed TR
2020-

07-08 Completed QC Checklist

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

IR until 2020-09-083-Internal review Kurtzke Expanded Disability Status Scale (EDSS)S. KopkoD. Booth2019-11-20 Completed TRAdd to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review requestIR until 2020-09-083-Internal review

Kurtzke Functional Systems Scores (KFSS)

F. Alipour

S. Kopko

2020-07-15 TR completed

Ready for IR

3-Internal review

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

National Early Warning Score 2 (NEWS2

)

D. Booth

S. Kopko

2019-04-

22 Completed TR

18 Completed IR
JIRA Issues Done

2020-

08-19 QC Checklist - Steve Copyright permission on OneDrive?Add to Copyediting Batch 4 and WORD doc needed for FDA IRPriority review requestIR until 2020-09-083-Internal review Patient Determined Disease Steps (PDDS)
Owner contacted CDISC with updated letter that removed the deference to Performance Scales (PS) due to potential copyright issues with that instrument

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.

Corey

Booth

2020

2019-

063-Internal review Rockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0)D. CoreyS. Kopko2020-07-08 Completed QC ChecklistReady for IR4-Between IR and PRAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. Kopko

04-

10: Completed TR
2020-07-08 Completed QC ChecklistIR until 2020-09-08

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

completed

2019-12-04 updated to current template

No JIRA Issues

Ready for copyediting for PRNeeds current QRS Template Updates4-Between IR and PRAJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko2019-04-18 Completed IR
JIRA Issues Done2020-01-13 Completed
2020-05-27: Restored and updates to current QRS template4-Between IR and PRAsthma Daytime Symptom Diary V1.0 (ADSD V1.0)D. CoreyD. Booth

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	S. Kopko	2019-04-18 Completed

2019-09-11 Completed TR
2019-10-04 Completed 2020

IR
JIRA issues approved

TBD

2021-

08-18 updated to current template - ready

04-09 Completed PR	TBD for PR
4-Between IR and PR

Asthma Nighttime Symptom Diary V1.0 (ANSD V1

European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0)

D

S.

Corey

Kopko

D

Jörg Sahlmann D. Booth

2019-

09

06-

11 Completed TR
2019-10-04 Completed

28 Completed IR
JIRA

issues approved TBD

Issues Approved

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

TBD April

2020-08-18 updated to current template - ready for PR


4-Between IR and PR

Baseline Dyspnea Index (BDI

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

S.

Karra

Kopko

S

Jörg Sahlmann D.

Kopko

Booth

2019-06-28 Completed IR
No JIRA Issues

2020-01-13 Completed Batch 5
Needs current QRS Template Updates

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

TBD April

.

Needs current QRS Template Updates

4-Between IR and PR

Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)

Geriatric Depression Scale Short Form (GDS SHORT FORM)

D. Booth

S. Kopko

K. Minkalis

2016-06-26 Completed TR
2019-

06

10-

28

04 Completed IR

No

JIRA Issues Open

PR Checklist TBD by DanaTBD Copyediting Batch 4 and WORD doc needed for FDA IRPriority review request

TBD for PR	No	Needs current QRS Template Updates
4-Between IR and PR

Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19

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

D. Corey

S. Kopko

D. BoothTBD

2018-05-11 IR Completed
2019-

04-18 Completed IR
No JIRA IssuesTBD for PR

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

Covi Anxiety Scale (COVI)

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

A Humphrey

2018-05-11 IR Completed
2019-

06-28 Completed IR
No JIRA IssuesTBD for PRNeeds current QRS Template Updates4-Between IR and PRDeployment Risk and Resilience Inventory-2 (DRRI-2)S. KopkoD. Booth2019-06-28 Completed IR
No JIRA IssuesTBD for PRS. Karra

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

Disease Steps (DISEASE STEPS)

PAIN Intensity (PI) Change Control v1.2

S. Kopko

2019-04-18

K. Minkalis

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

issues approved

Issues Under review	TBD for PR	2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.	Needs current QRS Template Updates
4-Between IR and PR

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

Psoriasis Area and Severity Index (PASI)

D. Corey

D. Booth

S. Kopko

2019-

06

10-

28

04 Completed IR

No JIRA Issues

TBD for PRNeeds current QRS Template Updates4-Between IR and PREuropean Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0TBD

CRF & Supplement being updaed		2020-06-29 FDA IR comments received
5-Public review	Suicidal Ideation Questionnaire (SIQ)	S. Kopko

Jörg Sahlmann D. Booth2019-06-28 Completed IR
JIRA Issues ApprovedCopy-editing and EORTC review will occur prior to FDA review

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

4-Between IR and PR

5-Public review

Suicidal Ideation Questionnaire-JR (SIQ-JR

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 D

A.

