CDISC Public Webinar – Standards Updates And Additions

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CDISC Public Webinar – StandardsUpdates and Additions23 July 2015 CDISC 20151

Agenda Virology Therapeutic-Area User Guide (TAUG) v2.0, PublicReview Jon Neville, C-Path Laura Butte, C-Path CDISC Online Education & Event Updates John Ezzell, CDISC CDISC 20152

Question & Answer ‘Panelist’: QuestionOR ‘Presentation’: QuestionExamples:Amy: What are new updates in the Virology TAUG?ORCDISC: When can we start registering for the USInterchange? CDISC 20153

Virology Therapeutic-Area UserGuide (TAUG) v2.0, Public ReviewPresented by Jon Neville,Critical Path Institute CDISC 20155

Project Background Goal Update Virology v1.0 to align with more recent development work, particularly inCFAST therapeutic areas Create a high-level go-to source for virus studies (intervention/prophylaxis) Focus Drug sensitivity testing (phenotypic and genotypic data) A more robust approach to handling virus nomenclature Multiple new concepts/examples based on recent development in Influenza andChronic Hepatitis C Update user guide layout (concept-based as opposed to SDTM domain-based) Inputs Virology v1.0 Existing User Guides: Pharmacogenomics (PGx), Influenza and ChronicHepatitis C FDA Guidance6 CDISC 2015

Review Status Summary Internal Review Concluded June 11th Team received and responded to 40comments CDISC SRC Review Received and addressed 100 comments Approval to post for public review on July 21 Public Review Happening now! Anyone welcome to review and comment Comment period closes 08/24/2015 CDISC 20157

Concepts Covered in v2.0 Diagnosis and laboratory confirmation of infection Viral resistance (drug sensitivity testing) Viral Load Immune response Virus Nomenclature Analysis Data

Changes from v1.0 Guide is organized by concept, not SDTM domainImmune response examples added (IS domain).Analysis data section addedProposed deprecation of Viral Resistance (VR)domain: Resistance data will be modeled in theMicrobiology Susceptibility (MS) domain New approach to nomenclature: draftOrganism Identifiers (OI) domain andORGNAMID variable Proposed deprecation of --NSTRN variable CDISC 20159

Guide Layout- CFAST TAUG StyleCONTENTS1INTRODUCTION . 31.1 PURPOSE . 31.2 ORGANIZATION OF THIS DOCUMENT . 41.3 CONCEPT MAPS . 51.4 CONTROLLED TERMINOLOGY . 51.5 RELATIONSHIPS TO OTHER STANDARDS . 61.5.1Summary of Changes from Version 1.0 . 61.6 KNOWN ISSUES . 62OVERVIEW. 73SUBJECT AND DISEASE CHARACTERISTICS . 83.1 DIAGNOSIS , CONFIRMATION OF INFECTION , AND VIRUS-TYPING . 83.1.1Examples for Diagnosis, Confirmation of Infection, and Virus-Typing . 93.2 VIRUS NOMENCLATURE . 103.2.1Example for Virus Nomenclature. 114DISEASE ASSESSMENTS. 154.1 RESISTANCE TESTING . 154.1.1Examples for Resistance Testing. 184.2 VIRAL LOAD . 224.2.1Examples for Viral Load . 224.3 HOST IMMUNE RESPONSE . 234.3.1Examples for Host Immunogenic Response . 245ANALYSIS DATA. 265.1 SUBJECT-LEVEL VARIABLES . 265.1.1Co-existing Diseases and Viral Co-Infections. 265.1.2Subgroup Variables . 275.1.3Non-Host Taxonomy at Screening and at Subsequent Time Points . 275.1.4Subject-Level Variables Associated with Efficacy Response. 285.2 ANALYSIS DATA FOR PHARMACOGENOMIC FINDINGS . 295.2.1Descriptive Variables for Non-Host Taxonomy . 295.2.2Derived Variables for Summary of Results at a Given Location . 305.2.3Derived-Flag Variables . 305.3 ANALYSIS DATA FOR PHENOTYPIC RESULTS . 315.4 CONSOLIDATION OF PHENOTYPIC AND GENOTYPIC ANALYSIS DATA . 32APPENDICES . 33APPENDIX A: PROJECT PROPOSAL . 33APPENDIX B: CFAST VIROLOGY V2.0 STANDARDS TEAM . 34APPENDIX C: GLOSSARY AND ABBREVIATIONS . 35APPENDIX D: FURTHER READING . 36APPENDIX E: REPRESENTATIONS AND WARRANTIES , LIMITATIONS OF LIABILITY , AND DISCLAIMERS . 3710

