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 |
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| 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 |
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| 1-Development Change Control | European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L) | D. Erabelly | S. Kopko |
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| 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 | 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 |
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| 3-Internal review | Functional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4) | D. Booth | S. Kopko |
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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 |
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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 |
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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 |
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| 3-Internal review | 2-Team reviewInternational Physical Activity Questionnaire ( | OctoberAugust 2002) | LongShort Last 7 Days | Self-AdministeredTelephone Format (IPAQ- | LF SELF-ADMINISTEREDSF PHONE VERSION) | D. Corey | S. Kopko |
| April IR|||||
| 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 | |||||||||
| 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 | |||||||||
| 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 | |||||||||
| 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 | |||||||||
| 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 | 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 PR | Yes | Needs current QRS Template Updates | ||||||
| 4-Between IR and PR | Covi Anxiety Scale (COVI) | S. Kopko | A Humphrey | 2019-06-28 Completed IR 2021-04-09 Completed PR | TBD for PR | ||||||||
| 4-Between IR and PR | Deployment Risk and Resilience Inventory-2 (DRRI-2) | S. Kopko | D. Booth | 2019-06-28 Completed IR 2021-04-09 Completed PR | TBD for PR | ||||||||
| 4-Between IR and PR | Disease Steps (DISEASE STEPS) | S. Karra | S. Kopko | 2019-04-18 Completed IR 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 | |||||||
| 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 | . | ||||||
| 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 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 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 | 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 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 | |||||||
| 4-Between IR and PR | Suicidal Ideation Questionnaire-JR (SIQ-JR) | S. Kopko | A. Palmer | 2018-08-04 Completed IR JIRA Issues Done | 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 | Transition Dyspnea Index (TDI) | S. Karra | S. Kopko | 2019-06-28 Completed IR No JIRA Issues | TBD for PR | Needs current QRS Template Updates | |||||||
| 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 | 2020-07-101 Updated PAR agreement signed-good to move forward | |||||||
| 5-Public review | Abnormal Involuntary Movement Scale (AIMS) Change Control QS->RS | S. Sudini | S. Kopko | 2019-06-28 IR completed 2020-09-23 updated to current template | Ready for copyediting for PR | ||||||||
| 5-Public review | Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) | D. Corey | D. Booth | 2019-09-11 Completed TR 2020-08-18 updated to current template | 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 2020-08-18 updated to current template | Ready for copyediting for PR | ||||||||
| 5-Public review | Baseline Dyspnea Index (BDI) | S. Karra | S. Kopko | 2019-06-28 Completed IR 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 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 | |||||||
| 5-Public review | Eastern Cooperative Oncology Group Performance Status (ECOG) | S. Sudini | S. Kopko | 2019-06-28 Completed IR 2020-10-12 updated to current template - ready for PR | Ready for copyediting for PR | 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 | ||||||||
| 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 | TBD for FDA IR | Priority review request | |||||||
| 5-Public review | KDIGO AKI Stage (KDIGO AKI) | D. Corey | S. Kopko | 2020-03-20: Completed TR 2020-09-08 Completed IR - 1 Issue Done | Ready for copyediting for PR | ||||||||
| 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 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 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 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 | 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 2020-09-08 Completed IR - 1 Issue Done | Ready for copyediting for PR | ||||||||
| 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 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-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 2020-06-22 PR Completed - 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 2020-06-22 PR Completed - 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 2020-06-22 PR Completed - 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 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 2020-08-26 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 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 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 2020-08-26 comment resolution review with FDA | |||||||
| 6-Between PR and Publication | 10-Meter Walk/Run | D. Corey | D. Booth | 2019-05-01 Completed PR 2020-07-22 Updated to current template | 2020-08-07 completed 2nd copyediting and WORD file | 2020-01-31 Completed FDA final quick review 2020-08-10 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 | 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-DevelopmentFunctional Assessment of Cancer Therapy-Colorectal Version 4 (FACT-C V4) | D. Booth | HOLD | 2019-06-12: Early draft supplement sent for FDA review. | ||||||||||
| 1-Development | Functional Assessment of Cancer Therapy-Lung Version 4 (FACT-L V4) | D. Booth | HOLD | ||||||||||
| 1-Development | Functional Assessment of Chronic Illness Therapy-Dyspnea (Dyspnoea) 10 Item Short Form (FACIT-DYSPNEA SF) | D. Booth | HOLD | ||||||||||
| 1-Development | Functional Assessment of Chronic Illness Therapy-Fatigue 13-Item Scale Version 4 (FACIT-FATIGUE 13-ITEM V4) | S. Karra | D. Booth | Team QC completed in May except need new terminology for total score and author codes in suppquals (db action items to start, then sk to finish) | Checking TBD | 2019-05-29 Completed TR | |||||||
| 9 QRS General Issues | Unified Huntington's Disease Rating Scale '99 (UHDRS 1999) | D. Corey | HOLD | xx |
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