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Paralysis and Madness: The Road to eSource Enlightenment by Dave Iberson-Hurst

Dave Iberson-Hurst discusses the evolution of the recently released EMA guidance on electronic Source Data and the challenges associated with developing new ideas.

Japan, Part 3 of CDISC in Asia by Rebecca Kush

In the final part of Dr. Kush's blog series, she arrives in Japan for the Interchange to round off an exciting and demanding two weeks. 

China, Part 2 of CDISC in Asia by Rebecca Kush

Yesterday, we posted Dr. Kush's experiences in Korea, today she and her two companions, Pierre-Yves Lastic and Sheila Leaman have reached China.  Here they meet with the CDISC China Advisory Council (CCAC), a new and important group. They also managed to visit one of China's most famous landmarks.

CDISC in Asia - by Dr. Rebecca Kush

During the month of July, Dr. Rebecca Kush spent two weeks building CDISC's relationships with 3 very different countries and cultures in Asia. Accompanied by Pierre-Yves Lastic (sanofi - aventis) and Sheila Leaman (CDISC), Dr. Kush found that the work was inspiring and the sights stunning.

Over the next 3 days, you can read about CDISC's presence on the global stage, as Dr. Kush reports from Korea, China and Japan.

CDISC SHARE – Progress Report by Rhonda Facile

By now, many of you have heard about the CDISC SHARE project.  For those of you that haven’t,   this new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model. In short we want to change the way we develop standards to an approach that focuses on precise definitions, terminology and metadata (BRIDG, datatypes, variable names, etc.) to take a date element/concept from the clinical protocol, through collection, analysis and submission.  To quote Dave Iberson-Hurst, CDISC is, “moving from the implicit world of data standards to the explicit world of data standards”.

FDA, CDISC Standards and the Critical Path by Rebecca Kush

June has been a month full of interesting meetings, events and activities for CDISC.  In particular, Bron Kisler and I attended a set of meetings in the Washington, DC area 8-11 June while others within CDISC met face-to-face in Philadelphia to advance the CDISC SHARE project. 

The Critical Path to TB Drug Regimens (CPTR) by Bron Kisler

The Critical Path to TB Drug Regimens (CPTR) is a recently formed collaboration of global pharmaceutical companies; government and regulatory agencies; foundations and donors; academia; and patient advocacy groups. The CPTR initiative was created and is managed by a partnership of the Bill & Melinda Gates Foundation, the Global Alliance for TB Drug Development (Global TB Alliance) and the Critical Path Institute (C-Path).

FDA CDER Data Standards Plan V 1.0 and PDUFA IV IT Plan Update Released By Dr. Rebecca Kush

Two new documents relevant to CDISC have now been posted to the FDA website and one announced in the Federal Register.  In this blog are a few highlights that I have pulled from each of the documents…but, please read them yourselves and  please sign up to attend the webinar on 29 June to hear directly from CBER and CDER representatives, Amy Malla and Dr. Chuck Cooper.

Important BRIDG News and an Update from the ISO Meeting

CDISC co-sponsored and participated in the ISO TC-215 meetings this past week in Rio de Janeiro, Brazil. It was an amazing week with Dr. Christopher Chute assuming the helm of ISO TC-215 Health informatics as Chairperson. It was a productive week for CDISC with positive movement on many fronts. The week began with a CDISC presentation to international delegates from Brazil, Singapore and Australia ...

Dr Rebecca Kush - Voices from the CDISC FDA Town Hall Meeting

The CDISC INTRAchange was launched this year on the evening of 23 March, following the DIA FDA CDER/CBER Computational Science Annual Conference, with a CDISC FDA Town Hall Meeting.  Frank Newby welcomed everyone and introduced the FDA representatives ...

An Update from London and the European Interchange

As part of my job for CDISC, I am privileged to work with the European CDISC Coordinating Committee (E3C) on the Interchange in Europe. This has a few wonderful perks. Firstly, I get to see the hotel and the evening event location before all of the attendees and most of the CDISC staff and secondly I spend a day with Dominik Ruisinger (who many of you will know), thrashing out the details.

Landen Bain - Healthcare Link Updates

Landen went to Phoenix AZ for the first IHE face-to-face meeting of 2010.  The four day meeting was particularly productive. CDISC participates in the Quality, Research, and Public Health (QRPH, rhymes with Smurf) domain. The integration profiles under development that directly influence CDISC’s Healthcare link initiative are Retrieve Protocol for Execution (RPE) and Redaction Services. QRPH schedules its face-to-face meetings with two other IHE domains (there are 14 in all): Information Technology Infrastructure (ITI) and Patient Care Coordination  (PCC)...

Clear Messages from FDA CDER and CBER

by Dr. Rebecca Kush

There are some very clear messages coming from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).  As of a meeting with CDER and CBER Representatives and the CDISC Executive Committee on 1 February ....

Reasons to Celebrate - The Protocol Representation Model

Diane Wold of GSK gives her personal insights into the Protocol Representation Model

Those of us who started working toward a structured protocol representation in 2003 were motivated by the feeling that there had to be a better way to communicate information about a study than a text document.  The protocol is at the heart of clinical research, so it's just not effective or efficient for all the parties involved to extract data from text ...

Protocol Representation Model V1.0 - Now Released!

The CDISC Protocol Representation Model (PRM) Version 1.0 is released and available at http://www.cdisc.org/protocol.

The Model contains study protocol concepts such as Trial Design, Eligibility Criteria, and addresses the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries.  Additional protocol domain areas, activities, definitions ...

