FAQ

Please look through our FAQ's and click on a question for more information.
If you need further assistance, please do not hesitate to contact a member of the team.

CDISC Standards

  1. CDISC is currently in the process of establishing a new set of online educational courses based on our current selection of classroom training; eventually, the online education offerings will cover all the CDISC Foundational Standards as well as the Therapeutic Area Standards currently in development. We expect to have the first course modules available Q1 2013 and will be adding course modules on a regular basis over the next several quarters.

     

    Click here for our most up-to-date CDISC Education offerings including upcoming on-line education!

  2. First, follow our announcements and visit our website often to learn what new standards are accepting review comments and participate in these reviews. Second, participate in discussions on our Discussion Forum or via social media, such as Linked In groups. Join our working teams and gain access to the CDISC teams portals, please contact us at volunteer@cdisc.org if you would like to join a CDISC team. CDISC teams are volunteers who dedicate their time and effort to contribute to the CDISC standards and be part of the CDISC mission and vision. In addition, you can volunteer to our standards through this link, please fill out the form and submit to the email address listed on the top of form page. And if you would like to be informed about our latest achievements and updates, please join our mailing list through this link (Join Our E-mail List).

  3. CDISC SHARE, a cornerstone of the CDISC technical roadmap, will be a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format. SHARE is envisioned to help users find, understand and use rich metadata and controlled terminologies relevant to clinical studies more efficiently and consistently, and to improve integration and traceability of clinical data from protocol through analysis.

  4. Individual CDISC data standards were originally developed as PDF documents to address discrete areas of the clinical research process, focusing on the most commonly used data elements that appear in most clinical studies – primarily for general safety data. Over time, as the use of standards matured, it became clear that the value of CDISC standards would be increased by extending CDISC data standards to incorporate efficacy data elements and enhancing access to CDISC metadata (beyond PDF). SHARE will eventually make all CDISC metadata standards electronically accessible to computer applications in an integrated system. SHARE will also provide a collaborative standards development environment that will improve the quality, integration, reach and consistency of CDISC standards.

    CDISC SHARE will guide an advanced information-based approach to standards definition and metadata development. This new process will involve consistent, unambiguous definition of clinical research concepts in the context of the BRIDG model, tracing the use of these concepts from protocol through data collection, tabulation and analysis, and binding them to specific controlled terminologies.

    Use of CDISC standards through SHARE will also facilitate aggregation of data to gain new insights to inform the research process, and will improve interoperability with healthcare by aligning research concepts with external healthcare concepts. SHARE will help CDISC realize the promise of defining data standards once so data can be reused many times for multiple research purposes.

  5. With the need to develop therapeutic area standards and the subsequent launch of the CFAST initiative, it quickly became evident that the process of defining therapeutic area data standards for a multitude of disease areas would require improved tools and capabilities that could not be fully met by the previous manual data standards development process. In particular, therapeutic areas need to capture patterns of data that may not currently exist in published domains, and match specific controlled terminologies for observations relevant to specific symptoms, diagnoses, tests and assessments. Moreover, many research concepts need to be reused across therapeutic area studies, and the breadth of information covered across these research areas may involve tens of thousands of unique concepts that need to be represented (often with customization) in protocols, CRFs, tabulations and analysis files. It quickly became clear that such an ambitious undertaking was unlikely to succeed unless a robust systems environment like SHARE could be made available.

  6. The CDISC SHARE project was initiated by members of the CDISC Board of Directors, CDISC leadership and volunteers in 2007. Early work began with a stakeholder analysis to define the initial proposed scope of SHARE. In 2009, a pilot project using Mayo Clinic’s LexGRID semantic wiki tool was conducted, which verified the potential value for SHARE and highlighted the need for a more controlled metadata repository environment with strong governance. Work proceeded after that to define detailed requirements and to begin organizing CDISC content so it would be SHARE-ready: well defined, mapped to BRIDG and ISO 21090 complex data types and clearly expressing relationships between collected CDASH elements and SDTM tabulations.

    In 2012, CDISC entered into a partnership with the Critical Path Institute, FDA and TransCelerate BioPharma Inc. (TCB) to establish the CFAST Initiative and the Therapeutic Area Data Standards Program, which quickly recognized the need for a metadata repository as an essential infrastructure component to support the development of numerous therapeutic area standards. With TCB’s strong support, CDISC engaged in a formal evaluation process to identify solution providers with SHARE, resulting in the selection of SOA Software’s Semantics Manager in June 2013.

