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7.6.2 CSU - unsolicited study data message (events C09-C12)

Data are entered in the clinical trials system or may reside in laboratory, pathology, radiology, pharmacy and/or other clinical applications. Most clinical trials data - clinical observations and study variables - will be communicated in OBR and OBX segments. The CSR, CSP, and CSS segments will identify the specific association these OBR and OBX have to the clinical trial. Data can be broadcast or transmitted in batch mode to study sponsors or the data management center for collaborative studies.

Event

Description

C09

Automated time intervals for reporting, like monthly

C10

Patient completes the clinical trial

C11

Patient completes a phase of the clinical trial

C12

Update/correction of patient order/result information

CSU    Unsolicited Study Data Message    Chapter
MSH    Message Header         2
{
 PID    Patient Identification       3
 [PD1]   Additional Patient Identification     3
 [{NTE}]   Notes and comments        2
 [PV1   Patient Visit         3
  [PV2]   Additional Patient Visit       3
 ] 
 CSR    Clinical Study Registration      7
 {[CSP]   Clinical Study Phase        7
    {[CSS]  Clinical Study Data Schedule      7
      {[[ORC] Common Order          4
          OBR Observation Battery        7
          {OBX} Observation Results        7
       }]
       {[ORC] Common Order          4
          {RXA Pharmacy Administration       4 
           RXR Pharmacy Route         4
           }
           }]
         }
      }
     }   

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