Page History

Date: 2020-0607-0509

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
1-Development Change Control

Columbia-Suicide Severity

Barnes Akathisia Rating Scale

Baseline

(

C-SSRS BASELINE)TBDTBDExample update needed based on QRS Skipped Records concept.

BARS)	S. Sudini
1-Development Change Control

Columbia-Suicide Severity

Brief Psychiatric Rating Scale-

Since Last Visit

Anchored (

C-SSRS

BPRS-A)	S. Karra	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

Barnes Akathisia

Columbia-Suicide Severity Rating Scale Baseline (

BARS

C-SSRS BASELINE)

S. Sudini

TBD

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

TBD

Example update needed based on QRS Skipped Records concept.

1-Development Change Control	Disability Rating Scale (DRS)	S. Karra
1-Development Change Control	European Quality of Life Five Dimension

Three

Five Level Scale (EQ-5D-

3L

5L)	TBD	TBD	update to include standardized numeric values from manual
1-Development Change Control	European Quality of Life Five Dimension

Five

Three Level Scale (EQ-5D-

5L

3L)	TBD	TBD	update to include standardized numeric values from manual
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	Functional Assessment Questionnaire (FAQ)	S. Karra	S. Kopko	In Process -conversion to WIKI supplement and existing title needs to be renamed to Functional Activity Questionnaire (FAQ)

CT change control to be presented to QRS CT team

1-Development

Change Control

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

Karnofsky Performance Scale (KPS SCALE)	S. Sudini
1-Development Change Control	PAIN Relief (PR) Change Control v1.2	S. Kopko	D. Booth

2019-12-04 TBD by Dana

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

Add to Copyediting Batch 4 and WORD doc needed for FDA IR

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)F. Alipour

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

PAIN Relief (PR) Change Control v1.2S. KopkoD. Booth1-Development Change Control

Patient Determined Disease Steps (PDDS)

S. KopkoD. CoreyOwner 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 CRF

Unified Parkinson's Disease Rating Scale (UPDRS)	TBD	TBD	Section 4 QSTESTCD = UPD128 response table correction needed
2-Team review	Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)	D. Corey	S. Kopko	2019-07-31 Completed TR
2-Team review	Hamilton Depression Rating Scale 17-Item (HAMD 17) Published supplement conversion to current WIKI template	S. Kopko	D. Booth	2019-12-04 TBD by Dana 2019-12-04 Completed TR (revised with "QRS skipped Item" logic based on agreement with FDA at follow-up QRS Skipped Records meeting on 12/9)	Add to Copyediting Batch 4 and WORD doc needed for FDA IR	Priority review request
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: Completed TR #2

1-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

Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES)D. CoreyS. Kopko

Kurtzke Expanded Disability Status Scale (EDSS)

S. Kopko

D. Booth

2019-11-20

2019-07-31

Completed TR		Priority review request
2-Team review

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

Kurtzke Functional Systems Scores (KFSS)

F. Alipour

D. Corey

S. Kopko

2020-02-26: Completed TR QC Checklist

2020-

03

07-

04: TR completed

08 TR in process
3-Internal review

2-Team review

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 by Dana

2019-11-20 Completed TR

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

2020-03-20: Completed TR QC Checklist

2020-03-20 TR completed

Ready for IR

07-08 Completed QC Checklist			Ready for IR
3-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	S. Kopko	D. Corey	2020-06-10: Completed TR 2020-07-08 Completed QC Checklist		Ready for IR
3-Internal review	Rockport One Mile Walk Test (ROCKPORT ONE MILE WALK TEST V1.0)	D. Corey	S. Kopko	2020-07-08 Completed QC Checklist		Ready for IR
4-Between IR and PR	Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS	S. Sudini	S. Kopko	2019-06-28 IR completed 2019-12-04 updated to current template No JIRA Issues	Ready for copyediting for PR

3-Internal review 4-A IR Comment ResolutionAbnormal Involuntary Movement Scale (AIMS) Change Control QS->RSS. SudiniS. Kopko

2019-06-28 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)D. CoreyD. Booth

2019-09-11 Completed TR

2019-10-04 Completed IR

JIRA issues approved

TBD

		Needs current QRS Template Updates
4-

A

Between IR

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

and PR

AJCC TNM Staging System 7th Edition (AJCC V7)

D.

