The CDISC standards that are ready to implement (i.e. are in production), are all open and free on the CDISC website and where they can be found in the Standards areas under “Standards in Production”. As of November 2009, CDISC will have completed the suite of standards to support clinical research from protocol representation and data collection through analysis and reporting. Standards that are in draft form and those available for comment can also be found in the Standards areas of the website, under “Standards in Development”.
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 Member Relations, where Tanyss Mason can assist you.
There is a “Proposed Rule” that is being considered now by the US Department of Health and Human Services (HHS) to amend the regulations that govern the format for submission of clinical study data and bioequivalence data in NDAs, BLAs, ANDAs and their supplements and amendments to FDA. This would require that these data be submitted in electronic format and that standardized data structures, terminology and code sets in FDA Guidance (i.e. SDTM developed by CDISC) be used ‘to allow for more efficient and comprehensive data review’. The date when this Proposed Rule will become a rule/regulation is currently not known. Please check the resources pages for links to relevant Federal documentation. There are statements that have been made (and withdrawal of three FDA Guidances – see the website above for details) indicating that, as of 1 January 2008, only the eCTD format will be acceptable for eSubmissions. However, the CDISC SDTM will still be a preferred but not required data specification until the proposed rule is approved.
The CDISC Technical Roadmap details what CDISC is undertaking technically in the next 2-3 years. This provides the technical aspects relative to the CDISC Strategy and Mission. The CDISC Operational Plan is established annually to delineate the technical and non-technical actions CDISC plans to take that year to achieve the Technical Roadmap, Strategy and Mission.
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.
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.
It is recommended that you contact the new FDA Office of Business Informatics (OBI) if you are considering making a regulatory submission using CDISC standards. Gary Gensinger is currently the main contact for SDTM submissions.
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 Dave Iberson-Hurst 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.
Any organization interested in furthering the CDISC mission is welcome and encouraged to join CDISC. CDISC would not be possible without it members and those who take advantage of its educational courses and in other ways show support for the CDISC cause. By becoming a member organization of CDISC, you will enable the work of the organization to continue and influence this important work that can and will change the direction of the industry. Members include biopharmaceutical companies, clinical/contract research organizations, academia, consulting companies, technology providers. See the CDISC website for a complete list.
Show support for industry-wide clinical research standards that facilitate exchange of information among partners (e.g. biopharmaceutical companies, CROs, technology vendors, regulatory authorities).
Gain access to the Members Area of the website. This area contains Case Studies, CDISC Business Case; Introduction to CDISC Course, access to CDISC Team minutes (the latest information on new standards in development as well as future releases of existing standards), and free access to tools (e.g. ODM viewer and more to come).
Receive discounts for CDISC Educational Courses and Events (e.g. Interchanges in US, Europe, Japan and China).
Have direct influence on and input to the standards that are in development or those being enhanced.
Funding from the CDISC membership makes it possible for CDISC to fulfil its mission; it is an integral requirement to continue the development and maintenance of the CDISC standards for the global benefit of the biopharmaceutical industry and clinical research, in addition to supporting CDISC communication and implementation services.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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 Dave Iberson-Hurst.
CDISC distributes monthly electronic newsletters, invitations to educational courses, webinars and conferences via email to all those interested who have subscribed to the CDISC mailing list. CDISC makes presentations at various venues. CDISC also has a Blog and regularly posts updates on Twitter.
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, 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 on here.
Code of Conduct and Professional Ethics (which applies to anyone involved in CDISC initiatives, especially team leaders and User Network leaders)
Communication Policy (which applies to anyone presenting on behalf of CDISC) – presentations and publications, when made available, are posted on the CDISC website)
Board Committee Charters and Policies
Note that CDISC also has procedures called CDISC Operating Procedures (COP) such as COP-001, which details the CDISC Standards Development Procedure.
