2025-08-20T13:50:55-05:00 2024-12-31 042571780 AAFCPAS INC 50 WASHINGTON STREET WESTBOROUGH MA 01581 990 2024-01-01 043503931 CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM INC CLIN 5123635826 401 WEST 15TH STREET 520 AUSTIN TX 78701 CHRIS DECKER CEO 5123635826 2025-08-20 1 1 CHARLES J WEBB CPA P01584539 5083669100 2025-08-20 2024 2025-03-06 01:10:19Z CHRIS DECKER 401 WEST 15TH STREET 520 AUSTIN TX 78701 9205905 0 X WWW.CDISC.ORG X 2000 MA TO CREATE CONNECTED STANDARDS ACROSS THE STUDY INFORMATION LIFECYCLE TO ENABLE RESEARCH. 14 14 40 14 0 0 4791339 4558549 4513613 4608298 28176 39058 0 0 9333128 9205905 0 0 0 0 7106100 5470645 0 0 654714 4118679 4021294 11224779 9491939 -1891651 -286034 3979569 3169764 2300927 1777156 1678642 1392608 X TO CREATE CONNECTED STANDARDS ACROSS THE STUDY INFORMATION LIFECYCLE TO ENABLE ACCESSIBLE, INTEROPERABLE, AND REUABLE DATA FOR MORE MEANINGFUL AND EFFECTIVE RESEARCH. 0 0 4726329 132186 IN 2024, CDISC INTRODUCED A STRATEGIC ROADMAP TO EXPAND AND ENABLE STANDARDS DRIVEN AUTOMATION ACROSS THE END-TO-END STUDY INFORMATION LIFECYCLE FROM STUDY DESIGN THROUGH RESULTS. CDISC IS MOBILIZING ITS WORK AROUND THREE KEY PILLARS: EXPAND & CONNECT, ENABLE & AUTOMATE, AND ENGAGE & ADOPT POSITIONING CDISC AND THE INDUSTRY FOR FUTURE INNOVATION AND TRANSFORMATION. EXPAND & CONNECT: WE AIM TO EMBRACE AND ADOPT DIGITAL STUDY DESIGN, CREATING CONNECTED STANDARDS ACROSS THE CLINICAL RESEARCH INFORMATION LIFECYCLE WHILE DEFINING A CLEAR PIPELINE FOR INTEGRATING NEW DATA SOURCES. ENABLE & AUTOMATE: WE WILL DEVELOP READY-TO-USE IMPLEMENTATION STANDARDS THAT ARE ENABLED THROUGH TECHNOLOGY, REDUCE VARIABILITY AND FOCUSED ON INTEROPERABILITY AND AUTOMATION TO LOWER THE BARRIER TO STANDARDS USE, AND INCREASING COMMUNICATION TO BETTER ENABLE OUR STAKEHOLDERS.THROUGHOUT 2024, CDISC CONTINUES TO UPDATE NEW VERSIONS OF THE CDISC FOUNDATIONAL AND THERAPEUTIC AREA STANDARDS (SEND, SDTM, SDTMIG, ADAM, CONTROLLED TERMINOLOGY, AND TMF) AS WELL AS HOSTING WORKSHOPS AND HACKATHONS TO FURTHER DEVELOP STANDARDS AND TOOLS TO DRIVE INNOVATION. 2024 TECHNICAL MILESTONES: -INTRODUCED THE ANALYSIS RESULTS STANDARD (ARS) V1.0 TO TACKLE THE INEFFICIENCIES IN GENERATING MACHINE-READABLE ANALYSIS RESULTS. ARS ENABLES AUTOMATION, REPRODUCIBILITY, TRACEABILITY, AND REUSABILITY, TRANSFORMING HOW ANALYSIS RESULTS ARE DESCRIBED, ORGANIZED, AND APPLIED.-LAUNCHED A NEW BIOMEDICAL CONCEPTS (BC) BROWSER TO SIMPLIFY ACCESS TO THE LATEST BCS AND SDTM DATASET SPECIALIZATIONS. THE BROWSER FEATURES SEARCH AND FILTER TOOLS, USER-FRIENDLY VIDEO GUIDES, AND OPTIONS TO DOWNLOAD FILES VIA EXCEL OR RETRIEVE DATA THROUGH CDISC LIBRARY APIS.