Sharing Clinical Research Data: Workshop Summary (2013)
Chapter: Front Matter
SHARING CLINICAL
RESEARCH DATA
WORKSHOP SUMMARY
Steve Olson and Autumn S. Downey, Rapporteurs
Forum on Drug Discovery, Development, and Translation
Forum on Neuroscience and Nervous System Disorders
National Cancer Policy Forum
Roundtable on Translating Genomic-Based Research for Health
Board on Health Sciences Policy
Board on Health Care Services
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
This study was supported by contracts between the National Academy of Sciences and AbbVie, Alzheimer’s Association, American Academy of Nursing, American Association for Cancer Research, American Cancer Society, American College of Medical Genetics and Genomics, American Diabetes Association, American Heart Association, American Medical Association, American Society for Microbiology, American Society of Clinical Oncology, American Society of Human Genetics, Amgen Inc., Association of American Cancer Institutes, Association of American Medical Colleges, Blue Cross and Blue Shield Association, Bristol-Myers Squibb, Burroughs Wellcome Fund, C-Change, Celtic Therapeutics, LLLP, CeNeRx Biopharma, Centers for Disease Control and Prevention (Contract Nos. 200-2005-13434 and 200-2011-38807), CEO Roundtable on Cancer, College of American Pathologists, Critical Path Institute, Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and HHSF22301026T), Department of Health and Human Services’ National Institutes of Health (NIH) (Contract No. N01-OD-4-2139) through the National Eye Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH Blueprint for Neuroscience Research, Department of the Air Force (Contract No. FA7014-10-P-0072), Department of Veterans Affairs (Contract No. V101(93) P-2238), Doris Duke Charitable Foundation, Eli Lilly and Company (Contract No. LRL-0028-07), Fast Forward, LLC, FasterCures, Foundation for the National Institutes of Health, Friends of Cancer Research, GE Healthcare, Inc., Genetic Alliance, GlaxoSmithKline, Health Resources and Services Administration (Contract No. HHSH250201100119P), Janssen Research & Development, LLC, Johnson & Johnson Pharmaceutical Research and Development, LLC, The Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation (Contract No. 20121257), Life Technologies, Lundbeck Research USA, March of Dimes Foundation, Merck & Co., Inc., Merck Research Laboratories, The Michael J. Fox Foundation for Parkinson’s Research, National Cancer Institute (Contract Nos. HHSN261200900003C and N01-OD-4-2139, TO#189), National Coalition for Health Professional Education in Genetics, National Heart, Lung, and Blood Institute (Contract No. N01-OD-4-2139, TO#275), National Human Genome Research Institute (Contract Nos. N01-OD-4-2139, TO#264 and HHSN263201200074I, TO#5), National Institute of Mental Health (Contract No. N01-OD-4-2139, TO#275), National Institute on Aging (Contract No. N01-OD-4-2139, TO#275), National Science Foundation (Contract No. OIA-0753701), National Society of Genetic Counselors, Northrop Grumman Health IT, Novartis Oncology, Novartis Pharmaceuticals Corporation, Office of Rare Diseases Research (Contract No. N01-OD-4-2139, TO#275), Oncology Nursing Society, One Mind for Research, Pfizer Inc. (Contract No. 140-N-1818071), Sanofi-Aventis, Society for Neuroscience, and Wellcome Trust. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the project.
