Review Period | Instrument Name | QRS Developer | QC Assignee | QC | Copy Editing | FDA Review? | QRS IR or PR |
1-Development |
EQ-5D-3L - update to include standardized numeric values from manual | | | | | | | Columbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING) | S. Kopko |
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1-Development |
EQ-5D-5L - update to include standardized numeric values from manual | | | | | | | 1-Development | Columbia-Suicide Severity Rating Scale Screening (C-SSRS SCREENING) | S. Kopko | | | | | 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 Change Control | PAIN Relief (PR) Change Control v1.2 | S. Kopko | D. Booth | | | | |
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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
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1-Development Change Control | Barnes Akathisia Rating Scale (BARS) | S. |
Sudini | | | | | S. Kopko | 2021-03-25: QRS CT change control approved |
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1-Development Change Control | Brief Psychiatric Rating Scale-Anchored (BPRS-A) |
S. Karra | | | |
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1-Development Change Control |
Disability Columbia-Suicide Severity Rating Scale |
(DRS)S. Karra | | | | | | - Since Last Visit (C-SSRS SINCE LAST VISIT) | TBD | TBD |
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| Example update needed based on QRS Skipped Records concept. |
1 |
1-Development Change Control |
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome Published supplement conversion to current WIKI template | S. Kopko | D. Booth | | | Priority review request | In Process 2019-11-26 |
1-Development Change Control |
Functional Assessment Questionnaire - NACC Version (FAQ-NACC) | European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) | D. Erabelly |
S. Sudini | | | - update to include standardized numeric values from manual
- 2021-03-18 Q&A with SK
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In Process 2019-09-25 new copyright received for v3.0 CRF |
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1-Development Change Control |
Functional Assessment Questionnaire (FAQ) | European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L) | D. Erabelly |
S. SudiniIn Process | | | - update to include standardized numeric values from manual
- 2021-03-18 Q&A with SK
- 2021-04-08 ready for TR
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1-Development Change Control |
Hamilton Depression Rating Scale 17-Item (HAMD 17) Exacerbations of Chronic Pulmonary Disease Tool (EXACT) - Patient-Reported Outcome v2.0 (Published supplement conversion to current WIKI template) | S. Kopko | D. Booth |
201911-15 TBD 01-08 Dana doing QC of final CT change control before updating WIKI supplement |
| Priority review request |
In Process 2019-11-15 |
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1-Development Change Control |
Karnofsky Performance Scale (KPS SCALE)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 |
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1-Development Change Control |
Kurtzke Functional Systems Scores (KFSS)PAIN Relief (PR) Change Control v1.2 | S. |
Sudini | | | | | | | | | | | | |
2-Team review | Glucose Monitoring System Satisfaction Survey Version: Type 1 Diabetes (GMSS VERSION TYPE 1 DIABETES) | D. Corey | S. Kopko | 2019-07-09 Completed TR QC | | | 2019-07-31 Completed Team Review |
2-Team review | Kurtzke Expanded Disability Status Scale (EDSS) | S. Kopko | D. Booth | 2019-11-19 TBD | | Priority review request | 2019-11-20 TR Completed |
| | | | | | | |
3-Internal review | Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR) | D. Corey S. Kopko | D. Corey | 2019-05-23 1st PAR review comments updated and Completed QC for PR | | TBD | 2018-05-11 IR Completed - 2019-06-12 sent for 2nd PAR review, SK sent update message to PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR |
3-Internal review | Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) (PAR comment revisions need to be re-reviewed by PAR) | D. Corey S. Kopko | D. Corey | 2019-05-23 1st PAR review comments updated and Completed QC for PR | | TBD | IR Completed - 2019-06-12 sent for 2nd PAR review; SK sent update message to PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR |
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4-A IR Comment Resolution | Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS | S. Sudini | S. Kopko | Completed | | | IR completed 2019-06-28 |
4-A IR Comment Resolution | AJCC TNM Staging System 7th Edition (AJCC V7) | D. Booth | S. Kopko | Completed | Copyediting in Batch 4 | | IR completed 2019-04-18 |
4-A IR Comment Resolution | Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) | D. Corey | D. Booth | 2019-09-10 Completed TR QC | | | 2019-09-11 Completed TR 2019-10-04 IR Completed |
