The CDISC Blog is Moving!

Just a quick note to let you all know that the CDISC blog is moving over to the CDISC web site. So head over to the new blog and see the latest post. This blog will no longer be updated and we will remove it in a month or so.

Dave Iberson-hurst

HITSP – EHR Interoperability – Public Comment Period Open!

The Healthcare Information Technology Standards Panel (HITSP) announces the opening of the public comment period for the Requirements, Design and Standards Selection (RDSS) document for:

HITSP Clinical Research Requirements, Design and Standards Selection (RDSS 144)

The public comment period will be open from Thursday, July 30th until Close of Business, Friday, August 28th.  HITSP members and public stakeholders are encouraged to review these documents and provide comments through the HITSP comment tracking system.  The RDSS documents and the HITSP comment tracking system are located on www.hitsp.org.

(NOTE FROM THE TIGER TEAM: We encourage all commenter’s to submit their comments by Monday, August 24th if at all possible.  This will enable the committee to disposition the comments during their face to face meetings August 25-27.  However, comments will be accepted until Friday, August 28th.)
All comments received on these documents will be reviewed and dispositioned by the Clinical Research Tiger Team.  The comments will be used to inform the on-going process of standards selection and Interoperability Specification construct development.  The RDSS documents will not be re-published but will be used, along with the accepted comments, to serve as the basis for the new constructs.
HITSP members and public stakeholders are encouraged to work with the Clinical Research Tiger Team as they continue the process of standards selection and construct development.  If your organization is a HITSP member and you are not currently signed up as a Tiger Team or Technical Committee member, but would like to participate in this process, please contact aclemons@hitsp.org.

Questions about the RDSS documents, or the process for review should be addressed to Michelle Maas Deane, the HITSP Secretariat at mmaasdeane@ansi.org.

CDISC Demo brings in the FDA at DIA!

Creating the right buzz and drawing people into your booth at an event like the DIA Annual is a real challenge when there are over 500 exhibitors. At CDISC, we are in a unique position at such an event as we are a neutral organisation where people can freely chat about their use of the standards, ask us questions and even eat the odd Fig Newton or Oreo! This year however we have added to our offering by providing the interoperability demo (which you can read about in our other blogs here). This is probably the only demonstration in the whole show where companies are working together to show how collaboration can bring about real world solutions to everyday challenges in the industry. There is no competition at CDISC just great ideas and practical solutions to help improve clinical research.

Dave Iberson-Hurst explaining eSource

Yesterday, several members of the FDA came to see exactly how the Retrieve Form for Data Capture profile can assist the work of the investigator at the site, the vendors, the sponsor companies and the regulatory authorities in improving the quality of the data that is collected. There was a real buzz in the air and the booth was packed with interested people listening to Landen Bain and Dave Iberson-Hurst talking about eSource and CDISC’s work with the IHE profile. The demo will run again today at 0930hrs, 1200hrs and 1530hrs (Pacific time) and with several CDISC sessions also taking place today, it should be another lively day at the CDISC Booth.

Landen Bain waxing lyrical about RFD

Tanyss Mason was busy visiting the CDISC members at the show and delivered the new CDISC member plaques to all the exhibiting member companies. Members were delighted to show their support for CDISC and, as you walk around the exhibit hall and see the number of plaques on display, there is a real sense that Strength through Collaboration is indeed the key to the success of the CDISC standards.

We look forward to seeing more of you at the booth today and if you are not at DIA there will be a full report in the next CDISC newsletter.

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.

It is the impact that Lance Armstrong has as part of his work with Cancer that made me think. Lance was posting daily videos from the tour about how it was all going, interviewing other riders etc. But as part of each video he would also mention a victim of cancer and detail the individuals fight against the disease. The one that caught my attention was a young boy in the UK dealing with cancer. He was being supported by a charity, Cyclists Fighting Cancer, that helps youngsters with specially equipped bikes to help them with muscle rehabilitation. The 30 second mention touched all the right buttons for me, it was UK-based, it was cancer – a disease that has affected my own immediate family – it was cycling, it was Lance Armstrong. It had an impact; I donated to the charity.

It also made me think about the influence CDISC has had and continues to have. It is to have an impact ensuring that those working to beat cancer and all the other diseases are able to share and use data with ease.

My thoughts went back to the meeting in San Francisco and the repository work. The CDISC repository of shared semantics (CRSS) work could, to my mind, have as great an impact as anything else CDISC have achieved to date, if we get it right. And that is the important qualifier, if we get it right. For CDISC the project is a significant effort and therefore it is only right that we are sure of our needs, our solution and our plans before proceeding.

As an aside, I am going to refer to the project as CRSS. There project may well be renamed in the near future to give it a more meaningful and non-IT name, but for the purposes of this post, CRSS will do.