International Standard Book Number-13: 978-0-309-26874-5
International Standard Book Number-10: 0-309-26874-5
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Suggested citation: IOM (Institute of Medicine). 2013. Sharing clinical research data: Workshop summary. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
PLANNING COMMITTEE ON SHARING CLINICAL RESEARCH DATA: AN INSTITUTE OF MEDICINE WORKSHOP1
SHARON TERRY (Chair), Genetic Alliance, Washington, DC
JOSEPHINE P. BRIGGS, National Institutes of Health, Bethesda, MD
TIMOTHY COETZEE, National Multiple Sclerosis Society, New York, NY
STEVEN GOODMAN, Stanford University School of Medicine, CA
ROBERT A. HARRINGTON, Stanford University School of Medicine, CA
LYNN HUDSON, Critical Path Institute, Tucson, AZ
CHARLES HUGH-JONES, Sanofi-Aventis, Inc., Bridgewater, NJ
JAN JOHANNESSEN, U.S. Food and Drug Administration, Silver Spring, MD
JEFFREY S. NYE, Janssen Research & Development, LLC, Titusville, NJ
RICHARD PLATT, Harvard Medical School, Boston, MA
WILLIAM Z. POTTER, FNIH Biomarkers Consortium, Philadelphia, PA
FRANK W. ROCKHOLD, GlaxoSmithKline Pharmaceuticals Research and Development, King of Prussia, PA
MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ
VICKI SEYFERT-MARGOLIS, U.S. Food and Drug Administration, Silver Spring, MD
DEBORAH A. ZARIN, National Institutes of Health, Bethesda, MD
IOM Staff
AUTUMN DOWNEY, Program Officer
CLARE STROUD, Program Officer
REBECCA A. ENGLISH, Associate Program Officer
CLAIRE GIAMMARIA, Research Associate
______________________
1Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Institute of Medicine, and they should not be construed as reflecting any group consensus.
FRANK VALLIERE, Research Associate
TONIA E. DICKERSON, Senior Program Assistant
CRYSTI PARK, Senior Program Assistant
BRUCE M. ALTEVOGT, Director, Forum on Neuroscience and Nervous System Disorders
ADAM C. BERGER, Director, Roundtable on Translating Genomic-Based Research for Health
ANNE B. CLAIBORNE, Director, Forum on Drug Discovery, Development, and Translation
ROGER HERDMAN, Director, Board on Health Care Services
SHARYL J. NASS, Director, National Cancer Policy Forum
ANDREW M. POPE, Director, Board on Health Sciences Policy
FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1
JEFFREY M. DRAZEN (Co-Chair), New England Journal of Medicine, Boston, MA
STEVEN K. GALSON (Co-Chair), Amgen Inc., Thousand Oaks, CA
RUSS BIAGIO ALTMAN, Stanford University, CA
MARGARET ANDERSON, FasterCures, Washington, DC
CHRISTOPHER AUSTIN, National Center for Advancing Translational Sciences, Bethesda, MD
ANN BONHAM, Association of American Medical Colleges, Washington, DC
LINDA BRADY, National Institute of Mental Health, Bethesda, MD
GAIL H. CASSELL, Harvard Medical School (Visiting), Carmel, IN
PETER B. CORR, Celtic Therapeutics, LLLP, New York, NY
ANDREW M. DAHLEM, Eli Lilly and Company, Indianapolis, IN
TAMARA DARSOW, American Diabetes Association, Alexandria, VA
JAMES H. DOROSHOW, National Cancer Institute, Bethesda, MD
GARY L. FILERMAN, Atlas Health Foundation, McLean, VA
MARK J. GOLDBERGER, Abbott Pharmaceuticals, Rockville, MD
HARRY B. GREENBERG, Stanford University School of Medicine, CA
LYNN HUDSON, Critical Path Institute, Tucson, AZ
S. CLAIBORNE JOHNSTON, University of California, San Francisco
MICHAEL KATZ, March of Dimes Foundation, White Plains, NY
PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD
JACK D. KEENE, Duke University Medical Center, Durham, NC
RONALD L. KRALL, University of Pennsylvania Center for Bioethics, Steamboat Springs, CO
FREDA LEWIS-HALL, Pfizer Inc., New York, NY
CAROL MIMURA, University of California, Berkeley
BERNARD H. MUNOS, InnoThink Center for Research in Biomedical Innovation, Indianapolis, IN
ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY
______________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
JOHN ORLOFF, Novartis Pharmaceuticals Corporation, East Hanover, NJ
