ODM Tutorial 4: Study, GlobalVariables and MetaDataVersion
In the last sections we talked about the ODM and why you might choose to use it for your study design. We then gathered some tools to help us build and understand the ODM format and looked at some sample case report forms.
Now at last we can start to actually create our ODM file. We already saw a minimal ODM file back in ODM Tutorial 2: Understanding ODM Files, now we’ll start to expand out that ODM file with information specific to the SAMP-101 study.
The Study Element
To define the metadata for a study we need a Study element inside the ODM element.
<Study OID="ST.001">
</Study>
Notice that Study is required to have an OID. I have chosen ST.001. An ODM element can contain zero or more Study elements so having a unique identifier for each Study makes sense even though no other element in an ODM file will make reference to this OID.
Although the ODM allows more than one Study element to appear in an ODM file you wouldn’t normally see this in practice. Splitting your study designs into separate files will make them easier to manage.
Sat Jun 20, 2015 4:34 pm
emma
Joined: 12 Dec 2013 Posts: 78
Many people working in this area are not clear about this basic facts and your post will really help them.By this they can easily define global variables and metadata.
electronic signature
You cannot post new topics in this forum You cannot reply to topics in this forum You cannot edit your posts in this forum You cannot delete your posts in this forum You cannot vote in polls in this forum
