FIRST QUARTER 2016 CDISC EDUCATION


Find out here where and when we’ll be having education courses around the world, as well as information on CDISC Online Courses and Members Only and Public Webinars!


Breaking Down Research Silos with New Course Teaching Standards Beginning to End


Shannon Labout, CDISC VP, Education


CDISC Education Supports Beginning-to-End Standards Implementation The benefits of implementing standards from the beginning of the research process are well-established and documented in the CDISC Business Case. To support beginning-to-end implementation, CDISC Education is launching a new, two-day course in 2016 that will provide an overview of the CDISC standards from beginning to end, and teach implementers how the standards work with each other throughout the research lifecycle. The course was designed for academic researchers and is geared toward a general, non-technical audience.


The Impact of Choosing Authorized CDISC Training


Have you seen our tag line "Learn CDISC from CDISC" in tweets and emails during the past couple of years? You may wonder why we encourage people to participate in authorized CDISC training. It's very simple: CDISC is a non-profit organization that develops standards and educates users on the standards. That is what we do, and that is all we do. The CDISC Education team works directly with our teams of CDISC standards experts to create training materials and qualify the instructors who will teach the standards consistently and accurately. Our only mission is to advance your knowledge of the standards to help you implement them in a reliable and conformant way.


There are several benefits when your organization chooses training from CDISC:


First: your staff will be trained in the same way, using the same materials, and by our CDISC team of instructors who are authorized to teach our courses around the globe. Your organization will gain the knowledge to implement the standards in alignment with others who have been trained by CDISC. And because the standards teams are directly involved in our training program as part of the standards development process (COP-001), a training certificate from CDISC has the authority of the CDISC organization behind it.


Second: training from CDISC facilitates consistency among implementers. Consistency is a primary goal of standardized data, and this consistency benefits all of the stakeholders. It allows your organization to build standard CRFs and programming so you can set up and close out your studies faster, and to leverage software that has been developed using the standards. Consistent, conformant implementation across sponsors benefits the regulators who will receive all of our data, and enhances their review process. Consistency also supports aggregating and sharing data in meaningful ways, supporting unexpected breakthroughs in health science. For example, in a recent Critical Path Institute (C-Path) project, aggregating existing Polycystic Kidney Disease (PDK) data from multiple patient registries using SDTM led to the identification of a new biomarker that will allow clinicians to identify PKD earlier when treatment may be more effective.


The third benefit of choosing training from CDISC is that your training dollars will also support the ongoing development of global standards to help us unlock treatments and cures for other deadly diseases. CDISC, in collaboration with many other organizations, is hard at work not only evolving the foundational standards, like CDASH, SDTM and ADaM, but we are also applying the foundational standards to specific diseases and therapeutic areas. In creating specific User Guides, controlled terminology and other supplemental documentation for therapeutic areas like asthma and malaria, CDISC helps you standardize your studies. Evolving the


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