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  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
    resource.nlm.nih.gov/9918351277606676
    ... 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
    resource.nlm.nih.gov/9918249007706676
    ... 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
    resource.nlm.nih.gov/9918350982006676
    ... of information between disparate information systems. The 124 Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model 125 (SDTM) and ...
  4. NLM Digital Collections - Hospital literature index (Volume 47) 
    resource.nlm.nih.gov/7807587X34
    ... 8):48, 50, 52 passim EDI (electronic data interchange) use coming sooner ... Proposed standard likely to spark increase in electronic payments. Gardner ...
  5. NLM Digital Collections - Hospital and health administration index (Volume 52) 
    resource.nlm.nih.gov/9601831X2
    ... 4):32, 34-5 Health Level Seven: the clinical data interchange standard. Hammond WE, et al. J AHIMA 1996 Sep; ... Center, Durham, NC, USA.): Health Level Seven: the clinical data interchange standard. J AHIMA 1996 Sep;67(8):42-5 ...
  6. NLM Digital Collections - Hospital literature index (Volume 50) 
    resource.nlm.nih.gov/7807587X37
    ... 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 ...
  7. NLM Digital Collections - Hospital literature index (Volume 45) 
    resource.nlm.nih.gov/7807587X32
    ... 11, 38 Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations—FDA. Proposed rule. Fed Regist 1988 Nov 10;53(218):45678-82 Nazi data: dissociation from evil. Sheldon M, et al. Hastings ...
  8. NLM Digital Collections - Hospital and health administration index (Volume 53) 
    resource.nlm.nih.gov/9601831X3
    ... 2): 147-58 STANDARDS Quality control for hospitals' clinical ethics services: proposed standards. Leeman CP, et al. Camb Q Healthc Ethics 1997 Summer;6(3):257-68 STATISTICS & NUMERICAL DATA Wisconsin healthcare ethics committees. Shapiro RS, et al. ...
  9. NLM Digital Collections - Hospital literature index (Volume 41) 
    resource.nlm.nih.gov/7807587X28
    ... 1985 Feb 22; 253(8): 1146-50 Measuring clinical performance of individual ... standard for interlaboratory information exchange. Elevitch FR, et al. ...
  10. NLM Digital Collections - Hospital and health administration index (Volume 51) 
    resource.nlm.nih.gov/9601831X1
    ... 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 ...
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