360i

The earlier pages explain how protocol information can be structured, shared and interpreted consistently. The next task is to connect that information to the specifications teams prepare from it.

CDISC 360i is the initiative connecting trial design through analysis using interoperable metadata. Its purpose is to preserve the relationships between the trial’s intent, the information collected and the results planned.

Add clinical meaning to the schedule

A schedule tells us that an assessment happens at baseline and Week 12. To prepare collection specifications, we also need to know what the assessment measures and which properties describe it.

A Biomedical Concept captures clinical meaning and associated data elements. A Dataset Specialization describes a particular dataset representation of that information. COSMoS provides the models and resources for these concepts and specializations in the CDISC Library.

Linking a scheduled activity to the appropriate concept gives downstream specifications a shared measurement definition. The timing comes from the trial design. The measurement properties come from the selected concept and its applicable specializations.

The semantic backbone

The 360i approach adds Analysis Concepts and Derivation Concepts alongside Biomedical Concepts. These layers of meaning support the specifications shown below.

%%{init: {"flowchart": {"nodeSpacing": 20, "rankSpacing": 24, "padding": 8}}}%%
flowchart LR
    subgraph Backbone["Semantic backbone"]
        direction TB
        BC["Biomedical Concepts"]
        AC["Analysis Concepts"]
        DC["Derivation Concepts"]
        BC ~~~ AC ~~~ DC
    end
    subgraph Specifications["Connected specifications"]
        direction TB
        CRF["eCRF specifications"]
        DTA["Data transfer agreement"]
        DDS["Data definition specification"]
        SDTM["SDTM Define-XML"]
        ADAM["ADaM Define-XML"]
        CRF ~~~ DTA ~~~ DDS ~~~ SDTM ~~~ ADAM
    end
    Backbone --> Specifications

These specifications describe collection forms, external transfers, operational metadata and dataset metadata. Their connections let teams trace requirements back to the design. The initiative develops models and reference implementations for making that reuse practical.

Follow the endpoint into analysis

Our endpoint is change from baseline in an assessment score at Week 12. The Analysis Concepts framework distinguishes the observations, the participant-level derivation and the result across participants.

Concept	In the example
Observation Concept	An assessment score for a participant at a specified time
Derivation Concept	That participant’s Week 12 score minus the selected baseline score
Analysis Concept	The mean change by arm and its confidence interval

Concepts describe what the information means. Methods describe the calculations. Bindings connect the method’s input and output roles to the relevant concepts. Baseline selection, visit windows and the statistical method still need explicit trial-specific decisions.

The protocol, form definition and analysis specification can then express the same endpoint for different purposes. The protocol explains it. The form defines the observations to collect. The analysis specification defines how those observations contribute to the planned result.

Follow a change through the same connections

If Week 12 changes to Week 16, the team needs to review the schedule, protocol timing, form placement and analysis timepoint rules. Connected metadata makes those dependencies available for impact review.

This is where the five foundations come together. M11 organizes the protocol content. USDM represents the trial design. Repositories make versions available to applications. Terminology preserves the meaning of coded values. The 360i approach connects those foundations with downstream specifications.

What TrialStack implements

TrialStack is the clinical development system for teams and agents. It combines the MDR and SDR roles with trial authoring, specification preparation and source-linked review. Reusable metadata and versioned trial definitions belong to the same governed workflow.

Teams use those records to prepare pre-submission artefacts: protocol content, collection definitions, SDTM mapping specifications and analysis specifications. Versioned handoffs carry the reviewed requirements to receiving systems, where dataset builds and statistical execution take place.

The practical result is three connected pieces of work that reviewers can inspect together: what the trial intends, what it needs to collect and how the planned analysis uses it. Explore Trial design or Analysis Specifications to see how that work is organized in TrialStack.