Host Immune Response: ImmunogenicitySpecimen (IS) Domain11

Analysis Data Section Identification of co-morbidities of interest Subgrouping subjects Virus taxonomy: distinguishing between baselineand follow-up Subject-level variables associated with efficacyresponse Analysis data for genotypic and phenotypicfindings CDISC 201512

Phenotypic Viral Resistance, now in MSDomain CDISC 201513

Genotypic Viral Resistance: PF Domain CDISC 201514

Nomenclature: The problem The terminology for classification/naming ofdifferent viruses at levels below species variesgreatly. VR domain variables allowed for a two-levelhierarchy only: --NSPCES (non-host species) and–NSTRN (Non-host strain)There are typically more than two levels required todescribe viruses“Strain” is not necessarily the only name, nor even avalid name, for sub-species taxonomy CDISC 201515

Virus Nomenclature Issue--NSPCESHIVSPECIES level SpeciesSubspeciesLevel 1TypeSubspeciesLevel 2GroupSubspeciesSubtypeLevel 3(or Clade)SubspeciesLevel 4Subclade CDISC 2015Influenza A Hep CHep e--NSTRN?16

Nomenclature, cont’dThis works! The values listed in VRNSTRNare in fact STRAINS of Influenza A CDISC 201517

Nomenclature IssueThis doesn’t work well. The values listed inPFNSTRN are Influenza Subtypes, not Strains. CDISC 201518

Nomenclature solution: OrganismIdentifiers (OI) domain OI is a special purpose domain that is modeledafter the Device Identifiers (DI) domain It allows for parsed nomenclature values to becondensed on a single identifier variable,ORGNAMID ORGNAMID can be used in relevant findingsdomains such as MS, PF, LB ORGNAMID is a link to the OI domain where fullyparsed taxonomy values reside Relieves burden from parent domain (MS, PF, etc) CDISC 201519

ORGNAMID and OI Dataset CDISC 201520

ORGNAMID ORGNAMID is sponsor defined, with the followingconstraints: A unique ORGNAMID must represent a unique identity asrepresented in its combination of OIPARMCD/OIVAL pairs. Study sponsors should populate ORGNAMID with intuitive namevalues based on either: the name of the organism as reported by a lab, or published references/databases where applicable andappropriate (e.g., when reference strain H77 is used in a HCVstudy, ORGNAMID for this strain should be populated with“H77” or “HCV1a-H77”). CDISC 201521

Quick Summary TAUG-Virology v2.0 available for public review until08/24/15 MS domain will be replacing VR domain for phenotypicdrug sensitivity testing data New OI domain/ ORGNAMID variable addressesnomenclature issues Not all concepts represented in the guide werediscussed in this presentation If you plan to review, please take note of section 1.6,known issues (some were discussed here today) We are on track to publish by end of September 2015Comments may also be sent to Laura Butte, Project Manager, at LButte@c-path.org CDISC 201522

Reviewing and commentingGo to www.cdisc.org/therapeutic, scroll down CDISC 201523

Funding for this project was provided by the U.S. Food and Drug Administration CDISC 201524

Q&A Session CDISC 201525

CDISC Education EventsAnnouncementsLearn CDISC from CDISC!Authoritative. Global. Vendor neutral. CDISC 201526

Standards currently out for review Traumatic Brain Injury TAUG Visit http://cdisc.org/therapeutic for more information. Comments due 21 Sept 2015 Virology v2.0 TAUG Visit http://cdisc.org/therapeutic for more information. Comments due 24 August 2015 ADam Supplement for Diabetes Visit http://cdisc.org/therapeutic for more information. Comments due 21 August 2015 SEND IG: Developmental and ReproductiveToxicology (DART) Visit http://www.cdisc.org/send for more information. Comments due 13 August 2015 Click here to submit your comments. CDISC 201527