4-A IR Comment Resolution | Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) | D. Corey | D. Booth | 2019-09-10 Completed TR QC | | | 2019-09-11 Completed TR 2019-10-04 IR Completed |
4-A IR Comment Resolution | Baseline Dyspnea Index (BDI) | S. Karra | S. Kopko | Completed | Copyediting in Batch 4 | | IR completed 2019-06-28 |
4-A IR Comment Resolution | Brief Psychiatric Rating Scale (BPRS) | S. Kopko | K. Minkalis | Completed | Copyediting and WORD doc needed for FDA IR | Priority review request | IR completed 2019-06-28 |
4-A IR Comment Resolution | D. Booth |
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1-Development Change Control | Tanner Scale Boy Version | S. Sudini | S. Kopko | CT change control from RP to RS approved 2020-04-23 |
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| 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 |
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| 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 |
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| In Process Contacting Author & NINDS on represenitng "ON/OFF" periods |
2-Team review |
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3-Internal review | Crohn's Disease Activity Index Version 1 (CDAI V1) | D. Corey | S. Kopko | - TR Completed
- 2021-04-13 IR Completed
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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
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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
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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
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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
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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
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7-Publication | Disability Rating Scale (DRS) | F. Alipour | S. Kopko | - 2020-09-30 Completed TR
- 2020-11-17 Completed IR
- 2021-02-11 Completed PR
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7-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
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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
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7-Publication | Kurtzke Functional Systems Scores (KFSS) | F. Alipour | S. Kopko | - 2020-07-15 TR completed
- 2020-11-17 Completed IR
- 2021-02-11 Completed PR
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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 |
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5-Public review | Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19 | S. Kopko | D. Booth | - 2019-04-18 Completed IR No JIRA Issues
- April PR
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| Yes |
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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 |
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5-Public review | Deployment Risk and Resilience Inventory-2 (DRRI-2) |
Children's Depression Rating Scale, Revised (CDRS-R) WPS completed review of draft Package 2019-02-19Copyediting needed for PR | TBD | IR completed 2019184-A IR Comment Resolution | | TBD for PR |
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5-Public review | Disease Steps (DISEASE STEPS |
Covi Anxiety Scale (COVI KopkoA Humphrey | Completed | | | IR completed 2019-06-28 | 4-A IR Comment Resolution | Karra | S. Kopko | - 2019-04-18 Completed IR
JIRA issues approved - 2021-04-09 Completed PR
| TBD for PR |
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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 |
Deployment Risk and Resilience Inventory-2 (DRRI-2DIR completed Completed | | | 4-A IR Comment Resolution | Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) | D. Corey | D. Booth | 2019-05-27 Completed TR QC | | | 2019-05-29 Completed TR 2019-10-04 IR Completed |
4-A IR Comment Resolution | Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS) | D. Corey | Completed IR JIRA Issues Approved | Copy-editing and EORTC review will occur prior to FDA review | TBD April |
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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- |
21 TR QC | | 2019-06-05 Completed TR 2019-10-04 IR Completed | 4-A IR Comment Resolution | Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS) | D. Corey | D. Booth | 2019-09-09 Completed TR QC | | 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 |
: IR CompletedCompleted IR JIRA Issues Open | TBD for PR | No | Needs current QRS Template Updates |
4- |
A Comment ResolutionEastern Cooperative Oncology Group Performance Status (ECOG) | and PR | Mini-Mental State Examination (MMSE) Functional Test (PAR comment revisions need to be re-reviewed by PAR) | D. Corey |
