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Difference between revisions of "Laboratory Result-based Adverse Event Assessment Messaging Project"

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The scope of this project is to develop specifications to support the messaging requirements of initial result data for laboratory result-based quantitative adverse event (AE) assessments/gradingThis message content represents only the first-level evaluation of lab results subject to quantitative AE assessment. Subsequent AE investigation must be conducted within the local clinical research environment in order to determine, in part, the reporting requirements established by such entities as the protocol sponsor, the oversight committee, the regulatory agencyThus, the messaging interaction of concern to this project is intended only to facilitate communication between an automated lab-based quantitative AE detection and grading service and a system within the local research environment such as a Clinical Trials Management System (CTMS) or Clinical Information System (CIS).
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[[Category:RCRIM]]
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Return to [[Regulated Clinical Research Information Management|RCRIM]] main page
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The scope of this project is to develop messaging specifications to support the request for an abnormality assessment of a laboratory test result and to support the response or outcome of the abnormality assessmentThe message content represents only the initial/first-level evaluation of a lab result for indications of an abnormal condition; investigation of a subject's condition must be conducted within the local clinical research environment to determine if an adverse event has occurredThe messaging interactions of concern to this project are intended only to facilitate communication between an automated lab-based abnormality assessment service and a system within the local research environment such as a Clinical Trials Management System (CTMS) or Clinical Information System (CIS).
  
 
== Project Artifacts ==
 
== Project Artifacts ==
* January 2008 Ballot Cycle
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* January 2008 Ballot Cycle: [http://informatics.mayo.edu/wiki/images/f/f2/Ballot_Reconciliation_Jan2008.ppt Ballot Reconciliation 2008/01/15]
** [[http://informatics.mayo.edu/wiki/images/f/f2/Ballot_Reconciliation_Jan2008.ppt Ballot Reconciliation 2008/01/15]]
 
  
* [[http://informatics.mayo.edu/wiki/images/1/10/ProjectScope_LabResultBasedAEAssmt_v2R3.doc Scope Statement 2007/10/30]]
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* Project Scope Statement: [http://gforge.hl7.org/svn/rcrim/trunk/Project%20Scope%20Statements/ProjectScope_LabResultBasedAEAssmt_v2R3.doc Scope Statement 2007/10/30]
* [[http://informatics.mayo.edu/wiki/images/4/45/ProjectCharter_LabTestResultAbnormalityAssmt_v0.10.doc Project Charter 2007/10/30]]
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* Project Charter: [http://informatics.mayo.edu/wiki/images/4/45/ProjectCharter_LabTestResultAbnormalityAssmt_v0.10.doc Project Charter 2007/10/30]
* Storyboards
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* Storyboards: [http://informatics.mayo.edu/wiki/images/4/45/Storyboard_Interactions.doc Storyboard & Interaction Design Elements]
** [[http://informatics.mayo.edu/wiki/images/4/45/Storyboard_Interactions.doc Storyboard & Interaction Design Elements]]
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* Lab-based AE Life Cycle: [http://informatics.mayo.edu/wiki/images/a/a5/LifeCycleLab-basedQuantitativeAE.pdf Draft Activity Diagram: Life Cycle of the Lab-based AE]
* [[http://informatics.mayo.edu/wiki/images/a/a5/LifeCycleLab-basedQuantitativeAE.pdf Draft Activity Diagram: Life Cycle of the Lab-based AE]]
 
 
* CMET Design Specification
 
* CMET Design Specification
** [[http://informatics.mayo.edu/wiki/images/d/d8/HL7V3Lab-BasedAEAssmntCMET20070807.ppt CMET Design Specification 2007/08/07]]
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** [http://informatics.mayo.edu/wiki/images/d/d8/HL7V3Lab-BasedAEAssmntCMET20070807.ppt CMET Design Specification 2007/08/07]
** [[http://informatics.mayo.edu/wiki/images/3/38/CMET_RMIM_Data_Dictionary.doc CMET RIMM & Data Dictionary]]
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** [http://informatics.mayo.edu/wiki/images/3/38/CMET_RMIM_Data_Dictionary.doc CMET RIMM & Data Dictionary]
* Vocabulary Domains & Value Sets
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* Vocabulary Domains & Value Sets: [http://informatics.mayo.edu/wiki/images/2/23/CMET_Vocabulary_Requirements.xls CMET Vocabulary Requirements]
** [[http://informatics.mayo.edu/wiki/images/2/23/CMET_Vocabulary_Requirements.xls Vocabulary Domains & Value Sets]]
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<br>
  
 
== Conference Call Schedule ==
 
== Conference Call Schedule ==
  
Tuesday, Every other week <br>
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'''New Schedule Effective October 9, 2008''' <br> <br>
10am - 11am Eastern Time <br>
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Recurrence: Thursdays, biweekly <br>
Next Meeting: February 26, 2008 <br>
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Time: 1pm - 2pm Eastern Time <br>
Phone Number: +1 (702) 894-2444 <br>
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Next Meeting: '''TBD''' <br>
Participant Passcode: 74859677
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Phone Number: 770.657.9270 <br>
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Participant Passcode: 745896
  
 
*[[Laboratory Result-based Adverse Event Assessment Messaging Project Meetings|Meeting Minutes]]
 
*[[Laboratory Result-based Adverse Event Assessment Messaging Project Meetings|Meeting Minutes]]

Latest revision as of 18:49, 9 November 2009

Return to RCRIM main page

The scope of this project is to develop messaging specifications to support the request for an abnormality assessment of a laboratory test result and to support the response or outcome of the abnormality assessment. The message content represents only the initial/first-level evaluation of a lab result for indications of an abnormal condition; investigation of a subject's condition must be conducted within the local clinical research environment to determine if an adverse event has occurred. The messaging interactions of concern to this project are intended only to facilitate communication between an automated lab-based abnormality assessment service and a system within the local research environment such as a Clinical Trials Management System (CTMS) or Clinical Information System (CIS).

Project Artifacts


Conference Call Schedule

New Schedule Effective October 9, 2008

Recurrence: Thursdays, biweekly
Time: 1pm - 2pm Eastern Time
Next Meeting: TBD
Phone Number: 770.657.9270
Participant Passcode: 745896