HDR Version 7 HL7 Version 3 Messaging Conformance Specification

4.5 Clinical Trial Laboratory Observation Periodic Report - PORT_RM030001HL02

This section contains the following topics:

4.5.1 Introduction
4.5.2 RMIM
4.5.3 State Transitions/Trigger Events
4.5.4 Interactions
4.5.5 Referenced CMETs
4.5.6 Links to Artifacts

4.5.1 Introduction

The Clinical Trial Laboratory Observation Periodic Report RMIM is used for communicating clinical trials laboratory result information. The model represents the administrative aspects of a clinical trial (protocols, trials, sites, investigators, subjects and study events), and the information requirements for representing the laboratory observations generated during the conduct of a clinical trial. It also represents the set of actions that define an experiment to assess the effectiveness and/or safety of a biopharmaceutical product (food, drug, device and so on). In the event mood, this designates the aggregate Act of applying the actions to one or more subjects.

Default Values

For HDR conformance, it is expected that the following values have been defaulted prior to the receipt of the message by the Inbound Message Processor. This must be done by either the source system or the message transport mechanism (Interface Engine).

4.5.2 RMIM

The following figure diagrams the Clinical Trial Laboratory Observation Periodic Report RMIM:

Figure: 4.5.2-1 Clinical Trial Laboratory Observation Periodic Report RMIM

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4.5.3 State Transitions/Trigger Events

The list of trigger events follows:

4.5.4 Interactions

The list of Interactions follows:

4.5.5 Referenced CMETs

4.5.6 Links to Artifacts

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