CDISC 2010 Strategy DocumentWe believe this document provides necessary direction for CDISC over the next fiveyears by maximizing its unique value to the global health care community andcapitalizing on the concepts of borderless innovation and strength throughcollaboration.This document will be a "living document" that will be reviewed regularly and changedas appropriate to the evolving environment.Clinical Data Interchange Standards ConsortiumCDISC_66605ad0-4cf9-11df-be29-34777a64ea2aCDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website._66605d64-4cf9-11df-be29-34777a64ea2aTo develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare._66605ecc-4cf9-11df-be29-34777a64ea2aLeadership (Business Leadership)* We formulate strategies, goals and decisions prudently,considering external input and appropriate criteria forproperly managing CDISC.* We inspire and stimulate others to achieve ourworthwhile goals.* We strive to make the best use of each individual'stalents, encouraging innovation and creativity,assumption of responsibility, and participation in definingand realizing the CDISC strategy and goals.* We use a cooperative leadership style; we allow our coworkersto participate and aid, expressing their opinion inmaking decisions.Relationships* Continue to build 'relationship capital' leading to a morestable and resilient economic growth, less sensitive tothe fluctuations of the marketplace* Strengthen good, sincere and respectful relations withthe CDISC community; take pride in being valuablemembers of the global healthcare and the medicalresearch community* Superb value for contributions made* Foster RICH relationships with respect, integrity,compassion and humility.* Respect for others' values, time and ideals.* Integrity - global integrity to include morals, ethics and honesty.* Compassion and empathy for the whole community.* Humility to improve the welfare and happiness of the community.Ethics* CDISC behaves ethically, morally and legally inall of its endeavors.* Ensure CDISC is a benefit to society, abovepersonal gain, and has consistency betweenwork and personal ethics.* Bring strength (clarity and focus) and impartialityin standards development activities.Environmental Harmony* The business applies management systems andorganizational structures that foster teamwork.* Continue to encourage and respect aharmonious structure based on teams and anenvironment of concentric communities thatinterrelate.* Be conscious of the global environment.Balance, QoL, Equilibrium* Foster a community to stimulate innovation and growthin maturity and productivity.* The health and well-being of every individual isimportant; work should be balanced with an individual'spersonal life.* Strive to provide a joyful and friendly work environment.* Have a positive impact on the quality of life of society.Education, Mentoring, Continuing Development* Recognizing that the individual is at the center ofCDISC, follow personnel selection criteria and aprogram of professional development andmentoring to enable the individual to achievepersonal and the CDISC objectives.* CDISC mentors lavishly, internally andexternally.Communications* Create a positive climate by assuming the best intentions, fosteringactive listening and open communications.* Provide adequate opportunities for the exchange of ideas andinformation, with judicious use of appropriate communicationmechanisms.* Celebrate successes and embrace a spirit of mutual support andsolidarity.* Take time to think before acting (TEA).* Recognize and accept that people are different and everyone'scommunication style is unique and of value.* Foster openness and a feeling of safety for human connections withinthe organization.StandardsEnsure the existence, harmonization, acceptance and support of standards for medical research_66605f80-4cf9-11df-be29-34777a64ea2a1As the science around discovery and development of therapies, medical research andpersonalized medicine progress, new measurements of patient status and disease statewill be introduced. These will range from biomarkers and laboratory values to measureearly activity of molecules to primary endpoints for clinical studies that are pivotal toapproval. Recent examples include imaging, pharmacogenomics, and patient reportedoutcomes. CDISC plays a role in determining the necessity for and timing of standardscreation around such parameters, influencing key stakeholders and other appropriategroups. CDISC will rely on the CDISC Advisory Board (CAB), Board StrategyCommittee and others to identify and raise awareness of new standards-relatedopportunities and needs.Biomedical research standards development is the domain expertise of CDISC, whetherCDISC acts as a doer, influencer, facilitator or enabler. CDISC must track newdevelopments and act nimbly to partner with important stakeholders to develop,influence, approve, harmonize, and lifecycle manage new and existing standards.CDISC must input views into public debate at the time of greatest potential impact.In addition to influencing decisions about emerging standards, CDISC must ensure itsstandards are harmonized