CDISC Public Webinar Standards Updates and Additions. 18 Dec 2014

Transcription

1 CDISC Public Webinar Standards Updates and Additions 18 Dec

2 Agenda Controlled Terminology Batch 20 Publication Release Bernice Yost, CDISC Controlled Terminology Batch 21 Public Review Bernice Yost, CDISC Planned Projects for 2015 & Upcoming IntraChange Wayne Kubick, CDISC CDISC Education and Events Updates* Saad Yousef, CDISC *After Q&A session & time permitting 2

3 CDISC CONTROLLED TERMINOLOGY Presented by Bernice F. Yost 4

4 Agenda Package 20 Publication Release (19 Dec 2014) What s new What s changed Package 21 Public Review (19 Dec 2014 to 23 Jan 2015) What s new What s changed 5

5 Publication Schedule Package Number Team Cutoff (requests must be received at least two months before this date) Public Review Start Date (1 wk from Team Cutoff) Public Review Closed Date (4 wks) Final Changes to NCI EVS (4 wks) Publication Date (6 wks) Codelists to be Included 18 3/14/2014 3/21/2014 4/18/2014 5/16/2014 6/27/2014 CV Device ECG General 18 Lab PK QS SEND 18 Unit Virology 19 6/13/2014 6/20/2014 7/18/2014 8/15/2014 9/26/2014 CV Device ECG General 19 Lab Oncology PK QS 19 SEND Spectype Speccond Unit Virology 20 9/5/2014 9/12/ /10/ /7/ /19/2014 CV Device ECG General 20 Lab Oncology PK QS 20 SEND 21 12/12/ /19/2014 1/23/2015 2/13/2015 3/27/ /13/2015 3/20/2015 4/17/2015 5/15/2015 6/26/2015 Spectype Speccond Unit Virology 6

6 Package 20 Publication Release 7

7 Package 20 Publication Release ECG Terminology Team Submission Value Change CDISC TEST CODE CDISC TEST NAME CDISC DEFINITION HRMAX EGHRMAX Summary (Max) Heart Rate ECG Maximum Heart Rate The minimum time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) An electrocardiographic measurement of the maximum rate of depolarization of a specific region of the heart during an interval of time, usually expressed in beats per minute. Unless otherwise specified, this is usually the maximum ventricular rate. HRMEAN EGHRMN Summary (Mean) Heart Rate ECG Mean Heart Rate The average (mean) number of cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) An electrocardiographic measurement of the average rate of depolarization of a specific region of the heart during an interval of time, usually expressed in beats per minute. Unless otherwise specified, this is usually the mean ventricular rate. HRMIN EGHRMIN Summary (Min) Heart Rate ECG Minimum Heart Rate The maximum time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) An electrocardiographic measurement of the minimum rate of depolarization of a specific region of the heart during an interval of time, usually expressed in beats per minute. Unless otherwise specified, this is usually the minimum ventricular rate. 8

8 Package 20 Publication Release ECG Terminology Team continued Submission Value Change continued CDISC TEST CODE CDISC TEST NAME CDISC DEFINITION VRMEAN EGVRMN Summary (Mean) Ventricular Rate ECG Mean Ventricular Rate The average (mean) number of cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) An electrocardiographic measurement of the average rate of ventricular depolarizations (QRS complexes) recorded during an interval of time, usually expressed in beats per minute. VRMIN EGVRMIN Summary (Min) Ventricular Rate ECG Minimum Ventricular Rate The minimum time between successive cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) An electrocardiographic measurement of the minimum rate of ventricular depolarizations (QRS complexes) recorded during an interval of time, usually expressed in beats per minute. VRMAX EGVRMAX Summary (Max) Ventricular Rate ECG Maximum Ventricular Rate The maximum time between successive cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) An electrocardiographic measurement of the maximum rate of ventricular depolarizations (QRS complexes) recorded during an interval of time, usually expressed in beats per minute. 9

