Laboratory Result-based Adverse Event Assessment Messaging Project
The scope of this project is to develop specifications to support the messaging requirements of initial laboratory result-based adverse event (AE) assessment information. This message content represents a first-level AE assessment only, which must be further investigated within the local clinical research environment in order to determine, in part, the reporting requirements established by the protocol sponsor, the oversight committee, and the regulatory agency. Thus, the messaging interaction is intended only to facilitate communication between an automated lab-based AE detection and grading service and a Clinical Trials Management System (CTMS) or Clinical Information System (CIS) within the local research environment.
Project Artifacts
- Scope Statement
- Project Charter
- Storyboards
- Lab-based AE Life Cycle Activity Diagram
- RMIM Design
- CMET Design
Conference Call Schedule
Tuesday, Every other week 10am - 11am Eastern Time Next Meeting: July 31, 2007
Meeting Minutes (link to page with itemized meeting minute doc)
- Meeting Minutes_20070703
- Meeting Minutes_20070717