S. SudiniCompleted | | | IR completed 2019-06-28 | 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
- CRF & Supplement being updaed
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| - 2020-06-29 FDA IR comments received
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5-Public review | Suicidal Ideation Questionnaire (SIQ) | S. Kopko | TBD | - 2018-08-04 Completed IR JIRA Issue under review
- April PR
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| 2019-11-06 PAR completed 2nd Review and looks good. 2020-07-101 Updated PAR agreement signed-good to move forward Needs current QRS Template Updates |
5-Public review | Suicidal Ideation Questionnaire-JR (SIQ-JR) | S. Kopko | A. Palmer | - 2018-08-04 Completed IR
- JIRA Issues Done
- April PR
| Needs current QRS Template Updates |
| 2019-11-06 PAR completed 2nd Review and looks good. 2020-07-101 Updated PAR agreement signed-good to move forward Needs current QRS Template Updates |
5-Public review | Transition Dyspnea Index (TDI |
4-A IR Comment Resolution | 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 | Completed | Needs review with EORTC | TBD | IR completed 2019-06-28 After that, copy-editing and EORTC review will occur prior to FDA review. |
4-A IR Comment Resolution | 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 | Completed | Needs review with EORTC | TBD | IR completed 2019-06-28 After that, copy-editing and EORTC review will occur prior to FDA review. Should wait for FDA review of QLQ-C30 as well since this is a subset of the QLQ-C30. |
4-A IR Comment Resolution | Geriatric Depression Scale Short Form (GDS SHORT FORM) | D. Booth | S. Kopko | 2019-06-28 Completed IR QC | | TBD | 2016-06-26: Completed TR 2019-10-04 IR Completed |
4-A IR Comment Resolution | PAIN Intensity (PI) Change Control v1.2 | S. Kopko | K. Minkalis | 2019-07-09 Completed TR QC | | 2019-10-22: CDER is currently re-considering its priorities for the standardization of pain instrument data. | 2019-07-31 Completed TR 2019-10-04 IR Completed |
4-A IR Comment Resolution | Psoriasis Area and Severity Index (PASI) | D. Corey | D. Booth | 2019-08-20 Completed TR QC | | | 2019-10-04 IR Completed |
4-A IR Comment Resolution | Transition Dyspnea Index (TDI) | S. Karra | S. Kopko | Completed | | | IR completed 2019-06-28 |
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4-Between IR and PR | Disease Steps (DISEASE STEPSCopyediting needed for PR | | IR completed 2019-04-18 | - IR No JIRA Issues
- Ready for PR - add to April?
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5-Public review | Trauma Symptom Checklist for Children (TSCC |
4-Between IR and PR | PEDSQL Instruments (18TBD | TBD for PR | TBD | | Hold for Batch 3 or 4? | 4-Between IR and PR | Suicidal Ideation Questionnaire (SIQ) | S. Kopko | TBD | TBD for PR | | | 2018-08-04 IR Completed - 2019-06-12 sent for 2nd PAR review, SK sent update message to PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR |
4-Between IR and PR | Suicidal Ideation Questionnaire-JR (SIQ-JR) | S. Kopko | A. Palmer | Completed | | | 2018-08-04 IR Completed - 2019-06-12 sent for 2nd PAR review, SK sent update message to PAR 2019-08-20 received reply 2019-11-06 that 2nd Review completed and looks good. 2019-11-20 Dana to draft new agreement based on reply from V. King, PAR |
4-Between IR and PR | Trauma Symptom Checklist for Children (TSCC) | D. Booth | TBD | Completed | | | 2018-08-14 IR Completed 2019-06-12 Requested PAR agreement update to include as a CDISC standard |
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6-Between PR and Publication | 4 Stair Ascend | D. Corey | S. Kopko | Completed | 2019-08-28 Completed | 2019-09-06 FDA final quick review | Completed Public Review 2019-05-01 |
6-Between PR and Publication | 4 Stair Descend | D. Corey | S. Kopko | Completed | 2019-08-28 Completed | 2019-09-06 FDA final quick review | Completed Public Review 2019-05-01 |
6-Between PR and Publication | Age, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS) | D. Corey | K. Kelly | Completed | Copyediting completed In Publication process | | Completed Public Review 2019-05-01 |
6-Between PR and Publication | - 2018-08-14 Completed IR JIRA Issues Done
- April PR
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| - 2020-07-10 Updated PAR agreement signed-good to move forward
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7-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 |
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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
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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
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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?
