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== Links == | == Links == | ||
| − | [[Study Design, Study Participation and Subject Data|CDISC HL7 Project Page]] | [[Stage | + | [[Study Design, Study Participation and Subject Data|CDISC HL7 Project Page]] | [[Stage IB Project Page|Stage I-B Page]] |
== Useful Guides == | == Useful Guides == | ||
Revision as of 16:15, 10 November 2009
Contents
Links
CDISC HL7 Project Page | Stage I-B Page
Useful Guides
For those wanting assistance in editing wiki pages have a look at these pages (Add any useful links you find)
- Basic Editing - Page on this Wiki, with additional links to other resources
- http://meta.wikimedia.org/wiki/Help:Editing
- http://en.wikipedia.org/wiki/Wikipedia:Cheatsheet
Study Participation
Study Design
Subject Data
No document at this time
Test Plan
Ballot Package September 2009
The ballot package can be found at : http://www.hl7.org/v3ballot/html/welcome/environment/index.htm
On the tree on the left click on the following location on the tree:
HL7 Version 3 Standards / Universal Domains / Regulated Studies /
You will find a sub folder for each of the ballot packages names Study Design Topic, Study Participation Topic and Subject Data Topic.
The Subject Data standard is new.
The following are the high level changes to the study participation standard:
- Some arrows act relationships arrows point a different direction
- Some act relationship class codes have changed
- There is now a separate concept from the study site (organization) from the place activities happen (physical location)
- We consider body parts as part of the subject as opposes to access points of the subject
The following are the high level changes to the study design standard:
- Some arrows act relationships arrows point a different direction
- Some act relationship class codes have changed
- One time point can belong to many arms at the same time.
- Added location where activities can occur
- Added the place activities happen (physical location)
- We consider body parts as part of the subject as opposes to access points of the subject
- You can define certain characteristics the experimental unit has to be assigned to a time point
