DIME PROJECT
DECODE CRS: Accelerating safer, scalable immunotherapy
Most patients can receive these therapies only at major medical centers, which have the infrastructure and experience to monitor and manage Cytokine Release Syndrome (CRS), a known and manageable reaction. That requirement has driven conservative care models tied to a clinic, even though CRS cases are relatively rare and increasingly predictable to identify and treat.
– Clinician, stakeholder interview
That’s why DiMe, in partnership with Ametris and pharma partners, built DECODE CRS. The coalition is developing effective early warning systems for CRS by enabling more standardized and precise clinical data collection and monitoring, bringing greater access to these immunotherapies to patients outside of the clinic.
The resources
Each resource below is grounded in the ASTCT (2019) consensus criteria and was developed through structured input from clinicians, clinical trialists, data scientists, and regulatory and technology stakeholders. Information was gathered through stakeholder interviews and multistakeholder workshops, then refined through external expert review.
Feasibility assessment for outpatient CRS monitoring

A stakeholder-informed look at what it takes to move CRS monitoring into outpatient and community settings, covering the clinical, operational, and economic conditions for adoption.
Read the full report and work through a readiness checklist to see where your program stands today.
CRS adjudication framework for CAR-T & TCE therapies

A shared method for identifying, documenting, and grading a complete CRS event, so data stays comparable across trials and institutions.
The framework includes a decision flowchart and a supporting guide to help sites consistently capture events.
Find your starting point
Clinicians & care teams
Our resources provide you with an approach for monitoring CRS in outpatient and community settings, closer to where patients live
- Site Readiness Checklist across six operational domains
- After-hours alert routing models for the “who answers at 2 a.m.” problem
- Emergency department integration into the safety pathway
Clinical researchers & sponsors
Without a shared definition of a CRS event and its severity, data cannot be compared across sites or trials.
Our resources provide:
- A standardized CRS Adjudication Framework for grading CRS events the same way across sites and trials, so the data becomes comparable
- ASTCT grading that captures the full course of an event, and a reporting template
- Considerations for integrating continuous physiologic data as supporting evidence
- A companion Feasibility Report on outpatient monitoring, including clinical, operational, and economic conditions
Building on a foundation of evidence
Where we started
In 2025, DATAcc by DiMe released resources to support the development of trustworthy CRS de-risking products, by defining a mature digital measures set for CRS detection.
What was still needed
Detection alone does not move care out of the hospital. Sites had no shared way to monitor a CRS event, and no clear read on whether outpatient monitoring is operationally feasible across care settings.
How we addressed the gap
DECODE CRS delivers resources built on structured interviews with stakeholders across clinical care, research, industry, and patient advocacy. Multistakeholder workshops then validated the findings to inform the adjudication framework and feasibility report.
Meet the coalition
The Digital Endpoint Collaboration for Outcomes DEvelopment (DECODE) CRS initiative, led by DiMe and Ametris, operates as a pre-competitive, cross-sector collaboration. It aligns clinical, regulatory, commercial, and patient perspectives to build scalable approaches to CRS detection and management. Visit the Ametris site to learn more about ongoing work with the DECODE CRS Coalition and subscribe to the DiMe newsletter for the latest updates.
We are grateful to the following subject matter experts, and others, who contributed to the success of the first phase of this initiative:
Myung-Ju Ahn, Hanyang University Medical Center, Korea
Sergej Andrushchenko, Boehringer Ingelheim
Stephane Champiat, MD Anderson Cancer Center
Meenakshi Chatterjee, J&J
Juliane Liese, Boehringer Ingelheim
Kelsey Miller, MSN, RN, AGCNS-BC, OCN, Reading Hospital, Tower Health
Andrea Mortera, Empatica
Ruth Phillips, Blue Spark Technologies
Matt Ream, Blue Spark Technologies
Neil Segal, Memorial Sloan Kettering Cancer Center
Mark Stewart, Friends of Cancer Research
Nick Tschernia, NIH
Dana Wolff-Hughes, NIH

