1. 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

2. Agenda Background & Issue
Proposal – Adjudication outcomes in a Findings domain
Challenges with other models – our experience
Current status at CDISC
Questions?
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3. 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
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4. 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.
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6. 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
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7. 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
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8. 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
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9. 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.
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10. 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 pipeline.
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