-RELEASED THE OBSERVATIONAL STUDIES GUIDE V1 TO PROVIDE STRATEGIES FOR USING SDTM WITH OBSERVATIONAL STUDIES AND REAL-WORLD DATA. DEVELOPED COLLABORATIVELY WITH THE DRAGON CONSORTIUM, CJUG, AND GLOBAL INDUSTRY EXPERTS, THE GUIDE HELPS INVESTIGATORS REPRESENT DATA CONCEPTS IN A CDISC-REVIEWED APPROACH.-LAUNCHED THE ETFL PORTAL IN PARTNERSHIP WITH CLYMB CLINICAL PROVIDING READY-TO-USE, ARS-COMPLIANT PACKAGES TO STREAMLINE TFL GENERATION. EACH PACKAGE INCLUDES DISPLAY SHELLS, ADAM DATASETS AND METADATA, ANALYSIS RESULTS METADATA, AND ANALYSIS OUTPUTS, PROMOTING THE ADOPTION OF ARS ACROSS THE INDUSTRY.-INTRODUCED VERSION 2.1 OF STUDY DATA TABULATION MODEL (SDTM) WHICH INCLUDES NEW DATASET AND VARIABLE STANDARDS TO MEET THE NEED FOR DOMAIN MODELS DESCRIBED IN THE TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 (TIG V1.0).-IN COLLABORATION WITH FDA CTP, LAUNCHED FOUNDATIONAL STANDARD FOR COLLECTING, ANALYZING, AND EXCHANGING TOBACCO PRODUCT DATA. THE TIG STANDARDIZES SUBMISSIONS USING CDASH, SDTM, AND ADAM MODELS TO SUPPORT RESEARCH, REVIEW, AND HARM REDUCTION EFFORTS.-INTRODUCED AN OPEN-SOURCE R PACKAGE DESIGNED TO FACILITATE THE CREATION OF STUDY DATA TABULATION MODEL (SDTM) DATASETS. DEVELOPED THROUGH A COLLABORATION AMONG PHARMACEUTICAL COMPANIES AND SPONSORED BY THE CDISC OPEN SOURCE ALLIANCE (COSA), {SDTM.OAK} OFFERS A MODULAR FRAMEWORK WITH REUSABLE ALGORITHMS TO AUTOMATE SDTM DATASET CREATION.-EXPANDED PROTOCOL DIGITALIZATION WITH FULL PROTOCOL COVERAGE IN THE USDM 3 MODEL, ENHANCING DOWNSTREAM CONNECTIVITY, ALIGNING WITH ICH M11, AND EXPLORING THE USE OF THE CDISC OPEN RULE ENGINE FOR USDM CONFORMANCE CHECKS.-INTRODUCED THE ECRF PORTAL, OFFERING READY-TO-USE, CDASH-COMPLIANT ANNOTATED ECRFS IN PDF, HTML, AND XML FORMATS. THESE ECRFS CAN BE USED AS-IS OR IMPORTED INTO EDC SYSTEMS FOR CUSTOMIZATION, PROVIDING FLEXIBLE EXAMPLES FOR DATA COLLECTION.-DEFINE-XML V2.1.7 PACKAGE UPDATED REFLECTING THE RELEASE OF CONTROLLED TERMINOLOGY PACKAGE 58. 799801 1018411 EDUCATION - IN 2024 CDISC EDUCATION TRAINED 940 INDIVIDUALS WITH OVER 100 INSTRUCTOR-LED TRAININGS, 30 HOURS OF NEW MATERIALS, IN 20 COUNTRIES WITH 2 NEW TRANSLATIONS. WE DEVELOPED NEW HANDS-ON TRAININGS FOR ARS IMPLEMENTATION, CDISC OPEN RULES IMPLEMENTATION, DATASET-JSON IMPLEMENTATION, ADAM ADVANCED IMPLEMENTATION, AND SDTM ADVANCED IMPLEMENTATION. WE DEVELOPED AND OFFERED NEW VIRTUAL TRAININGS INCLUDING NORD RARE DISEASES, TAUG SDTM MEDICAL