RE: draft template for Stephen's clinical data


Here is the Time Ontology page for everyone's reference:
basically it is composed of time instances and durations (intervals with a beginning instant and an end instant)

I think we can apply it to the following aspects:

- Period (Interval) of study
- Birthdate (Instant) of patient
- Age (Interval) of patient (determined from from birthdate and study beginning)
- Interval of treatment (or each arm for dose changes)
- Date (Instant) of visit
- Interval of AE
- Duration (Interval) of body position or activity (context) 
- any others?

As for CDISC vocab, I see mainly predicates (e.g., SDTM columns) and (e.g., MedDRA codes); where we will differ from the standard SDTM is in the possible use of blank nodes (e.g., context) and URIs. Is this a fair assessment? 

Lets plan to discuss this on friday...


-----Original Message-----
From: on behalf of Forsberg, Kerstin L
Sent: Mon 2/19/2007 3:39 AM
Subject: Re: draft template for Stephen's clinical data

Hi Eric,
the first draft for the three kinds of observation data do raise a number of question in my head.

We assume a quite large CDISC vocabulary ( that does not exist today. I think it is important that we think through how such a vocabulary should be constructed. Should we keep it close to the way CDISC today define their tabulation model, general observation classes and domain specific variable names that implies a flat file structure approach? Could be a good alternative if we would like to make our case stronger in our discussions with CDISC. Or, should we construct one or more ontologies that applies a more "semantic web approach" of observations as evolvable information resources instead? 

The integration of the time owl ontology makes good sense but I do get a bit confused on how it should be applied.

As discussed in the last TC, I think it is important that we include examples showing the value of having assigned URI:s for annotating clinical data, such as Adverse Event encoding using MedDRA codes. Instead of only using strings of texts.

With regards to the first question about the cdisc vocabulary / ontologies I will try to exemplify the two different options for our next TC. However, I may have to decline that TC on Friday due to a conflicting meeting.

Kind regards

Received on Monday, 26 February 2007 15:41:52 UTC