AMY PATTERSON, National Institutes of Health, Bethesda, MD
MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ
JANET SHOEMAKER, American Society for Microbiology, Washington, DC
ELLEN SIGAL, Friends of Cancer Research, Washington, DC
ELLEN R. STRAHLMAN, GlaxoSmithKline, Research Triangle Park, NC
BRIAN L. STROM, University of Pennsylvania Perelman School of Medicine, Philadelphia
NANCY SUNG, Burroughs Wellcome Fund, Research Triangle Park, NC
JANET TOBIAS, Ikana Media and Mount Sinai School of Medicine, New York, NY
JOANNE WALDSTREICHER, Janssen Research & Development, LLC, Raritan, NJ
JANET WOODCOCK, U.S. Food and Drug Administration, White Oak, MD
IOM Staff
ANNE B. CLAIBORNE, Director, Forum on Drug Discovery, Development, and Translation
REBECCA A. ENGLISH, Associate Program Officer
ELIZABETH F. C. TYSON, Research Associate
ROBIN GUYSE, Senior Program Assistant
ANDREW M. POPE, Director, Board on Health Sciences Policy
FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS1
STEVEN HYMAN (Chair), The Broad Institute, Cambridge, MA
SUSAN AMARA, University of Pittsburgh School of Medicine, PA
MARC BARLOW, GE Healthcare, Inc., Chalfont St. Giles, United Kingdom
MARK BEAR, Massachusetts Institute of Technology, Cambridge, MA
KATJA BROSE, Neuron, San Francisco, CA
DANIEL BURCH, CeNeRx Biopharma, Morrisville, NC
C. THOMAS CASKEY, Baylor College of Medicine, Houston, TX
TIMOTHY COETZEE, National Multiple Sclerosis Society, New York, NY
EMMELINE EDWARDS, National Institutes of Health Neuroscience Blueprint, Bethesda, MD
MARTHA FARAH, University of Pennsylvania, Philadelphia
RICHARD FRANK, GE Healthcare, Inc., Princeton, NJ
DANIEL GESCHWIND, University of California, Los Angeles
HANK GREELY, Stanford University, CA
MYRON GUTMANN, National Science Foundation, Arlington, VA
RICHARD HODES, National Institute on Aging, Bethesda, MD
THOMAS INSEL, National Institute of Mental Health, Bethesda, MD
PHILLIP IREDALE, Pfizer Global Research and Development, Groton, CT
DANIEL JAVITT, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY
FRANCES JENSEN, University of Pennsylvania School of Medicine, Philadelphia
STORY LANDIS, National Institute of Neurological Disorders and Stroke, Bethesda, MD
ALAN LESHNER, American Association for the Advancement of Science, Washington, DC
HUSSEINI MANJI, Johnson & Johnson Pharmaceutical Research and Development, Inc., Titusville, NJ
DAVID MICHELSON, Merck Research Laboratories, North Wales, PA
______________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
RICHARD MOHS, Lilly Research Laboratories, Indianapolis, IN
ALEXANDER OMMAYA, U.S. Department of Veterans Affairs, Washington, DC
ATUL PANDE, GlaxoSmithKline, Inc., Research Triangle, NC
STEVEN PAUL, Weill Cornell Medical College, New York, NY
TODD SHERER, Michael J. Fox Foundation for Parkinson’s Research, New York, NY
PAUL SIEVING, National Institutes of Health, Bethesda, MD
JUDITH SIUCIAK, Foundation for the National Institutes of Health, Bethesda, MD
MARC TESSIER-LAVIGNE, The Rockefeller University, New York, NY
WILLIAM THIES, Alzheimer’s Association, Chicago, IL
NORA VOLKOW, National Institute on Drug Abuse, Bethesda, MD
KENNETH WARREN, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD
JOHN WILLIAMS, Wellcome Trust, London, United Kingdom
STEVIN ZORN, Lundbeck USA, Paramus, NJ
CHARLES ZORUMSKI, Washington University School of Medicine
IOM Staff
BRUCE M. ALTEVOGT, Director, Forum on Neuroscience and Nervous System Disorders
DIANA E. PANKEVICH, Program Officer
ELIZABETH K. THOMAS, Senior Program Assistant
ANDREW M. POPE, Director, Board on Health Sciences Policy
NATIONAL CANCER POLICY FORUM1
JOHN MENDELSOHN (Chair), MD Anderson Cancer Center, Houston, TX
PATRICIA A. GANZ (Vice Chair), University of California, Los Angeles
AMY P. ABERNETHY, Duke University School of Medicine, Durham, NC
RAFAEL G. AMADO, GlaxoSmithKline-Oncology, Collegeville, PA
