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Austin, TX – 11 March 2014 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the participation of high-level speakers from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), as well as leaders from industry and academia at the 2014 CDISC Europe Interchange from 7-11 April in Paris, France.

 

Dr. Frank Rockhold, Senior Vice President and Head of Global Clinical Safety and Pharmacovigilance at GlaxoSmithKline, and former Chair of the CDISC Board of Directors will be presenting on Data Sharing during the opening Plenary session of the Interchange.

 

Dr. Fergus Sweeney, Head of the Inspections and Human Medicines Pharmacovigilance Division of the EMA will give an update from the EMA and participate in a panel discussion during the closing session of the conference.

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Austin, TX – 31 January 2014 – CDISC is pleased to announce that four highly qualified individuals will add invaluable expertise to the CDISC Board of Directors (BoD) for a three-year term beginning this month (2014—2017). Dr. Charles Cooper, Dr. Dipak Kalra, Joyce Sensmeier and Nevine Zariffa each contribute unique skillsets to the BoD that will greatly assist CDISC as it moves forward with its Strategic Goals in 2014. Dr. Pierre-Yves Lastic is now the new Chair to the CDISC Board, and Ms. Paula Brown Stafford continues her service to the BoD as Past Chair. Dr. David Hardison was voted Chair-Elect to the Board, and Dr. Kiyoteru Takenouchi was re-elected to serve on the BoD for a second term. Sincere appreciation goes to Dr. Frank Rockhold, Sue Dubman and Dr. Eliot Siegel, who completed their CDISC Board service in December 2013.

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Austin, TX – 28 January 2014 – The Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute (C-Path) and TransCelerate BioPharma Inc. (“TransCelerate”) announced today that version 1.0 of the Asthma Therapeutic Area (TA) User Guide (UG) and version 2.0 of the Alzheimer’s TAUG are now available for implementers on the CDISC website. These user guides and the new standards development process through which they were formed are expected to further accelerate the development of additional TA standards. This is expected to streamline the process of developing new therapies for patients.

 

The release of these two standards marks the first time that TA standards have been fully developed through the CFAST partnership using the enhanced CDISC standards development process. CFAST is a joint initiative of CDISC and C-Path, with partners such as TransCelerate, the U.S. Food and Drug Administration (FDA) and the National Institute of Health’s (NIH) National Cancer Institute – Enterprise Vocabulary Services (NCI-EVS), and with participation and input from many other organizations. An aim of the CFAST effort is to support the goals of the FDA's Therapeutic Area Standards (TAS) Initiative Project Plan.

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FDA Posts Notice of Pilot Project to Evaluate CDISC SDS-XML

 

Austin, TX - 20 December 2013 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce that the StudyDataSet–XML Specification Version 1 (SDS-XML) has been released for Public Comment. To view the draft standard and provide comments, please visit the CDISC website. Comments on SDS-XML are due by 3 January 2014.

 

SDS-XML is a CDISC Extensible Markup Language (XML) format for CDISC SDTM, SEND, ADaM or legacy data sets. It has been developed to provide an alternative to SAS Version 5 Transport (XPT) for data set transmission and is designed to work with Define-XML. Sam Hume, XML Technologies Team co-lead, noted: “SDS-XML is a relatively simple, ODM-based transport standard that complements Define-XML v2.0 nicely. It is really the first step in eliminating restrictions in the CDISC standards that carry over from the transport format. SDS-XML was designed to support the standards as they exist today, but also to enable innovative enhancements to the standards going forward.”

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Development of Standards Aid FDA in Meeting Commitments under PDUFA V


Tucson, AZ, 6 November 2013 —The FDA has awarded a two-year, $2 million grant to Critical Path Institute for its joint initiative with the Clinical Data Interchange Standards Consortium (CDISC) to strengthen the framework and further the objectives of the Coalition for Accelerating Standards and Therapies, known as CFAST. The grant comes as part of FDA efforts to support the development of new data standards needed to streamline the process for evaluation and approvals of new medical products.

 

CFAST is focused on developing data standards, tools and methods for conducting research in therapeutic areas that are important to public health.

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Austin, TX – 10 October 2013 – The Clinical Data Interchange Standards Consortium (CDISC) will prominently feature two of its major initiatives, CDISC SHARE and CFAST, at its flagship event on 4-8 November 2013 in Bethesda, Maryland. Also to be highlighted is the way these initiatives are integrally linked and the way in which they are, in fact, quite synergistic. SHARE will accelerate the development of standards for new Therapeutic Areas (TA) while making all CDISC standards more readily accessible.