  7. The creation and management of CDISC Controlled Terminology will continue to be maintained and extended through CDISC’s partnership with NCI’s Enterprise Vocabulary Services (EVS) as has been the case for many years. However, while EVS manages the fundamental code lists used by CDISC standards, the binding of specific value sets selected from those code lists with variables for specific use cases, such as therapeutic area standards, will eventually be managed through SHARE.

  8. The SHARE logical data model is built upon a framework based on the BRIDG Model and ISO 21090 data types. BRIDG provides the underlying reference context for consistent representation of metadata across multiple CDISC standards and therapeutic area use cases. ISO 21090 complex data types allow standards to be represented as higher level concepts or building blocks, which can then be decomposed into physical representations such as SDTM variables in datasets but also can be more easily transformed into newer data exchange formats and more easily related to healthcare concepts.

  9. CDISC has assigned a senior executive to lead the SHARE project and is providing a team to support its implementation and use. But the success of SHARE, like all other CDISC standards, depends entirely on the active involvement of CDISC volunteers. Each individual company that adopts data standards must currently assess, interpret and implement, often making decisions and judgments that may lead in different directions. By working together in SHARE, those involved in the use of standards in individual companies can share their knowledge and pool their resources to support the betterment of clinical research for all.

  10. We anticipate that an initial release of the CDISC SHARE system will be available for initial use by early 2014. Additional details regarding features and delivery dates will be posted as they become available.

  11. The SHARE system will be built on a licensed commercial software product, SOA Software’s Semantics Manager, in an externally hosted computing environment, and will involve significant incremental costs to CDISC for licenses, operations activities and support. CDISC is currently evaluating what are the most cost effective alternatives for making CDISC standards available through SHARE easily accessible to the CDISC community to ensure that the benefits of SHARE can be realized at a fair and reasonable cost to users.

  12. Although access to the full set of SHARE features will likely involve an additional nominal cost to licensed users, CDISC will also continue to make all of its published standards free and open to the full research community (members and non-members) as has been our practice since our inception.

  13. SHARE is a controlled system using a commercially licensed software product, so access will be limited to named users who have been trained and qualified in the use of the system. CDISC will be publishing additional details on how to gain access as the project nears delivery.

  14. You can offer to take an active role in the SHARE project by completing a volunteer form and pledging time to work with the SHARE implementation and content development teams. You can contribute financial support by becoming a CDISC member or giving a donation. Finally, you can support the use of CDISC standards throughout your own organization and among your partners. The benefits of CDISC standards can only be realized when more and more organizations are using standards consistently and effectively, delivering on the promise offered by SHARE.

  15. CDISC. CDISC owns the intellectual property of all of its standards (data, metadata, and transport) per the CDISC IP Policy (http://www.cdisc.org/bylaws-and-policies). This includes all translations that are done of CDISC standards into other languages. By retaining ownership, CDISC ensures its standards can remain open and free, which will encourage adoption, and therefore, ensure better and more useful standards.

  16. There are several parts to this answer.

     

    a) CDISC has an IP Policy to ensure that no one else, other than CDISC, can own the CDISC standards or their translations. No one can charge royalties for the use of the CDISC standards.

     

    b) CDISC raises funds to continue to enhance and maintain the standards and to offer them freely. This includes monies contributed by generous supporters and member organizations, as well as other sources of revenue, such as education and grants.

     

    c) CDISC standards development is largely done by volunteers and individuals loaned to CDISC by its supporters. CDISC has a small staff to assist volunteers, to provide leadership and education, to obtain sufficient funding and to ensure appropriate processes are followed.

     

    CDISC is the common language for Clinical Research.  No other standards developing organization (SDO) in healthcare or research has completely open and freely available standards. CDISC is the only SDO dedicated to standards for clinical research. CDISC appreciates the generous contributions of all of its member organizations for making it possible to maintain open and free standards.

  17. The CDISC standards that are ready to implement (i.e. are a standard in production) are all available through the CDISC website.  CDISC completed the suite of Foundational Standards in 2009. These standards support clinical research, from protocol representation and data collection through analysis and reporting. The CDISC standards are harmonized, such that they all work together to support the end-to-end clinical research process through the BRIDG (Biomedical Research Integrated Domain Group) model.   The CDISC standards can be found under the Standards & Innovations tab on the CDISC home page (http://www.cdisc.org/standards).   On this page, you will see the ‘dashboard’ diagram with the CDISC standards listed under the research process areas that they address. Clicking on a standard ‘button’ will take you to the documentation for that standard.