Corey

Booth

D

S.

Booth

Kopko

2019-

09

04-

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)S. KopkoK. Minkalis

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 2019-02-19

18 Completed IR JIRA Issues Done	2020-01-13 Completed 2020-05-27: Restored and updates to current QRS template
4-Between IR and PR	Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)	D. Corey	D. Booth	2019-09-11 Completed TR 2019-10-04 Completed IR JIRA issues approved	TBD	Needs current QRS Template Updates
4-Between IR and PR	Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)	D. Corey

S. Kopko

D. Booth

2019-

04-18

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

Issues DoneCopyediting needed for PR

issues approved

TBD

	Needs current QRS Template Updates
4-

A

Between IR

Comment Resolution

and PR

Baseline Dyspnea Index (BDI)

S. Karra

Covi Anxiety Scale (COVI)

S. Kopko

A Humphrey

2019-06-28 Completed IR
No JIRA Issues

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

TBD

		Needs current QRS Template Updates
4-

A

Between IR

Comment ResolutionDeployment Risk and Resilience Inventory-2 (DRRI-2

and PR

Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)

S. Kopko

D

K.

Booth

Minkalis

2019

-06-28 Completed IR

No JIRA Issues

TBD Needs current QRS Template Updates4-A IR Comment ResolutionEastern Cooperative Oncology Group Performance Status (ECOG)S. SudiniS. Kopko

-06-28 Completed IR No JIRA Issues PR Checklist TBD by Dana	TBD Copyediting Batch 4 and WORD doc needed for FDA IR	Priority review request
4-Between IR and PR	Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19	S. Kopko	D. Booth	2019-04-18

2019-06-28

Completed IR
No JIRA Issues

TBD

TBD for PR

TBD	Needs 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 PR

Covi Anxiety Scale (COVI)

S. Kopko

Jörg Sahlmann D. Booth

A Humphrey

2019-06-28 Completed IR
No JIRA Issues

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

TBD for PR

TBD

	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 PR

Deployment Risk and Resilience Inventory-2 (DRRI-2)

S. Kopko

Jörg Sahlmann

D. Booth

2019-06-28 Completed IR
No JIRA Issues

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

TBD for PR

TBD

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

	Needs current QRS Template Updates
4-

A

Between IR

Comment ResolutionGeriatric Depression Scale Short Form (GDS SHORT FORM)

and PR

Disease Steps (DISEASE STEPS)

S. Karra

D. Booth

S. Kopko

2016-06-26 Completed TR

2019-

10

04-

04

18 Completed IR
JIRA

Issues Open TBD

issues approved

TBD for PR

No

	Needs current QRS Template Updates
4-

A

Between IR

Comment Resolution

and PR

Eastern Cooperative Oncology Group Performance Status (ECOG)

S. Sudini

PAIN Intensity (PI) Change Control v1.2

S. Kopko

K. Minkalis

2019-

07-31 Completed TR2019-10-04

06-28 Completed IR
No JIRA Issues

Under review

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

TBD for PR		Needs current QRS Template Updates
4-

A IR Comment Resolution

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

Transition Dyspnea Index (TDI

)

S.

Karra

Kopko

S

Jörg Sahlmann D.

Kopko

Booth

2019-06-28 Completed IR

No

JIRA Issues

TBD

Approved

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

TBD

Needs current QRS Template Updates

4-Between IR and PRAJCC TNM Staging System 7th Edition (AJCC V7)D. BoothS. Kopko

2019-04-18 Completed IR

JIRA Issues Done

2020-01-13 Completed Needs restore and updates to current QRS template

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 D. Booth	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.
4-Between IR and PR

Disease Steps (DISEASE STEPS

Geriatric Depression Scale Short Form (GDS SHORT FORM)

S

D.

Karra

Booth

S. Kopko

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

-18

 Completed IR
 JIRA 

issues approved

Issues Open

TBD for PR

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

Needs current QRS Template Updates

TBD for PR

Yes

2019

-06

-

12 sent for 2nd PAR review, SK sent update message to PAR 2019-08-20 received reply 2019-

11-06

that

PAR completed 2nd Review

completed

and looks good.