FRED APPELBAUM, Fred Hutchinson Cancer Research Center, Seattle, WA
PETER B. BACH, Memorial Sloan-Kettering Cancer Center, New York, NY
EDWARD BENZ, JR., Harvard School of Medicine, Boston, MA
MONICA BERTAGNOLLI, Harvard University Medical School, Boston, MA
OTIS BRAWLEY, American Cancer Society, Atlanta, GA
MICHAEL A. CALIGIURI, Ohio State University, Columbus
RENZO CANETTA, Bristol-Myers Squibb, Wallingford, CT
MICHAELE CHAMBLEE CHRISTIAN, Retired, Washington, DC
WILLIAM DALTON, Moffitt Cancer Center, Tampa, FL
WENDY DEMARK-WAHNEFRIED, University of Alabama at Birmingham
ROBERT ERWIN, Marti Nelson Cancer Foundation, Davis, CA
ROY S. HERBST, Yale Cancer Center, New Haven, CT
THOMAS J. KEAN, C-Change, Washington, DC
MICHELLE LE BEAU, University of Chicago, IL
DOUGLAS R. LOWY, National Cancer Institute, Bethesda, MD
DANIEL R. MASYS, University of Washington, Seattle, WA
MARTIN J. MURPHY, Roundtable on Cancer, Durham, NC
BRENDA NEVIDJON, Duke University School of Nursing, Durham, NC
STEVEN PIANTADOSI, Cedars-Sinai Medical Center, Los Angeles, CA
______________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
LISA C. RICHARDSON, Centers for Disease Control and Prevention, Atlanta, GA
DEBASISH ROYCHOWDHURY, Sanofi Oncology, Cambridge, MA
YA-CHEN TINA SHIH, University of Chicago, IL
ELLEN SIGAL, Friends of Cancer Research, Washington, DC
STEVEN STEIN, Novartis Oncology, East Hanover, NJ
JOHN A. WAGNER, Merck and Company, Inc., Rahway, NJ
RALPH R. WEICHSELBAUM, University of Chicago, IL
JANET WOODCOCK, U.S. Food and Drug Administration, Rockville, MD
IOM Staff
SHARYL J. NASS, Director, National Cancer Policy Forum
LAURA LEVIT, Program Officer
ERIN BALOGH, Associate Program Officer
PAMELA LIGHTER, Research Assistant
MICHAEL PARK, Senior Program Assistant
PATRICK BURKE, Financial Associate
SHARON B. MURPHY, Scholar in Residence
ROGER HERDMAN, Director, Board on Health Care Services
ROUNDTABLE ON TRANSLATING GENOMIC-BASED RESEARCH FOR HEALTH1
WYLIE BURKE (Co-Chair), University of Washington, Seattle
SHARON TERRY (Co-Chair), Genetic Alliance, Washington, DC
NAOMI ARONSON, Blue Cross and Blue Shield Association, Chicago, IL
EUAN ANGUS ASHLEY, Stanford University School of Medicine, Palo Alto, CA
PAUL R. BILLINGS, Life Technologies, Carlsbad, CA
BRUCE BLUMBERG, The Permanente Medical Group, Oakland, CA
DENISE E. BONDS, National Heart, Lung, and Blood Institute, Bethesda, MD
PHILIP J. BROOKS, National Center for Advancing Translational Research, Rockville, MD
C. THOMAS CASKEY, Baylor College of Medicine, Houston, TX
SARA COPELAND, Health Resources and Services Administration, Rockville, MD
MICHAEL J. DOUGHERTY, American Society of Human Genetics, Bethesda, MD
VICTOR DZAU, Duke University, Durham, NC
W. GREGORY FEERO,Journal of the American Medical Association, Chicago, IL
ANDREW N. FREEDMAN, National Cancer Institute, Rockville, MD
GEOFFREY GINSBURG, Duke University, Durham, NC
RICHARD J. HODES, National Institute on Aging, Bethesda, MD
SHARON KARDIA, University of Michigan School of Public Health, Ann Arbor
MOHAMED KHAN, BC Cancer Agency, Vancouver, British Columbia, Canada
MUIN KHOURY, Centers for Disease Control and Prevention, Atlanta, GA
THOMAS LEHNER, National Institute of Mental Health, Bethesda, MD
______________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
DEBRA LEONARD, Weill Cornell Medical Center of Cornell University, New York, NY
ELIZABETH MANSFIELD, U.S. Food and Drug Administration, Silver Spring, MD
KELLY MCVEARRY, Northrop Grumman Information Systems, Rockville, MD
GARRY NEIL, Johnson & Johnson, New Brunswick, NJ
ROBERT L. NUSSBAUM, University of California, San Francisco, School of Medicine
MICHELLE A. PENNY, Eli Lilly and Company, Indianapolis, IN
AIDAN POWER, Pfizer Inc., Groton, CT
VICTORIA M. PRATT, Quest Diagnostics Nichols Institute, Chantilly, VA
RONALD PRZYGODZKI, Department of Veterans Affairs, Washington, DC
ALLEN D. ROSES, Cabernet, Shiraz and Zinfandel Pharmaceuticals; Duke University, Durham, NC
