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, 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
- Draft Activity Diagram: Life Cycle of the Lab-based AE
- [CMET Design Specification]
- Vocabulary Domains & Value Sets
Conference Call Schedule
Tuesday, Every other week
10am - 11am Eastern Time
Next Meeting: July 31, 2007
Phone Number: +1 (702) 894-2444
Participant Passcode: 74859677