At the CDISC Board meeting in April 2009, held in Budapest, the board decided that we should proceed with the CRSS project. The aim is to make a decision at the next CDISC Board face-to-face meeting – to be held in September 2009 – as to whether or not CDISC should build a production repository. To allow the board to make that decision we need to answer some simple questions. Unfortunately the answers may not be quite so straightforward. The questions are of the fundamental type: What is it we want to build, why do we want to build it, is there a business case for building it, what are the risks?

To allow for such questions to be answered we will use a methodology borrowed from the software industry called the Unified Process. The first phase of the process is the inception phase and it is this phase that we will execute between now and September. Emerging from the inception phase will be the required information that the board needs to make it decision. If the decision is yes then the next phase (the elaboration phase) can proceed but that is not yet in scope.

I was going to write something about the inception phase but a document supplied by Charlie Mead contains words that are better than anything I could conjure up:

In the Inception Phase, the project’s overarching ‘business case’ is critically examined in terms of vision and scope, critical risks that must be managed, budget and resource requirements, etc. The Inception Phase ends with a ‘Go/No Go’ decision on the project, thereby ensuring that projects with unmanageable risks, insufficient resources, and/or unclear scope or vision are terminated early rather than late.

As part of the inception phase we will execute a small pilot “sub-project” to address two risks.

One of the biggest issues we as CDISC face is the scale of the work. SDTM has given us a solid base to build on and built the common “safety” domains. Now we need to build the therapeutic area domains. We will attempt to achieve this by bringing together the varied definitions used within research organizations (biopharma, CROs, academic institutions etc) to date and attempt to harmonize them. But this is a large undertaking and we need to assess the scale of the work, the necessary processes and costs (metrics). This will allow us to determine if the project’s business case is sound.

The second risk is around ensuring the quality of the definitions placed into the repository. We want to ensure these are of high quality and protect against such things as overlapping or duplicate definitions. To assist in this, we want to evaluate some of the work being performed in semantic wikis and ontologies to assess whether or not these can help us populate the repository with high-quality definitions. Such technology may also help in improving the process of harmonizing the content for the repository.

Given the scale of the work and the importance placed upon it by the CDISC board we have decided to allocate significant resources to the project. Rhonda Facile will be leading the project with Julie Evans and Bron Kisler assisting. Julie is working on some of the key documents and with modelling support, while Bron will assist in the areas of content governance and business requirements. This may result in existing work being impacted but we are taking steps to add extra resources to minimise this.

So the inception phase is there to ensure we get it right, to ensure that CRSS has the impact we think it can have. It will allow CDISC to improve  our existing standards such as SDTM and CDASH by improving the quality of definitions contained within those standards, it will provide a platform by which CDISC can expand those standards into therapeutic areas and it will provide the means by which those standards can be delivered in an electronic form to our members and consumed by applications to help streamline the clinical research process. Not a bad impact.

Dave Iberson-Hurst

Press Release from CCHIT announcing Town Calls

CCHIT TO PROPOSE NEW PATHS TO CERTIFICATION
Seeks input on new concepts for certifying EHR technologies

CHICAGO – June 9, 2009 – The Certification Commission today announced a series of two Town Call web conferences on June 16 and 17 to gather stakeholder input on new paths to certification of electronic health record (EHR) technologies, with the goal of supporting more rapid, widespread adoption and meaningful use under the American Recovery and Reinvestment Act of 2009 (ARRA).

“ARRA has turbocharged the drive for health IT adoption and meaningful use,” said Mark Leavitt, M.D., Ph.D., Commission chair.  “Certification — an explicit requirement of that law — must become more robust and more flexible at the same time, to allow these powerful incentives to deliver the desired result: improved health and healthcare.  We will share our new ideas and invite feedback from the health community.”

Areas to be explored during the Town Calls include the crosswalk from certification to meaningful use, enhancements to current programs, and new and updated programs to make certification more accessible to a wider variety of EHR technologies, including modular, self-developed, and open source applications.

The first Town Call, “New Paths to Certification: Dialog with the Open Source Community”, on June 16 at 1:00 PM Eastern will focus on concerns regarding certification of applications licensed under open source models. During the Web conference, Mark Leavitt, M.D., Ph.D., Commission chair, and Dennis Wilson, the Commission’s technology director, will discuss the new concepts from the perspective of technology developers.

The second Town Call, “New Paths to Certification”, on June 17 at 11:00 AM Eastern is intended for a general audience, and will explore all of the new programs and their intended goals.    During both events, participants will be invited to submit questions and comments online. Registration is required for the free Town Calls at http://cchit.org/towncalls.

