Including clinical trial data as clinical data
submitted by JimBrinkley over 15 years ago

I note that clinical data is specifically defined not to include clinical trial data. So is anyone already thinking about where at a high level subtrees might be added to deal with clinical trial data and clinical trial management systems? Or is it premature to do that? This is for the CTSAs.

DavidStates over 15 years ago
Not sure I follow the argument here.  Clinical trial data is covered under PHI so no distinction there.  Data generated in the course of delivering routine standard of care may be needed in the course of a clinical trial.  Does this make clinical trial data an overlapping superset of clinical data?
JimBrinkley over 15 years ago
David,
I was only reacting to the definition of BRO:Clinical_Data in the current version: "Any type of data obtained in the course of caring for humans outside of measurements obtained in clinical trials".

I think I'm agreeing with you that clinical trial data should be overlapping clinical data (whether its a superset I'm not sure). So I'm not clear why the definition that is in the current version is there.

Somehow this might be related to the fact that BRO:Data_Object is subclassed partly by function (eg clinical data) and partly by data type (eg image). I would think images could also be a type of clinical data.


ShawnMurphy over 15 years ago
Hi David and all,

Clinical Trial Data should probably be dealt with separately from Clinical Data
collected in the course of administering clinical care.  The use of Clinical
Trial data will be governed by the Consent that the patient signs as part of the
IRB Protocol that is set up to allow its collection, while the use Clinical Care
Data will be governed by the HIPAA notification that the patient receives, as
well as any IRB Protocols set up for the research involved.