     

    The foundational standards focused initially on data elements that are common to all research studies.  Now, there are augmentations or enhancements of these foundational standards that are being developed to support many therapeutic areas and other important areas (e.g. imaging and devices). Click on “Therapeutic Areas” on the dashboard diagram referenced above. You will then be sent to the Therapeutic Area Standards page, where you will see a link to the Summary Table. This table keeps you up to date on the new TA standards that are either coming out for review or have been posted recently.

     

    On the sidebar on the Standards and Innovations page, clicking on the “Technical Plan Project Schedule” will show the CDISC Project Plan Gantt Chart, showing the projected timeline for new standards development and standards updates. The Gantt chart shows timelines for Foundational Standards development and development of the semantics to support CDISC standards and implementations (i.e. Healthcare Link Initiative and the Therapeutic Area Standards).

  18. Ultimately, the greatest value/benefits associated with standards implementation occurs when using standards from the start in clinical/medical research studies, and this value can be seen in the saving of time and money.  Hovering over the Membership tab at the top of the CDISC website, you will see on the scroll down screen an option labeled “Business Case.” Clicking on this selection will send you to a business case put together by Gartner, which elaborates on these savings. Additional information on this can be found in the CDISC Success Stories and Case Studies, found in the CDISC eJournals. You can find the eJournals by hovering over the tab “Resources” on the CDISC website.

     

    In addition to direct time and cost savings, standards users have experienced improved communications among project teams, higher quality data, faster data transfers and ready aggregation across data sharers, more efficient archive and recovery procedures, more accessible information, higher quality, and more efficient reviews of submissions (Please note: mapping data collected without using CDISC standards, e.g. CDASH, into the CDISC standards at the back end is time consuming and costly.  Using standards can have advantages such as enabling aggregated databases that are very valuable; however, the greatest value of the standards is realized when they are implemented up front in the research studies). Most importantly, CDISC standards facilitate the entire clinical research process and the biopharmaceutical product development process, which means that research results can be more quickly available to inform medical decisions, and safe and efficacious therapies can be available more readily to patients who need them. After all, in the end we are all patients.

  19. The CDISC Technical Roadmap describes the landscape of CDISC standards currently available or in development, and describes a vision for improving the harmonization, interoperability, consistency, availability and use of CDISC standards in a more advanced, integrated architecture based on the BRIDG model and our proposed SHARE metadata repository.

  20. The Protocol Representation Model (PRM) Toolkit is designed to be a template that readily allows protocol authors to enter certain information from a protocol such that it can be easily reused in the future, e.g. for clinical trial registration and regulatory submissions. The purpose of offering this tool is to make it easy for protocol authors to reap more benefits from the CDISC Protocol Representation Model (PRM), which has been developed over the past decade by global clinical research experts from academia, industry and government.

     

    The current release of the PRM Toolkit includes a standard Study Outline Template in MS Word format, a standard list of Study Outline Concepts, and a complete mapping of the Study Outline Concepts to both the Biomedical Research Integrated Domain Group (BRIDG) model and the CDISC Study Data Tabulation Model (SDTM) Trial Summary (TS) Domain.  The next release of the Toolkit will include the PRM Protocol Wizard. The Wizard will allow the end user to simply “plug and play” different protocol elements into a simple-to-use web-based form. Rather than writing out each part of the protocol outline, the form will prompt the author with specific step-by-step concept inquiries. The author can then enter the specified fields or select from a list of controlled terminology, and the form will generate a protocol study outline document.  Further developments planned include generating a structured protocol document, a trial registry message to populate a clinical trial registry, and creating the SDTM TS Domain to ensure that submission variables are accounted for up front. What once took hours to reengineer into different formats will require only a few “button clicks.”

     

    For more information please see click here.

    See also the archived webinar from 18 December 2012.

  21. Yes. The PRM can be used without the toolkit, it just requires implementers with an understanding of the BRIDG model and how to best use it.  The toolkit was designed to make it easier to use PRM without such IT expertise.  The PRM has already been successfully utilized by organizations like Genzyme and the National Cancer Institute prior to the release of this new tool. For more information on how these organizations utilized PRM, please see our eJournal, which can be found under the Resources tab on the CDISC website.

  22. All of the CDISC standards are open, free of charge, and available via the CDISC website. The PRM Toolkit, and the development of tools, however, is decidedly different than that of standards. Many tools utilizing CDISC standards are developed and provided at a cost by commercial vendors. The PRM Toolkit is contributed by members, for members, to provide added benefit and value to those in the CDISC community who support CDISC through their memberships. We encourage those who believe in and benefit from standards developed through the efforts of hundreds of dedicated volunteers to become members of the CDISC community.