9 Package 20 Publication Release ECG Terminology Team continued New Terms for Ventricular/Atrial Rate CDISC TEST CODE CDISC TEST NAME CDISC DEFINITION EGVRMED ECG Median Ventricular Rate An electrocardiographic measurement of the median rate of ventricular depolarizations (QRS complexes) recorded during an interval of time, usually expressed in beats per minute. EGARMN ECG Mean Atrial Rate An electrocardiographic measurement of the average rate of atrial depolarizations (P waves) recorded during an interval of time, usually expressed in beats per minute. EGARMED ECG Median Atrial Rate An electrocardiographic measurement of the median rate of atrial depolarizations (P waves) recorded during an interval of time, usually expressed in beats per minute. EGARMIN ECG Minimum Atrial Rate An electrocardiographic measurement of the minimum rate of atrial depolarizations (P waves) recorded during an interval of time, usually expressed in beats per minute. EGARMAX ECG Maximum Atrial Rate An electrocardiographic measurement of the maximum rate of atrial depolarizations (P waves) recorded during an interval of time, usually expressed in beats per minute. 10

10 Package 20 Publication Release ECG Terminology Team continued New Term Added to Existing Codelist ECG Test Code/Test Name ECG Result 11

11 Package 20 Publication Release Questionnaire Terminology Team Questionnaire (QS) and Functional Test (FT) now become Clinical Outcome Assessments (COA) COA will also include terminology for the new Clinical Classification (CC) domain The Clinical Classification domain is named for instruments whose output is an ordinal or categorical score that serves as a surrogate for, or ranking of, disease status or other physiological or biological status. They are based on observable findings as opposed to rigidly structured patient interviews or patient self-reports. They are sometimes composite scores based on multiple findings that may be found in other SDTM domains such as labs, vital signs, or clinical events. 12

12 Package 20 Publication Release COA Terminology Team continued New Category Codelist Category of Clinical Classification (CCCAT) New COA Instruments QS CC Alcohol Use Disorder Identification Test: Self-Report Version (AUDIT-SR) Alcohol Use Disorder Identification Test-Consumption Questions (AUDIT-C) Clinical COPD Questionnaire (CCQ 24 Hour Version) Clinical COPD Questionnaire (CCQ 1 Week Version) Craig Handicap Assessment and Reporting Technique - Short Form Paper Version (CHART-SF PAPER VERSION) Dermatology Life Quality Index (DLQI) Rivermead Post Concussion Symptoms Questionnaire (RPQ) Coronary Thrombus TIMI Grade Coronary Artery Dissection NHLBI Grade Stent Thrombosis Coronary Arc Timing Stent Thrombosis Coronary Arc Grade 13

13 Package 20 Publication Release Cardiovascular Terminology Team Codelist Name Change Cardiovascular Test Code/Test Name CVEXAMCD/CVEXAM A terminology codelist to describe the findings test code from a cardiac examination. Cardiovascular Test Code/Test Name CVTESTCD/CVTEST A terminology codelist to describe the test code for a physiological examination of the cardiovascular system. TIMI Flow Responses TIMIFLOW TIMI Flow Responses TIMIFLRS 14

14 Package 20 Publication Release Cardiovascular Terminology Team continued Submission Value Change TIMI Flow Responses Codelist Grade 0 TIMI Grade 0 Grade 1 TIMI Grade 1 Grade 2 TIMI Grade 2 Grade 3 TIMI Grade 3 Submission Value Change Coronary Artery Dominance Codelist LEFT DOMINANCE LEFT DOMINANT RIGHT DOMINANCE RIGHT DOMINANT 15

15 Package 20 Publication Release Cardiovascular Terminology Team continued New Codelist Cardiovascular Findings About Test Code/Test Name Cardiovascular Findings About Results Coronary Thrombus TIMI Grade Responses Coronary Artery Dissection NHLBI Grade Responses Stent Thrombosis, Coronary, ARC Timing Responses Stent Thrombosis, Coronary, ARC Grade Responses New Term Added to Existing Codelist Cardiovascular Test Code/Test Name Coronary Vessel Disease Extent Morphology Test Code/Test Name 16