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5-Public review | Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION) | S. Kopko | K. Minkalis | - 2019-06-28 Completed IR No JIRA Issues
- 2020-09-05 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 |
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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
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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
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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
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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
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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
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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
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| TBD April with PR |
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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
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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
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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 |
7-Publication | Combat Exposure Scale (CES) | D. Booth | S. Kopko | - 2019-05-01 Completed PR
- 2019-05-31 Completed Publication QC No JIRA Issues
| Completed | No | 2021-03-08 Published |
7-Publication | Epworth Sleepiness Scale (ESS) | S. Kopko | D. Booth | 2019-08-17 Completed PR | Completed | No | 2021-03-08 Published |
7-Publication | Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) | D. Corey | D. Booth | 2019-05-29 Completed TR 2019-10-04 Completed IR No JIRA Issues 2020-06-22 PR Completed - No Issues 2020-09-24 Updated to current template | Completed |
| 2021-03-08 Published |
7-Publication | Diabetes Distress Scale for Parents of Teens with Type 1 Diabetes (PARENT-DDS) | D. Corey | D. Booth | 2019-06-05 Completed TR 2019-10-04 Completed IR JIRA issues approved 2020-06-22 PR Completed - No Issues 2020-09-22 Updated to current template | Completed |
| 2021-03-08 Published |
7-Publication | Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes (PARTNER-DDS) | D. Corey | D. Booth | 2016-06-26 Completed TR 2019-10-04 Completed IR JIRA issues approved 2020-06-22 PR Completed - No Issues 2020-09-22 Updated to current template | Completed |
| 2021-03-08 Published |
6-Between PR and Publication | Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0 |
Combat Exposure Scale (CES-31 Completed Publication QC - need comment confirmationTBD | | Completed Public Review 2019-05-01 | - -01 Completed PR
JIRA Issues Done
| - 2021-01-25 2nd Copyediting Completed
| - 2020-04-09 Full Package in FDA COA review
- 2020-06-03 Received FDA IR comments
- 2020-08-26 comment resolution review with FDA
- 2921-02-12 2nd FDA Review Request
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7-Publication | Paced Tapping (PACED TAPPING |
6-Between PR and Publication | Emotion Recognition (EMOTION RECOGNITIONCompleted Public Review 05-01Copyediting completed In Publication process | | Completed Public Review 2019-05-01 | 6-Between PR and Publication | Epworth Sleepiness Scale (ESS) | S. Kopko | D. Booth | Completed | Completed | | 2019-08-17 Public Review completed |
6-Between PR and Publication | Hamilton Anxiety Rating Scale (HAM-A) | S. Kopko | L. McLeod | Completed Public Review 2019-05-01 | Copyediting completed In Publication process | | - 08-17 Completed PR JIRA issues approved
| Completed | No | 2021-03-08 Published |
7-Publication | Pediatric Quality of Life (PedsQL) Neuromuscular Module Version 3 (PEDSQL01 - PEDSQL18) | D. Corey | S. Kopko | - 2018-10-01 Completed IR
No JIRA Issue2020- - 2020-09-17 Completed PR 1 JIRA Issue Done
| Completed |
| 2020-12-10 Published |
7-Publication | RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT) | D. Booth | S. Kopko | - 2019-08-17 Completed PR JIRA Issues Done
| Completed | No | 2021-03-08 Published |
Completed PR 2019-05-01 |
6-Between PR and Publication |
| Rising From Floor | D. Corey |
Hospital Anxiety and Depression Scale (HADS)K. Minkalis2019-05-01 Completed PR 2019-05- |
31 Completed Publication QCCopyediting completed In Publication process | | 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 |
Completed PR 2019-05-01 |
6-Between PR and Publication |
