Bridging the Gap Between Legacy & Standards. d-wise. Bill Qubeck, Life Sciences Director

Transcription

1 Standards Bridging the Gap Between Legacy & Bill Qubeck, Life Sciences Director d-wise

2 Agenda Case Study Details SDTM Mapping Process Factors that Influence the Path Lessons learned and Best Practices Conclusion d-wise 2

3 Case Study Details q Top 5 pharmaceu-cal company q Ini-a-ves underway to re-re, upgrade or replace legacy clinical systems q Mature business processes q Undergoing organiza-onal changes q 8-months to convert 400+ sponsor defined collec-on standards to CDISC SDTM d-wise 3

4 Process Flow: SDTM Mapping Execu=on d-wise 4

5 Mapping Informa=on Inputs Sponsor Data Standards CDISC Informa-on Sponsor Stakeholders d-wise 5

6 Mapping Informa=on Outputs Output Deliverables Ø Data Metadata Ø Mapping instruc-ons/transforma-ons Ø Source to Target CDISC SDTM Data Domain Ø Data Mapping (e.g., algorithms, logic, business rules) Ø Variable and Value Level Metadata Ø Controlled Terminology Ø Annotated CRF(s) Ø Mapping Handbook : A supplemental guide includes global and TA conven-ons, etc. d-wise 6

7 Factors that Influence the Path Business Priori=es Business Complexi=es Governance & Prac=ces d-wise 7

8 A Framework for Analyzing and Understanding an Organiza=ons Informa=on Flow* * Based d-wise s Clinical Trial Operational Model and Assessment Framework d-wise 8

9 Success! q 441 sponsor defined collec-on standards converted to CDISC SDTM in 8-months q Over 600 CRFs Annotated q Approximately 46,000 Control Terms mapped or created to support the conversion q Review/approval dura-on varied greatly from 3-days to 149-days! d-wise 9

10 Lessons Learned Assess & Address Percep=ons Ø Project was ini-ally perceived as a Standards only project Ø Do not assume that everyone understands the impact on Processes, Technology, Roles and Responsibili-es Ø Different groups can and do have different priori-es, needs, and expecta-ons d-wise 10

11 Lessons Learned Effec=vely Manage the Control Terminology (CT) Ø We strongly encourage not parsing the accountability across mul-ple individuals Ø Consolidate the project's CT management under a Global CT Curator Ø They interface with many individuals across func-ons (e.g., Dic-onary, Mappers, Standards, Implementers) and ensure consistency! d-wise 11

12 Lessons Learned Support Sponsor s SDTM Understanding Ø Do not underes-mate the -me and effort required to embed or support the sponsor's understanding and knowledge of CDISC SDTM Ø Assess and plan for knowledge sessions Ø Implement strategies to avoid Philosophical Debates/Arguments ; there maybe more than one possible interpreta-on or solu-on d-wise 12

13 Best Prac=ces From the Start: Integrate and align across func=ons Ø Be inclusive Ø Advocate for involvement and communica-on across the sponsor organiza-on Ø Integrate and align across the various func-ons such as Standards & Data Governance, Data Capture, and the Implementa-on Teams d-wise 13

14 Best Prac=ces Mispercep=ons Must be Addressed! Ø Address unwrigen assump-ons and percep-ons such as "it's just data structures", "this should be easy and straight forward", etc. Ø We encourage the advocacy of understanding Ø Will affect the en-re Clinical Trial Ø Process (data collec-on, management, repor-ng, signal detec-on, etc.) Ø Technology (e.g., EDC, CDMS, A&R Systems) Ø Organiza-onal func-ons (Data Management, Biometrics, Safety, etc.) d-wise 14

15 Best Prac=ces Implement Opera=onal Enhancements Ø We strongly encourage the development of materials to facilitate domain decisions such as Pre-Annota-ng the CRF Ø Obtain agreement on the CT prac-ces Ø A key challenge will be the up-versioning of CT sources as it could affect (significantly) previously approved 'domain mappings Ø Obtain agreement on how to handle lelover variables, those not 'submit-able' per CDISC standards (e.g., "Not Done") d-wise 15

16 Conclusion q The direc=ve is clear: deliver CDISC SDTM compliant submissions in the most efficient and effec+ve manner q Taking a holis-c approach increases the probability of successful while decreasing the risk of crea-ng disjointed, conflic-ng, and inefficient processes q We strongly encourage sponsors to review, align, and op-mize their governance prac-ces, business processes, and roles/responsibili-es as this will help ensure long-term success d-wise 16

17 Thank You Contact informa-on 1500 Perimeter Park Dr., Suite 150, Morrisville, NC d-wise 17