16 Package 20 Publication Release Device Terminology Team Submission Value Change Device Identifier Long Name Model Model Number 17

17 Package 20 Publication Release General Terminology Team continued Term Removed Units for Vital Signs Results Codelist Ohm» A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one Ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in Siemens. Method Codelist Angiogram» Angiogram is not a method. It is the product created when an Angiography is conducted. The correct method is Angiography and it already exists. New Codelist Ophthalmic Focus of Study Specific Interest 18

18 Package 20 Publication Release General Terminology Team continued: New Term Added to Existing Codelist Anatomical Location Respiratory Test Code/Test Name Reproductive System Findings Test Code/Test Name Evaluator Method Route of Administration Morphology Test Code/Test Name Trial Summary Parameter Test Code/Test Name 19

19 Package 20 Publication Release Lab Terminology Team (Laboratory Test Codelists) Submission Value Change Test Name: Amyloid Beta Precursor Protein Test Code: APP APPB APPT = Total Amyloid Precursor Protein APPA = Amyloid Precursor Protein Alpha APPB = Amyloid Precursor Protein Beta 20

20 Package 20 Publication Release Lab Terminology Team (Laboratory Test Codelists) New Term Added to Existing Codelist Laboratory Test Code/Test Name Microscopic Findings Test Code/Test Name 21

21 Package 20 Publication Release Lab Terminology Team (Specimen Type/Specimen Condition Codelists) New Term Added to Existing Codelist Specimen Type 22

22 Package 20 Publication Release Lab Terminology Team (Unit Codelist) Submission Value Change Unit Codelist uiu/ml Micro-International Unit per milliliter» Synonyms: Micro-International Unit per milliliter; miu/l; mciu/ml; uiu/ml miu/l Milli-International Units per Liter» makes this unit SI compliant IN Inch in Term Removed Unit Codelist g/g Creatinine g/mol Creatinine ug/g Creatinine» The lab rule is that if the test code/test name has Creatinine in it then it does not need to be in the unit code. Please use g/g (C70453) or g/mol (C73721) or mg/kg (C67401). 23

23 Package 20 Publication Release Lab Terminology Team (Unit Codelist continued) New Term Added to Existing Codelist Unit Codelist 24

24 Package 20 Publication Release Oncology Terminology Team New Term Added to Existing Codelist Oncology Tumor Properties Test Code/Test Name Tumor Identification Test Code/Test Name 25

25 Package 20 Publication Release PK Terminology Team Submission Value Change PK Parameters Code/PK Parameters Codelist PK Parameters: Conc Concentration PK Parameters Code: CONC» Definition: The quantity of a specified substance in a unit volume or weight of another substance. PK Parameters: Average Conc Average Concentration PK Parameters Code: CAVG» Definition: AUCTAU divided by TAU. 26

26 Package 20 Publication Release PK Terminology Team continued Term Removed PK Parameter Units of Measure Codelist nmol/l/umol Nanomoles per liter per micromole PK Terminology Team» Our standard rule is to dose normalize by mg or ug, not molar units. New Term Added to Existing Codelist PK Parameter Units of Measure 27

27 Package 20 Publication Release SEND Terminology Team Submission Value Change Neoplasm Type Codelist ADENOMA, BASAL CELL, BENIGN BASAL CELL TUMOR, BENIGN» Update submission value to be more precise. Adenoma is a bit of a misnomer (though not incorrect) since basal cell tumors do not form glandular structures. 28

28 Package 20 Publication Release SEND Terminology Team continued New Term Added to Existing Codelist Neoplasm Type Specimen 29

29 Package 20 Publication Release Virology Terminology Team Term Removed Microorganism Codelist ENTEROBACTER TAYLORAE» ENTEROBACTER TAYLORAE is a synonym to the term ENTEROBACTER CANCEROGENUS New Term Added to Existing Codelist Microorganism 30

