Page History

Date: 2021-0304-2609

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		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. 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	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)	D. Erabelly	S. Kopko	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)	D. Erabelly	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	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)	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

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. Corey	S. Kopko	TR Completed

2020

2021-

02-26: Completed TR QC Checklist

2020-06-03: Completed TR #2

April IR

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	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 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. Corey	S. 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. 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	TR Completed 2021-04-13 IR Completed
7-Publication

3-Internal review

Disability Rating Scale (DRS)

F. Alipour

S. Kopko

2020-09-30 Completed TR
2020-11-17 Completed  IR
2021-02-11 Completed PR

April Publishing PUB-382

		2021-04-03 Publiished
7-Publication

3-Internal review

Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ)

D. Corey

S. Kopko

2020-09-30 Completed TR
2020-11-17 Completed  IR
2021-02-11 Completed PR

April Publishing PUB-382

		2021-04-03 Publiished
7-Publication

3-Internal review

Karnofsky Performance Scale (KPS SCALE)

F. Alipour

S. Kopko

2020-09-09 Completed TR
2020-11-17 Completed  IR
2021-02-11 Completed PR

April Publishing PUB-382

		2021-04-03 Publiished
7-Publication

3-Internal review

Kurtzke Functional Systems Scores (KFSS)

F. Alipour

S. Kopko

2020-07-15 TR completed
2020-11-17 Completed  IR
2021-02-11 Completed PR

April Publishing PUB-382

		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

4-Between IR and PR


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

TBD for 4-Between IR and PR

April PR

Yes

Needs current QRS Template Updates

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

4-Between IR and 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

PR4-Between IR and

PR
5-Public review	Disease Steps (DISEASE STEPS)	S. Karra	S. Kopko	2019-04-18 Completed 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 D. Booth	2019-06-28 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 Completed TR 2019-10-04 Completed IR JIRA 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 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	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	2019-10-04 Completed IR

No JIRA Issues

Completed for FDA IR

Dana revising for 2nd FDA IR

4-Between IR and PR

CRF & Supplement being updaed

2020-06-29 FDA IR comments received

Needs current QRS Template Updates

5-Public review

Suicidal Ideation Questionnaire (SIQ)

S. Kopko

TBD

2018-08-04 Completed IR

JIRA Issue under review

Needs current QRS Template Updates

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)

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

4-Between IR and PR

5-Public review

Transition Dyspnea Index (TDI)

S. Karra

S. Kopko

2019-06-28 Completed IR

No JIRA Issues

TBD for PRNeeds current QRS Template Updates

Ready for PR - add to April?
5-Public review

4-Between IR and PR

Trauma Symptom Checklist for Children (TSCC)

D. Booth

TBD

D. Corey

2018-08-14 Completed IR

JIRA Issues Done

Needs current QRS Template Updates

April PR

2020-07-

101

10 Updated PAR agreement signed-good to move forward

5


7-

Public review

Publication

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

S. Sudini

S. Kopko

2019-06-28 IR completed
No JIRA Issues

2020

2021-

09-23 updated to current templateReady for copyediting for PR

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 Completed TR 2019-10-04 Completed IR JIRA issues

approved

2020-08-18 updated to current template

approved
2021-03-05 Completed PR

Completed

2021-04-07 1st FDA Review

Ready for copyediting for PR


5-Public review	Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)	D. Corey	D. Booth	2019-09-11 Completed TR 2019-10-04 Completed IR JIRA issues approved

2020

2021-

08-18 updated to current templateReady for copyediting for PR

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

2020-09-28 updated to current template - ready for PR

2020-01-13 Completed Batch 5
Ready for 2nd copyediting for PR

. 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. Kopko	K. Minkalis	2019-06-28 Completed

IR
No

IR No JIRA Issues
2020-09-

05PR

05 PR Checklist by Dana

2020

2021-

09-24 updated to current template

Issue on reference papers and CRF differences in process

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

TBD and WORD doc needed for FDA IRPriority review request5-Public review

Eastern Cooperative Oncology Group Performance Status (ECOG)

S. Sudini

S. Kopko

2019-06-28 Completed IR
No JIRA Issues

2020

2021-

10-12 updated to current template - ready for PRReady for copyediting for PR

03-05 PR Completed

2021-04-03 Publiished

Needs current QRS Template Updates


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

Ready for copyediting 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

2020-10-23 Issue on reference papers and CRF differences in process

- 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

TBD for FDA IRPriority review request


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

Ready for copyediting for PR

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

Ready for copyediting & WORD file for FDA IRPriority review request

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

Ready for copyediting & WORD file for FDA IR

April PR

TBD April with PR

Priority review request


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

Ready for copyediting for PR

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

Ready for copyediting for

April PR

Ready for IR



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 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	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 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

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

2020-09-24 Updated to current template

Ready for copyediting and WORD file for publishingDana doing QC before Publication

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

2020-09-22 Updated to current template

Ready for copyediting and WORD file for publishingDana doing QC before Publication

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

2020-09-22 Updated to current template

Ready for copyediting and WORD file for publishing

Completed

2021-03-08 Published

Dana 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-

09-16 Updated to current template2020-10-16
2nd copyediting and WORD file for FDA IR in process

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

7-

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
(PEDSQL01 - PEDSQL18)

D. Corey

S. Kopko

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

PR

PR 1 JIRA Issue Done

Diane comp0leted QC for publishing

Completed

2020-12-10

-16 final copyediting and WORD file request for publishing in Batch 8

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

Publication QC TBD

JIRA Issues Done

2020

2021-

10-16 Updated to current template2020-10-16
2nd copyediting and WORD file for FDA IR in process

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	10-Meter Walk/Run	D. Corey	D. Booth	2019-05-01 Completed

PR
2019-05-12 Publication QC Completed

PR
JIRA Issues Done

2020-08-07

-22 Updated to current template2020-08-07 completed 2nd

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

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

Page tree

Versions Compared

Old Version 141

New Version Current

Key