DEVICES, TOBACCO IMPLEMENTATION GUIDE V1, AND TMF EXCELLENCE AND A NEW ON-DEMAND COURSE "INTRO TO TMF." 1014489 1304724 EVENTS - CDISC HELD 7 GLOBAL EVENTS (UNITED STATES, GERMANY, JAPAN, CHINA, KOREA) ACROSS THREE CONTINENTS WITH MORE THAN 1,200 ATTENDEES GATHERING TO NETWORK, SHARE THEIR EXPERTISE, BEST PRACTICES, AND LESSONS LEARNED ABOUT LEVERAGING CDISC STANDARDS TO BRING EFFICIENCIES AND CLARITY TO DATA. 2024 BROUGHT TOGETHER PROFESSIONALS FROM A WIDE RANGE OF ROLES, INCLUDING MANAGERS, DIRECTORS, OPERATIONS EXPERTS, AND EXECUTIVES. ATTENDEES ARE FROM PHARMACEUTICAL, BIOTECH, CRO, TECHNOLOGY, AND ACADEMIC SECTORS. 407480 2152977 PARTNERSHIPS & COLLABORATION - CDISC HAS OVER 450 ACTIVE MEMBER ORGANIZATIONS. OUR MEMBERS' SUPPORT ENSURES THAT THE CDISC STANDARDS REMAIN OPEN AND FREE. MEMBERSHIP DUES ALLOW CDISC TO ACCOMPLISH THE PROGRAM SERVICES MENTIONED ABOVE. CDISC ALSO WORKS CLOSELY WITH REGULATORS AROUND THE WORLD TO ENSURE THAT CDISC STANDARDS FACILITATE THE E-SUBMISSION REVIEW PROCESS AND SUPPORT THE APPROVAL OF NEW CURES AND TREATMENTS. OUR IMPACT AS AN ORGANIZATION IS MULTIPLIED BY OUR COLLABORATIONS WITH OUR GLOBAL PARTNERS. THROUGH PARTNERSHIP, WE CAN CONTINUE TO ADVANCE INTEROPERABLE STANDARDS ACROSS A WIDE RANGE OF THERAPEUTIC AREAS SO GREATER CLARITY IS ACHIEVED, MORE POWERFUL RESEARCH IS CONDUCTED, AND MORE MEANINGFUL CONNECTIONS ARE DISCOVERED. AND AS OUR DEDICATION AND COLLABORATION CONTINUE TO GROW, SO TOO WILL OUR COLLECTIVE IMPACT ON GLOBAL HEALTH. 407480 2152977 6948099 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 1 0 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 1 35 0 1 40 1 0 0 0 0 0 1 1 0 0 0 0 0 0 X 14 14 0 0 0 0 0 1 0 1 1 0 0 1 1 1 1 1 1 1 1 0 MA AL AK CA CO CT FL GA HI IL KS KY MD MI MN MS NV NH NJ NM NY NC ND OH OR PA RI SC TN UT VA WA WV WI DC ME MO OK AR LA X X NICOLE HARMON 5123635826 401 WEST 15TH STREET 520 AUSTIN TX 78701 ERIK PULKSTENIS CHAIR 3.00 X X 0 0 0 BROOKE HINKSON CHAIR-ELECT 2.00 X X 0 0 0 PAM HOWARD PAST-CHAIR 2.00 X X 0 0 0 CHRISTINA REITH DIRECTOR 2.00 X 0 0 0 MIHOKO OKADA DIRECTOR 2.00 X 0 0 0 WENJUN BAO DIRECTOR 2.00 X 0 0 0 JONATHAN CHAINEY DIRECTOR 2.00 X 0 0 0 KAREN CURRAN DIRECTOR 2.00 X 0 0 0 DAVID HARDISON DIRECTOR 2.00 X 0 0 0 PANDU KULKARNI DIRECTOR 2.00 X 0 0 0 DOMINIC LABRIOLA DIRECTOR 2.00 X 0 0 0 LISA LIN DIRECTOR 2.00 X 0 0 0 HIROSHI MASUMOTO DIRECTOR 2.00 X 0 0 0 RHONA O'DONNELL DIRECTOR 2.00 X 0 0 0 DAVID E EVANS FORMER PRESIDENT & CEO 40.00 X 220202 0 29981 CHRIS DECKER PRESIDENT & CEO (AS OF 1/1/24) 40.00 X 324220 0 47487 RHONDA