30 Package 21 Public Review 31

31 Package 21 Public Review Device Terminology Team New Term Added to Existing Codelist Device Properties Test Name/Test Code Device Identifier Short Name/Long name 32

32 Package 21 Public Review ECG Terminology Team New Codelist Holter Findings About Test Name/Test Code Holter Findings About Results New Term Added to Existing Codelist ECG Test Code/Test Name ECG Result 33

33 Package 21 Public Review General Terminology Team Move Terms to a Different Codelist Consensus Cardiac Classification System Test Name/Test Code Codelist to COA Clinical Classification Codelist TIMI Flow (TIMIFLOW)» TIMI01-TIMI Flow (TIMI0101) ACC/AHA Lesion Complexity Class (LSNCPCLS)» LSCP01-ACC/AHA Lesion Complexity Class (LSCP0101) New York Heart Association Class (NYHACLS)» NYHA01-New York Heart Association Class (NYHA0101) Canadian CV Society Grading Scale (CCSGRDS)» CCSG01-Canadian CV Society Grading Scale (CCSG0101) Killip Class (KILLIPCL)» KLPC01-Killip Class (KLPC0101) 34

34 Package 21 Public Review General Terminology Team continued: New Term Added to Existing Codelist Anatomical Location Reproductive System Findings Test Code/Test Name Control Type Relationship to Subject Method Morphology Test Code/Test Name Ophthalmic Exam Test Code/Test Name Respiratory Test Code/Test Name Trial Type 35

35 Package 21 Public Review Lab Terminology Team (Laboratory Test Codelists) Submission Value Change Laboratory Test Name Codelist Platelet Derived Growth Factor Isoform AB Platelet Derived Growth Factor IsoformAB» The length of the test name was one character too long. It should not be longer than 40 characters. New Term Added to Existing Codelist Laboratory Test Code/Test Name 36

36 Package 21 Public Review Lab Terminology Team (Specimen Type/Specimen Condition Codelists) Submission Value Change Specimen Condition Codelist AUTOLIZED AUTOLYZED New Term Added to Existing Codelist Specimen Type 37

37 Package 21 Public Review Lab Terminology Team (Unit Codelist) Term Removed Unit Codelist CCID 50 EID 50 log10 CCID 50 log10 EID 50 log10 TCID 50» CCID50, TCID50, EID50 alone are not valid units of measure. meq/g Creatinine mg/g Creatinine mmol/g Creatinine mmol/mol Creatinine U/g Creatinine ug/g Creatinine U/g HGB cells/kg cells/ul» Team decision: this information is reflected in the lab test, it does not need to be in the unit. 38

38 Package 21 Public Review Lab Terminology Team (Unit Codelist) continued New Term Added to Existing Codelist Unit Codelist 39

39 Package 21 Public Review Oncology Terminology Team Term Removed Tumor Response Result Codelist UPD (Unequivocal Progression)» The scope of the RSSTRESC codelist is expanding to include all currently relevant and accepted responses for various oncology criteria and the following principle was followed during the expansion effort: Each individual response is meant to convey the general use of the term (non-tumor specific) and will be defined in the general sense. The specific details on the requirements for each response within a criteria used in a clinical study reside in the criteria to be applied and within the protocol.» It was agreed, after review of many criteria during the expansion effort, that progressive disease is unequivocal progressive disease and PD is the appropriate RSSTRESC submission value. Unequivocal progressive disease has been added as a synonym of PD. If the status of the response is open to question then PD would not be recorded as the RSSTRESC submission value.» At the time it was added, UPD was included to support a specific RECIST 1.1 table for subjects with non-target disease only and was to apply only to the Non-target response (RSTESTCD=NTRGRESP) component of the overall response. Following the principle above, PD is the appropriate RSSTRESC submission value. The use of the word unequivocal in the RECIST table was likely included to make the point that for subjects with non-target disease only, the overall response can be based on unequivocal progression of the non-targets only. In addition, the definition of UPD in the CT, contains the statement even in the presence of SD or PR in target disease which contradicts the intended use case. 40

