tag:blogger.com,1999:blog-8346061623186564263.post3705264766427427850..comments2023-06-28T06:36:02.110-04:00Comments on Thoughts on Medical Informatics: The Future of Study Data ExchangeArmando Oliva, M.D.http://www.blogger.com/profile/02189597761383088518noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-8346061623186564263.post-87932052275296943462017-03-14T15:19:02.978-04:002017-03-14T15:19:02.978-04:00This was recommended reading for ODM v2 discussion...This was recommended reading for ODM v2 discussion. Consider project DataSphere. A sponsor de-identified patient level data and is making them available to other researchers.Vojtech Huserhttps://www.blogger.com/profile/17180875686156096790noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-54268190353347867522015-10-12T09:15:06.507-04:002015-10-12T09:15:06.507-04:00Chris, thank you for your perspective. The operati...Chris, thank you for your perspective. The operational use case is one that I had not considered. Would it be useful to document high level requirements for this use case? Has this already been done? I believe ODM was developed to support this use case and I'm curious to hear from others how well that is working. I have no personal experience in that regard. Others have correctly pointed out that there is no benefit in moving towards a more multi-dimensional, multi-relational data model if the relationships are not being captured at the point of data collection (e.g. CRF). This is very true...but I do think that a multi-relational data model will enable the design of smarter eCRFs that can capture those relationships automatically "behind the scene." Armando Oliva, M.D.https://www.blogger.com/profile/02189597761383088518noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-53221285137778211132015-08-12T13:36:27.936-04:002015-08-12T13:36:27.936-04:00Armando, it's interesting that you refer to th...Armando, it's interesting that you refer to the exchange and analysis roles as that is what was important in your role at the FDA. There is a whole other role within the sponsor organizations which revolves around being able to use the model operationally to get the work done on a day by day basis. Unfortunately, I believe SDTM also falls short of fulfilling this role as well. I'll quote something you presented many years ago - the world is not flat and neither is clinical data. One of my colleagues has begun calling the data multi-dimensional and we need a model to support that relationship. I think we can leverage the great work done within SDTM and the other standards to move it to the race car. Chrishttps://www.blogger.com/profile/02136402653768293575noreply@blogger.com