Life Events Checklist for DSM-5, Standard Version (LEC-5 STANDARD VERSIONSymptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0) | D. Booth |
L McLeod30 Completed Publication QCBatch 5 Copyediting for Publication | FDA quick review needed | - 01 Completed PR
JIRA Issues Done
| - 2021-01-25 2nd Copyediting Completed
| - 2020-04-09 Full Package in FDA COA review
- 2020-06-03 Received FDA IR comments
- 2020-08-26 comment resolution review with FDA
- 2921-02-12 2nd FDA Review Request
|
Completed PR 2019-05-01 |
|
6-Between PR and Publication |
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0)10-Meter Walk/Run | D. Corey | D. Booth |
S. Kopko | 2019-05-30 Completed Publication QC | Batch 3 Copyediting completed 2109-09-24 | | Completed PR 2019-05-01 | - 2019-05-01 Completed PR
JIRA Issues Done
| - 2020-08-07 completed 2nd copyediting and WORD file
- 2021-02-17 completed 3rd copyediting and WORD file
| - 2020-01-31 Completed FDA final quick review
- 2020-03-25 & 04-01 meetings-FDA quick review issues reviewed & revisions needed
- 2020-06-24 Draft Updates presented to FDA
- 2020-08-10 WORD file generated and send for 2nd FDA final quick review
- 2021-02-17 WORD file generated and send for 3rd FDA final quick review
|
6-Between PR and Publication | Paced Tapping (PACED TAPPING) | D. Corey | S. Kopko | Completed | Completed | | 2019-08-17 Public Review completed |
|
6-Between PR and Publication |
PTSD Checklist for DSM-5 (PCL-5Completed PR Veterans Administration Lung Study Group (VALG) | D. Booth | S. Kopko | |
30 Completed Publication QCBatch 5 Copyediting for Publication | FDA quick review needed | - 01 Completed PR JIRA Issues Done
|
-016-Between PR and Publication | - -13 Publication QC Completed-need comment confirmation
- Needs CDISC CRF by Dana
| TBD | No |
|
7-Publication | Age, treatment with systemic antibiotics, leukocyte count, serum albumin and serum creatinine as a measure of renal function (ATLAS |
RAND Social Support Survey Instrument (RAND SOCIAL SUPPORT SURVEY INSTRUMENT BoothS KopkoKellly | 2019-05-01 Completed PR No JIRA Issues | 2020-01-21 Completed
|
| 201908-17 Public Review completed6-Between PR and Publication | Rising From Floor | 05-21 WORD/PDF Revised for publishing |
| 5/27/2020 |
7-Publication | Clinical Global Impressions (CGI) |
D. Corey2019-05-13 Completed Publication QC | 2019-08-28 Completed | 2019-09-06 FDA final quick review | Completed PR 2019-05-01 | D. Booth |
| Completed 2019-04-11 |
| 3/20/2019 |
7-Publication | Emotion Recognition (EMOTION RECOGNITION) | D. Corey |
6-Between PR and Publication | Symptoms of Major Depressive Disorder Scale v1.0 (SMDDS V1.0) | D. Booth30 Completed Publication QC need comment confirmationBatch 3 Copyediting completed 2109-09-24 | | Completed PR 2019-05-01 | 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 |
6-Between PR and Publication | Ten Meter Walk/Run | D. Corey | D. Booth | Publication QC Completed 2019-05-12 | 2019-08-28 Completed | 2019-09-06 FDA final quick review | Completed PR 2019-05-01 |
6-Between PR and Publication | Veterans Administration Lung Study Group (VALG) | D. Booth | S. Kopko | Publication QC Completed 2019-05-13 need comment confirmation | TBD | | Completed PR 2019-05-01 |
| | | | | | | |
7-Publication | Clinical Global Impressions (CGI) | S. Kopko | D. Booth | | Completed 2019-04-11 | | 3/20/2019 |
7-Publication | Patient Global Impressions (PGI) | S. Kopko | D. Booth |
| | | | | | | | | |
QRS General Issues | 7-Publication | PTSD Checklist for DSM-5 (PCL-5) | D. Booth | S. Kopko | 2019-05-01 Completed PR 2019-05-30 Completed Publication QC JIRA Issues Done | 2020-02-21 Completed 2020-03-12 WORD/PDF created | No | 3/31/2020 |
5-Public review | Controlled Oral Word Association Test (COWAT) | D. Corey |
HOLD | | | | | S. Kopko | April PR |
|
|
|
9 QRS General Issues | Dermatology Life Quality Index |
(DLQI)D. Booth | HOLD | | | | | QRS General Issues | Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4QRS General Issues | | 2019-06-12: Early draft supplement sent for FDA review. | | 1-Development | Functional Assessment of Cancer Therapy-Lung Version 4 (FACT-L V4) | D. Booth | HOLD |
| | | | QRS General Issues | QRS General Issues |
|
|
|
|
1-Development | Functional Assessment of Chronic Illness Therapy-Dyspnea (Dyspnoea) 10 Item Short Form (FACIT-DYSPNEA SF) | D. Booth | HOLD |
| | | | 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 |
| |