2019-11-20 Dana to draft new agreement based on reply from V. King, PAR

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

S. Kopko

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

TBD for PR

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

Yes2019-06-12 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-Between IR and PR	PAIN Intensity (PI) Change Control v1.2	S. Kopko	K. Minkalis	2019-07-31 Completed TR 2019-10-04 Completed IR JIRA 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	Psoriasis Area and Severity Index (PASI)	D. Corey	D. Booth

2019-10

	2019-10-04 Completed IR No JIRA Issues	Completed for FDA IR	2020-06-29 FDA IR comments received	Needs current QRS Template Updates
4-Between IR and PR	Suicidal Ideation Questionnaire (SIQ)	S. Kopko	TBD	2018-08-04 Completed IR

No JIRA Issues

Copyediting Batch 4 and WORD doc needed for FDA IR

JIRA Issue under review

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

Yes

Dana sent for FDA IR 2020-05-05


4-Between IR and PR	Suicidal Ideation Questionnaire-JR (

SIQ

SIQ-JR)

S. Kopko

TBD

A. Palmer

2018-08-04 Completed IR

Jiraserver

Issue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyQRSSUPP-74JIRA 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

JIRA Issues Done

Needs current QRS Template Updates

2019-11-06

that

PAR completed 2nd Review

completed

and looks good.

2019-11-20 Dana to draft new agreement based on reply from V. King, PAR

2020-07-101 Updated PAR agreement signed-good to move forward
Needs current QRS Template Updates

4-Between IR and PR

Suicidal Ideation Questionnaire-JR (SIQ-JR

Transition Dyspnea Index (TDI)

S.

Kopko

Karra

A

S.

Palmer

Kopko

2018

2019-

08

06-

04

28 Completed IR
No JIRA Issues

Done

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, PAR

Template Updates
4-Between IR and PR	Trauma Symptom Checklist for Children (TSCC)	D. Booth	TBD	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 8

Updates

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

5-Public Review

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

2020-01-13 Completed Batch 6

May PR

		2020-06-22 PR Completed Issue Resolution in Process Needs current QRS Template Updates
5-Public Review	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	2020-01-13 Completed Batch 6

2020-06-22 PR Completed
 Issue Resolution in Process
 Needs current QRS Template Updates

May PR


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

May PR

		2020-06-22 PR Completed Issue Resolution in Process Needs current QRS Template Updates
5-Public Review	Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 (PQL01 - PQL18)	D. Corey	S. Kopko	2018-10-01 Completed IR No JIRA Issues	2020-01-22 Completed Batch 8

June

	July PR
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 and WORD file generatin for final quick review	FDA quick review issues

to be

reviewed at 2020-03-25 &

04-01 meetings - CRF NOT DONE questions in CDISC review

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 and WORD file generatin for final quick review	FDA quick review issues

to be

reviewed at 2020-03-

25 & 04-01 meetings - CRF NOT DONE questions in CDISC review

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	Combat Exposure Scale (CES)	D. Booth	S. Kopko	2019-05-

31 Completed Publication QC

01 Completed PR
2019-05-

01 Completed PR

31 Completed Publication QC No JIRA Issues	TBD	No	Needs current QRS Template Updates
6-Between PR and Publication	Epworth Sleepiness Scale (ESS)	S

. KopkoD. Booth

2019-08-17 Completed PR

Jira

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

JIRA Issue under review

. Kopko	D. Booth	2019-08-17 Completed PR	TBD	No	Needs current QRS Template Updates
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	2020-01-13 Completed 2020-03-10 WORD/PDF Created	2020-04-09 Full Package in FDA COA review 2020-06-03 Received FdA IR comments	FDA IR comments resolution in processNeeds current QRS Template Updates
6-Between PR and Publication	Paced Tapping (PACED TAPPING)	D. Corey	S. Kopko	2019-08-17 Completed PR JIRA issues approved	TBD	No	Needs current QRS Template Updates
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	TBD	No	Needs current QRS Template Updates
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

2020-01-31 Completed FDA

FDA final quick review
2020-06-24 Draft Updates based on 10 Meter Walk/Run presented to FDA - minor revisons and WORD file generatin for final quick review

FDA quick review issues

to be

reviewed at 2020-03-25 & 04-01 meetings

- CRF NOT DONE questions in CDISC review

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	2020-01-13 Completed 2020-03-10 WORD/PDF Created	2020-04-09 Full