Booth

Palmer

2019

2018-

06

08-

28

04 Completed IR

No

JIRA Issues

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

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

4-Between IR and PRGeriatric Depression Scale Short Form (GDS SHORT FORM)D. Booth

S. Kopko

2016

2019-06-

26 Completed TR
2019-10-04 Completed IR

28 Completed IR No JIRA Issues

Open

TBD

Ready for PR

NoNeeds current QRS Template Updates4-Between IR and PR

- add to April?
5-Public review	Trauma Symptom Checklist for Children (TSCC

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

)

D.

Corey

Booth

S

D.

Kopko

Corey

2018-

05

08-

11 IR

14 Completed

2019-05-23 1st PAR

review comments updated and Completed QC for PR

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

IR JIRA Issues Done
April PR

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

Needs current QRS Template Updates


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

4-Between IR and PRMini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR)D. Corey

S. Kopko

2018

2019-

05-11 IR Completed
2019-05-23 1st PAR review comments updated and Completed QC for PR TBD for PRYes2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates

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. Corey	D. Booth	2019-09-11

4-Between IR and PRPAIN Intensity (PI) Change Control v1.2S. KopkoK. Minkalis2019-07-31

Completed TR
2019-10-04 Completed IR
JIRA

Issues Under reviewTBD for PR2019-10-22: CDER currently re-considering its priorities for the standardization of pain instrument data.Needs current QRS Template Updates

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

4-Between IR and PRPsoriasis Area and Severity Index (PASI

)

D. Corey

D. Booth

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

No JIRA IssuesCompleted for FDA IR2020-06-29 FDA IR comments receivedNeeds current QRS Template Updates

JIRA issues approved 2021-03-05 Completed PR	Completed	2021-04-07 1st FDA Review
5-Public review	Baseline Dyspnea Index (BDI)	S. Karra	S. Kopko	2019-06-28 Completed IR No JIRA Issues Ready for PR - add to April?
5-Public review	Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION

4-Between IR and PRSuicidal Ideation Questionnaire (SIQ)S. KopkoTBD2018-08-04 Completed IR
JIRA Issue under reviewNeeds current QRS Template Updates2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates4-Between IR and PRSuicidal Ideation Questionnaire-JR (SIQ-JR

)

S. Kopko

A

K.

Palmer

Minkalis

2018

2019-

08

06-

04

28 Completed

IR

IR No JIRA Issues

DoneNeeds current QRS Template Updates2019-11-06 PAR completed 2nd Review and looks good.
2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates4-Between IR and PRTransition Dyspnea Index (TDI)S. KarraS. Kopko2019-06-28 Completed IR
No JIRA IssuesTBD for PRNeeds current QRS Template Updates4-Between IR and PRTrauma Symptom Checklist for Children (TSCC)D. BoothTBD2018-08-14 Completed IR
JIRA Issues DoneNeeds current QRS Template Updates

2020-09-05 PR Checklist by Dana 2021-02-03 FDA Responses reeived on Research Request PR after FDA review	2021-03-03 Completed copyediting for FDA Review	PUB-341 to be sent in April
7-Publication	Eastern Cooperative Oncology Group Performance Status (ECOG)	S. Sudini	S. Kopko	2019-06-28 Completed IR No JIRA Issues 2021-03-05 PR Completed			2021-04-03 Publiished
5-Public review	Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)	D. Corey	S. 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 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)	D. Corey	S. Kopko	2020-07-08 Completed QC Checklist from TR on 2020-03-18 2020-09-08 Completed IR - 1 Issue Done April PR

2020-07-101 Updated PAR agreement signed-good to move forward



6-Between PR and Publication	4 Stair Ascend	D. Corey	S. Kopko	2019-05-01 Completed PR 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

revisons

revisions and WORD file

generatin

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	4 Stair Descend	D. Corey	S. Kopko	2019-05-01 Completed PR 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

revisons

revisions and WORD file

generatin

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

7-

Between PR and

Publication

Combat Exposure Scale (CES)