with one another and with other healthcare standards,specifically the HL7 Reference Information Model (RIM). This can be accomplished byemploying the domain analysis model, specifically the BRIDG (Biomedical ResearchIntegrated Domain Group) model. CDISC must maintain, support and enhance, asappropriate, the standards it develops; and, CDISC must promote acceptance of itsstandards through various methods and implementation services.This strategic theme needs to balance the old with the new. CDISC will supportstandards maintenance, but CDISC will not be expected to provide maintenance a priori.This decision should be made each time new work is considered.The long-term benefit of any standards organization is measured through widespreadadoption of its standards. A significant challenge for potential adopters of CDISC datastandards, especially large organizations, is determining how best to implement thosestandards within the organization's overall plans for business transformation andtechnology management. It is difficult for organizations to change their businesspractices, and CDISC should support all degrees of conformance to standards. CDISCshould support standard data content (semantic interoperability) as expressed in BRIDGand the core concepts of existing standards, standard data transport (application and datainteroperability) through work with HL7 and support of CDISC define.xml. CDISC mustexplore standard architectures that support common user interfaces and work processes(application integration). Distinguishing between data content, data transport, and dataarchitecture will allow businesses to use CDISC standards to the extent they support theirbusiness objectives. CDISC should make clear these distinctions and support all degreesof business and technology standardization.CDISC has had tremendous success in developing standards in several areas due in largepart to the efforts of volunteer subject matter experts (SMEs). CDISC standards arestrong because of the relative simplicity of their structures and because of their intuitivedesign aimed at meeting the users' needs. CDISC standards are continuously evolvingwithin a stable process targeting compliance with existing and future regulatoryrequirements. CDISC standards simplify data collection and end-to-end data handlingprocesses. CDISC has also successfully developed controlled terminology and bestpractices across its various models all of which can be viewed as a complete package thataddresses both format and content. Therefore, CDISC has a responsibility to ensure thesestandards, related terminology and best practices are properly maintained with continuedsupport from the industry SMEs who have helped bring about success._66606048-4cf9-11df-be29-34777a64ea2aEducationPromote and provide education on the use and benefits of standards_66606156-4cf9-11df-be29-34777a64ea2a2CDISC has a key role in facilitating education for its standards, and seeking additionalSMEs in new areas aligned with its mission. It is especially important that CDISCestablishes an international network of experts to provide education in regions outside theUS. This educational effort is important both to medical researchers and to keystakeholders in the implementation of the CDISC standards.We recognize that there are different levels of stakeholder education. High level policymaking and funding bodies require education around business use cases and benefits thatare aligned with the Communications Plan for CDISC. Education of technical andapplication-focused users of CDISC tools and standards necessitates a morecomprehensive program. And, the U.S. FDA has sought education from CDISC for itsreviewers. CDISC Education should continue to be managed and implemented throughthe work of the CDISC Operations staff and instructors and the training programs theyoffer.CDISC needs to promote standards usage to ensure smooth integration across thehealthcare domain. CDISC should be aligned with further development and/orenhancement of best practices and terminology. A well designed Education andCommunication Plan will support and promote more advocates in the medical researchcommunity.CDISC needs to be proactive toward decisions that provide education about its initiatives.It needs to ensure education but can decide to defer operational aspects of education toother organizations. CDISC also needs to accept that part of our leadership role is toeducate the world about "Standards" and not just "CDISC standards"._66606264-4cf9-11df-be29-34777a64ea2aEHR/HIT IntegrationFacilitate the integration with Electronic Health Record (EHR) / HealthInformation Technology (HIT)_6660637c-4cf9-11df-be29-34777a64ea2a3CDISC and other opinion leaders envision that the future of clinical data capture will beintegrated into the broader world of healthcare information technology and the EHR.This integration will have a profound impact by:- Improving a sponsor's ability to recruit patients into trials- Enhancing accessibility to data for research- Streamlining the data capture process by reducing data entry and transcription errorswhile reducing