Package in FDA COA review

Package in FDA COA review 2020-06-03 Received FdA IR comments	FDA IR comments resolution in processNeeds current QRS Template Updates
6-Between PR and Publication	Ten Meter Walk/Run	D. Corey	D. Booth	2019-05-01 Completed PR 2019-05-12 Publication QC Completed JIRA Issues Done	2019-08-28 Completed	2020-01-31 Completed FDA final quick review

FDA quick review issues to be reviewed at

2020-03-25 & 04-01 meetings-

CRF NOT DONE questions in CDISC review

FDA quick review issues reviewed & revisions needed 2020-06-24 Draft Updates presented to FDA - minor revisons and WORD file generatin for final quick review
6-Between PR and Publication	Veterans Administration Lung Study Group (VALG)	D. Booth	S. Kopko	2019-05-01 Completed PR 2019-05-13 Publication QC Completed-need comment confirmation JIRA Issues Done	TBD	No	Needs current QRS

Template Updates

7-Publication

Clinical Global Impressions (CGI)S. KopkoD. Booth Completed 2019-04-11

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

2019-03-20

7-Publication

Patient

Clinical Global Impressions (

PGI

CGI)

S. Kopko

D. Booth

Completed 2019-04-11

2019-03-20

3/20/2019

7-Publication

Life Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION

Emotion Recognition (EMOTION RECOGNITION)

D.

Booth

Corey

L

S.

McLeod

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

19 WORD/PDF

created

Revised for publishing

No

2020-03-31

5/22/2020

7-Publication

PTSD Checklist for DSM-5 (PCL-5)D. Booth

Hamilton Anxiety Rating Scale (HAM-A)

S. Kopko

L. McLeod

S. 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

created

Revised for publishing

No

2020-03-317-PublicationAge, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS)D. Corey

5/22/2020
7-Publication	Hospital Anxiety and Depression Scale (HADS)	S. Kopko	K. Minkalis

K. Kellly

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		5/22/2020
7-

05-277-Publication

Publication

Life Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSION

Emotion Recognition (EMOTION RECOGNITION

)

D.

Corey

Booth

S

L.

Kopko

McLeod

2019-05-01 Completed PR

No

2019-05-30 Completed Publication QC
JIRA Issues Done

2020-

01

02-21 Completed
2020-03-

20

12 WORD/

PDFs requested

2020-05-19 WORD/PDF Revised for publishing

PDF created

No

3/31/2020

2020-05-22

7-Publication

Hamilton Anxiety Rating Scale (HAM-A

Patient Global Impressions (PGI)

S. Kopko

L

D.

McLeod

Booth

Completed 2019-

05

04-

01 Completed PR

No JIRA Issues

2020-01-21 Completed

2020-03-20 WORD/PDFs requested

2020-05-21 WORD/PDF Revised for publishing

2020-05-227-PublicationHospital Anxiety and Depression Scale (HADS)S. Kopko

11		3/20/2019
7-Publication	PTSD Checklist for DSM-5 (PCL-5)	D. Booth	S. Kopko

K. Minkalis

2019-05-01 Completed PR
2019-05-

31

30 Completed Publication QC

No

JIRA Issues Done

2020-

01

02-21 Completed
2020-03-

20

12 WORD/

PDFs requested

2020-05-21 WORD/PDF Revised for publishing

PDF created	No	3/31/2020
9 QRS General Issues	Columbia-Suicide Severity Rating Scale - Since Last Visit (C-SSRS SINCE LAST VISIT)	TBD	TBD

2020-05-22

Example update needed base on QRS Skipped Records concept.
9 QRS General Issues	Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)	TBD	TBD

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)TBDTBD

Change control needed: Example update needed base on QRS Skipped Records concept.
9 QRS General Issues	Controlled Oral Word Association Test (COWAT)	D. Corey	HOLD
9 QRS General Issues	Dermatology Life Quality Index (DLQI)	D. Booth	HOLD
9 QRS General Issues	Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4)	D. Booth	HOLD		2019-06-12: Early draft supplement sent for FDA review.
9 QRS General Issues	Functional Assessment of Cancer Therapy-Lung Version 4 (FACT-L V4)	D. Booth	HOLD
9 QRS General Issues	Functional Assessment of Chronic Illness Therapy-Dyspnea (Dyspnoea) 10 Item Short Form (FACIT-DYSPNEA SF)	D. Booth	HOLD
9 QRS General Issues	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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