  23. Comment: Before answering this question, it may be of interest to know that this topic is frequently associated with a few common ‘myths’ or misperceptions. Some think that CDISC receives all of its funding through memberships. Some think that CDISC revenue comes from the FDA. Some think that pharmaceutical companies have ‘deep pockets,’ so CDISC must be ‘rich.’ Others don’t really stop to think about where CDISC funding comes from, and how we manage to keep the CDISC standards open and free. Yes, the first three are definitely myths; and there is a real need for CDISC to have a revenue stream (actually more than one) since standards development and maintenance have associated costs. We do receive great help from volunteers; however, volunteers have other/day jobs and CDISC needs dedicated staff to serve all of our stakeholder needs, to develop more standards, to maintain the standards that are developed, to widely communicate about these CDISC activities, to coordinate volunteer activities and to partner with others to ensure continued progress.

     

    ANSWER: If you would like to see a graph on where CDISC revenue comes from, please see our Annual Report, located on the right side of the CDISC home page. To answer the question directly, CDISC has multiple revenue streams having diversified significantly since our initial 2000 revenue, which was completely from charter members. In 2011, CDISC income came from Membership Renewals (47%), Education (26%), New Members (8%), US Interchange (6%), EU Income (4%), and the remaining (~ 9%) was made up from Healthcare Link, ODM Certification, Project-specific Income, and new sources of income, including grants (e.g. the SHARP Grant) and sponsorships. The CDISC 2011 Annual Report also has graphs on how the CDISC revenue was spent last year and the types and names of companies that make up the CDISC membership. Please look also at the summary of the CDISC accomplishments over the past 15 years and stay tuned for the 2012 Annual Report.

  24. Yes! There have been numerous demonstrations (CDISC, DIA, HIMSS) showing how a regulated clinical research study can be done using an EHR. (See the CDISC Healthcare Link area of the CDISC website under Standards & Innovations – Implementations).

     

    One key enabler for this process is the use of an integration profile developed by CDISC with IHE (Integrating the Healthcare Enterprise). It is called Retrieve Form for Data Capture (RFD). A number of EHRs support this profile; and there is a letter of support for this novel yet easily implementable solution from the EHR Association on the CDISC website. Please hover over the Standards & Innovations tab, go to Innovations, and click on Healthcare Link Initiative. The letter is near the bottom of the page. Additional profiles are also now available, including those that address content and security in addition to the workflow piece.  

     

    A challenge has also been issued by CDISC, FDA and HHS/ONC for a sponsor to do a regulated research study using EHRs.  See the June 2012 press release in our Newsroom found here.

  25. CDISC currently has LinkedIn, Facebook, YouTube, and Twitter pages where official CDISC messages and videos are posted. We encourage anyone interested in receiving official updates and announcements from CDISC to consider joining these groups. Below are the direct links to our official pages, and you can additionally find buttons that will link you directly to these pages on the CDISC homepage and in every CDISC eNewsletter:

     

       

     

    On sites like LinkedIn and Facebook, interested third parties have the ability to create and manage CDISC-related pages, which are usually developed by individuals that are supportive of CDISC and have experience implementing or assisting in the development of CDISC standards. Some of these groups have information that is pertinent to specific teams or interested parties, but management of these groups rests with the creator and is outside the purview of CDISC. The content of these pages is not managed by CDISC staff and does not necessarily reflect the views of the organization. For all official messages from CDISC, please visit and join the official CDISC group pages listed above.

  26. Ultimately all benefits associated with standards implementation --- efficiency, time saving, process improvement, reduced time for regulatory submissions, more efficient regulatory reviews of submission, savings in time and money on data transfers among business partners, more efficient archive and recovery procedures, more accessible information, better communications amongst team members --- come down to saving money - whether it be in time, resources or actual funds. Most importantly, CDISC standards facilitate the clinical research process and the biopharmaceutical product development process so; this means that research information can be more quickly available to inform medical decisions and safe and efficacious therapies can be available more readily to patients who need them.  And, we are all patients.
    The Gartner Business Case for Standards prepared by, and based on research conducted by, CDISC and Gartner is available here.  If you have any questions, or if we can provide support to help outline the advantages of CDISC membership for your organization please contact: CDISC Global Relations, where Sheila Leaman can assist you.