Upcoming North America Public Courses and EventsLocationDatesCoursesOfferedRegister ByEarlyRegistrationDiscountsDurham, NC27-31 July2015SEND, SDTM,ADaM27 June 2015ExpiredGaithersburg,MD1-4 Sep 2015SDTM,CDASH,ADaM1 Aug 2015ExpiredWhippany, NJ29 Sep – 2OctSDTM,CDASH,ADaM29 Aug 2015ExpiredSeattle, WA6-9 Oct 2015SDTM, ADaM,ODM/DefineXML Combo6 Sep 2015ExpiredChicago, IL(Interchange)9-13 NovVisithttp://www.cdisc.org/public-courses formore details!26 Oct 201531 July 2015HostRegistration deadline indicates online deadline. Onsite registration is available before each eventbegins. Additional 2015 public training events can be found @ http://cdisc.org/public-courses.Check CDISC website for up-to-date information on Public Courses CDISC 201530

Upcoming Europe Public Courses and urt),Germany28-31 Jul2015SDTM,CDASH,ADaM28 June 2015ExpiredBrussels,Belgium7-10 Sep2015SDTM,CDASH,ADaM7 August 2015ExpiredHostRegistration deadline indicates online deadline. Onsite registration is available before each eventbegins. Additional 2015 public training events can be found @ http://cdisc.org/public-courses.Check CDISC website for up-to-date information on Public Courses CDISC 201531

Upcoming Asia Public Courses and hina8-11 Sep2015SDTM,CDASH,ADaM8 August2015ExpiredGuangdongProvincialHospital ofChineseMedicineOsaka, Japan14-18 Sep201514 Aug 2015ExpiredBeijing, China20-23 Oct2015SDTM,CDASH,ADaM, ODM,Define-XMLSDTM,CDASH,ADaM, ODM,Define-XML20 Sep 2015ExpiredSDTM,CDASH,ADaM, ODM,Define-XML20 Sep 2015ExpiredShanghai, China 26-29 Oct2015Registration deadline indicates online deadline. Offline registration deadlines for each event availableup until start date. Additional public training events can be found @ http://cdisc.org/public-courses.Check CDISC website for up-to-date information on Public Courses CDISC 201532

In-House Classroom TrainingBenefits: Learn with your group using specific usecases and implementation questions On-location authorized instructor Cost-effective group training CDISC 2015

Licensed Training - Exclusively for our MembersBenefits: Standard qualification and training process All materials developed by standards teams Your instructor delivers training Training when your staff needs it Official CDISC Education certificatesYou get the besttraining, just when youneed it, and save timeand money! CDISC 2015

CDISC Online Training Online training created with support from CDISCstandards development teams New CDISC trainings developed in tandem withstandards development Online courses benefits: flexibilitymore contentgreater depthupdated frequently CDISC 2015

Next Public Webinar Agenda: Breast Cancer TA Public Review ADaM Supplement for Diabetes TA Public Review Date: 12 August 2015, 11:00-12:30 PM EST Speakers: John Owen, CDISCSusan Kenney, Maximum LikelihoodMario Widel, Eli LillyRachael Zirkle, Eli Lilly Register here.Webinar details also at www.cdisc.org/webinars CDISC 201537

Next Members Only Mini-Training Agenda: Implementation of Oncology-Specific SDTM Domains Date: 20 Aug 2015, 08:00 - 09:30 AM Central European Time(01:00 - 02:-30 AM Central USA Time) Speakers: Jan De Cleir, SGS Life Science Services Register here.Webinar details also at www.cdisc.org/webinarsAccess to these mini-training webinars is an exclusive benefit of beinga member. Visit www.cdisc.org/membership for more information. CDISC 201538

Any more questions?Thank you for attending this webinar.CDISC’s vision is to:Inform Patient Care & Safety Through Higher Quality Medical Research CDISC 201539

CDISC Members Drive Global StandardsThank you for your support!Learn CDISC from CDISC!Authoritative. Global. Vendor neutral. CDISC 201540

Jul 23, 2015 · Review Status Summary Internal Review Concluded June 11. th Team received and responded to 40 comments CDISC SRC Review Received and addressed 100 comments Approval to post for public review on July 21 Public Review Happening now! Anyone welcome to review and comment Comment period closes . 08/24/2015. 7

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