The Certification Commission is actively adapting its certification programs and timelines to conform to the new requirements of ARRA as the definition of meaningful use emerges. Instead of immediately launching a 2009-10 certification program, the Commission submitted its new released 09 criteria to the Health Information Technology Standards Committee for review and, anticipating a draft definition of meaningful use by June 16 and draft standards and certification criteria by August 26, will work to quickly resolve any gaps and begin accepting applications for newly designed certification programs as quickly as possible after that.

C Sue Reber
Marketing Director, CCHIT
Certification Commission for Healthcare Information Technology
503.288.5876 office | 503.703.0813 cell | 503.287.4613 fax

sreber@cchit.org

Learn more about CCHIT

Learn more about EHR Decisions

Rebecca Kush on Moving into the Future – New Dimensions and Strategies for Women’s Health Research for the National Institutes of Health

Last week, I had the opportunity to attend a very interesting meeting that I hope will provide a productive path for the future of clinical research and standards to support this work in the NIH Office of Research in Women’s Health (ORWH).  Sue Dubman of Genzyme, one of our CDISC Board members, encouraged me to attend “Moving into the Future – New Dimensions and Strategies for Women’s Health Research for the National Institutes of Health” on behalf of CDISC.  This was a Public Hearing and Scientific Workshop, which included public testimony and breakout groups around particular topic areas to gather input into the NIH ORWH; it is one of three such meetings and the only one to include a breakout group on technology and standards.  Sue Dubman and Dr. Laura Esserman of UCSF led this breakout group, which generated recommendations, including some encouraging expansion in the area of standards development and adoption/implementation for clinical research in this area.
In addition to very interesting discussions around IT and standards to support research in the future and the importance of linking these efforts with strategic plans for healthcare IT and healthcare-related standards, the presentations and testimonies were excellent.  In particular, there was a presentation by Dr. Elizabeth Blackburn, Professor of Biology and Physiology, UCSF on Telomeres and Aging.  If you are not aware of this work, I would encourage all of you who want to keep long telomeres (associated with a longer lifespan) to reduce stress and read a bit about this exciting work.  Another excellent presentation was “Why so Slow: The Advancement of Women in Science and Medicine” by Dr. Virginia Valian, Distinguished Professor from Hunter College and CUNY Graduate Center.
The ORWH is actually an office within the NIH and not an individual center. It focuses on ensuring that women are adequately represented as subjects across research studies and as scientists within research-related activities, and that specific health issues related to women (e.g. pregnancy and diseases that affect women disproportionately) are adequately addressed through research.
Other NIH areas where CDISC is collaborating, CDISC standards are being used, and/or  discussions are taking place regarding use of the CDISC standards include the NIH/National Cancer Institute, NIAID (National Institute of Allergy and Infectious Disease) Department of AIDS, NHLBI (National Heart Lung and Blood Institute), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the NIH Office of the Director through representation on the BRIDG Board.

CDISC Hosts Live Healthcare Link Demonstration at DIA 2009 Press Release

Leading industry companies collaborate to demonstrate seamless exchange of data between clinical sites, research sponsors and regulators using the RFD standard

The Clinical Data Interchange Standards Consortium (CDISC), the leading standards development organization for clinical research, announced it will host a live Healthcare Link Demonstration at the 45th Annual Meeting of the Drug Information Association (DIA), being held June 21-25 at the San Diego Convention Center (Booth # 1915). The demonstration will showcase the Retrieve Form for Data-capture (RFD) integration profile, developed through the collaboration of key stakeholders and two standards groups, CDISC and Integrating the Healthcare Enterprise (IHE).  The RFD standard facilitates data interoperability between clinical research and clinical care by integrating the processes and workflows of electronic data capture (EDC) and electronic health records (EHR) platforms.

“RFD is particularly effective in integration efforts because it enables EHR applications to directly request electronic case report forms from clinical research sponsors,” said Landen Bain, CDISC Liaison to Healthcare. “It also enables post-market reporting of drug safety adverse events, as well as applications in quality reporting and public health.”
The development of RFD has progressed rapidly, to the point where it’s being used in two real-world situations: Greenway Medical and Outcome Sciences are using RFD in a registry study and the ASTER study is using RFD to pilot a new model for capturing and reporting AEs. The Wall Street Journal printed an overview of the project in January 2009 (http://online.wsj.com/article/SB123085142405347511.html).

CDISC and Integrating the Healthcare Enterprise (IHE) have jointly supported the development of a process to electronically transcribe information from an EHR into an electronic case report form (eCRF) in an EDC system.  In this process, routine patient information is documented in the EHR.  When the user initiates RFD, the relevant data are sent to the EDC system where they are pre-populated into the eCRF which displays within the EHR interface.  The eCRF is then completed, reviewed, verified for accuracy, and submitted to the EDC system.   This same process can be automatically triggered by pre-defined drug safety triggers in the EHR that initiate the reporting of adverse drug events for drug safety reporting.

