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56 results
  1. NLM Digital Collections - Technical specifications for submitting clinical trial data sets for treatment of ... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
    ... Basic Data Structure CAC Cardiac Adjudication Committee CDISC Clinical Data Interchange Standards Consortium CK-18 Cytokeratin-18 CRN Clinical Research Network ...
  2. NLM Digital Collections - Qualification process for drug development tools : guidance for industry and FDA staff 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
    ... encouraged to use relevant data standards (e.g., Clinical Data Interchange Standards Consortium standards 41) when submitting these data for review. ... via the portal. 41 For more information on Clinical Data Interchange Standards Consortium standards, see https://www.fda.gov/industry/fda- ...
  3. NLM Digital Collections - Providing regulatory submissions in electronic format : standardized study data 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
    ... of information between disparate information systems. The 124 Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model 125 (SDTM) and ...
  4. ... 7):92-4, 99 Health Level Seven: the clinical data interchange standard. Hammond WE, et al. J AHIMA 1996 Sep; ... 4):32, 34-5 Health Level Seven: the clinical data interchange standard. Hammond WE, et al. J AHIMA 1996 Sep; ...
  5. ... Healthc 1993 Dec 6; 23(49):56 A data interchange standard for clinical neurophysiology. Jacobs EC, et al. Proc Annu Symp ... 1994 Apr;ll(4):39, 44, 46 A data interchange standard for clinical neurophysiology. Jacobs EC, et al. Proc Annu Symp ...
  6. ... Electrical and Electronic Engineers) PI 157 Medical Data Interchange (MEDIX): application of open systems to health care communications. Harrington JJ. Top Health Rec Manage 1991 Jun;ll(4):45-58 Standards for the electronic transfer of clinical data: progress and promises. McDonald CJ, et al. Top ...
  7. ... 1994 Sep;l 1(8):8-10 The Clinical Messages Project. IHRIM 1994 Nov; 35(4): 15 The electronic data interchange: avoiding potholes to add value & power for payors & providers. Bigley J. Infocare 1995 Aug;:34-7 The status of healthcare standards in the United States. Hammond WE. Int J ...
  8. ... 38, 40 Hospitals, vendors eye quick dawning of standard EDI (electronic data interchange). Barlow RD. Hosp Mater Manage 1992 Nov;17( ... 40-1 Hospitals, vendors eye quick dawning of standard EDI (electronic data interchange). Barlow RD. Hosp Mater Manage 1992 Nov;17( ...
  9. ... Healthc 1997 Aug 11;27(32):70, 74 STANDARDS Finding clinical data in claims: the search for gold. McCormack J. ... Hageman W see Ryan M Hagemeier G.: Uniform standards are basic building blocks for Electronic Data Interchange. Healthcare EDI Coalition. J Healthc Resour Manag 1997 ...
  10. ... Inf Manage 1998 Aug; 19(1):1—10 STANDARDS Selecting an electronic clinical data system. Hollers FK, et al. Caring 1997 Dec; ... Defining measurable OR-PR scheduling, efficiency, and utilization data ... procedural times glossary. Donham RT. Int Anesthesiol Clin 1998 Winter;36( ...
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