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

Journals

  1. Sen A, Hedley V, Owen J, Cornet R, Kalra D, Engel C, Palmeri A, Lee J, Roze J, Standing J, Warris A, Pansieri C, Leary R, Turner M, Straub V. Standardizing Paediatric Clinical Data: The Development of the conect4children (c4c) Cross Cutting Paediatric Data Dictionary. Journal of the Society for Clinical Data Management 2023;2(3) View
  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

Books/Policy Documents

  1. Niland J, Hom J, Hmwe S. Clinical Research Informatics. View