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The Power of

Computable Operational Definitions (CODef)

CODef: A regulatory requirement for RWE Design in the Age of Data

FDA Guidance for Real World Data in September 2021 and December 2023 directed researchers regarding factors affecting their assessment of the reliability and relevance of real-world data, and outlined their expectation on how these should be addressed in study protocols. 

The guidance specifically recommends the need for Conceptual Definitions and Operational Definitions (CODef) to be outlined for study design elements (e.g. inclusion/exclusion criteria for study population, exposure, outcomes, covariates).

The challenge for RWE Researchers to perform RWE Design in the Age of Data
  • Ensuring that you can support the scientific rigor behind the conceptual and operational definitions in your protocol will be a key requirement for regulators and stakeholders.
  • Ensuring you have confidence that the study design elements you set for regulators are aligned with the Real World Data assets you wish to utilise for your project.

Align Science with Data


Computable Operational Definitions (CODef) allow the translation of Scientific Objectives, into specific definitions which align and enhance access and use of Real World Data for research.

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Our RWE SherpaTM Platform provides access to a range of indication-specific CODef Libraries.

Harnessing the Power of CODefs through RWE Sherpa can drive

the following benefits for your RWE Organisation: 

Knowledge Management

Utilize technology to curate and access a library of scientifically consistent definitions across your RWE Organisation.


Reduce the need to Reinvent the Wheel

Consistently deploy definitions each time you perform RWE Design or RWD Assessment.



Consistent RWE Design

By utilizing CODefs you can ensure that you have consistent robust scientific justifications for each Conceptual and Operational Definition used within your study protocol.

Consistent RWD Assesment

By utilizing CODefs you can ensure that you can provide data-aligned queries to your data partners, ensuring your partners feel they are always fairly assessed against study requirements

Watch the video below to understand more about the

 Power of Computable Operational Definitions



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Industry conversations

Computable Operational Definitions (CODef)


"Computable Phenotypes" - Understanding Their Importance in Regulatory Submissions of RWE.

Our CEO Aaron Kamauu, spoke at ISPOR 2024 alongside Marie Bradley from the FDA and Scott DuVall from US Department for Veterans Affairs, to showcase how the Power of CODefs can be used to illustrate fit-for-purpose use of real world data sources to regulators.


Presented at ISPOR Annual Meeting, Atlanta. 4th-8th May 2024.


Objective Fit-4-Purpose Assessment of Real-World Data for Evidence Generation in Type 2
Diabetes Mellitus: A Trial Tokenization Approach

The Navidence Team working alongside our colleagues from Datavant showed how the use of CODefs can derive significant value in the assessment of the value of RWD Tokenisation, as well and providing robust evidence of quality and fit-for-purpose to regulatory agencies.


Presented at ISPOR Annual Meeting, Atlanta. 4th-8th May 2024.

ISPOR 2022 AZ Navidence Paper-1

Development of Computable Operational Definitions to Maximize Comparability & Consistency Across a Multi-Data Source Global Real-World Effectiveness Program

The Navidence Team working alongside a team from AstraZeneca to develop source-agnostic Computable Operational Definitions (CODef) to support a multinational, multi-data source real-world effectiveness program.

Presented at the 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) | August 23–27, 2023, Halifax, Nova Scotia, Canada