40 Package 21 Public Review PK Terminology Team Submission Value Change PK Parameters/PK Parameters Code Midpoint of Collection Interval (MIDPTLST)» Midpoint of Interval of Last Nonzero ER (ERTLST) Time of Max Excretion Rate (ERTMAX)» Midpoint of Interval of Maximum ER (ERTMAX) MRT Infinity Obs (MRTIFO)» MRT Intravasc Infinity Obs (MRTIVIFO) MRT Infinity Pred (MRTIFP)» MRT Intravasc Infinity Pred (MRTIVIFP) MRT to Last Nonzero Conc (MRTLST)» MRT Intravasc to Last Nonzero Conc (MRT Intravasc to Last Nonzero Conc) 41

41 Package 21 Public Review PK Terminology Team continued Term Removed PK Parameter Units of Measure Codelist ul» Our std base units for volume are ml and L. L/umol/day - L/ng/h L/umol/h - L/ng/min L/umol/min - L/nmol/day L/mmol/day - L/nmol/h L/mmol/h - L/nmol/min L/mmol/min - L/pg/day L/mol - L/pg/h L/mol/day - L/pg/min L/mol/h - ml/mol/day L/mol/min - ml/mol/h L/ng/day - ml/mol/min» We limit the units of dose to micrograms and/or milligrams. 42

42 Package 21 Public Review PK Terminology Team continued New Term Added to Existing Codelist PK Parameters Code/PK Parameters PK Parameter Units of Measure 43

43 Package 21 Public Review SEND Terminology Team New Term Added to Existing Codelist Specimen 44

44 Package 21 Public Review Virology Terminology Team Submission Value Change Viral Resistance Findings Test Name/Test Code IC50 Treatment Result (IC50T)» IC50 Subject Result (IC50S) IC95 Treatment Result (IC95T)» IC95 Subject Result (IC95S) 45

45 Package 21 Public Review Virology Terminology Team continued New Codelist Microbiology Test Code/Test Name Immunogenicity Specimen Assessments Test Code/Test Name Anti-Viral Outcome of Treatment New Term Added to Existing Codelist Microorganism 46

46 CDISC Standards: Status and Plans Wayne R. Kubick CDISC CTO 47

47 Progress Update Foundational Stds Foundational Products Released in 2014: Dataset-XML v1 Final SDTMIG 3.3 Batch 1 (7 draft domains) SDTMIG 3.3 Batch 2 (Milestones, 2 Domains) Pharmacogenomics SDTMIG v1 Draft SEND v3.1 Draft ADaM Occurrence Data Structure v1 Draft ADaM IG v1.1 Draft ADaM Results Metadata Spec for Define-XML Periodic Terminology and COA Packages Updated COP and Process Docs Upcoming New Drafts for Comment: ADaM Data Structure for Integration (ADSL) CDISC in RDF Reference Guide (PhUSE) CDASH v2 and Model Define-XML IG & Validation Rules 48

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49 2014 CDISC Technical Plan 50

