How to manage changes to CDISC standards at Novo Nordisk PhUSE EU Connect 2018 Sune Dandanell and Mikkel Traun
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 2 How to manage changes to CDISC standards Challenge: Many CDISC SDTM CT changes during recent releases Operational systems and collection standards are used consistently over long time New SDTM versions and TAUGs Data needs to be mapped to new domains and variables Requirement: Compliance to CDISC standards and CT must be managed Our solution: Topic Code Concept, CDISC CT and SDTM domain linkage Process for handling changes to CDISC CT CT: Controlled Terminology; TAUG: Therapeutic Area User Guide
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 3 Changes to CDISC CT from 2016-2018 3000 Codes 2000 Update Update CDISC Synonym Update CDISC Definition Update NCI Preferred Term Update CDISC Submission Value 1000 Remove Add Remove CDISC Code Remove CDISC Code List 0 26 27 28 29 30 31 32 33 Add CDISC Code Add CDISC Code List CDISC CT package number 34
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 4 The famous example by Johannes Ulander: Credits: Johannes Ulander, S-Cubed
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 5 Our Topic Code concept and domain linkage Default CAT and SCAT SDTM Domain Linkage SDTM Master Model Topic Code Concept Fasting Plasma Glucose Type: Numeric Finding Glucose Result Supported Collection Units Standard Reporting Unit SI Unit US Conventional Unit Preferred Label Blood Specimen Value in plasma equivalent ADaM PARAM CDISC CT Linkage CDISC CT version Sponsor Defined CT
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 6 CT Versions over the lifecycle of a Trial Project Standard Lifecycle of Trial Trial Planning Trial Conduct Analysis & Reporting Cross Trial Integration Data Standards Plan CRF EDC Select CT Version SDTM Generation SDTM SDTM Operational codes and labels aligned with CDISC CT semantics and synonyms or Sponsor Defined CT Meta Data Repository Operational Code Lists CT Linkage Sponsor Defined CT CDISC CT versions CDISC CT 2015-03-27 Lab Test Code BUN [C61019] CDISC CT 2018-06-29 Lab Test Code UREAN [C125949]
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 7 Solution for the BUN mystery Topic Code concept ADaM PARAM SDTM Domain Linked CDISC CT Sponsor Defined CT
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 8 Process for handling changes to CDISC CT Step 1: Step 2: Step 3: Step 4: Public review Subject matter experts review and comment according to expertise area Load package into our MDR Newly released CDISC CT package is loaded into our system Impact assessment Verify report Conflict Change Deleted New Same Linking Linking of Topic Codes to CDISC or Sponsor Defined CT Step 5: Trials choose CDISC CT package SDTM CDISC CT 2018-03-30 SDTM CDISC CT 2018-06-29
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 9 Step 2: Load of package into our MDR Load from local folder
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 10 Step 2: Load of package into our MDR CDISC CT version loaded All codelists and codes loaded in draft
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 11 Step 3: Impact assessment Verification report against previous version of CDISC CT
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 12 Step 3: Impact assessment Verification report result: - Same - Change - Conflict - New - Delete Change + Conflict + Delete => Lost link of Topic Code to CDISC CT!!
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 13 Step 3: Impact assessment Filters can be applied for conflicts, change, delete, which are the lost links we need to resolve Manual process to evaluate all lost links
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 14 Step 3: Impact assessment 1) SDTM terminology change log available at https://www.cancer.gov/research/resources/terminology/cdisc 2) Conflict in CHILD, BIOLOGICAL 3)
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 15 Recent example: CHILD/CHILD, BIOLOGICAL ADD/ REMOVE of CHILD, BIOLOGI CAL New CDISC Code for CHILD in RELSUB Codelist What is the impact of new CDISC-code for existing code? What is the impact addition of a more unspecific code?
Step 4: Linking How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 16 Different CDISC- Code in different versions of CDISC CT Linking of CHILD is changed with new CDISC CT
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 17 Step 5: Trials select CDISC CT version No specification of BIOLOGICAL or NON- BIOLOGICAL relationship on this CRF Solution: Link to CHILD, use previous version of CDISC CT or Sponsor Define Future trials should have the term BIOLOGICAL on CRF if that is what we intend to collect
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 18 CT Versions over the lifecycle of a Trial Project Standard Lifecycle of Trial Trial Planning Trial Conduct Analysis & Reporting Cross Trial Integration Data Standards Plan CRF EDC Select CT Version SDTM Generation SDTM SDTM Operational codes and labels aligned with CDISC CT semantics and synonyms or sponsor CT Operational Code Lists MDR CT Linkage Sponsor Defined CT CDISC CT versions CDISC CT 2018-03-30 Related Subjects CHILD [*] CHILD, BIOLOGICAL [C100807] CDISC CT 2018-06-29 Related Subjects CHILD [C150886] CHILD, BIOLOGICAL [C42708]
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 19 Linking to CDISC or Sponsor Defined CT Select CDISC CT version Linked SDTM Domain Sponsor Defined code Linked CDISC CT code
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 20 Linking to CDISC or Sponsor Defined CT CT in Define.xml for version 2014-03-28 CACR is Sponsor Defined CT in Define.xml for version 2015-03-27 CACR is CDISC CT Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C119272 C65047 Laboratory Test Code CACR Calcium Corrected A measurement of calcium, which has been corrected for albumin, in a biological specimen. Calcium Corrected Measurement
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 21 Case on how new SDTM domains are to be used New SDTM domains in new SDTM versions New SDTM domains in TAUGs (may be Sponsor Defined) New Sponsor Defined domains for improved SDTM FT Functional Tests New SDTM Domains ML Meal Data XA Physical Activity RE Respiratory System Findings
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 22 Internal SDTM versions over the lifecycle of a trial Project Standard Lifecycle of Trial Trial Planning Trial Conduct Analysis & Reporting Cross Trial Integration EDC Map CDW Observations identified by Topic Code Concepts Source Data Mappings Global Mappings Topic Code Concept Definitions Select Internal SDTM Version MDR SDTM Generation Domain Linkage NN SDTM Master Model SDTM SDTM 3.2-NN02 QS Questionnaire SDTM SDTM 3.2-NN05 FT Functional Test
How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 23 Linking Topic Code Concepts to SDTM Domains Internal SDTM Version Linked SDTM Domain
Conclusion How to manage changes to CDISC standards at Novo Nordisk 06-Nov-2018 24 Within our MDR we manage our Topic Code Concept: Semantic definition Link to CDISC CT by versions or Sponsor Defined CT Link to SDTM domains by internal SDTM versions Link to ADaM PARAM/PARAMCD definitions Define our preferred labels, operational codes, unit conversions, etc. This enable us to support: Impact assessment changes to CT and SDTM mappings and usage Apply new versions of CT and SDTM on trials during execution Up or down version SDTM deliverables when preparing data integrations
How to manage changes to CDISC standards at Novo Nordisk Thank you Sune Dandanell Senior Standards Developer Clinical Data Standards Novo Nordisk A/S sdne@novonordisk.com Mikkel Traun Principal System Developer CDW & Systems Support Novo Nordisk A/S mt@novonordisk.com 06-Nov-2018 25