This paper is in the following e-collection/theme issue:

Standards and Interoperability (74) Adverse Drug Events Detection, Pharmacovigilance and Surveillance (156) Secondary Use of Clinical Data for Research and Surveillance (366) Electronic Health Records (1053)

Published on in Vol 10, No 1 (2022): January

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/30363, first published .
Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey

Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey

Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey

Authors of this article:

Rhonda Facile1 Author Orcid Image ;   Erin Elizabeth Muhlbradt2 Author Orcid Image ;   Mengchun Gong3, 4 Author Orcid Image ;   Qingna Li5, 6, 7 Author Orcid Image ;   Vaishali Popat8 Author Orcid Image ;   Frank Pétavy9 Author Orcid Image ;   Ronald Cornet10 Author Orcid Image ;   Yaoping Ruan11 Author Orcid Image ;   Daisuke Koide12 Author Orcid Image ;   Toshiki I Saito13 Author Orcid Image ;   Sam Hume1 Author Orcid Image ;   Frank Rockhold14 Author Orcid Image ;   Wenjun Bao15 Author Orcid Image ;   Sue Dubman1 Author Orcid Image ;   Barbara Jauregui Wurst1 Author Orcid Image
Article Authors Cited by (31) Tweetations (3) Metrics

Journals

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  2. Lewis A, Valla V, Charitou P, Karapatsia A, Koukoura A, Tzelepi K, Bergsteinsson J, Ouzounelli M, Vassiliadis E. Digital Health Technologies for Medical Devices – Real World Evidence Collection – Challenges and Solutions Towards Clinical Evidence. International Journal of Digital Health 2022;2(1):8 View
  3. Klimek P, Baltic D, Brunner M, Degelsegger-Marquez A, Garhöfer G, Gouya-Lechner G, Herzog A, Jilma B, Kähler S, Mikl V, Mraz B, Ostermann H, Röhl C, Scharinger R, Stamm T, Strassnig M, Wirthumer-Hoche C, Pleiner-Duxneuner J. Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus. JMIR Medical Informatics 2022;10(6):e34204 View
  4. Clay I, Cormack F, Fedor S, Foschini L, Gentile G, van Hoof C, Kumar P, Lipsmeier F, Sano A, Smarr B, Vandendriessche B, De Luca V. Measuring Health-Related Quality of Life With Multimodal Data: Viewpoint. Journal of Medical Internet Research 2022;24(5):e35951 View
  5. Sen A, Palmeri A, Lee J, Hedley V, Thuet J, Lignon P, Cotonnec V, Leary R, Nally S, Straub V. Understanding paediatric data standards challenges through academia‐industry partnerships: A conect4children (c4c) qualitative study. The International Journal of Health Planning and Management 2023;38(2):416 View
  6. Wang B, Lai J, Jin F, Liao X, Zhu H, Yao C. Clinical Source Data Production and Quality Control in Real-world Studies: Proposal for Development of the eSource Record System. JMIR Research Protocols 2022;11(12):e42754 View
  7. Wheatley-Price P, Moore S, Lee C. The Role of Real-World Evidence to Support Treatment Choices in Malignant Pleural Mesothelioma. JTO Clinical and Research Reports 2022;3(4):100300 View
  8. Cheng A, Facile R, Owen J, Marshall R, Mellars K, Kennedy N, Minor B, McGuffin K, Harris P. Making Clinical Data Acquisition Standards Harmonization (CDASH) Electronic Case Report Forms Available on the REDCap Shared Data Instrument Library. Journal of the Society for Clinical Data Management 2022;2(3) View
  9. Nahm E, Zhu S, Seidl K, Chen L, Day J, Seong H. Real-World Data for Interdisciplinary Health Care Research. Advances in Nursing Science 2023;46(4):349 View
  10. Muhlbradt E, Li J, Whiteman L, Remennik L. NCI-EVS: Building the Semantic Infrastructure to Support CDISC Data Standards and Real-World Data. Journal of the Society for Clinical Data Management 2023 View
  11. Queder N, Tien V, Abraham S, Urchs S, Helmer K, Chaplin D, van Erp T, Kennedy D, Poline J, Grethe J, Ghosh S, Keator D. NIDM-Terms: community-based terminology management for improved neuroimaging dataset descriptions and query. Frontiers in Neuroinformatics 2023;17 View
  12. Burns L, Le Roux N, Kalesnik-Orszulak R, Christian J, Dudinak J, Rockhold F, Khozin S, O’Donnell J. Real-world evidence for regulatory decision-making: updated guidance from around the world. Frontiers in Medicine 2023;10 View
  13. Baker R, Hamidi M, McKenzie L, Denney C, Edgar T. The Story Behind the HL7 FHIR to CDISC Mapping Implementation Guide. Journal of the Society for Clinical Data Management 2023;3(1) View