FACILE VP, DEV. & PARTNERS (UNTIL 9/26/24) 40.00 X 188836 0 29705 SHEILA LEAMAN VP GLOBAL RELATIONS (UNTIL 12/31/24) 40.00 X 220273 0 40024 ANTHONY CHOW EXECUTIVE DIR., STRATEGY & INNOVATION 40.00 X 177915 0 12386 CHARLES SHADLE HEAD OF DATA SCIENCE OPERATIONS 40.00 X 200052 0 13579 PETER VAN REUSEL CHIEF STANDARDS OFFICER 40.00 X 287695 0 0 BESS LEROY NIETO HEAD OF STANDARDS DEVELOPMENT 40.00 X 173665 0 31217 CHRISTINE CONNOLLY HEAD OF STANDARDS PROJECTS 40.00 X 181045 0 11960 1973903 0 216339 18 0 1 0 DATA4KNOWLEDGE APS BYLEDET 15 GENTOFTE COPENHAGEN DA 2820 STANDARDS DEVELOPMENT CONSULTING SERVICE 320593 INNOVION BBA BEATRIJSSTRAAT 57 SINT KATELIJNE WAVER BE 2860 CHIEF STANDARDS OFFICER SERVICES 310216 ECLIPSE DATABASE CONSULTANTS 10 MILLERS WHARF RODE HEALTH CHESHIRE UK ST73QD PROJECT MANAGEMENT SERVICES 204542 LEX JANSEN CONSLTING LLC 221 RAYMOND BLVD PARSIPPANY NJ 07054 SOFTWARE DEVELOPER - DATA SCIENCE 151088 LAXTON CFO SERVICES LLC 5441 WINTERCREST LANE CHARLOTTE NC 28209 CHIEF FINANCIAL OFFICER SERVICES 144400 5 3166766 269927 1121856 4558549 P'SHIP & COLLABORATION 541512 2111177 2111177 CONFERENCE REVENUE 541512 1304724 1304724 EDUCATION COURSES 541512 1018411 1018411 TECHNICAL PROJECTS 541512 132186 132186 ODM PRODUCT CERTIFICAT 541512 41800 41800 4608298 39058 39058 9205905 4608298 0 39058 X 1100728 325026 528963 246739 3423834 2708673 572788 142373 177479 157484 19995 398060 255641 127064 15355 370544 246096 95139 29309 3704 3704 100074 100074 2135295 1889662 224475 21158 55462 3854 50032 1576 161513 100400 43652 17461 96403 50134 30213 16056 93286 81178 12108 4724 4724 21712 13497 5868 2347 EVENTS 652225 651154 765 306 INSTRUCTION 329429 329429 MISCELLANEOUS 188836 135871 37341 15624 MEMBERSHIP 146410 146410 32221 32221 9491939 6948099 1889126 654714 1219676 733119 1163483 932117 62590 61846 505090 399168 130625 147310 149900 118603 52756 31297 845349 864907 3979569 3169764 868188 610663 1332739 1166493 100000 0 2300927 1777156 X 1678642 1365772 26836 1678642 1392608 3979569 3169764 -286034 0 X X 0 1 X 1 0 X 4128054 3571494 3930952 4791339 4558549 20980388 2587548 3398409 3935285 4513613 4608298 19043153 6715602 6969903 7866237 9304952 9166847 40023541 0 0 0 40023541 245443 4025 39306 28176 39058 356008 245443 4025 39306 28176 39058 356008 6961045 6973928 7905543 9333128 9205905 40379549 0.99120 0.99060 0.00880 0.00940 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 0 149900 118603 31297 31297 X 10089525 883620 883620 9205905 0 9205905 10375559 883620 883620 9491939 0 9491939 PART X, LINE 