  27. CDISC is working towards a fully implemented certification program which would "certify" that an application is compliant with a certain version of one or more CDISC standards. The first such program, which is now available, is for the CDISC Operational Data Model (ODM). You can find more information here.

  28. The short answer to this question is that the US National Cancer Institute (NCI) has one of the best tools available to manage terminology through their EVS (Enterprise Vocabulary Services)and it is openly available at no charge to anyone in the world.  This is a very good relationship for CDISC; through its working relationship with NCI EVS, CDISC is able to leverage existing services, expertise and infrastructure designed specifically for development, harmonization, delivery and support & maintenance of controlled terminology.  And, NCI is a strong supporter of the CDISC standards.  If CDISC were to simply deliver terminology code lists to our user community via Excel spreadsheets, that is not “controlled” terminology. NCI EVS staff works with the CDISC team to develop controlled terminology from the code lists CDISC provides. Via the NCI Thesaurus, CDISC metadata and code list terms are broken down and defined to the most basic atomic unit. Then, everything is pieced back together into Common Data Elements (CDEs) in the caDSR. This detailed process allows CDISC and the user community to maximize interoperability and integration of information, moving CDISC much further down the road toward its mission.

  29. The following avenues are available for providing input to the CDISC standards:

    • Review draft standards for comment and provide feedback to the authoring team. Draft standards can be found on the CDISC website.
    • Post suggestions to the CDISC public Discussion Forum. 
    • Provide a case study detailing your implementation experiences with one or more CDISC standards. If you are willing to do this, we will even provide someone to interview you so that you don’t have to write it up yourself. Please contact Julie Evans.
    • Participate on a CDISC project team. Send an e-mail to info@cdisc.org expressing your interest in becoming involved in a project and any further information that would permit an assessment of opportunities that will fit your skill set and interests. 
    • Attend an annual Interchange in the US, Europe, Japan or China.
    • Join one of the many User Networks groups and make your thoughts known.

CDISC & The Food & Drug Administration (FDA)

  1. Under PDUFA V reauthorization, FDA is directed to develop data standards by FY2017.  
    In a presentation at the 2012 CDISC International Interchange, Amy Malla of FDA CBER stated that an FDA Guidance document is being prepared that will specify FDA requirements for CDISC SDTM (and presumably other associated CDISC submission standards such as ADaM, Define-xml and CDISC controlled terminologies).  Use of data standards will become mandatory 2 years after the final guidance is issued for NDAs and BLAs, and will apply to all new studies begun 1 year after the final guidance is published.

  2. While the process of making FDA submissions is quite complex and can’t be described in detail in a brief paragraph, here are a few tips.  First, you should become familiar with FDA standards requirements by reviewing the FDA Study Data Standards Resources web page.  Next, become familiar with the CDISC SDTM, SEND, ADaM and Define.xml standards by reading the implementation guides, enrolling in CDISC education courses and interacting with other CDISC adopters by participating in CDISC interchanges or even joining standards development teams.  Finally, it is critical to meet with the appropriate FDA review division to discuss your plans well in advance.  It is expected that upcoming FDA guidance will ask sponsors to include a study data standardization plan as part of an IND.

CDISC Membership & Benefits

  1. CDISC User Networks enable face-to-face interactions in specific regions or languages, depending on the region. They are self-formed groups that encourage the adoption and understanding of the usefulness and value of CDISC standards.

     

    The purpose and benefits of CDISC User Networks are to:

    • Share CDISC implementation experiences periodically in a given region or language
    • Discuss draft standards and comments to CDISC
    • Discuss mature standards and feedback to CDISC on usefulness
    • Discuss new ideas to be channeled into CDISC
    • Network among colleagues
    • Share recent conference participation and learning

     

    User networks represent CDISC in China, Japan, Europe (French-speaking, English-speaking and German-speaking), and in ten areas of the United States [Bay Area, CA; Boston (BACUN); Atlantic region (CT, NJ, NY); San Diego; Midwest; Delaware Valley; Raleigh-Durham; Heartland; Seattle, Washington DC (DCDISC)].

     

    For further details on CDISC User Networks, please follow this link to review the CDISC Operating Procedure on User Networks.

     

    To join a CDISC User Network, feel free to contact Diana Harakeh. The CDISC User Network portal area is open to anyone and provides information on specific User Networks, including announcements of their next meetings.

  2. CDISC has become much "more than standards", making a clear impact on improving the clinical research process and helping to bring new safe and effective therapies to patients sooner. Any organization interested in furthering the CDISC mission is welcome and encouraged to join CDISC as a member.

