DIME PROJECT

CRS adjudication framework for CAR-T & TCE therapies

Grounded in ASTCT (2019) consensus criteria.

Shaped by clinical, data science, regulatory, and technology experts.

Built to fit existing workflows:

Works with the clinical data teams already collect
Preserves clinical judgment rather than replacing it
Imposes no rigid minimum dataset
Can be applied retrospectively or prospectively, in trial and care workflows

ADJUDICATION RESOURCES

The flowchart walks reviewers through adjudicating an event step by step.

The companion guide supplies the principles, definitions, and documentation behind each step.

Why it’s needed

CRS can evolve after CAR-T and TCE therapies, but current approaches typically capture only a peak grade and onset time, not the full trajectory of symptoms, physiologic findings, interventions, and response over time.

That gap makes CRS hard to compare across studies, slows shared understanding of these toxicities, and stands in the way of delivering these therapies safely beyond major centers.

What it does

The CRS Adjudication Framework is a standardized, reproducible method for characterizing a complete CRS event, from the earliest qualifying signs through resolution. It gives reviewers a structured way to:

Determine whether an event is CRS
Grade it consistently using the ASTCT (2019) consensus standard
Document the event’s full trajectory and the clinical rationale behind each determination

CRS Adjudication Flowchart

A systematic approach to assessing potential CRS events in patients receiving CAR-T or T-cell engager therapies

This flowchart maps the sequence of questions a reviewer works through to determine whether an event is CRS, then documents its course from onset to resolution.

The workflow is intended to support consistent and reproducible CRS adjudication while preserving clinical judgment and alignment with established CRS definitions and grading criteria.

Download full Flowchart

CRS Adjudication Guide

Recommended elements for structured CRS event review following CAR-T and T-cell engager therapies

This companion guide gives clinical researchers the context behind each step of the flowchart: the principles, definitions, and recommended documentation needed to apply the framework consistently.

Download Guide

When to use this framework

The CRS Adjudication Framework can be applied retrospectively or prospectively to support consistent identification, documentation, and characterization of CRS events. The appropriate approach depends on the intended use, study design, and timing of review.

Retrospective
adjudication

USE WHEN
Independent review of CRS events is needed, such as centralized safety review or endpoint adjudication after events have occurred.

VALUE
Provides a structured, consistent approach to evaluating available clinical evidence, supporting comparability of CRS assessments across studies.

CONSIDERATIONS
The quality of the review depends on the availability of source documentation, including accurate timing of clinical findings, interventions, and outcomes.

Prospective point-of-care implementation

USE WHEN
Standardized CRS documentation is needed during clinical care or clinical trial conduct as events evolve.

VALUE
Captures CRS events in real time, including clinical findings, physiologic changes, interventions, and response, while information is available to the treating clinical team.

CONSIDERATIONS
Requires integration into clinical workflows and does not replace independent review when adjudication is required.

Consider both approaches

Prospective documentation and retrospective adjudication serve different purposes and are strongest in combination. Prospective structured documentation captures clinical findings, physiologic changes, and interventions in real time, producing more complete and contemporaneous records. Retrospective adjudication applies consistent, independent review to those records, supporting comparability across studies.

Using both means events are well-documented as they occur and consistently adjudicated afterward.

Designed for real-world use

This framework supports:

Standardized identification and grading across therapies, settings, and trials, using the ASTCT (2019) standard
Harmonized, independent review, consistent evaluation across sites rather than site-by-site reporting
Full-trajectory capture of CRS evolution: changes in grade, clinical manifestations, and management over time
High-quality longitudinal datasets that improve comparability across studies, therapies, and real-world data
A foundation for future DHT use and algorithm-based tools built on complete, comparable CRS data

FAQs

Does this framework replace ASTCT grading?

No. The framework complements ASTCT by providing a structured methodology for identifying and documenting CRS events.

Is this intended for adjudication only?

No. The framework can support prospective documentation, retrospective review, sponsor adjudication, and research.

What are the data sources needed for adjudication of CRS?

CRS adjudication should incorporate all relevant available clinical information. The framework recognizes that data completeness may vary across studies and institutions. The absence of a specific data element should not prevent adjudication when sufficient clinical evidence exists for clinical interpretation.

Recommended data sources include:

Vital signs
Medication administration records
Laboratory data
Continuous physiological data
Hospitalization records
Site-reported CRS documentation
Clinical notes

What data sources should be used when a conflict arises in available documentation?

Because CRS events are reconstructed from multiple clinical sources, discrepancies may occur between documentation systems. The framework recommends a structured review approach to support consistent interpretation of available information.

The purpose of the data source hierarchy is not to establish that one source always supersedes another, but rather to guide reviewers toward the most objective and contemporaneous evidence available.

Factors considered when evaluating conflicting information include:

Proximity of documentation to the clinical event
Whether data represent direct measurement versus interpretation
Completeness of the clinical timeline
Relationship between findings and clinical interventions

When is adjudication for CRS required?

The adjudication population should include all patients receiving CAR-T or T-cell engager therapy within the study. This approach ensures that CRS events are identified consistently and minimizes variability introduced by selective referral for adjudication.

How should the framework be implemented with continuous data?

Continuous physiologic data may provide valuable insight into the evolution of CRS events. When available, continuous data should be preserved whenever feasible rather than reduced to summary values alone.

The framework encourages the development of standardized approaches for translating continuous measurements into clinically meaningful events, including pattern changes relative to personalized baselines for vital signs and activity levels, the duration of abnormal findings, and timing relative to interventions. This approach allows future analyses while maintaining the clinical context required for interpretation.

What are the events output from CRS adjudication?

The goal of CRS adjudication is to create a consistent longitudinal representation of each potential CRS event. Following completion of adjudication, the following outputs should be captured:

CRS event determination
Adjudication/clinical rationale for each determination
CRS onset date & time
CRS resolution date & time
Maximum CRS grade
Grade escalation & timing
CRS recurrence (new event after resolution of prior CRS event)
Alternative diagnosis including ICANS

Additional DiMe resources to support your success

De-Risking CRS: Digital Measures Development

This project established the common digital clinical measures used to identify CRS onset, the detection layer this framework builds on. Find a practical guide for developing CRS de-risking products, an ontology to standardize data collection, and an innovation roadmap for de-risking products.

Explore CRS Resources

The sDHT Adoption Navigator

This project offers a vetted library and interactive roadmap for teams building or validating the sensor-based technology behind CRS monitoring. Find a curated resource library for sDHT development and clinical trial use, featuring NaVi, your AI-powered research assistant, and an interactive roadmap for navigating endpoint strategy and implementation.

Explore sDHT Roadmap

Next steps

Now that you’ve explored how the adjudication framework applies to CRS monitoring in CAR-T and TCE therapies, we recommend returning to the homepage to ensure you haven’t missed key resources developed to help you succeed with other aspects of CRS adjudication and outpatient monitoring.

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