2: CDISC ACCOUNTS FOR UNCERTAINTY IN INCOME TAXES IN ACCORDANCE WITH ASC TOPIC, INCOME TAXES. THIS STANDARD CLARIFIES THE ACCOUNTING FOR UNCERTAINTY IN TAX POSITIONS AND PRESCRIBES A RECOGNITION THRESHOLD AND MEASUREMENT ATTRIBUTE FOR THE CONSOLIDATED FINANCIAL STATEMENTS REGARDING A TAX POSITION TAKEN OR EXPECTED TO BE TAKEN IN A TAX RETURN. CDISC HAS DETERMINED THAT THERE ARE NO UNCERTAIN TAX POSITIONS WHICH QUALIFY FOR EITHER RECOGNITION OR DISCLOSURE IN THE CONSOLIDATED FINANCIAL STATEMENTS AT DECEMBER 31, 2024. CDISC'S INFORMATION RETURNS ARE SUBJECT TO EXAMINATION BY THE FEDERAL AND STATE JURISDICTIONS. EUROPE (INCLUDING ICELAND & GREENLAND) 0 11 PROGRAM SERVICE STANDARDS DEVELOPMENT 1216551 NORTH AMERICA 0 1 PROGRAM SERVICE STANDARDS DEVELOPMENT 60512 EUROPE (INCLUDING ICELAND & GREENLAND) 0 1 PROGRAM SERVICE PROJECT MANAGEMENT 67021 EAST ASIA AND THE PACIFIC 0 6 PROGRAM SERVICE TRAINING 17593 EUROPE (INCLUDING ICELAND & GREENLAND) 0 10 PROGRAM SERVICE TRAINING 65093 EAST ASIA AND THE PACIFIC 0 1 PROGRAM SERVICE INTERCHANGE 133755 EUROPE (INCLUDING ICELAND & GREENLAND) 0 0 PROGRAM SERVICE INTERCHANGE 203231 EUROPE (INCLUDING ICELAND & GREENLAND) 0 1 PROGRAM SERVICE FINANCE & ACCOUNTING 48870 0 31 0 0 0 31 1812626 0 1812626 0 0 0 0 0 0 X X X X 0 0 0 1 0 0 0 0 0 CHRIS DECKER PRESIDENT & CEO (AS OF 1/1/24) 324220 0 0 0 0 0 15075 0 32412 0 371707 0 0 0 PETER VAN REUSEL CHIEF STANDARDS OFFICER 287695 0 0 0 0 0 0 0 0 0 287695 0 0 0 SHEILA LEAMAN VP GLOBAL RELATIONS (UNTIL 12/31/24) 200266 0 20007 0 0 0 13558 0 26466 0 260297 0 0 0 DAVID E EVANS FORMER PRESIDENT & CEO 220202 0 0 0 0 0 13202 0 16779 0 250183 0 0 0 RHONDA FACILE VP, DEV. & PARTNERS (UNTIL 9/26/24) 168829 0 20007 0 0 0 9025 0 20680 0 218541 0 0 0 CHARLES SHADLE HEAD OF DATA SCIENCE OPERATIONS 186838 0 13214 0 0 0 11979 0 1600 0 213631 0 0 0 BESS LEROY NIETO HEAD OF STANDARDS DEVELOPMENT 161373 0 12292 0 0 0 10666 0 20551 0 204882 0 0 0 CHRISTINE CONNOLLY HEAD OF STANDARDS PROJECTS 169916 0 11129 0 0 0 10852 0 1108 0 193005 0 0 0 ANTHONY CHOW EXECUTIVE DIR., STRATEGY & INNOVATIO 165908 0 12007 0 0 0 10689 0 1697 0 190301 0 0 0 PART I, LINE 5 THE ORGANIZATION HAD A THREE-YEAR AGREEMENT WITH A SENIOR EXECUTIVE FOR PERFORMANCE-BASED BONUSES BASED ON THE FINANCIAL CONDITION OF THE ORGANIZATION, AS DEFINED IN THE CONTRACT. THE BONUSES WERE PAID IN 2024 AT THE CONCLUSION OF THE 2023 AUDIT. FORM 990, PART VI, SECTION A, LINE 7A THE COMPANY'S PLATINUM MEMBERS HAVE A SEAT ON THE COMPANY'S ADVISORY COUNCIL WHICH MEETS QUARTERLY TO DISCUSS HOT TOPICS RELATED