50 Program Overview December 2014 Approved Therapeutic Area Standards Projects Therapeutic Area QT Studies v1 Traumatic Brain Injury v1 Chronic Hepatitis C Virus v1 Schizophrenia v1 Breast Cancer v1 Dyslipidemia v1 COPD v1 Diabetic Kidney Disease Coordinating Organizations/ Project Manager TCB John Owen CDISC Rhonda Facile TCB John Owen CDISC/DCRI Amy Palmer TCB Pam Harvey TCB John Glover TCB John Glover TCB/CDISC Rachael Zirkle Proposal Approval Date Stage 0 Scoping & Planning Stage 1 Concept Modeling Stage 2 Standards Development TAUGs released in 2014: Multiple Sclerosis Diabetes Cardiovascular Influenza QT Studies Stage 3a Internal Review *Stage 3b Public Review *Stage 3c **Projected Publication Aug 13 Oct Feb Mar Jul Sept Q414 Oct 13 Nov Dec Jan Q215 Nov 13 Feb Apr Jul Nov Jan Q115 Nov 13 May Jul Aug Dec Feb Q215 Upcoming drafts: Hep-C Diabetes ADaM Supplement Schizophrenia Dyslipidemia Nov 13 Aug Dec Jan Feb Q215 Dec 13 May Sept Dec Feb Q215 Nov 13 Aug Dec Feb Apr Q315 May 14 Jan Mar Q116 Key Stage completed Stage ongoing All months reflect when stage is, or is projected to be, completed. *The Stage3b concludes at the end of the 30-day review period and Stage 3c concludes when all tasks have been completed and the standard is publically available. ** Specific projected publication dates to be added to the notes section at the conclusion of Stage 3b.

51 Current CFAST Plan for Project Starts 52

52 CDISC Technical Roadmap Foundational Standards PROTOCOL SDS/SDTM Products CDASH SEND ADAM Others XML Technologies Semantics Controlled Terminology BRIDG CDISC SHARE R1 R2 R3 Data Exchange Layer XML, RDF, Semantic Layer BRIDG/Terminologies/SHARE Functional Layer SDTM, SEND, ADaM, CDASH Implementation Layer Therapeutic Area Guides, Questionnaire Guides Healthcare Interoperability Kits Therapeutic Areas (CFAST) Track 1 Projects Track 2 Projects Track 3 Projects Health Care Interoperability The Roadmap depicts evolution from siloed standards to an integrated stack based on BRIDG and SHARE 53

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54 Strength through collaboration. 55

55 Questions? 56

56 CDISC Education & Events Announcements Saad Yousef, CDISC, Manager of Education and Membership Services 57

57 Other News CDASH planning to release v2.0 in 2015; send input & feedback on v1.1 by 31 Dec via CDISC Discussion Forum. Europe Interchange abstracts due Monday, 5 Jan 2015 CDISC Membership drive in effect until 20 Dec; visit our website 60

58 Upcoming USA Public Course Events Location Dates Courses Offered Registration Deadline Discounts? Host Carlsbad, CA Jan 2015 SDTM, CDASH, ADaM 27 Dec %; 31 Dec 2014 Reading, Berkshire, UK Jan 2015 SDTM, ADaM, Define-XML, Dataset-XML 27 Dec %; 31 Dec 2014 Morrisville, NC Feb 2015 SDTM, CDASH, ADaM 10 Jan %; 31 Dec 2014 Chicago, IL Mar 2015 SDTM, CDASH, ADaM 24 Feb %; 31 Dec 2014 Palo Alto, CA Apr 2015 SEND, ODM, Dataset-XML, Define-XML 14 Mar 2015 Expired Registration deadline indicates online deadline. Offline registration deadlines for each event can be found here. Additional 2015 public training events can be 61

59 CDISC In-House Education Below courses readily available for in-house training: ADaM BRIDG Deep Dive CDASH SDTM SDTM for Medical Devices SEND Others pending availability For more information visit our website or submit request here. 62

60 Online Training SDTM, CDASH, and BRIDG Deep Dive modules & bundles available for sale on CDISC Training Campus ( ADaM and TA modules coming soon! All members should contact to retrieve company-specific discount code. 63

61 Next Public Webinar Agenda: Public Review: Hepatitis C Date: 8 Jan 2015, 11:00-12:30 PM EST Speaker: John Owen, Janssen Pharmaceuticals Register here. Webinar details also at 64

62 Next Members Only Webinar Topic: Overview on Define-XML and Dataset-XML Date/Time: 15 Jan 2015, 11:00-12:30 PM EST Speaker: Sally Cassells, Next Step Clinical Systems Register here. Webinar details also at 65

63 Any more questions? Thank you for attending this webinar. CDISC s vision is to: Inform Patient Care & Safety Through Higher Quality Medical Research 66