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7 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
    resource.nlm.nih.gov/9918351274206676
    ... provide data for additional scoring systems conforming to CDISC standards. 9 Subjects should have an overall histological diagnosis ... data for all subjects in accordance with existing CDISC standards. In addition to prescription medications, sponsors should include ...
  2. NLM Digital Collections - Submitting clinical trial datasets and documentation for clinical outcome assessments using ... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
    resource.nlm.nih.gov/9918733086906676
    ... and an Analysis Data Reviewer's Guide (ADRG), respectively. Standard CDISC Controlled 15 More information is available at FDA's ... is available at CDISC's QRS web page: https://cdisc.org/standards/foundational/qrs. 17 More information is available at ...
  3. NLM Digital Collections - Submitting patient-reported outcome data in cancer clinical trials : guidance for industry : .... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
    resource.nlm.nih.gov/9918733087006676
    ... and an Analysis Data Reviewer's Guide (ADRG), respectively. Standard CDISC Controlled Terminology16 developed and maintained by CDISC, and ... is available at CDISC's QRS web page: https://cdisc.org/standards/foundational/qrs. 4 Contains Nonbinding Recommendations 3.1. ...
  4. NLM Digital Collections - E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
    resource.nlm.nih.gov/9918469488506676
    ... Committee for Standardisation (CEN), the Clinical Data Interchange Standards Consortium (CDISC), the International Health Terminology Standards Development Organisation (IHTSDO), ...
  5. 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
    ... disparate information systems. The 124 Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model 125 (SDTM) and Standard ... of Nonclinical Data (SEND), available at http://www.cdisc.org. 4 132 3. Controlled Terminology Standard 133 134 The use of controlled terminology standards, ...
  6. NLM Digital Collections - Subcommittee on Blood Substitutes - reports 
    https://resource.nlm.nih.gov/101085500X212
    ... of the red blood corpuscle given as a cdisc roughly & 4« (80,000 A) in diameter, and ...