How to manage changes to CDISC standards at Novo Nordisk. PhUSE EU Connect 2018 Sune Dandanell and Mikkel Traun
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1 How to manage changes to CDISC standards at Novo Nordisk PhUSE EU Connect 2018 Sune Dandanell and Mikkel Traun
2 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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
3 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Changes to CDISC CT from 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 Add CDISC Code Add CDISC Code List CDISC CT package number 34
4 How to manage changes to CDISC standards at Novo Nordisk 06-Nov The famous example by Johannes Ulander: Credits: Johannes Ulander, S-Cubed
5 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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
6 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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 Lab Test Code BUN [C61019] CDISC CT Lab Test Code UREAN [C125949]
7 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Solution for the BUN mystery Topic Code concept ADaM PARAM SDTM Domain Linked CDISC CT Sponsor Defined CT
8 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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 SDTM CDISC CT
9 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Step 2: Load of package into our MDR Load from local folder
10 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Step 2: Load of package into our MDR CDISC CT version loaded All codelists and codes loaded in draft
11 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Step 3: Impact assessment Verification report against previous version of CDISC CT
12 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Step 3: Impact assessment Verification report result: - Same - Change - Conflict - New - Delete Change + Conflict + Delete => Lost link of Topic Code to CDISC CT!!
13 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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
14 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Step 3: Impact assessment 1) SDTM terminology change log available at 2) Conflict in CHILD, BIOLOGICAL 3)
15 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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?
16 Step 4: Linking How to manage changes to CDISC standards at Novo Nordisk 06-Nov Different CDISC- Code in different versions of CDISC CT Linking of CHILD is changed with new CDISC CT
17 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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
18 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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 Related Subjects CHILD [*] CHILD, BIOLOGICAL [C100807] CDISC CT Related Subjects CHILD [C150886] CHILD, BIOLOGICAL [C42708]
19 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Linking to CDISC or Sponsor Defined CT Select CDISC CT version Linked SDTM Domain Sponsor Defined code Linked CDISC CT code
20 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Linking to CDISC or Sponsor Defined CT CT in Define.xml for version CACR is Sponsor Defined CT in Define.xml for version CACR is CDISC CT Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C C65047 Laboratory Test Code CACR Calcium Corrected A measurement of calcium, which has been corrected for albumin, in a biological specimen. Calcium Corrected Measurement
21 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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
22 How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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
23 How to manage changes to CDISC standards at Novo Nordisk 06-Nov Linking Topic Code Concepts to SDTM Domains Internal SDTM Version Linked SDTM Domain
24 Conclusion How to manage changes to CDISC standards at Novo Nordisk 06-Nov 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
25 How to manage changes to CDISC standards at Novo Nordisk Thank you Sune Dandanell Senior Standards Developer Clinical Data Standards Novo Nordisk A/S Mikkel Traun Principal System Developer CDW & Systems Support Novo Nordisk A/S 06-Nov
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