Stage II Project Page

From HL7Wiki
Revision as of 18:59, 18 April 2013 by Callard (talk | contribs) (→‎DSTU Testing)
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to navigation Jump to search

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)

Study Participation

Study Design

Subject Data

No document at this time

SDTM Mapping for Study Participation, Study Design and Subject Data

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

DSTU Testing

Functional Requirement Resources

Study Design Function - Test Case Matrix

Study Data XForms

Media:javascript.zip

XForms with narrative XForms: Media:Xforms_v3.zip (need to add .img folder from previous version of XFroms.)

HL7 Study Participation and Patient Narrative/CDA DSTU Draft Testing Plan


HL7 Study Participation xForm and associated documents (Zip file)


HL7 Patient Narrative associated documents (Zip file)

HL7 Study Design Installation Guide (zip file)

Meeting Minutes and Agendas

2013 Stage II Meeting Agendas and Minutes

2012 Stage II Meeting Agendas and Minutes

2011 Stage II Meeting Minutes

2010 Stage II Meeting Minutes

2009 Stage II Meeting Minutes

2008 Stage II Meeting Minutes

2007 Stage II Meeting Minutes