Rebecca Kush - FDA Messages from the Interchange: Use CDISC Standards Now

In the prior CDISC Blog, Dave Iberson-Hurst explored the ‘disappearing’ timelines for the HL7 transport mechanisms for CDISC content.  Since these HL7 standards (which by the way will be co-owned by CDISC and HL7 if and when they are ready) are not yet available nor tested, what does FDA want to see now (TODAY) when it comes to data standards? ...

The FDA, HL7 and a Disappearing Timeline

It might not have been a presidential debate but the closing session at the North American Interchange was no less intriguing. The session was an FDA panel that opened with a speech from the FDA Deputy Commissioner Dr Sharfstein ...

Landen Bain - Healthcare Link, More than Learning ...

Fifteen attendees and presenters spend Friday the 13th teaching, learning, and sharing concepts around CDISC’s healthcare link project.  This is the second time that CDISC has presented a training session on healthcare link, the first being at the Japan Interchange in July of this year ...

An evening with the Sharks!

The CDISC Interchange rounded off the first day with an evening social event at the National Aquarium. And what an event it was, with the food and beverages organised across the various levels of the aquarium, attendees were able to see a variety of interesting animals, including sharks, rays and a fantastic jellyfish exhibit.

Rather than write about it ... take a look at the wonderful photos taken by Pierre-Yves Lastic.

Interoperability ... the Value of Standards - Live from the CDISC Conference

The CDISC conference is underway with the opening session and whilst the presentations were diverse, all of the speakers emphasised the importance of standards and the value they bring to medical research ...

Rebecca Kush: Live from the Conference - the Global Update

Dr. Rebecca Kush gave a compelling and engaging update on CDISC's global activities over the past year. Firstly, she thanked the members of the CDISC Advisory Board (CAB) who had developed the program for this year's conference and highlighted the new demonstrations that are taking place in the exhibition area during the event ...

Landen Bain - Awards, Phenotypes and EHRs, all in a day's work.

The NIH sponsored symposium "Widening the use of EHR data for Clinical Research" took place on October 30, at the end of the Clinical and Translational Science Awards (CTSA) face-to-face meeting on the NIH campus in Bethesda, MD.  NIH manages forty-six awards in this program, and the CTSA sites represent a cross-section of the high-end academic medical centers in the US. So a face-to-face meeting of CTSA sites brings together a broad spectrum of academic medical center informatics types ...

Chris Tolk, Reports from FDA at White Oak

I attended the Coalition Against Major Disease (CAMD) Coordinating Committee Meeting at the FDA’s White Oak Campus this week. The initial goal of CAMD is to define clinical data standards and establish a pooled database of the control group of pharmaceutical clinical trials in order to develop quantitative disease progression models for both Alzheimer’s and Parkinson’s disease ...

Rebecca Kush, CDISC & the Standards Landscape

The International Standards Organization (ISO) recently held one of its twice-yearly meetings in Durham, North Carolina. Past meetings CDISC attended were in Istanbul, Turkey; Goteborg, Sweden; Edinburgh, Scotland. Here you can see one of the banners at the Durham meetings, thanks to Bron Kisler for the photo...

Rebecca Kush, 'What is a Standard?'

The HHS Workshop on 15 October was entitled “Identifying Opportunities to Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange”.  Notice that the word “Standard” is not mentioned; this was intentional.  Some of you may ask why?  
I have been informed many times that the word ‘standard” connotes such ideas as rigidity, stifling creativity, inhibiting innovation. There are indeed many different types of standards (from a sort of flag, to a type of rather mundane beef to a standard operating procedure)...

Landen Bain - Reports from Under the Deliverables Mountain!

Poor Landen is in over his head this month with three deliverables hitting at the same time: HITSP IS 158, CCHIT clinical research criteria, and IHE Redaction Services proposal all due the last week of October.  That’s this week!  So what do these deliverables mean for CDISC?  Here’s a sketch, with more to follow ...

Consensus through SHAREing!

Since I last wrote on the blog much has changed. As you may have noticed, we have a new website. This has taken a great deal of effort by the CDISC communications staff to get this developed and the content from the old site moved across. It took a little longer to get the blog up and running as part of the new site but we are there now.

The other day, I looked at one of my computer screens. My twitter feed started reporting...

Julie Evans at ISO in North Carolina

I’m just back from the ISO TC 215 Joint Working Group meeting in Durham, North Carolina.  I was there to give a BRIDG update to Working Groups 1 and 2.  The update included a quick BRIDG status, a review of the New Work Item Proposal (NWIP) results  for BRIDG (it passed in August 2009), and the plans for the upcoming ballot through the Joint Initiative Committee (JIC) process.  The group voted to propose  a resolution to the plenary to ballot BRIDG.  So, we’re making progress in our effort to make BRIDG a global, open, publicly available standard.

The Impact of Shared Semantics

Last week, I had just returned from San Francisco after a face-to-face meeting about the CDISC work to build a repository of shared semantics. After a long trip home, I indulged in my interest in cycling and caught up with the Tour of Italy, the Giro d’Italia. The Giro, along with the Tour of Spain – the Vuelta – and the Tour de France are the three premier events on the annual cycling calendar. This year was the 100th running of the Giro and, after being out of professional cycling for three years, Lance Armstrong was competing in the event for the first time. Lance was there to raise awareness of his Livestrong charity and its work in fighting cancer. With Lance at the event the media interest exploded....

One Man's Metadata is ...

One of the main reasons for starting the CDISC blog was to improve the flow of communication from CDISC to the CDISC community. It is a feature of CDISC that the less we communicate the better the quality of the rumours. The problem we face is that however much we do actually communicate, we could always do more. This has certainly be true when I think about the CDISC HL7 project and some of the rumours that surround that work. However, more about that project in a later post ...