: Public Class
Created: 8/21/2016 4:40:37 PM
Modified: 4/17/2018 11:18:29 AM
DEFINITION:<br/>An ordered program of clinical trials, each with specific objectives. This plan describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. (Adapted from ICH E8, E9)<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The plan should have appropriate decision points and allow modification as knowledge accumulates. <br/>
Public DSET<CD>
Notes: DEFINITION:<br/>A coded value specifying the field of knowledge that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual.<br/><br/>EXAMPLE(S):<br/>eye disease, nervous system disease<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The HL7 BR&R Work Group recognizes that there are other semantics related to this concept that may require more fully understanding and developing the relationships between therapeutic area, medical condition and organization-specific categorizations. Consequently, this concept may mature in future releases of BRIDG.<br/><br/>
Tag Value
Map:Vendor1v1.1 Project
Object Type Connection Direction Notes
Project Class Generalization To DESCRIPTION: Each ClinicalDevelopmentPlan always specializes one Project. Each Project might be specialized by one ClinicalDevelopmentPlan. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):