associated costs/resources to resolve such discrepancies- Improving pharmacovigilance- Facilitating decision support- Decreasing the number of systems required at an investigator siteAn equally relevant issue is the ability of clinicians to provide care that is evidencebasedand predicated on safety where knowledge can be derived from medical databases.As part of this vision, CDISC expects to take a leading role on behalf of the medicalresearch industry by linking biomedical research and healthcare standards efforts. Thiswill require continued involvement by CDISC and its Board in worldwide healthcare ITinitiatives, at the technical and political levels.CDISC has been actively engaged with the pharmaceutical industry and Integrating theHealthcare Enterprise (IHE) and various HIT initiatives operated through theDepartment of Health and Human Services (HHS) Office of the National Coordinator(ONC) in an effort to identify how data can be harvested from the EHR for safety andmedical research. This work promises to bring about process improvements andcontribute to the aggregation of data for safety reporting, signal detection and evaluation,including but not limited to comparative effectiveness and to streamlining biomedicalresearch processes._66606494-4cf9-11df-be29-34777a64ea2aData Collection and ReportingUse CDISC standards to support data collection and reporting with a focus ondata aggregation for the purposes of scientific investigation and comparativeeffectiveness_666065d4-4cf9-11df-be29-34777a64ea2a4With increasing demands for aggregated data for comparative effectiveness evaluations,biosurveillance and drug safety surveillance, the knowledge base supportingpharmacovigilance data is growing. There are increasing pressures to enhance the accessto information for such purposes to improve evaluations of safety and efficacy forbiopharmaceutical products and other therapies. Requirements are generated at thelegislative level as well as from regulatory authorities.CDISC has an opportunity to leverage its experience to great advantage. The use orapplication of existing CDISC standards can contribute to several key domains, includingbiomedical research, adverse event reporting, post-marketing pharmacovigilance, and potentially certified supply chain documentation. Coordination with regulatory agenciesis paramount, but support of other co-existing standards is essential for success.Appropriate areas of expansion for CDISC may included: a) the implementation of theCDISC Integrating the Healthcare Enterprise (IHE) Retrieve Form for Data Capture(RFD) integration profile to support drug safety reporting, clinical research, andpopulation of registries using EHRs (through the CDISC Healthcare Link Initiative), b)the FDA Integrated Safety Data pilot and c) the harmonization of AE standards, includingNational Institutes of Health (NIH) and cancer Bioinformatics Grid (caBIG) models intoBRIDG. These should be areas of focus for TAC and our EHR/HIT programs.CDISC should remain both agile and forward-looking in support of the evolving,complex environment. Since one of the principle benefits of the use of consistentstandards is the ability to aggregate and "re-use" data, this feature will be highlighted tostakeholders in the execution of this part of the strategy._6660670a-4cf9-11df-be29-34777a64ea2aCollaborationLeverage our global, nonprofit, vendor neutral, independent status to forgeproductive collaborations with other Standards Development Organizations(SDOs) and key stakeholder communities including regulators and healthagencies_66606868-4cf9-11df-be29-34777a64ea2a5Standards Development OrganizationsCDISC plays many vital roles in the business of standards development, implementation,and maintenance. CDISC has the ability to visibly and compellingly enter into publicdebates about standards issues without fear of conflict of interest because of its nonprofit,vendor neutral, independent status. This status, along with subject matterexpertise contributed by its membership, contributes to the credible voice it enjoys in themedical research community. CDISC's independence and its record of accomplishmentselevate the organization to a leadership role that carries the responsibility of drivingchange.Independent, neutral views and consensus-building are vital to the advancement of globalstandards that are in the best interest of science and patients in the long run. Thisapproach requires clear vision, policy statements, and a communications strategy fromthe Executive Committee, Board of Directors and Operations when speaking on behalf ofCDISC and its constituents on relevant issues. At every meeting, the Board shouldreview CDISC's position on emerging relevant issues and its strategy for communicatingto its membership, stakeholders and the public at large. CDISC should continue toactively engage in industry trade groups and national standards/HIT groups to leverage itscredibility.Relationship to the Food and Drug Administration (FDA), European Medicines Agency(EMEA), and Japan's Ministry of Health Labor and Welfare (MHLW) andPharmaceutical and Medical Devices Agency (PMDA) other regulatory and healthagencies -- CDISC has a long-standing and admirable relationship with the FDA. Because the FDAis the only agency that requires submission of raw data in standard format, therelationship is unique. Moreover, the United States is the single largest market forethical pharmaceuticals, representing better than 50% of pharmaceutical sales. It isimportant, therefore, that CDISC continue to cultivate its relationship with the FDA onbehalf of its constituents.It is also important to understand the pace of emerging markets in the European Unionand Asia. CDISC has been given an advisory role to EMEA for its eSource DataInterchange (eSDI) work that is being referenced in EMEA documents. Additionally, theJapanese MHLW has now included CDISC as a part of its 5-year plan and CDISC has aproject planned with PMDA. CDISC has also met with the State FDA (SFDA) in Chinaand should assess how best to develop a relationship with that agency. CDISC mustbalance its efforts to interact with these organizations and evolve its role in these regions.This may require influencing the adoption of existing standards to speed new therapies topatients worldwide.There are other government agencies that may have interest in standards for healthcareand biomedical research, such as the U.S. Department of Defense (DoD) or Departmentof Veteran Affairs (VA), the National Health Services (NHS) in the UK, and othergovernmental agencies throughout the world. Certain of these entities play the role ofbeing the payer of services, provider of services, and a government agency. As a result,their needs may be different than those of regulatory authorities (e.g. more related tobusiness-to-business standards); these may need to be satisfied in the greater healthcaredomain.Collaborations with other Standards Development Organizations (SDOs) and other keystakeholder organizations -- Since 2001, with the initiation of an Associate Charter Agreement (Memorandum ofUnderstanding or MOU), CDISC has built a formal and strong relationship with HealthLevel Seven (HL7). This collaboration was further strengthened through CDISC'sinitiation of the BRIDG model, which has now been adopted by the HL7 RegulatedClinical Research Information Management (RCRIM) Workgroup as its domain analysismodel and serves to link the biomedical research standards with the healthcare standardsfrom HL7. CDISC also has a position on the HL7 Board of Directors.CDISC is the expert on Biomedical Research Standards and thus brings value to HL7 andother SDOs as a separate but collaborative organization. CDISC continues to see the HL7relationship as a top priority. However, CDISC will also seek to strengthen its globalreach through direct collaboration with the International Organization for Standardization(ISO) (leveraging its new Liaison A status), Comite Europeen de Normalisation (CEN)and other international organizations, particularly through its role as a member of theJoint Initiative Council (JIC). CDISC will work with other key stakeholderorganizations as appropriate, including but not limited to the Pharmaceutical Researchand Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Japan Pharmaceutical ManufacturingAssociation (JPMA). CDISC is also now a charter member of the US StandardsDeveloping Charter Organization (SCO).Routine, detailed submission of data for regulatory review remains primarily arequirement for US New Drug Applications (NDAs). Other agencies around the worldhave not adopted such requirements. As a key stakeholder, PhRMA represents a largecontingent of industry focusing on discussions with FDA regarding drug developmentand regulatory submissions. As a standards development organization, CDISC focuseson meeting industry and Agency submission requirements for data content and format.As a result of these realities, it is imperative that CDISC maintains a collaborativerelationship with PhRMA to define, develop and implement data standards for regulatorysubmissions and for information exchange with business partners. CDISC will haveworking liaisons as appropriate to PhRMA initiatives. CDISC will continue itsrelationship to other areas of PhRMA through its work on CDASH data collectionstandards and other relevant CDISC projects.CDISC will continue to build an awareness of EFPIA activities and priorities, whiledeveloping a long-term policy regarding meaningful relationships with this association.CDISC will continue to strengthen its relationship with JPMA since their datamanagement group has now explicitly endorsed CDISC standards and has initiatedrelationship with CDISC and the CDISC Japan CDISC Coordinating Committee (J3C).Given the growth and influence of CDISC, the Board and a Collaborations team havebegun to set a more structured approach for collaborations since 2008. This should bereviewed annually to manage the resources needed to maintain these relationships._666069d0-4cf9-11df-be29-34777a64ea2a2010-01-052015-01-052010-04-20http://www.cdisc.org/stuff/contentmgr/files/0/30bedda0d0a4ea396a74a96b4df37113/misc/cdisc_strategy_document_2010__fin.pdfOwenAmburOwen.Ambur@verizon.net