 

The first of these initiatives, the CDISC Shared Health and Clinical Research Electronic Library (SHARE), is a cornerstone of the CDISC technical roadmap, and will be a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format. SHARE is expected to dramatically improve integration among CDISC foundational standards and controlled terminologies, and support greater interoperability with healthcare. The second initiative for which there will be major updates at the Interchange is the Coalition for Accelerating Standards and Therapies (CFAST). A joint initiative of CDISC and the Critical Path Institute (C-Path), CFAST was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health.

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Austin, TX – 18 September 2013 – The Clinical Data Interchange Standards Consortium (CDISC) and TransCelerate BioPharma, Inc. (“TransCelerate”), are pleased to announce that version 1.0 of the Asthma Therapeutic Area (TA) Data Standard is now available for public review on the CDISC website.

 

The Asthma TA standard is the first standard to have been developed with TransCelerate’s active participation in the Coalition for Accelerating Standards and Therapies (CFAST) initiative. CFAST, a joint initiative of CDISC and the Critical Path Institute (C-Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health. CFAST collaborators include the U.S. Food and Drug Administration (FDA), TransCelerate, the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), with participation and input from many other organizations.

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CDISC and HealthCarePoint (HCP) are proud to announce the launch of CDISC Online Education on 24 June 2013, the first day of the 2013 DIA conference in Boston. CDISC has long offered in-person Authorized Training Courses around the globe, and with the recent level of increased interest in CDISC Education, it was determined that offering courses online would be beneficial to those seeking CDISC Authorized Education and for which ongoing, traditional public and private training courses did not match the level of need.

 

“We are enthusiastic to begin the rollout of our online education courses with the initial SDTM and SDTMIG Basics Modules,” said Frank Newby, CDISC Executive VP of Education. “Our partnership with HealthCarePoint and the use of their unique Training Campus system will allow us to reach everyone who has a need for CDISC Education. Additionally, our new online training courses will feature the opportunity to become certified at the end of the CDISC Authorized Education course taken. This chance to reach new audiences with a need for CDISC Authorized Education, and also to ensure understanding of course material through certification will help to advance our mission to improve medical research and related areas of healthcare.”

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Tucson, AZ , Austin, TX - Critical Path Institute’s (C-Path) Polycystic Kidney Disease Outcomes Consortium (PKDOC) (http://www.c-path.org/pkd.cfm) , the Clinical Data Interchange Standards Consortium (CDISC), and the PKD Foundation announced today the launch of version 1.0 of the Polycystic Kidney Disease (PKD) Therapeutic Area User Guide, a clinical data standard that provides guidance on the implementation of the CDISC Study Data Tabulation Model (SDTM) to represent PKD data in regulatory submissions. This user guide, when used with the SDTM, is intended to guide the organization, structure, and format of standard PKD clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA). This clinical data standard has also been used to aggregate data from several PKD patient registries and observational studies to analyze disease progression in PKD. “The development of the PKD Data Standard represents a major step forward in the development of therapies for PKD,” said Ron Perrone, Professor of Medicine at Tufts University School of Medicine, and Director of the Tufts Center for PKD and Co-Director of the PKDOC. “This kidney disease specific standard will shorten the time for initiation of clinical trials and will facilitate data interchange with regulatory agencies, thereby helping to speed the pace of therapeutics development and potentially improving outcomes for patients.” Perrone is also a member of the PKD Foundation’s Scientific Advisory Committee. The PKD Foundation provided funding for the PKDOC and the CDISC standards development effort.

 

CDISC standards are freely available via the CDISC website. To learn more about the PKD Therapeutic Area User Guide and to download the associated standards package, please visit the CDISC website: http://www.cdisc.org/therapeutic.

 

“This release marks another major milestone in the development of a set of global, platform-independent therapeutic area data standards. The way we were able to work with academic clinicians from Emory University, the Mayo Clinic, Tufts University and the University of Colorado-Denver to develop and reach consensus on PKD data elements was ground breaking for us.

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Austin, TX – 12 June 2013 – CDISC has long proven itself to be a catalyst for collaborative innovation, as evidenced through the many opportunities it has created for partners and stakeholders to streamline the medical research processes. Recent releases of CDISC consensus-based data standards for tuberculosis, Alzheimer’s disease, Parkinson’s disease, pain and polycystic kidney disease are examples.