The RFD integration profile enables the integration of research and drug safety data capture into the healthcare workflow.  Integrating patient care and clinical research minimizes manual data transcription, increases efficiency, and improves the quality of data received by research sponsors. This live demonstration will showcase how the implementation of RFD, coupled with CDISC standards, accelerates interoperability between EDC and EHR systems.

RFD demonstration participants include, Cerner Corporation, Greenway Medical Technologies, Nextrials, Inc., Outcome Sciences, Inc. and BioClinica, Inc, sponsored by Pfizer, Inc.

The DIA Annual Meeting is the biopharmaceutical industry’s largest, longest running, global, multidisciplinary event. Those interested in attending the annual meeting can visit http://www.diahome.org.

CDISC Healthcare Link Live Interoperability Demo!

Those of you planning to attend this year’s 45th Annual Meeting of the Drug Information Association (DIA), being held June 21-25 at the San Diego Convention Center, should ensure that you visit the CDISC booth (#1915). This year as well as our traditional stand, CDISC will host a live Healthcare Link Demonstration. The demonstration will showcase the Retrieve Form for Data-capture integration profile, developed by CDISC and Integrating the Healthcare Enterprise (IHE).  RFD sets up data interoperability between clinical research and healthcare industries using IHE and CDISC-developed standards that facilitate the integration of electronic data capture (EDC) platforms with platforms in use for electronic health records (EHRs). RFD demonstration participants include, Cerner Corporation, Greenway Medical Technologies, Nextrials, Inc., Outcome Sciences, Inc. and BioClinica, Inc., sponsored by  Pfizer, Inc.

CDISC also has 11 presentations at the Annual Meeting and you can find out all the details of those on the CDISC website.

HITSP EHR Clinical Research Tiger Team

The HITSP EHR Clinical Research Tiger Team had their kick off meeting this week.  They will be recommending the standards and developing the interoperability specification for the EHR-Clinical Research Use Case.  The timeline will be very tight.  Gene Ginther was appointed chair and Walter Suarez co-chair; they are both experienced HITSP Committee Leaders.  The subsequent telecons will be on Thursdays from 1-3 EDT.  If you are interested in being on the listserve and/or participating, please e-mail Allyn Clemons at aclemons@himss.org. For more information about the EHR-Clinical Research Tiger Team, please e-mail Gene Ginther at gginther@jbsinternational.com.

There will be a full HITSP Tiger Team/Technical Committee Face to Face Meeting on June 9-11th, 2009. This will include meetings of the Clinical Research Tiger Team.  The purpose of the meeting is to finalize the HITSP American Recovery and Reinvestment Act deliverables. The meeting will be held at the Hilton Arlington, 950 North Stafford Street, Arlington, Virginia, near the Ballston Metro stop. TC members should RSVP to Allyn Clemons at aclemons@himss.org by Monday, June 1st, 2009. Participation in the HITSP Technical Committee/Tiger Team face-to-face meetings is encouraged.

The appointed HIT Standards Committee met for the first time on 15 May.  One of their first activities will be to review the work of HITSP to date.

Terminology Update and Call for Terminology Review

The online Terminology Request Page has been in operation since January 2009. The CDISC New Term Request web page is the mechanism for both new terminology requests and changes to existing terminology. The CDISC Term Request Tracking web page provides review and accepts comments on previously submitted requests. To access these sites, go to the CDISC website and click on the link under Standards in Production, Terminology.

Between January 1 and March 31, 2009 (Q1), 83 terminology requests were submitted. The terms have been assessed, addressed, answered and changes have been implemented to the controlled terminology as appropriate. The requests are assigned a Level I, II, or III based on the change requested. Level I=spelling fixes, duplication of terms, or minor changes to the definition (about 50 terms), Level II= synonyms added, significant additions or changes in the meaning of definition (about 30 terms), Level III= new terms added to an existing codelist and suggestions for new codelists. The Level I requests have been implemented and are in production in the NCI thesaurus. The document that details Level I changes can be found at the NCI EVS CDISC SDTM directory in the “Change Document” dated 2009-05-01. Level II terms will be posted for public review for a period of approximately 2 weeks. Level III terms, especially additions of new terms to codelists will be included in a review cycle as is done for new terminology development.

The Q1 Level II changes requested via the CDISC New Term Request page are available for public review. The document with the changes and the comment spreadsheet can be found on the CDISC website.

The review period closes on Wednesday 27 May 2009.