TO CDISC STANDARDS AND THE REGULATORY ENVIRONMENT GLOBALLY. FORM 990, PART VI, SECTION B, LINE 11B THE 990 IS REVIEWED BY THE FINANCIAL OVERSIGHT COMMITTEE AND MADE AVAILABLE TO THE BOARD OF DIRECTORS FOR REVIEW BEFORE THE RETURN IS FILED. FORM 990, PART VI, SECTION B, LINE 12C ALL NEW BOARD MEMBERS BENEFIT FROM AN ONBOARDING TRAINING, WHICH TOUCHES ON THEIR VARIOUS ROLES AND RESPONSIBILITIES. THIS INCLUDES REVIEWING THE CONCEPT OF FIDUCIARY DUTIES AND THE REQUIREMENT THAT THEY DISCLOSE ANY POTENTIAL CONFLICTS OF INTEREST THAT THEY MAY HAVE. ALL BOARD MEMBERS, OFFICERS, AND KEY EMPLOYEES ARE REQUESTED TO REVIEW THE ETHICS AND CONFLICT OF INTEREST POLICY AT LEAST ANNUALLY. TO ENSURE THIS ACTUALLY TAKES PLACE, THEY ARE REQUIRED TO SIGN EVERY YEAR AN ACKNOWLEDGMENT THAT THEY HAVE READ IT AND AGREE TO COMPLY WITH ITS PROVISIONS. IN ADDITION, UPON JOINING THEY MUST DISCLOSE ANY CONFLICT OF INTEREST THAT THEY MAY HAVE. EVERY YEAR THEREAFTER, THEY ARE REQUIRED TO UPDATE THAT DISCLOSURE. FORM 990, PART VI, SECTION B, LINE 15 THE BASE COMPENSATION FOR THE CEO IS DETERMINED BASED ON THIRD-PARTY INDUSTRY SURVEYS, SIMILAR ORGANIZATIONS' 990 DATA, AND PAST COMPENSATION OF THE CEO. THE COMPENSATION IS REVIEWED EVERY YEAR. AN INCREASE MAY BE RECOMMENDED BY THE EXECUTIVE COMMITTEE (TASKED WITH OVERSEEING EXECUTIVE COMPENSATION), BASED ON THE ORGANIZATION'S PERFORMANCE AND MARKET INFORMATION. THE ANNUAL BONUS AMOUNT IS DETERMINED TAKING INTO ACCOUNT CRITERIA USED ACROSS THE ORGANIZATION. THE EXECUTIVE COMMITTEE MAKES A RECOMMENDATION REGARDING THE FINAL BONUS AMOUNT. BOTH THE ANNUAL INCREASE (IF ANY) OF THE BASE COMPENSATION AND THE ANNUAL BONUS ARE APPROVED BY THE BOARD. FORM 990, PART VI, SECTION C, LINE 19 ALL POLICIES AND GOVERNING DOCUMENTS ARE AVAILABLE ON THE CDISC WEBSITE. FORM 990, PART IX, LINE 11G DATA STANDARD CONSULTING: PROGRAM SERVICE EXPENSES 1,863,023. MANAGEMENT AND GENERAL EXPENSES 212,893. FUNDRAISING EXPENSES 16,525. TOTAL EXPENSES 2,092,441. PAYROLL SERVICES: PROGRAM SERVICE EXPENSES 26,639. MANAGEMENT AND GENERAL EXPENSES 11,582. FUNDRAISING EXPENSES 4,633. TOTAL EXPENSES 42,854. FORM 990, PART XII, LINE 2C: THE ORGANIZATION HAS NOT CHANGED ITS PROCESS FOR OVERSIGHT OF THE AUDIT OF ITS FINANCIAL STATEMENTS AND SELECTION OF AN INDEPENDENT ACCOUNTANT. CDISC EUROPE FOUNDATION SOUTH CENTER TITANIUM 4TH FLOOR MARCEL BROODTHAERS SQUARE BRUXELLES BE 837718228 RESEARCH BE CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 CDISC EUROPE FOUNDATION D 290000 FAIR VALUE CDISC EUROPE FOUNDATION B 222118 FAIR VALUE