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8.10.1 Clinical trials master file message (MFN/MFK)

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

MFN     Master File Notification     Chapter
MSH     Message Header        2
MFI     Master File Identification     8
 { MFE    Master File Entry        8
 CM0    Clinical Study Master       8
    [{ CM1   Clinical Study Phase       8
      [{CM2}] }]  Clinical Study Schedule      8
   }
MFK     Master File Acknowledgment    Chapter
MSH     Message Header        2
MSA     Acknowledgment        2
MFI     Master File Identification     8
  { [MFA] }   Master file ACK         8

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

MFI-1-master file identifier code = CMB

MFN     Master File Notification     Chapter
MSH     Message Header        2
MFI     Master File Identification     8
 { MFE    Master File Entry        8
 CM0    Clinical Study Master       8
   [ {CM2}] Clinical Study Schedule       8
   }
MFK     Master File Acknowledgment    Chapter
MSH     Message Header        2
MSA     Acknowledgment        2
MFI     Master File Identification     8
  { [MFA] }   Master file ACK        8

When the Clinical Trials master segments are used in the MFR message, the part of the message represented by:

      {MFE
    [Z..] }

is replaced by, in case 1 above:

{ MFE
 CM0  
 [{ CM1
      [ {CM2}]
 }

In case 2 above, the corresponding segments in the MFR message represented by:

      {MFE
   [Z..] } 

are replaced by

{ MFE   
 CM0                 
  [ {CM2}] }]
   }

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