 

In 2011, the Innovative Medicines Initiative (IMI) and the Clinical Data Interchange Standards Consortium (CDISC) signed a Memorandum of Understanding to outline the collaboration between the two organizations. It was agreed that common data standards and formats are necessary to effectively pool, manage and analyze information both within and across IMI projects. In 2012, through the CDISC Europe Foundation (CEF), CDISC became a partner on three IMI project consortia: EHR4CR, BioVacSafe, and most recently eTRIKS. Additional IMI consortia are using CDISC standards, and CDISC is providing education and training as well as data standards expertise to assist in integration of both prospective and retrospective clinical research data.

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In The News

CDISC Press Release

10.28.2010  

Austin, TX – 28 October 2010 – CDISC standards now cover the entire biomedical research process, from protocol representation through analysis and reporting. Over the last two years it has become clear that in order to increase the delivery of standards updates and meet the needs of industry and regulatory bodies, CDISC needed a different model to augment its current processes. The CDISC Shared Health And Clinical Research Electronic Library (CDISC SHARE) is envisioned as a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare.  This new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model.

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CDISC Press Release

10.12.2010  

Austin, TX – 12 October 2010 – The CDISC North American Interchange is to be held in Baltimore, MD, 1 – 5 November 2010. The CDISC Board of Directors and Dr. Rebecca Kush, President & CEO are pleased to announce three exceptional keynote speakers to introduce this year’s event: Dr. Doug Fridsma, acting director of the Office of Interoperability and Standards in the Office of the National Coordinator for Health Information Technology; Dr. Theresa M. Mullin, Ph.D., Director, Office of Planning and Informatics, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA) and Dr. Raymond L. Woosley, Founder and Chief Executive Officer of the Critical Path Institute (C-Path).

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The CDISC English Speaking User Group (www.esug.org.uk) is fast approaching its third birthday and, as time passes, we firmly believe that we are not only making significant progress in promoting the work and deliverables of CDISC amongst the English speaking world, but also developing the tools and structures which will help us to continue to do this in the months and years ahead.

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The completion of the Human Genome Project in 2003 has heralded a new era representing a significant rise in the use of Pharmacogenomic (PGx) data in both research and clinical care.  It promises to be an exciting time to pursue greater understanding of molecular pathways and underlying disease risks in certain populations ...

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In January, 2010, the CDISC Protocol Representation Group published the final Protocol Representation Model Version 1.0.  The PRM has been described in detail in a number or articles, blogs and in its own documentation.  The intent of this article is to provide simple, basic answers to questions that have arisen recently about the PRM ...

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As always, CDISC begins the year with a flurry of activity (do keep an eye on the website for regular updates and news on the standards).  In addition to the CDISC standards themselves, the CDISC Board and Operations Staff also spent the last quarter of the year reviewing the CDISC Strategy and making appropriate changes (see the new CDISC Strategy 2010)...

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As Dr. Frank Rockhold assumes the position of Chair, CDISC Board of Directors, this month, CDISC would like to formally congratulate Paula Brown-Stafford on being voted as the new Chair Elect of the CDISC Board.  Paula has more than 20 years experience of working in the Pharmaceutical and CRO industry. She has worked closely with the CDISC standards and has ensured that Quintiles has devoted time and energy to their implementation within the organization ...

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The CDISC-AdvaMed Device Team has covered a lot of ground since the last CDISC newsletter update.  As many of you are aware, this project seeks to develop in parallel the CDASH data collection fields, the SDTM submission variables and the associated metadata for basic device clinical studies...

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The day saw 53 delegates attend from across UK, Germany, Switzerland and Ireland. There was variety amongst those in attendance in their working disciplines, from Data Managers, Statistical Programmers and Medical Writers. There were also Software Vendors in attendance and also presenting ...

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Expert CDISC Group

01.15.2009  

CDISC, the Clinical Data Interchange Standards Consortium is an international standards development organization whose mission is “to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare”.


As members and/or supporters of the Clinical Data Interchange Standards Consortium (CDISC) Global Expert Group, we wish to encourage the advocacy and adoption, along with continued collaborative development, harmonization and support of the CDISC global clinical data standards that facilitate the clinical research process while integrating it into the healthcare arena.

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