     

    As a non-profit organization, although CDISC is continuously diversifying its revenue streams, membership remains our primary source of income. In order to support increased implementation of CDISC standards around the globe and to keep pace with growing industry and regulatory requirements for new standards, we need financial support from organizations in the industry.

     

    In 2011, CDISC applied for and was approved as a 501(c)(3) organization by the IRS. This will permit direct individual and corporate contributions to CDISC in the form of donations or membership fees to be tax-deductible.

     

    By being a CDISC Member your organization can:

    • Support CDISC in serving the community as demonstrated by the fact we are the only SDO whose Standards are focused on research and provided free to the public and the growing CDISC global community
    • Make it possible for CDISC to fulfill its mission; it is an integral requirement to continue the development and maintenance of the CDISC standards for the benefit of the global biopharmaceutical industry and clinical research, in addition to supporting CDISC communication and implementation services
    • Increase recognition by your peers and regulators as an organization willing to support CDISC financially and contributing to the betterment of biomedical/clinical research overall
    • Have direct influence on and input to the standards that are in development or those being enhanced
    • Receive discounts (20% for Gold Members/40% for Platinum Members) for CDISC Educational Courses and annual Events (e.g. Interchanges in US, Europe, Asia-Pacific, Japan and China)
    • Gain access to the Members Area of the website
    • Enroll for the Registered Service Program
    • Keep abreast of emerging technologies, standards, compliance requirements, regulations and continuous process improvements
    • Platinum members have the opportunity for representation on the CDISC Advisory Council
    • Leverage invaluable partnership prospects and networking opportunities with industry peers and visionaries
    • Enable the important work of CDISC to continue around the world
  3. CDISC has over 300 organizational members from 19 countries in 11 different industries. CDISC members include organizations from biopharmaceutical companies, clinical/contract research, healthcare, medical devices, academia, consulting companies, technology providers, and more. See the CDISC website for a complete list.

  4. The "Members Area" of the CDISC web site is an area to which only CDISC members in good standing (membership fees are up to date) have access. The purpose is to provide added value to those who make CDISC possible, especially since all of the CDISC standards are open and free to anyone. The Members Area contains tools (eg. ODM viewer, Protocol Outline tool and more to come such as the Excel spreadsheet version of the SDTM domains); the Introduction to CDISC Course (Global Approach to Accelerating Medical Research course will be available online soon); Supplements (training, examples, data); Computer readable metadata; Project Schedules, Project Progress Reports and Plans; Team Minutes; Case Studies from companies demonstrating how they have implemented the CDISC Standards. There is also a quick link to the CDISC SDTM standard to avoid having a file sent via email.

  5. The Members Area is password protected. Anyone who belongs to a CDISC Member Organization can have the company username and password for the Members' Area. If you need your company's login credentials, you can get it either from your company’s member contact person or you can use theforgot password option to retrieve the password information. However, you will need your company’s corporate email (eg. john.doe@healthcare.com) to gain access to the password information.

  6. Just complete the simple Member Application at http://www.cdisc.org/membership-benefits-and-options (click ‘Become a Member’ for the form). Once we receive the form, we will send you membership information together with the annual fee which is based on the total number of employees in your company and the level at which your organization joins.

    • Sponsors receive substantially greater discounts for CDISC Educational Courses and Events than do Members.
    • Sponsors have a seat on the CDISC Advisory Board (CAB). This Board has the following roles in CDISC
    • Provide input into the CDISC Strategy (developed by the CDISC Board Strategy Committee)
    • Provide input into the CDISC Technical Roadmap. 
    • Elect one representative from the CAB to the CDISC Board of Directors. 
    • Have two ex-officio members on the CDISC Board (CAB Chair and Chair-elect). 
    • Have CAB members on Board Committees (Strategy, Technical Advisory, Governance, and Financial Oversight). 
    • Recognition by your peers and regulators as an organization that is willing to financially support CDISC’s extremely valuable contribution to the betterment of the biopharmaceutical industry and biomedical/clinical research overall.
  7. The "Members Area" of the CDISC web site is an area to which only CDISC members (i.e. Member Organizations such as Sponsors, Members, Associate Members) in good standing (membership fees are up to date) have access. The purpose is to provide added value to those who make CDISC possible, since all of the CDISC standards are open and free to anyone. The Members Area contains tools such as the Excel spreadsheet version of the SDTM domains, the Introduction to CDISC Course, Case Studies from companies demonstating how they have implemented the CDISC Standards. There is also a quick link to the CDISC SDTM standard to avoid having a file sent via email. In addition, there are a number of tools in the members’ area including those for viewing ODM files and those that can assist members with ODM Certification. Anyone who belongs to a Member Organization can have their company username and password.

