Standardization of Adjudication Outcomes Data Modelling using CDISC standards Aparna Kulkarni, Data Scientist Jacques Lanoue, AD Statistical Programming Standards Ram Govindaraju, AD Statistical Programming Standards Novartis

Agenda Background & Issue Proposal – Adjudication outcomes in a Findings domain Challenges with other models – our experience Current status at CDISC Questions? | Presentation Title | Presenter Name | Date | Subject | Business Use Only

Background Results of an adjudication process are of very high value as they validate study results. Considering the impact of this adjudication data on decision making regarding the safety and effectiveness of a medicinal product, there is currently no standard in place for the submission of this data. Adjudication Charter What will be adjudicated – Events or other findings Identification and Tracking of Adjudication Events Who will adjudicate – Adjudication Committee members Adjudication criteria used by the committee Adjudication outcome form – Records results from adjudication | Presentation Title | Presenter Name | Date | Subject | Business Use Only

Proposal What data model is the best for Adjudication outcomes data? Adjudication outcome data is the “result” of an adjudication process. We need a flexible structure that can accommodate various types of adjudication data. For that we are proposing to use a standalone Findings about domain. Adjudication outcome data may include: Description of adjudication events or findings. Result of adjudication – answer to confirmatory questions. Decision process. E.g. Unanimous, Majority Identification of the expert evaluator. E.g. Adjudication Committee. Multiple adjudications performed at various time points. | Presentation Title | Presenter Name | Date | Subject | Business Use Only

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Proposal FATEST is controlled Continued FATEST is controlled OCCUR CLASSIFY TYPE RPTERM DICTERM ADTERM FAOBJ is free text to allow the flexibility needed to represent Adjudication data | Presentation Title | Presenter Name | Date | Subject | Business Use Only

Challenges with the proposed model FA domain is a generic domain. To take advantage of standardization, there is a need for specific controlled terminology FACAT and FASCAT TEST FAEVAL : INDEPENDENT ASSESSOR (n), ADJUDICATOR Dates such as adjudicated start of event - collect as a result? SDTM IG 3.2 section 4.1.4.9 | Presentation Title | Presenter Name | Date | Subject | Business Use Only

Challenges with other models Previously modeled to the source domain – e.g. AE Challenges Risk of double-counting events Need additional documentation Compliance issues Addition of numerous SUPPQUALs | Presentation Title | Presenter Name | Date | Subject | Business Use Only

Conclusion Adopt a FA Sub-class domain like “Skin Response (SR) domain” Standardize the location, data structure and terminology for presenting Adjudication data while keeping a high level of flexibility. | Presentation Title | Presenter Name | Date | Subject | Business Use Only

Current Status at CDISC There is a proposal to develop adjudication in a similar way to a stand-alone TA standard.  This has been an agenda topic at TAPSC (the CFAST steering committee).  A survey within TransCelerate to measure interest and priority in relation to other TAs still to be developed.  The results of that survey will be taken into consideration for 2017 CFAST pipeline discussions - evaluate priorities of TA development between FDA, CPath, NCI-EVS, CDISC and TransCelerate.  CFAST 2017 pipeline discussions will occur at the end of September at the CDISC interchange.  TAPSC will communicate a decision by October 2016 on the 2017 pipeline. | Presentation Title | Presenter Name | Date | Subject | Business Use Only