Page History

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TBD for Needs current QRS Template Updates
Needs current QRS Template UpdatesReady for copyediting for PR

2020-09-08 Completed IR - 1 Issue Done

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

Priority review requestReady for copyediting for PR

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
3-Internal review	Crohn's Disease Activity Index Version 1 (CDAI V1)	D. Corey	S. Kopko	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	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
37-Internal review 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
37-Internal review Publication	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			2021-04-03 Publiished
37-Internal review 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
37-Internal reviewPublication	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
4-Between IR and PR5-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	Needs current QRS Template Updates
4-Between IR and PR5-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 PR4-
Between IR and PR5-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 PR5-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	CRF & Supplement being updaed		2020-06-29 FDA IR comments received	Needs current QRS Template Updates
4-Between IR and PR5-Public review	Suicidal Ideation Questionnaire (SIQ)	S. Kopko	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 PR5-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 PR5-Public review	Transition Dyspnea Index (TDI)	S. Karra	S. Kopko	2019-06-28 Completed IR	No JIRA Issues	TBD for PR
4-Between IR and PR	Trauma Symptom Checklist for Children (TSCC)	D. Booth	TBD	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

57-Public review Publication	Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS	S. Sudini	S. Kopko	2019-06-28 IR completed No JIRA Issues 2021-03-05 Completed PR	Completed		2021-04-03 Publiished
5-Public review	Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)	D. Corey	D. Booth	2019-09-11 Completed TR 2019-10-04 Completed IR JIRA issues approved 2021-03-05 Completed PR	Completed	2021-04-07 1st FDA Review
5-Public review	Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)	D. Corey	D. Booth	2019-09-11 Completed TR 2019-10-04 Completed IR JIRA issues approved 2021-03-05 Completed PR	Completed	2021-04-07 1st FDA Review
5-Public review	Baseline Dyspnea Index (BDI)	S. 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
5-Public review	Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)	S. Kopko	K. Minkalis	2019-06-28 Completed IR No JIRA Issues 2020-09-05PR Checklist by Dana 2020-09-24 updated to current template Issue on reference papers and CRF differences in process	TBD and WORD doc needed for FDA IR	Priority review request
57-Public review Publication	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 PR	Ready for copyediting for PR	Needs current QRS Template Updates	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	TBD for FDA IR	Priority 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 2021-04-09 PR Completed	Ready for copyediting for PR
57-Public review Publication	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 IR	Priority review request
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 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	Ready for IR 2020-07-08 Completed QC Checklist from TR on 2020-03-18 2020-09-08 Completed IR - 1 Issue Done	Ready for copyediting for PR	April 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 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-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	No	Needs current QRS Template Updates
6-Between PR and Publication	Epworth Sleepiness Scale (ESS)	S. Kopko	D. Booth	2019-08-17 Completed PR	TBD	No	Needs current QRS Template Updates
6-Between PR and 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 publishing		Dana doing QC before Publication
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 publishing		Dana doing QC before Publication
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		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 2020-09-16 Updated to current template	2020-10-16 2nd copyediting and WORD file for FDA IR in process	2020-04-09 Full Package in FDA COA review 2020-06-03 Received FDA IR comments 2020-08-26 comment resolution review with FDA
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	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 Diane comp0leted QC for publishing	2020-10-16 final copyediting and WORD file request for publishing in Batch 8
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 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 2020-10-16 Updated to current template	2020-10-16 2nd copyediting and WORD file for FDA IR in process	2020-04-09 Full Package in FDA COA review 2020-06-03 Received FDA IR comments 2020-08-26 comment resolution review with FDA
6-Between PR and Publication	10-Meter Walk/Run	D. Corey	D. Booth	2019-05-01 Completed PR 2019-05-12 Publication QC Completed JIRA Issues Done 2020-07-22 Updated to current template	2020-08-07 completed 2nd 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 FDA 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	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-Development	Controlled Oral Word Association Test (COWAT)	D. Corey	HOLD
9 QRS General Issues	Dermatology Life Quality Index (DLQI)	D. Booth	HOLD
1-Development		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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