Strategic Alliances

  1. CDISC has an Associate Charter Agreement (MOU) with HL7 that was originally signed in 2001 and is renewed approximately every two years. The Charter Agreement encourages a relationship that focuses on harmonization of the CDISC clinical research standards and the HL7 healthcare standards.  To this end, BRIDG was initiated in 2004 and is now a collaborative model (www.bridgmodel.org) governed by a Board comprised of CDISC, HL7, NCI, NIH and FDA.

    The newest Charter Agreement allows for “CDISC content-rich HL7 messages to be jointly owned and posted in the members’ area of the websites for both CDISC and HL7".  The LAB model was the first CDISC content model for which an HL7 V3 message was developed (The LAB standard content can also be transported via CDISC ODM, XML, SAS, ASCII).

    The CDISC President and CEO, Rebecca Kush, was recently elected to the HL7 Board of Directors.  The current HL7 CEO served 6 years on the CDISC Board before taking his HL7 CEO position.  These relationships can facilitate understanding in terms of the importance and need to link healthcare and research through standards.  In light of the CDISC mission statement, the collaboration of SDOs is becoming increasingly important in this information-rich age that begs for system interoperability.

    The HL7-CDISC Charter Agreement also includes reciprocal organizational memberships and an HL7 Outreach Committee for Clinical Research (OCCR). This committee, which is comprised of members from FDA, CDISC, HL7, NIH and other groups involved in clinical research, was appointed by the Board of HL7 to strategically represent the domain of clinical research within the context of HL7 and to reach out to the clinical research community to encourage harmonized standards development.

  2. FDA's official position is that of "observer" when involved in CDISC activities. FDA representatives participate as liaisons on CDISC teams, present at CDISC conferences, present at other industry conference on the need for (CDISC) standards. FDA presentations have provided public endorsement of CDISC activities, including encouragement to those developing eSubmissions to use SDTM and ADaM. CDISC is specifically named in the Critical Path Opportunities List for developing standards to streamline clinical trials.

    CDISC was awarded a contract from FDA to teaching reviewers and statisticians about CDISC; through this relationship, there are four different CDISC courses, including SDTM and ADaM, which have been taught now to over 300 reviewers. 

    Representatives of the Department of Scientific Investigation (DSI) requested the work that generated the eSource Data Interchange (eSDI) document

    FDA is leading an effort to develop HL7 transport standards that would carry CDISC content, including Study Design (a major portion of the Protocol Representation model).  FDA/DHHS have publicly endorsed the SDTM, with awards going to the SDS team, and CDISC standards are listed as specifications in FDA Final Guidance (see question 3 under Standards).

Implementation Advice

  1. CDISC Registered Solutions Providers (RSPs) are CDISC Members companies who are consultants, technology and service providers, system integrators, and subject matter experts that have demonstrated sufficient knowledge and experience implementing the various CDISC standards to be included in the RSP list. The purpose of the RSP list is to provide information about organizations and companies with CDISC implementation experience and capabilities so that those who need that experience or service have a place to find such CDISC resources. CDISC is making the information available in the RSP list as a service but makes no claim as to the suitability for a particular need or accuracy of the information. As with any service provider engagement, you should verify that the chosen provider is the best fit for your organization's need.

     

    Click here to see our current list of RSPs

  2. CDISC is currently in the process of updating the ODM Certification Program in preparation for a re-launch in Q1 2013. CDISC began the original ODM Certification Program in 2007. We believe the ODM certification program is valuable for the industry as well as the companies that have ODM-capable products and wish to provide potential customers with the assurance that their products are ODM compliant by way of the CDISC ODM Certification program. Additionally, FDA has expressed renewed interest in ODM, and many have proposed ODM as an alternative to SAS V5 Transport file format, which FDA plans to replace.

     

    The re-launch of the CDISC ODM Certification program will take place in Q1 2013 with an updated set of certification tools capable of testing products against the latest ODM version requirements! Watch the eNewsletter, our web site and the various social media outlets for more information!

     

    Currently, the ODM Certification Program is our only certification program.

