CRM^C01 — Register a Patient on a Clinical Trial
Patient registration in a clinical trial, from the CTMS (Clinical Trial Management System) to the EHR. Initialises the phase and experimental arm.
Purpose
CRM^C01 enrols a patient on a clinical trial. The message carries the protocol number, phase (screening, randomization, treatment, follow-up), experimental arm, principal investigator, and registration date. Paired with CSU (Clinical Study Data Update) for later updates.
Segment structure
Structure CRM_C01: MSH, [PID, [PV1], [CSR, [CSP]]].
| Segment | Role |
|---|---|
CSR | Clinical Study Registration — protocol #, status, investigator. |
CSP | Clinical Study Phase — phase sequence (screening, randomization, treatment). |
Real-world example
Screening phase registration for cardiovascular trial ANSM 2025-CVAR-001:
MSH|^~\&|CTMS|TRIAL_CENTER|EHR|HOSP01|20260518150500||CRM^C01^CRM_C01|CRM01001|P|2.5.1|||AL|NE
PID|1||MR998877^^^HOSP^MR||RAYNAUD^OLIVIA^^^MS.||19710521|F
CSR|TRIAL2025-CVAR-001|||SCREENING|20260518150000|20260518150000|ACTIVE^Active^HL70319|||CARDIO_LYON|DR_BLANC^Blanc^Sophie|||
CSP|1|SCREEN^Screening^L|20260518150000|||ELIGIBLE^Eligible^HL70320
CSP|2|RAND^Randomization^L|20260520090000|||PENDING^Pending^HL70320Acknowledgment (ACK)
MSH|^~\&|EHR|HOSP01|CTMS|TRIAL_CENTER|20260518150508||ACK^C01^ACK|ACKCRM01001|P|2.5.1
MSA|AA|CRM01001Common errors
- CSR-1 (Study ID) not compliant with national registry: in France EUDRACT/ANSM, in US NCT (ClinicalTrials.gov).
- Non-sequential CSP-1: phases must follow the protocol order (screen → rand → treat → followup).
- No consent recorded: HL7 v2 does not carry consent ; it must be stored in the EHR before CRM.
- CRM / CSU confusion: CRM = initial registration, CSU = update.