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Practical Metadata and Standards for Clinical Research

Author: Dave IH

Step Three & Keeping My Promise

October 22, 2015
22/102015

It is getting towards the end of the week and I am conscious of a slide I presented in Vienna at the PhUSE conference and a promise to write up progress, lessons learned and anything else I can think of that might be useful. I am also thinking it might be beneficial to some to… Continue reading…

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No Leffe But You Can’t Have Everything

October 15, 2015
15/102015

I find myself in yet another airport lounge after yet another conference. Its a little grey outside, the rain reminds me of England and the mind is a little tired. All that said, it was a good conference. PhUSE always is. This year the conference was held in Vienna. It is a city I enjoy travelling… Continue reading…

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I Want It All

October 13, 2015
13/102015

Recently I was invited to present at an event organized by the PSDM (Pharmaceutische Statistiek en Data Management). The PSDM, and I quote from their website, is a Dutch network group of statisticians, clinical programmers and data managers working in and for the pharmaceutical industry. The title for the event was “Implementation of CDISC standardization: Pragmatic… Continue reading…

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Over For Another Year

July 27, 2015
27/072015

I always lament the passing of July. As we leave the third week of the month it mark the passing of my annual cycling extravaganza, the Tour de France. This year I managed to spend the first week in France watching the race following it from Northern France down across the north of the country… Continue reading…

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Simple MDR Tools

July 3, 2015
03/072015

Last 5 Posts In Series A Bit Of A Tangent Terminology And ISO 25964 All Things To All Men – ISO 11179 So Many To Choose From Requirements & Technology In yesterday’s post I outlined the simple MDR and study build tool that I have been put together over the last few weeks. As I… Continue reading…

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A Bit Of A Tangent

July 2, 2015
02/072015

Last 5 Posts In Series Terminology And ISO 25964 All Things To All Men – ISO 11179 So Many To Choose From Requirements & Technology A Little Step Back Introduction It has been a while since I last posted so I am going to try and explain that there is a good reason for this. I… Continue reading…

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Terminology and ISO 25964

May 12, 2015
12/052015

Last 5 Posts In Series All Things To All Men – ISO 11179 So Many To Choose From Requirements & Technology A Little Step Back Right Tool For The Job In the previous post in this series I looked at the first building block in the standards stack, the metadata standard ISO 11179. In using… Continue reading…

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Research Concepts – A What, Why and How

May 6, 2015
06/052015

Introduction Today (Wednesday 6th May 2015) I gave a presentation at the EuroInterchange in Basel about Research Concepts based on work I have performed over the last the five or more years. Last year at the CDISC Interchange I provided a write up to accompany my presentation and, as some of you may know my slides… Continue reading…

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Latest Terminology Update

April 30, 2015
30/042015

As you are all probably aware CDISC now updates the controlled terminology on a quarterly basis and the latest release came out in late March. I wrote about some of the issues with the terminology when the last release came out but this will just be a short post to point out some of the… Continue reading…

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All Things To All Men – ISO 11179

April 13, 2015
13/042015

Previous Related Blogs So Many To Choose From Requirements & Technology A Little Step Back Right Tool For The Job In the last post I described the overall model that I came up with and the thought that went into arriving at the final picture. Once of the main dilemmas was whether to use ISO 11179… Continue reading…

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ADaM Biomedical Concepts CDASH CDER CDISC CDISC SHARE clinical research Communications Data data standards define.xml DIA eClinical EHRs electronic source data EMA eSource FDA FHIR Gartner HL7 HL7 FHIR ISO 11179 ISO 25964 Marketing Metadata Metadata Repository ODM Ontology OWL PhUSE PR Research Concepts Research Concept Templates SDTM Semantic Semantics semantic web SKOS social media standards Terminology Therapeutic Area Therapeutic Area Standards Tools
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