KEVIN A. SCHULMAN, Duke University School of Medicine, Durham, NC
JOAN A. SCOTT, National Coalition for Health Professional Education in Genetics, Lutherville, MD
DAVID VEENSTRA, University of Washington, Seattle
MICHAEL S. WATSON, American College of Medical Genetics and Genomics, Bethesda, MD
DANIEL WATTENDORF, DARPA/Defense Sciences Office, Arlington, VA
CATHERINE A. WICKLUND, Northwestern University, Chicago, IL
IOM Staff
ADAM C. BERGER, Director, Roundtable on Translating Genomic-Based Research for Health
SEAN P. DAVID, James C. Puffer, M.D./American Board of Family Medicine Fellow
TONIA E. DICKERSON, Senior Program Assistant
ANDREW M. POPE, Director, Board on Health Sciences Policy
Reviewers
This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published summary as sound as possible and to ensure that the summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:
William W. Chin, Harvard Medical School
Carolyn Compton, Critical Path Institute
Barry Gertz, Affairs, Merck Research Laboratories
Jeffrey Nye, Janssen Research & Development, LLC
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this summary was overseen by Melvin Worth, Jr. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this summary rests entirely with the authors and the institution.
5 STANDARDIZATION TO ENHANCE DATA SHARING
Developing Standards to Enable Data Sharing
Retrospective Versus Prospective Approaches to Data Standardization
Data-Sharing Approaches That Have Benefited from the Use of Standards
6 CHANGING THE CULTURE OF RESEARCH
Incentivizing Change by Ensuring Credit
Protecting Against Misuse of Shared Data
Patient-Driven Sharing of Clinical Research Data
7 FINAL REFLECTIONS ON SHARING CLINICAL RESEARCH DATA
The Boundaries of Precompetitive Collaboration
BRIDG | Biomedical Research Integrated Domain Group |
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CAMD | Coalition Against Major Diseases |
CDA | clinical documentation architecture |
CDASH | Clinical Data Acquisition Standards Harmonization |
CDE | common data element |
CDER | Center for Drug Evaluation and Research |
CDISC | Clinical Data Interchange Standards Consortium |
CEO | chief executive officer |
CFAST | Coalition for Accelerating Standards and Therapies |
CLIA | Clinical Laboratory Improvement Amendments |
C-Path | Critical Path Institute |
CSR | clinical study report |
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eDISH | Electronic Drug-Induced Serious Hepatoxicity |
EHR | electronic health record |
EMA | European Medicines Agency |
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FDA | Food and Drug Administration |
FDASIA | FDA Safety and Innovation Act |
FNIH | Foundation for the National Institutes of Health |
FTC | Federal Trade Commission |
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HHMI | Howard Hughes Medical Institute |
HIPAA | Health Insurance Portability and Accountability Act |
HL7 | Health Level 7 International |
iDASH | Integrated Data for Analysis, Anonymization, and Sharing |
IHE | Integrating the Healthcare Enterprise |
IOM | Institute of Medicine |
IRB | institutional review board |
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NDA | new drug application |
NEWMEDS | Novel Methods for Development of Drugs in Depression and Schizophrenia |
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NHLBI | National Heart, Lung, and Blood Institute |
NIH | National Institutes of Health |
NINDS | National Institute of Neurological Disorders and Stroke |
NSF | National Science Foundation |
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PDUFA | Prescription Drug User Fee Act |
PHI | protected health information |
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SDO | standards development organization |
SDTM | Study Data Tabulation Model |
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YODA | Yale University Open Data Access |
