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RE: Follow up: Clinical Observations Interoperability Telcon @ Tue Oct 30

From: Forsberg, Kerstin L <Kerstin.L.Forsberg@astrazeneca.com>
Date: Sun, 4 Nov 2007 22:08:34 +0100
Message-ID: <00EF518168DD14409AA8DB92601D87360175B394@SEMLRDEMBX02.rd.astrazeneca.net>
To: "Alan Ruttenberg" <alanruttenberg@gmail.com>, "Kashyap, Vipul" <VKASHYAP1@PARTNERS.ORG>
Cc: <public-hcls-dse@w3.org>, "Stanley Huff" <Stan.Huff@intermountainmail.org>, "Oniki, Tom (GE Healthcare, consultant)" <Tom.Oniki@ge.com>

> [AR] I call this [SDTM] the record level.  

Kerstin: Agree. 

FYI, see how 'observations' and the general classes and specific domains of them are decribed in CDISC SDTM model document, version 1.2 draft (from http://www.cdisc.org/models/sdtm/v1.2/index.html and http://www.cdisc.org/glossary/)

"The model is built around the concept of observations, which  consist of discrete pieces of information collected during a study. Observations normally correspond to rows in a dataset. A collection of observations on a particular topic is considered a domain."

"The majority of observations collected during a study can be divided among three general classes: Interventions, Events, 
or Findings"

"* The Interventions class captures investigational, therapeutic and other treatments that
are administered to the subject (with some actual or expected physiological effect) either as specified by the
study protocol (e.g., "exposure"), coincident with the study assessment period (e.g., "concomitant
medications"), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine).
* The Events class captures planned protocol milestones such as randomization and
study completion ("disposition"), and occurrences or incidents independent of planned study evaluations
occurring during the trial (e.g., "adverse events") or prior to the trial (e.g., "medical history").
* The Findings class captures the observations resulting from planned evaluations to address
specific tests or questions such as laboratory tests, histopathology, ECG testing, and questions listed on questionnaires".

Domains (abreviations), with models based on the general classses, are defined in a controlled terminiligy using concepts in NCI Thesaurus. Here some examples of the 40+ defined domains so far:

AE = Adverse Events = Concept C49587 defintion "Adverse events may be captured either as free text or a pre-specified list of terms."
VS = Vital Signs = Concept C49562 defintion "Measurements including but not limited to blood pressure, temperature, respiration, body surface area, BMI, height and weight."
EX = Exposure = Concept C49622 defintion "The Exposure domain model records the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject"

Received on Sunday, 4 November 2007 21:08:54 UTC

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