D. Booth

S. Kopko

2019-05-01 Completed PR
2019-05-31 Completed Publication QC

No JIRA Issues

TBD

Completed

No

Needs current QRS Template Updates

2021-03-08 Published

7-

6-Between PR and

Publication

Epworth Sleepiness Scale (ESS)

S. Kopko

D. Booth

2019-08-17 Completed PR

TBD

Completed

No

Needs current QRS Template Updates6-Between PR and

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

Needs current QRS Template Updates before WORD file for publishingDana/Diane doing QC before Publication

2020-09-24 Updated to current template	Completed		2021-03-08 Published
7-

6-Between PR and

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

Needs current QRS Template Updates before WORD file for publishingDana/Diane doing QC before Publication

2020-09-22 Updated to current template	Completed		2021-03-08 Published
7-

6-Between PR and

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

Needs current QRS Template Updates before WORD file for publishing

2020-09-22 Updated to current template

Completed

2021-03-08 Published

Dana/Diane doing QC before Publication


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

Publication QC TBD

JIRA Issues Done

2020

2021-01-

13

25 2nd Copyediting Completed

2020-

03-10 WORD/PDF Created2020-

04-09 Full Package in FDA COA review
2020-06-03 Received FDA IR comments
2020-08-26 comment resolution review with FDA

Needs current QRS Template Updates

2921-02-12 2nd FDA Review Request
7-

6-Between PR and

Publication

Paced Tapping (PACED TAPPING)

D. Corey

S. Kopko

2019-08-17 Completed PR

JIRA issues approved

TBD

Completed

No

Needs current QRS Template Updates

2021-03-08 Published

7-

6-Between PR and

Publication

Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3
(

PQL01

PEDSQL01 -

PQL18

PEDSQL18)

D. Corey

S. Kopko

2018-10-01 Completed IR
No JIRA Issue2020-
2020-09-17 Completed

PR

PR 1 JIRA Issue Done

Completed

2020-

01-22 Completed Batch 8Dana/Diane doing QC before Publication

12-10 Published

7-

6-Between PR and

Publication

RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT)

D. Booth

S. Kopko

2019-08-17 Completed PR

JIRA Issues

Open

Done

TBD

Completed

No

Needs current QRS Template Updates

2021-03-08 Published
6-Between PR and 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

revisons

revisions and WORD file

generatin

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 V1.0)	D. Booth	S. Kopko	2019-05-01 Completed PR

Publication QC TBD

JIRA Issues Done

2020

2021-01-

13 Completed
2020-03-10 WORD/PDF Created

25 2nd Copyediting Completed

2020-04-09 Full Package in FDA COA review
2020-06-03 Received FDA IR comments
2020-08-26 comment resolution review with FDA

Needs current QRS Template Updates

2921-02-12 2nd FDA Review Request
6-Between PR and Publication	10-Meter Walk/Run	D. Corey	D. Booth	2019-05-01 Completed

PR
2019-05-12 Publication QC Completed

PR
JIRA Issues Done

2019

2020-08-

28 Completed2020-08-

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 Publication	Veterans Administration Lung Study Group (VALG)	D. Booth	S. Kopko	2019-05-01

Completed PR

Completed PR JIRA Issues Done
2019-05-13 Publication QC Completed-need comment confirmation

JIRA Issues Done

Needs CDISC CRF by Dana

TBD

No

Needs current QRS Template Updates


7-Publication	Age, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)	D. Corey	K. Kellly	2019-05-01 Completed PR No JIRA Issues	2020-01-21 Completed 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	S. Kopko	2019-05-01 Completed PR No JIRA Issues	2020-01-21 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
7-Publication	Patient Global Impressions (PGI)	S. Kopko	D. Booth		Completed 2019-04-11		3/20/2019
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

1

5-

Development

Public review

Controlled Oral Word Association Test (COWAT)

D. Corey

HOLD

S. Kopko	April PR
9 QRS General Issues	Dermatology Life Quality Index (DLQI

)D. BoothHOLD1-DevelopmentFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4

)

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
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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