     

    Click here to see our current list of ODM Certified products/vendors

  3. There are several different ways to reach out to the CDISC Community to receive assistance in implementing and utilizing the CDISC standards:

     

    • The CDISC Discussion Forum is an excellent way to reach out with questions regarding the standards, and you can get assistance with your questions from staff, volunteers that worked to develop the standards, and from veteran users of the standards. You can reach the CDISC Discussion Forum through this link: http://www.cdisc.org/public-discussion-forum.

     

    • The CDISC LinkedIn Group is a fantastic way to not only ask questions about implementation of the CDISC standards, but also offers an opportunity to connect and engage your peers in the community. You can reach the CDISC LinkedIn Group through this link: http://www.linkedin.com/groups/CDISC-56393?trk=myg_ugrp_ovr.

     

    • Should you need assistance in implementation that has not been addressed on one of our forums, or should you like to reach out to someone directly with your questions, please contact us at info@cdisc.org. We will connect you with the right individual to help you.
  4. Suggestions for obtaining implementation assistance include, but are not limited to:

    • Make sure your organization is a CDISC Organizational Member or Organizational Sponsor and that you can access the Members Area of the website.
    • Buy the CDISC Primer available here and refer to the chapter, 'How to Start Implementing the CDISC Standards.'
    • Add your name on the CDISC Mailing list to receive the newsletter and invitations to CDISC Events.
    • Take a CDISC Educational Course.
    • Volunteer on a CDISC Standards team; there is no better way to get to know a standard than to participate in developing one.  
    • Attend one of the annual CDISC Interchanges (US, Europe, Japan or China). Hear how your colleagues are implementing CDISC standards and network with CDISC leaders in person.
    • Look at the CDISC Registered Solution Providers if you need to contract assistance.
    • Join a Users Network - Contact Frank Newby for information.
    • Review the Resources section on the CDISC website.
    • Send specific questions via the CDISC Discussion Forum.
  5. Registered Solution Providers (RPS) are those individuals and companies that claim to have expertise in one or more CDISC standards. The CDISC Technical Leadership Committee (TLC) undertakes a thorough review of each Registered Solution Provider to ensure the provider’s claims are valid. The RSP list is, in essence, a recommended list of companies to help you with CDISC standards implementation. However, CDISC does not make guarantees for RSPs. If you would like the assistance of one of the companies, please contact Diana Harakeh and she will forward your request to the appropriate person.

Other

  1. The following are the CDISC communication channels through which we connect with our members and non-members. Please make sure to join our mailing list to get the most current information.

    • CDISC Website: The “What’s New” section provides the latest CDISC updates and news
    1. You can also join our mailing list on the CDISC homepage through the following link: Join Our E-mail List to receive latest information on our standards, events and education courses. 
    2. The CDISC Members Area of the website also includes tools and new information available to those who join CDISC (see this link to find out if your company is a member and, if not, see this link to view the benefits of becoming a Member).
    • CDISC Newsletter: It is issued on a monthly basis and can be accessed through theCDISC homepage
    • CDISC Social Media: (LinkedIn, Twitter, YouTube and Facebook)

       

  2. The CDISC Intellectual Property (IP) Policy is designed to facilitate the activities of CDISC in developing open standards, to maximize the adoption of such standards by protecting against the ownership of the standards by one party and to protect the legitimate intellectual property rights of contributors to the standards. In its role of leading the development of standards for clinical/medical research, CDISC must protect those standards to ensure that, to the extent practicable, they remain neutral, open, compensation (royalty)-free, and without encumbering ties to prior intellectual property. The entire policy is posted here.

  3. The CDISC Policies include a description of these policies, our procedures and processes, and include the following:

     

    Note that CDISC also has bylaws, charters for its Board committees, and procedures calledCDISC Operating Procedures (COP) such as COP-001, which details the CDISC Standards Development Procedure.  The COPs are in the process of being updated at this time.

  4. CDISC User Networks are CDISC "user groups". They are folks, usually in a specific geographic area, that have organized themselves so that they can share implementation experiences with respect to CDISC standards.  For information regarding joining or finding your nearest User Network, please contact Frank Newby.

  5. Your organization can join CDISC - your monetary contributions help support our ongoing efforts.

    • You can provide a case study detailing your implementation experience with one or more CDISC standards. If you are willing to do this, we will even provide someone to interview you so that you don’t have to write it up yourself. Please contact Julie Evans.
    • You can join a User Network.
    • You can comment on standards posted for comment. 
    • You can volunteer to join one of our various project teams by sending your contact information and information on your interests and skill sets to info@cdisc.org.
  6. There are several vLearning (virtual learning) courses that you can access via the CDISC website and, which allow you to learn at your own pace. You can find full details about them here.