Laboratory Result-based Adverse Event Assessment Messaging Project

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

• January 2008 Ballot Cycle: Ballot Reconciliation 2008/01/15

• Project Scope Statement: Scope Statement 2007/10/30
• Project Charter: Project Charter 2007/10/30
• Storyboards: Storyboard & Interaction Design Elements
• Lab-based AE Life Cycle: Draft Activity Diagram: Life Cycle of the Lab-based AE
• CMET Design Specification
  • CMET Design Specification 2007/08/07
  • CMET RIMM & Data Dictionary
• Vocabulary Domains & Value Sets: CMET Vocabulary Requirements

Conference Call Schedule

New Schedule Effective October 9, 2008

Recurrence: Thursdays, biweekly
Time: 1pm - 2pm Eastern Time
Next Meeting: Friday, October 24, 2008 (rescheduled from October 23, 2008)
Phone Number: 888.387.4875
Participant Passcode: 603296

• Meeting Minutes