MFN^M07 — Clinical Study With Phases

Broadcast of the clinical studies reference set: registered protocols (ClinicalTrials.gov / EU CTR), phases (I/II/III/IV), arms (placebo, treatment, crossover). Bridge between the CTMS (Clinical Trial Management System) and HIS for recruitment and data collection.

Purpose

M07 transmits the active studies catalog in the institution and their successive phases. Allows oncology consultations to instantly propose an inclusion protocol, or the lab to tag specimens with the right study ID. Research counterpart of the CM0/CM1/CM2 master file.

Segment structure

Structure MFN_M07: MSH, MFI, { MFE, CM0, {CM1, {CM2}} } (1..* studies).

• CM0-2 — Sponsor Study ID (internal study identifier).
• CM0-3 — Alternate Study ID (typically NCT*).
• CM0-4 — Title of Study.
• CM0-6 — Principal Investigator.
• CM0-12 — Patients Registered on Study.
• CM1 — Phase / Schedule (CM1-1 phase ID, CM1-3 duration).
• CM2 — Scheduled Time Point (planned visits).

Real-world example

Opening a new phase III oncology pembrolizumab vs placebo study:

MSH|^~\&|CTMS|RESEARCH01|EHR|HOSP_CTR|20260519191500||MFN^M07^MFN_M07|MFNM07001|P|2.5.1|||AL|NE
MFI|CM0^Clinical Study^HL70175|CTMS|UPD|20260519191500|20260519191500|AL
MFE|MAD|CM0-ONCO-CTR-2026-001|20260519191500|ONCO-CTR-2026-001^PD-L1 Pembrolizumab vs Placebo Trial^L|CWE
CM0|1|ONCO-CTR-2026-001^PD-L1 Pembrolizumab vs Placebo Trial^L|NCT05887766^ClinicalTrials.gov|F|R|DR_LEFEVRE^Lefevre^Marie^Investigator|24|MO|20260101|20281231|||0
CM1|1|PHASE-III|PHASE-III|||F|R|20260101|20281231
CM1|2|FOLLOW-UP|FOLLOW-UP|||F|R|20281231|20291231

CDISC ODM / SDTM link

HL7 M07 is the HIS-side equivalent of the CDISC ODM Study Element on the EDC side (Medidata Rave, Veeva CDB). A study broadcast via M07 should mirror an ODM Protocol Element with the same Study OID. For FDA/EMA submission, the SDTM layer extracts from the EDC, but the CM2 scheduled visits feed pre-fills for HIS-side questionnaires.

Common errors

• CM0-3 without NCT: inclusions must be traceable to ClinicalTrials.gov for ICMJE publication.
• CM1 without dates: planned phases without start/end dates block the inclusion window computation.
• MAD without CM0-12 = 0: a newly created study must start at 0 patients; otherwise cumulative count errors.
• Confusion M07 vs M04: M04 = charges/procedures, M07 = clinical studies. Both can coexist but don't map.

Related master files

See also: MFN^M05, MFN^M06, MFN^M02.