18.4.80 MFN/MFK - Clinical Trials Master File Message (Event M06-M07) (8.11.1)

The CM0 (Clinical Study Master), CM1 (Clinical Study Phase), and CM2 (Clinical Study Schedule) segments can be used to transmit master files information between systems. The CM0 segment contains the information about the study itself; the CM1 contains the information about one phase of the study identified in the preceding CM0; and the CM2 contains the information about the scheduled time points for the preceding study or phase-related treatment or evaluation events. When these segments are used in an MFN message, the abstract definition is described below.

Case 1: MFN message for Clinical Study with phases and schedules

MFI-1 - Master File Identifier Code = CMA

• Message
• ACK Choreography
• FHIR Structure Definition
• v2.xml XSD
• ER7 Example
• XML Example

Segment	Cardinality	Implement	Status
MFN^M06^MFN_M06
MSH Message Header	[1..1]	SHALL
SFT Software Segment
UAC User Authentication Credential Segment	[0..1]
MFI Master File Identification	[1..1]	SHALL
MF_CLIN_STUDY	[1..*]	SHALL
MFE Master File Entry	[1..1]	SHALL
CM0 Clinical Study Master	[1..1]	SHALL
MF_PHASE_SCHED_DETAIL
CM1 Clinical Study Phase Master	[1..1]	SHALL
CM2 Clinical Study Schedule Master

 

MFN_M06

MSH-15	MSH-16	Immediate ACK	Application Ack
Blank	Blank	-	MFK^M06^MFK_M01
NE	NE	-	-
AL, SU, ER	NE	ACK^M06^ACK	-
NE	AL, SU, ER	-	MFK^M06^MFK_M01
AL, SU, ER	AL, SU, ER	ACK^M06^ACK	MFK^M06^MFK_M01

We need some ER7 examples...

We need some XML examples...

• Message
• ACK Choreography
• FHIR Structure Definition
• v2.xml XSD
• ER7 Example
• XML Example

Segment	Cardinality	Implement	Status
MFK^M06^MFK_M01
MSH Message Header	[1..1]	SHALL
SFT Software Segment
UAC User Authentication Credential Segment	[0..1]
MSA Message Acknowledgment	[1..1]	SHALL
ERR Error
MFI Master File Identification	[1..1]	SHALL
MFA Master File Acknowledgment

 

MFK_M01

MSH-15	MSH-16	Immediate ACK	Application Ack
Blank	Blank	ACK^M15^ACK	-
Blank	Blank	-	-
Blank	Blank	-	-
Blank	Blank	ACK^M04^ACK	-
Blank	Blank	-	-
Blank	Blank	ACK^M06^ACK	-
Blank	Blank	-	-
Blank	Blank	ACK^M07^ACK	-
Blank	Blank	-	-
Blank	Blank	ACK^M05^ACK	-
Blank	Blank	-	-
Blank	Blank	ACK^M16^ACK	-
Blank	Blank	-	-
Blank	Blank	ACK^M17^ACK	-
Blank	Blank	-	-
Blank	Blank	-	-
Blank	Blank	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
NE	NE	-	-
AL, SU, ER	NE	ACK^M13^ACK	-
AL, SU, ER	NE	ACK^M19^ACK	-
AL, SU, ER	NE	ACK^M14^ACK	-
AL, SU, ER	NE	ACK^M17^ACK	-
AL, SU, ER	NE	ACK^M02^ACK	-
AL, SU, ER	NE	ACK^M16^ACK	-
AL, SU, ER	NE	ACK^M08^ACK	-
AL, SU, ER	NE	ACK^M18^ACK	-
AL, SU, ER	NE	ACK^M09^ACK	-
AL, SU, ER	NE	ACK^M07^ACK	-
AL, SU, ER	NE	ACK^M10^ACK	-
AL, SU, ER	NE	ACK^M06^ACK	-
AL, SU, ER	NE	ACK^M11^ACK	-
AL, SU, ER	NE	ACK^M04^ACK	-
AL, SU, ER	NE	ACK^M12^ACK	-
AL, SU, ER	NE	ACK^M05^ACK	-
AL, SU, ER	NE	ACK^M15^ACK	-
NE	AL, SU, ER	-	-
AL, SU, ER	AL, SU, ER	ACK^M19^ACK	-

We need some ER7 examples...

We need some XML examples...

Case 2: MFN message for Clinical Study without phases but with schedules

MFI-1 - Master File Identifier Code = CMB

• Message
• ACK Choreography
• FHIR Structure Definition
• v2.xml XSD
• ER7 Example
• XML Example

Segment	Cardinality	Implement	Status
MFN^M07^MFN_M07
MSH Message Header	[1..1]	SHALL
SFT Software Segment
UAC User Authentication Credential Segment	[0..1]
MFI Master File Identification	[1..1]	SHALL
MF_CLIN_STUDY_SCHED	[1..*]	SHALL
MFE Master File Entry	[1..1]	SHALL
CM0 Clinical Study Master	[1..1]	SHALL
CM2 Clinical Study Schedule Master

 

MFN_M07

MSH-15	MSH-16	Immediate ACK	Application Ack
Blank	Blank	-	MFK^M07^MFK_M01
NE	NE	-	-
AL, SU, ER	NE	ACK^M07^ACK	-
NE	AL, SU, ER	-	MFK^M07^MFK_M01
AL, SU, ER	AL, SU, ER	ACK^M07^ACK	MFK^M07^MFK_M01

We need some ER7 examples...

We need some XML examples...