  14. Nieminen M, Stolpe O, Kuhring M, Weiner J, Pett P, Beule D, Holtgrewe M. SODAR: managing multiomics study data and metadata. GigaScience 2022;12 View
  15. Yang X, Huang K, Yang D, Zhao W, Zhou X. Biomedical Big Data Technologies, Applications, and Challenges for Precision Medicine: A Review. Global Challenges 2024;8(1) View
  16. Morland K, Gerges C, Elwing J, Visovatti S, Weatherald J, Gillmeyer K, Sahay S, Mathai S, Boucly A, Williams P, Harikrishnan S, Minty E, Hobohm L, Jose A, Badagliacca R, Lau E, Jing Z, Vanderpool R, Fauvel C, Leonidas Alves J, Strange G, Pulido T, Qian J, Li M, Mercurio V, Zelt J, Moles V, Cirulis M, Nikkho S, Benza R, Elliott C. Real‐world evidence to advance knowledge in pulmonary hypertension: Status, challenges, and opportunities. A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative's Real‐world Evidence Working Group. Pulmonary Circulation 2023;13(4) View
  17. Qin R, Alayande B, Okolo I, Khanyola J, Jumbam D, Koea J, Boatin A, Lugobe H, Bump J. Colonisation and its aftermath: reimagining global surgery. BMJ Global Health 2024;9(1):e014173 View
  18. Witt C, Graca S, Lee Y. Artificial Intelligence and Acupuncture: A Data-Driven Synergy. Journal of Integrative and Complementary Medicine 2024;30(4):316 View
  19. Sen A, Hedley V, Degraeuwe E, Hirschfeld S, Cornet R, Walls R, Owen J, Robinson P, Neilan E, Liener T, Nisato G, Modi N, Woodworth S, Palmeri A, Gaentzsch R, Walsh M, Berkery T, Lee J, Persijn L, Baker K, An Haack K, Segovia Simon S, Jacobsen J, Reggiardo G, Kirwin M, Trueman J, Pansieri C, Bonifazi D, Nally S, Bonifazi F, Leary R, Straub V. Learning from conect4children: A Collaborative Approach towards Standardisation of Disease-Specific Paediatric Research Data. Data 2024;9(4):55 View
  20. Lee H, Ahn H, Kwon S, Kang H, Han E. Expert survey on real‐world data utilization and real‐world evidence generation for regulatory decision‐making in drug lifecycle in Korea. Clinical and Translational Science 2024;17(4) View
  21. Mohseni Z, Masiello I, Martins R. A technical infrastructure for primary education data that contributes to data standardization. Education and Information Technologies 2024 View
  22. Tabatabaei Hosseini S, Kazemzadeh R, Foster B, Arpali E, Süsal C. New Tools for Data Harmonization and Their Potential Applications in Organ Transplantation. Transplantation 2024 View
  23. Stellmach C, Hopff S, Jaenisch T, Nunes de Miranda S, Rinaldi E. Creation of Standardized Common Data Elements for Diagnostic Tests in Infectious Disease Studies: Semantic and Syntactic Mapping. Journal of Medical Internet Research 2024;26:e50049 View
  24. Owen J, Sen A, Aurich B, Engel C, Cavallaro G, Degraeuwe E, Kalra D, Cornet R, Walsh M, Berkery T, Palmeri A, Mahler F, Malik S, Persijn L, Amadi C, Thuet J, Woodworth S, Nally S, Leary R, Marshall R, Straub V. Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration. Frontiers in Medicine 2024;11 View
  25. Adewole K, Alozie E, Olagunju H, Faruk N, Aliyu R, Imoize A, Abdulkarim A, Imam-Fulani Y, Garba S, Baba B, Hussaini M, Oloyede A, Abdullahi A, Kanya R, Usman D. A systematic review and meta-data analysis of clinical data repositories in Africa and beyond: recent development, challenges, and future directions. Discover Data 2024;2(1) View
  26. Lim S, Johannesson P. An Ontology to Bridge the Clinical Management of Patients and Public Health Responses for Strengthening Infectious Disease Surveillance: Design Science Study. JMIR Formative Research 2024;8:e53711 View
  27. Ueno S, Komiyama Y, Doi M, Hoshi K. Need for Data Standardization and Infrastructure of Research Data Management to Promote Using Real-world Data. Journal of the Society for Clinical Data Management 2024;0(1) View
  28. Richardson A. Representing Clinical Study Schedule of Activities as FHIR Resources: Required Characteristic Attributes. Journal of the Society for Clinical Data Management 2024;5(2) View

Books/Policy Documents

  1. Niland J, Hom J, Hmwe S. Clinical Research Informatics. View
  2. Hedley V, Leary R, Sen A, Irvin A, Heslop E, Straub V. Essentials of Translational Pediatric Drug Development. View